Chiropractic Studies
Evidence-Based Studies on Chiropractic Efficacy,
Chiropractic Cost-Effectiveness, Opioid Use and Surgery
California Chiropractic Association
1451 River Park Drive, Suite 230
Sacramento, CA 95815
916.648.2727
calchirogov.org
Table of Contents
California Chiropractic Scope Of Practice
Efficacy Of Chiropractic Treatment

Chiropractic Evidence Summary; Christine Goertz, DC, PhD; Palmer Center For Chiropractic Research (2015)

Chiropractic Management of Low Back Disorders: Report From A Consensus Process; Gary A. Globe, MBA, DC,
PhD; Journal of Manipulative and Physiological Therapeutics (2008)

Clinical Effectiveness of Manual Therapy for the Management of Musculoskeletal and Nonmusculoskeletal
Conditions: Systematic Review and Update of UK Evidence Report; Christine Clar, et.al.; Chiropractic & Manual
Therapies (2014)

Dose-Response and Efficacy of Spinal manipulation For Care of Chronic Low Back Pain: A Randomized Controlled
Trial; Mitchell Haas, DC, et.al.; The Spine Journal (2014)

Effectiveness of Manual Therapies: The UK Evidence Report; Gert Bronfort, et. al.; Chiropractic & Osteopathy
(2010)

ABSTRACT: Long-term Outcomes Of Lumbar Fusion Among Workers' Compensation Subjects: A Historical Cohort
Study. Nguyen TH, Randolph DC, Talmage J, Succop P, Travis R. Spine (2011)

Management of Chronic Spine-Related Conditions: Consensus Recommendations of a Multidisciplinary Panel;
Ronald J. Farabaugh, DC, et. al.; Journal of Manipulative and Physiological Therapeutics (2010)

Manual Therapy, Physical Therapy, Or Continued Care By A General Practitioner For Patients With Neck Pain: A
Randomized, Controlled Trial; Jan Lucas Hoving, PT, PhD, et.al.; Annals Of Internal Medicine (2002)

Outcomes From Magnetic Resonance Imaging-Confirmed Symptomatic Cervical Disk Herniation Patients Treated
With High-Velocity, Low-Amplitude Spinal Manipulative Therapy: A Prospective Cohort Study With 3-Month
Follow-Up; Cynthia K. Peterson, RN, DC, M.Med.Ed., et.al.; Journal of Manipulative and Physiological Therapeutics
(2013)

Soft Tissue; Clinical Compass (2014)

Spinal Manipulative Therapy For Chronic Low Back Pain; The Cochrane Collaboration (2011)

ABSTRACT: United States Trends In Lumbar Fusion Surgery For Degenerative Conditions. Deyo RA, Gray
DT, Kreuter W, Mirza S, Martin BI. Department of Medicine, University of Washington, Seattle, Washington,
USA. Spine (2005)
Chiropractic Cost-Effectiveness

The Association of Complementary and Alternative Medicine Use and Health Care Expenditures For Back and Neck
Problems; Brook I. Martin, PhD, MPH; Medical Care (2012)

Chiropractic Physicians: A Low Cost Solution to High Cost Healthcare - Talking Points; American Chiropractic
Association, et.al.(2012)

Cost-Effectiveness of Manual Therapy For The Management Of Musculoskeletal Conditions: A Systematic Review
and Narrative Synthesis of Evidence From Randomized Controlled Trials; Alexander Tsertsvadze, MD, MSc, et.al.;
Journal of Manipulative and Physiological Therapeutics (2014)

Cost Minimization Analysis of Low Back Pain Claims Data For Chiropractic vs Medicine In A Managed Care
Organization; Brian Grieves, DC, MPH, et.al.; Journal of Manipulative and Physiological Therapeutics (2009)
Cost of Care For Common Back Pain Conditions Initiated With Chiropractic Doctors vs Medical Doctor/Doctor of
Osteopathy As First Physician; Richard L. Liliedahl, MD, et.al.; Journal of Manipulative and Physiological
Therapeutics (2010)


Overtreating Chronic Back Pain: Time To Back Off?; Richard A. Deyo, M.D., M.P.H., Sohail K. Mirza, M.D., M.P.H.,
Judith A. Turner, Ph.D., and Brook I. Martin, M.P.H.; Journal Of The American Board Of Family Medicine (2009)

The Path To Change In The US Healthcare System: Chiropractic Cost-Effectiveness Supplement, Joint Policy
Statement; ACA, ICA, et.al. (2012)

The Path To Change In The US Healthcare System: Chiropractic Cost-Effectiveness Supplement, Joint Policy
Statement; ACA, ICA, et.al. (2009)
Opioid Use and Surgery

Back Surgery: Too Many, Too Costly and Too Ineffective; J.C. Smith, MA, DC; To Your Health, Vol. 5, Issue 06
(June 2011)

Early Predictors of Lumbar Spine Surgery after Occupational Back Injury: Results from a Prospective Study of
Workers in Washington State; Benjamin J. Keeney, PhD; Spine (2013)

Never Only Opioids: The Imperative for Early Integration of Non-Pharmacological Approaches and Practitioners in
the Treatment of Patients with Pain: (PAINS Project Policy Brief: Fall 2014, Issue 5)

Opioids For Chronic Noncancer Pain: A Position Paper of The American Academy of Neurology; Gary M. Franklin;
Neurology (2014)
Oregon Health Evidence Review Commission (HERC) and Oregon Health Plan (OHP)
Documentation

New Back Conditions Lines and Guidelines

State of Oregon Evidence-based Clinical Guidelines Project Evaluation and Management of Low Back Pain: A
Clinical Practice Guideline Based on the Joint Practice Guideline of the American College of Physicians and the
American Pain Society (Diagnosis and Treatment of Low Back Pain); Oregon Health Authority (October 2011)

Health Evidence Review Commission (HERC) Coverage Guidance: Lower Back Pain – Nonpharmacological/NonInvasive Interventions

Oregon Changes In Coverage For Back Conditions Fact Sheet
For further information, please contact:
California Chiropractic Association
Governmental Affairs Department
Cris Forsyth, CCA Chief Operating Office &
Governmental Affairs Director
[email protected]
916.648.2727, ext. 130
1451 River Park Drive, Suite 230
Sacramento, CA 95815
calchirogov.org
California Chiropractic Scope Of Practice
Since 1922, doctors of chiropractic in California have been educated
and licensed by the State of California to serve as portal of
entry/primary care providers. After undergraduate study, chiropractic
students earn a four-year doctorate degree with classroom and
laboratory work in basic clinical sciences, physical examination,
diagnosis and differential diagnosis, x-ray and interpretation of
laboratory blood work and other treatment procedures. Clinical
education includes a year-long internship overseen by a licensed
doctor of chiropractic on patients with various clinical presentations
using various conservative treatment approaches, including most
prominently manipulation. Chiropractic doctors are required by law to
refer patients to another health care provider if a condition is detected
that is not a part of the chiropractic scope of practice.
The California Chiropractic Association is a Sacramento-based statewide, nonprofit organization
of doctors of chiropractic and allied industries representing the chiropractic
profession. Established in 1928, CCA's mission is to promote high standards of professionalism
and patient care through education, advocacy and accountability.
Chiropractic Initiative Act of California
§302. Practice of Chiropractic.
(a) Scope of Practice.
(1) A duly licensed chiropractor may manipulate and adjust the spinal column and other joints of the human
body and in the process thereof a chiropractor may manipulate the muscle and connective tissue related
thereto.
(2) As part of a course of chiropractic treatment, a duly licensed chiropractor may use all necessary mechanical,
hygienic, and sanitary measures incident to the care of the body, including, but not limited to, air, cold, diet,
exercise, heat, light, massage, physical culture, rest, ultrasound, water, and physical therapy techniques in the
course of chiropractic manipulations and/or adjustments.
(3) Other than as explicitly set forth in section 10(b) of the Act, a duly licensed chiropractor may treat any
condition, disease, or injury in any patient, including a pregnant woman, and may diagnose, so long as such
treatment or diagnosis is done in a manner consistent with chiropractic methods and techniques and so long as
such methods and treatment do not constitute the practice of medicine by exceeding the legal scope of
chiropractic practice as set forth in this section.
(4) A chiropractic license issued in the State of California does not authorize the holder thereof:
(A) to practice surgery or to sever or penetrate tissues of human beings, including, but not
limited to severing the umbilical cord;
(B) to deliver a human child or practice obstetrics;
(C) to practice dentistry;
(D) to practice optometry;
(E) to use any drug or medicine included in materia medica;
(F) to use a lithotripter;
(G) to use ultrasound on a fetus for either diagnostic or treatment purposes; or
(H) to perform a mammography.
(5) A duly licensed chiropractor may employ the use of vitamins, food supplements, foods for special dietary
use, or proprietary medicines, if the above substances are also included in section 4057 of the Business and
Professions Code, so long as such substances are not included in materia medica as defined in section 13 of the
Business and Professions Code. The use of such substances by a licensed chiropractor in the treatment of illness
or injury must be within the scope of the practice of chiropractic as defined in section 7 of the Act.
(6) Except as specifically provided in section 302(a)(4), a duly licensed chiropractor may make use of X-ray and
thermography equipment for the purposes of diagnosis but not for the purposes of treatment. A duly licensed
chiropractor may make use of diagnostic ultrasound equipment for the purposes of neuromuscular skeletal
diagnosis.
(7) A duly licensed chiropractor may only practice or attempt to practice or hold himself or herself out as
practicing a system of chiropractic. A duly licensed chiropractor may also advertise the use of the modalities
authorized by this section as a part of a course of chiropractic treatment, but is not required to use all of the
diagnostic and treatment modalities set forth in this section. A chiropractor may not hold himself or herself out
as being licensed as anything other than a chiropractor or as holding any other healing arts license or as
practicing physical therapy or use the term “physical therapy” in advertising unless he or she holds another such
license.
(b) Definitions.
(1) Board. The term “board” means the State Board of Chiropractic Examiners.
(2) Act. The term “act” means the Chiropractic Initiative Act of California as amended.
Note: The Chiropractic Initiative Act of California is listed in West's Annotated California
Codes following section 1000 of the Business and Professions Code, and in Deering's California
Codes Annotated as an appendix to the Business and Professions Code.
(3) Duly licensed chiropractor. The term “duly licensed chiropractor” means any chiropractor in the State of
California holding an unrevoked certificate to practice chiropractic, as that term is defined in section 7 of the
Act that has been issued by the board.
NOTE: Authority cited: Sections 1000-4(b) and 1000-10(a), Business and Professions Code. Reference: Sections
1000-5 and 1000-7, Business and Professions Code.
Efficacy Of
Chiropractic Treatment
CHIROPRACTIC EVIDENCE SUMMARY
Christine Goertz, DC, PhD
.............................................
EVIDENCE-BASED PRACTICE
Evidence-based practice is defined as “the conscientious, explicit and judicious use of current best evidence in
making decisions about the care of individual patients.”1 Increasingly, high-quality research evidence is the
cornerstone to evidence-based healthcare decisions and is critically important to physicians, patients,
policymakers and payers. This data-driven evolution will impact the chiropractic profession in important ways.
It has the potential to serve as the play-field leveler that the chiropractic profession has long demanded.
However, it also forces us to collect and interpret data correctly. This paper provides a very brief summary of
the state of the evidence in chiropractic related to clinical outcomes, cost, safety and patient satisfaction. It also
identifies areas where more research is needed.
Individual
Clinical
Expertise
EBM
Best
External
Evidence
Patient
Values &
Expectatio
ns
Evidence-based Triad
The evidence-based triad illustrates an approach
to decision making that integrates the
chiropractic physician’s individual clinical
expertise with the best external evidence while
taking into account a patient’s values and
expectations of care.
Clinical Outcomes
LOW BACK PAIN





There is moderate evidence to support that spinal manipulative therapy is effective for acute low back
pain in adults. There is strong evidence to support that spinal manipulative therapy is effective for
chronic low back pain in adults.2
Chou et al. found good evidence that spinal manipulation is moderately effective for chronic or subacute
(>4 weeks' duration) low back pain compared to placebo, sham or no treatment. There is fair evidence to
support that spinal manipulation has a small to moderate level of effectiveness for acute low back pain
(<4 weeks' duration).3
A joint clinical practice guideline from the American College of Physicians and the American Pain
Society suggests that “For patients who do not improve with self-care options, clinicians should
consider the addition of nonpharmacologic therapy with proven benefits-for acute low back pain, spinal
manipulation; for chronic or subacute low back pain, intensive interdisciplinary rehabilitation, exercise
therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy, or
progressive relaxation (weak recommendation, moderate-quality evidence).”4
A 2011 Cochrane review reported that there are no clinically meaningful differences between spinal
manipulative therapy and other interventions for pain reduction and functional improvement for chronic
low back pain.5
Results of a 2013 randomized controlled trials suggest that 12 sessions of spinal manipulative therapy
for chronic low back pain offer the best “dose.”6

There is strong evidence that spinal manipulative therapy is as effective as a combination of medical
care and exercise instruction. There is moderate evidence that spinal manipulative therapy works as well
as prescription nonsteroidal anti-inflammatory drugs combined with exercises. And, there is limited-tomoderate evidence that spinal manipulative therapy works better than physical therapy and home
exercise.7
NECK PAIN


Results of a 2008 best evidence synthesis by the Bone and Joint Decade 2000-2010 Task Force on Neck
Pain and Its Associated Disorders found that manual therapy combined with exercise was more effective
than other noninvasive interventions for neck pain. 8
In a 2012 randomized controlled trial, spinal manipulative therapy was more effective than medication
for acute and sub-acute neck pain for both short and long term outcomes. 9
HEADACHE



Spinal manipulative (SM) therapy is effective for cervicogenic and migraine headaches. 2, 10
A 2008 literature review suggests that spinal manipulative therapy of the cervical spine may prevent
migraines as well as amitriptyline and may be effective for tension-type headaches.11
Spinal manipulative therapy may be as effective as propranolol and topiramate for prophylaxis of
migraine headache. 12
Risk of Complications
STROKE


There is no evidence of excess risk of VBA stroke associated with chiropractic care compared to
primary care. Increased risks of VBA stroke associated with chiropractic and PCP visits are likely due
to patients with headache and neck pain from VBA dissection seeking care before their stroke 13
The rate of serious complications is 5-10 per 10 million adjustments.14
COSTS




Lower overall episode costs of care when low back pain treatment is initiated with DC as compared to
care initiated with MD15
Chiropractic users with neck and back problems did not have higher levels of overall healthcare
spending when compared to medical users in a nationally representative sample.16
Direct costs associated with Medicare’s 2005-2007 Demonstration could have been substantially lower
had DCs in Chicago area counties responded similarly to other demonstration counties.17
A 2013 prospective population-based cohort study of 1,885 workers found that only 1.5% of workers
whose first provider was a chiropractic physician had lumbar spine surgery within 3 years compared
with 42.7% of patients whose first provider was a surgeon.18
ebp_pp_outline_4-25-14_final
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PATIENT SATISFACTION


Chiropractic patients are more satisfied than medical patients with their back care providers after 4
weeks of treatment.19
Back pain patients are more satisfied with chiropractic care than with medical care.20-22
W HAT DO WE NOT KNOW ?
Evidence Gaps
WHY ARE THERE GAPS IN WHAT WE KNOW ABOUT CHIROPRACTIC?






Study results don’t apply to all patient populations
Different studies use different methods to answer the same general question
Study design flaws, especially with studies that were conducted more than 10 years ago.
Results from two or more studies may not be the same
In many areas we don’t have enough studies, especially for conditions that are not musculoskeletal in
nature.
Quality of studies is sometimes poor from a clinical and/or scientific perspective
WHAT QUESTIONS NEED TO BE ANSWERED?







Can we predict which patients are most likely to respond best to chiropractic care?
How well do DCs deliver prevention and wellness care?
Do different chiropractic techniques have different patient outcomes?
What happens when you combine therapies (PT, massage, etc.) with adjustments?
Why do clinicians in private practice experience more dramatic outcomes than found in clinical trials?
How does chiropractic help patients that are pediatric, elderly, pregnant?
How effective and reliable are DC diagnostic techniques?
SUMMARY: W HAT CAN WE SAY?




Chiropractic management for low back pain, neck pain, and headache is as good as or better than other
forms of conservative medical care.
There is a very low risk of serious adverse events.
Patient satisfaction with chiropractic is very high.
Chiropractic care costs no more, and perhaps a bit less, than other conservative treatments for back and
neck pain.
ebp_pp_outline_4-25-14_final
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1996;312(7023):71-2. http://www.ncbi.nlm.nih.gov/pubmed/8555924
Bronfort G, Haas M, Evans R, et al. Effectiveness of manual therapies: the UK evidence report. Chiropractic & Osteopathy. 2010;18(3):1–33.
http://www.ncbi.nlm.nih.gov/pubmed/20184717
Chou R, Huffman LH, American Pain Society, American College of P. Nonpharmacologic therapies for acute and chronic low back pain: a
review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. Oct 2
2007;147(7):492-504. http://www.ncbi.nlm.nih.gov/pubmed/17909210
Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of
Physicians and the American Pain Society. Ann Intern Med. Oct 2 2007;147(7):478-491. http://www.ncbi.nlm.nih.gov/pubmed/17909209
Rubinstein SM, van Middelkoop M, Assendelft WJ, et al. Spinal manipulative therapy for chronic low-back pain. Cochrane Database of
Systematic Reviews. 2011;(2):CD008112. http://www.ncbi.nlm.nih.gov/pubmed/21328304
Haas M, Vavrek D, Peterson D, et al. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized
controlled trial. Spine Journal. October 16, 2013. Epub ahead of print. http://www.ncbi.nlm.nih.gov/pubmed/24139233
Bronfort G, Haas M, Evans R, et al. Evidence-informed management of chronic low back pain with spinal manipulation and mobilization.
Spine Journal. 2008;8(1):213–225. http://www.ncbi.nlm.nih.gov/pubmed/18164469
Hurwitz EL, Carragee EJ, van der Velde G, et al. Treatment of neck pain: noninvasive interventions: results of the Bone and J oint Decade
2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). Feb 15 2008;33(4 Suppl):S123-152.
http://www.ncbi.nlm.nih.gov/pubmed/18204386
Bronfort G, Evans R, Anderson AV, et al. Spinal manipulation, medication, or home exercise with advice for acute and subacute neck
pain. Annals of Internal Medicine. 2012;156(1):1–10. http://www.ncbi.nlm.nih.gov/pubmed/22213489
Bryans R, Descarreaux M, Duranleau M, et al. Evidence-based guidelines for the chiropractic
treatment of adults with headache. J Manipulative Physiol Ther. Jun 2011;34(5):274-289. http://www.ncbi.nlm.nih.gov/pubmed/21640251
Sun-Edelstein C, Mauskop A. Complementary and alternative approaches to the treatment of tension-type headache. Current Pain Headache
Report. 2008 Dec;12(6):447-50. http://www.ncbi.nlm.nih.gov/pubmed/18973739
Chaibi A, Tuchin PJ, Russell MB. Manual therapies for migraine: a systematic review. J Headache Pain. Apr 2011;12(2):127-133.
http://www.ncbi.nlm.nih.gov/pubmed/21298314
Cassidy JD, Boyle E, Côté P, et al. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and casecrossover study. Spine. 2008;33(4 Suppl):S176–S183. http://www.ncbi.nlm.nih.gov/pubmed/18204390
Hurwitz EL, Aker PD, Adams AH, Meeker WC, Shekelle PG. Manipulation and mobilization of the cervical spine. A systematic review of the
literature. Spine. 1996;21(15):1746-59. http://www.ncbi.nlm.nih.gov/pubmed/8855459
Liliedahl RL, Finch MD, Axene DV, Goertz CM. Cost of care for common back pain conditions initiated with chiropractic doctor vs medical
doctor/doctor of osteopathy as first physician: experience of one Tennessee-based general health insurer. J Manipulative Physiol Ther
2010;33:640-643.http://www.ncbi.nlm.nih.gov/pubmed/21109053
Martin BI, Gerkovich MM, Deyo RA, Sherman KJ, Cherkin DC, Lind BK, Goertz CM, Lafferty WE. The association of complementary and
alternative medicine use and health care expenditures for back and neck problems. Med Care. 2012;50(12):1029-36.
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Weeks WB, Whedon JM, Toler A, Goertz CM. Medicare’s demonstration of expanded coverage for chiropractic services: limitations of the
demonstration and an alternative direct cost estimate. J Manipulative Ther. 2013;36(8):468-81. http://www.ncbi.nlm.nih.gov/pubmed/23993755
Keeney BJ, Fulton-Kehoe D, Turner JA, Wickizer TM, Chan KC, Franklin GM. Early predictors of lumbar spine surgery after occupational
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Carey TS, Garrett J, Jackman A, McLaughlin C, Fryer J, Smucker DR. The outcomes and costs of care for acute low back pain amo ng patients
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Kane RL, Olsen D, Leymaster C, Woolley FR, Fisher FD. Manipulating the patient: a comparison of the effectiveness of physician and
chiropractor care. Lancet. 1974;1:1333–1336. http://www.ncbi.nlm.nih.gov/pubmed/4134675
Hurwitz EL. The relative impact of chiropractic vs medical management of low back pain on health status in a multispecialty group practice. J
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CHIROPRACTIC MANAGEMENT OF LOW BACK DISORDERS:
REPORT FROM A CONSENSUS PROCESS
Gary A. Globe, MBA, DC, PhD, a Craig E. Morris, DC, b,c Wayne M. Whalen, DC,d,e
Ronald J. Farabaugh, DC, f,g and Cheryl Hawk, DC, PhDh
ABSTRACT
Objective: Although a number of guidelines addressing manipulation, an important component of chiropractic
professional care, exist, none to date have incorporated a broad-based consensus of chiropractic research and clinical
experts representing mainstream chiropractic practice into a practical document designed to provide standardized
parameters of care. The purpose of this project was to develop such a document.
Methods: Development of the document began with seed materials, from which seed statements were distilled. These
were circulated electronically to the Delphi panel until consensus was reached, which was considered to be present when
there was agreement by at least 80% of the panelists.
Results: The panel consisted of 40 clinically experienced doctors of chiropractic, representing 15 chiropractic colleges
and 16 states, as well as both the American Chiropractic Association and the International Chiropractic Association.
The panel reached 80% consensus of the 27 seed statements after 2 rounds. Specific recommendations regarding
treatment frequency and duration, as well as outcome assessment and contraindications for manipulation were agreed
upon by the panel.
Conclusions: A broad-based panel of experienced chiropractors was able to reach a high level (80%) of consensus
regarding specific aspects of the chiropractic approach to care for patients with low back pain, based on both the
scientific evidence and their clinical experience. (J Manipulative Physiol Ther 2008;31:651-658)
Key Indexing Terms: Chiropractic; Low Back Pain; Manipulation, Spinal
n an era where increasing health care costs weigh heavily
on all industrialized countries, effective modes of
conservative management that emphasize improved
quality of life and self-reliance, while attempting to conserve
the costly resources of medications and surgery, become
critically important. In light of the burgeoning standards and
volume of scientific research, the evolving chiropractic
profession continues to integrate updated evidence as a key
cornerstone of emerging standards of practice, as evidenced
I
by the Council on Chiropractic Guidelines and Practice
Parameters (CCGPP) process.
The profession recognizes its responsibilities as a partner
in the health care system. These begin with acknowledging
that the profession exists solely to serve its patients. However,
the privilege of serving patients mandates that doctors of
chiropractic (DCs) act as responsible stewards by constantly
striving to increase their knowledge base and to practice in an
evidence-informed manner. Patients must be empowered
a
of Research and Scholarship, Cleveland Chiropractic Research
Center, Kansas City, Mo and Los Angeles, Calif.
All authors, independent reviewers, and panelists participated
without compensation from any organization. Cleveland Chiropractic College made an in-kind contribution to the project by
allowing Drs Globe and Hawk to devote a portion of their work
time to this project.
Submit requests for reprints to: Cheryl Hawk, DC, PhD, Vice
President of Research and Scholarship, Cleveland Chiropractic
Research Center. Kansas City and Los Angeles, USA
(e-mail: [email protected]).
Paper submitted April 29, 2008; in revised form July 2, 2008;
accepted September 8, 2008.
0161-4754/$34.00
Copyright © 2008 by National University of Health Sciences.
doi:10.1016/j.jmpt.2008.10.006
Provost and Academic Dean, Cleveland Chiropractic College
Los Angeles, Calif; Vice President of Institutional Assessment and
Planning, Cleveland Chiropractic College, Kansas City, Mo and
Los Angeles, Calif.
b
Clinical Professor, Department of Clinical Sciences, Cleveland
Chiropractic College, Los Angeles, Calif.
c
Clinical Director, F.I.R.S.T. Health, Torrance, Calif.
d
Immediate Past Chair, Council on Chiropractic Guidelines and
Practice Parameters, Lexington, SC.
e
Clinical Director, Whalen Chiropractic, Santee Calif.
f
Vice Chair, Council on Chiropractic Guidelines and Practice
Parameters, Lexington, SC.
g
Clinic Director, Farabaugh Chiropractic Clinic, Columbus,
Ohio.
h
Chair, Scientific Commission of Council on Chiropractic
Guidelines and Practice Parameters, Lexington, SC; Vice President
651
652
Globe et al
Chiropractic Low Back Consensus
with choice in their health care and encouraged to become
more self-directed and self-reliant. The chiropractic profession acknowledges its obligation to work ethically and
responsibly with other stakeholders in the health care delivery
system. Chiropractors can serve as crucial members of an
interprofessional team dedicated to achieving comprehensive
solutions to the complex problems confronting the health care
system today.
Chiropractic, as a profession dedicated to science-based,
conservative health care approaches, is, like medicine,
osteopathy, and other health professions, more than a singular
therapeutic procedure. Although spinal manipulation/mobilization is an important treatment tool in the chiropractic
therapeutic armament, it is but one of many clinical options
chiropractic doctors provide to their patients. Chiropractic
doctors typically serve as portal of entry providers focused
primarily, although not exclusively, on neuromusculoskeletal
disorders. They serve, at other times, as specialists who either
assume primary provider status or as co-managers with other
clinicians. They use standard approaches to assess patient
needs, including evaluation and management services,
orthopedic, neurologic and other common physical examination procedures, specialized assessment approaches, and a
wide variety of common diagnostic studies including radiography, laboratory diagnostics, and neurodiagnostics, among
others. Doctors of chiropractic provide conservative, often
“hands on” treatment, including, but not limited to, manual
techniques such as manipulation and mobilization, commonly used physiologic therapeutic modalities, exercise,
counseling on ergonomics, and also patient education to
include diet and lifestyle advice, coping strategies, and selfcare approaches. Chiropractic doctors are trained to diagnose
and make referrals to other health care practitioners when
appropriate, and they frequently engage in co-management
and referral for the variety of the conditions they encounter.1
Significant research regarding chiropractic care has been
directed to disorders of the thoracolumbar, lumbosacral, and
pelvic regions, generically known as the “low back.” A number
of guidelines addressing manipulation, an important component of chiropractic professional care, have been released over
the past 15 years. These efforts have admirably served the goal
of enhancing the effectiveness of care. Despite these prior
efforts, none have incorporated a broad-based consensus of
chiropractic research and clinical experts representing mainstream chiropractic practice into a practical document designed
to provide standardized parameters of care.
The Scientific Commission of the CCGPP recently
completed a thorough synthesis of the available literature
regarding chiropractic treatment of low back disorders. The
following is a summary of conclusions from this document:2
Spinal manipulation/mobilization:
1. For acute and subacute low back pain (LBP), strong
evidence supports the use of spinal manipulation to
reduce symptoms and improve function.
Journal of Manipulative and Physiological Therapeutics
November/December 2008
2. There is good evidence that the use of exercise in
conjunction with manipulation is likely to speed and
improve outcomes as well as minimize episodic
recurrence.
3. There is fair evidence for the use of manipulation for
patients with LBP and radiating leg pain, sciatica, or
radiculopathy; manipulation in combination with other
common forms of therapy may be of clinical value.
4. Cases with high severity of symptoms may benefit by
referral for co-management of symptoms with medication.
5. For chronic LBP, strong evidence supports the use of
spinal manipulation/mobilization to reduce symptoms
and improve function.
Exercise:
1. For acute LBP, there is evidence that exercises are not
more effective than other conservative interventions.
2. For subacute LBP, moderate evidence supports use of a
graded-activity exercise program in occupational settings, although the effectiveness for other types of
exercise therapy in other populations is unclear.
3. In chronic LBP, there is strong evidence that exercise is
at least as effective as other conservative treatments.
Individually designed strengthening or stabilizing
programs appear to be effective in health care settings.
The CCGPP Low Back document along with other
systematic reviews and studies provide a strong collective
evidence-influenced context upon which the following
recommendations are based. The Delphi consensus process
was selected as an established and appropriate methodology
for translating the literature synthesis into reasonable
practice recommendations.3,4
METHODS
Development of the document began with seed
materials, from which seed statements were distilled.
These were circulated electronically to the Delphi panel
until consensus was reached. Details of the process are
described below.
Seed Document Identification
Seed documents were collected for distribution to the
Delphi panelists as background material. The full texts of the
following documents were provided to all Delphi panelists:
the CCGPP Low Back literature synthesis,2 the clinical
practice guidelines on low back pain from the American
College of Physicians and the American Pain Society,5 and
the 2008 “Evidence-informed management of chronic low
back pain with spinal manipulation and mobilization” article
in the Spine Journal.6
Journal of Manipulative and Physiological Therapeutics
Volume 31, Number 9
Seed Statement Development
Seed statements were developed by a separate committee,
addressing treatment frequency, intensity, and duration of
chiropractic care for acute and chronic LBP, process of care,
documentation of therapeutic response, consideration of
complicating factors, safety considerations, and other aspects
of appropriate chiropractic practice. The seed document
committee was appointed by the CCGPP Executive
Committee, based on clinical experience, knowledge of the
scientific literature, and experience in preparing documents.
Representatives of the CCGPP Scientific Commission also
reviewed and critiqued the seed statements, as independent
reviewers, and the document was revised as per their
comments before circulation to the Delphi panel.
Selection and Composition of the Delphi Panel
The CCGPP asked the Congress of Chiropractic State
Associations and other interested stakeholders including all
chiropractic professional organizations to submit nominations for members from the field. Representation of all
stakeholders was felt to be essential. Efforts were made to
include a broad representation of the profession in terms of
chiropractic college of graduation, geographic location,
practice characteristics (such as chiropractic technique and
use of modalities and other ancillary procedures), and
spectrum of practice, from broad scope to focused scope, as
described in the survey of the chiropractic profession by
MacDonald et al.7 A public representative was also invited
to participate in the process. Multidisciplinary input was
encouraged. A selection committee, composed of representatives of the CCGPP and the Scientific Commission,
reviewed nominations to ensure that the panelists were
highly experienced in clinical practice and represented a
broad spectrum of US DCs.
Method for Conduct of Delphi Rounds
The Delphi process followed established methodology4,8
and was conducted in early 2008, as follows:
The project director, Chair of the Scientific Commission
of CCGPP, conducted Delphi rounds by electronic mail. The
RAND/UCLA method for rating appropriateness was used,
as follows:9 for each of 27 seed statements, panelists were
asked to indicate the appropriateness of the procedure or
practice described. “Appropriateness” indicated that the
expected health benefit to the patient exceeds the expected
negative consequences by a sufficiently wide margin that it is
worth doing, exclusive of cost.9 A scale of 1 to 9 (highly
inappropriate to highly appropriate) was provided, where
1 to 3 were scored as “inappropriate,” 4 to 6 as “undecided,”
and 7 to 9 as “appropriate.” Panelists were instructed to
provide specific reasons for “inappropriate” ratings, providing a citation from the peer-reviewed literature to support it,
if such exists. In analyzing the responses, agreement on
appropriateness was considered to be present if at least 80%
Globe et al
Chiropractic Low Back Consensus
of panelists marked 7, 8, or 9 and the median response score
was 7 to 9.
RESULTS
Delphi Panel Composition
The group included clinically experienced DCs from
across the nation as well as content experts and
recognized academic/research experts in LBP. Of 51
nominees from organizations and institutions, the selection
committee approved 47 and 7 declined to participate, for
a total of 40 panelists, who graduated from 15 different
chiropractic colleges (there were no graduates of Palmer
Davenport or Life West) practicing in 16 states (California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Minnesota, Missouri, New Jersey, New
Mexico, New York, Pennsylvania, South Dakota, Texas,
Wisconsin). Most (22) practice in suburban locations, but
rural and urban, were also represented. Professional
organization affiliations included the American Chiropractic Association (18), International Chiropractic Association (4), American Public Health Association (4), and
International Chiropractic Pediatric Association (1). The
median years in practice was 22.5 (5-40 years). Median
practice volume was 115 patient visits per week (10-350
visits per week). Most panelists are in private practice,
although there were also clinical and academic faculty
and 3 scientific representatives who are no longer in
active practice. Although most panelists primarily use
traditional manual techniques, there was representation of
instrument- and table-assisted techniques, as well as less
commonly used techniques such as sacro-occipital and
torque release. Soft tissue techniques such as myofascial
release were also commonly reported. For scope of
practice, where 1 indicates broad scope and 9 indicates
focused scope, there were panelists ranging from 1 to 9,
with a median of 2.
Results of Delphi Rounds
For the first Delphi round, 27 seed statements were sent to
the 40 panelists. Thirty-nine of 40 responded, after 4 email
reminders. The median ratings were within the “appropriate”
category, with 80% agreement, for 24 statements. For 3
statements, the median ratings were in the appropriate
category, but there was only approximately 70% agreement,
which fell short of the 80% established at the outset as the
requirement for consensus. All panelists' comments and
ratings were sent to the seed document committee, who
provided the panel with explanatory discussion and revision
for the 3 statements on which there was no consensus. This,
along with all panelists' comments, was sent back to the
panelists for additional deliberation.
On the second round, 36 of 40 panelists responded, after
4 reminders, with median ratings in the appropriate category
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654
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Chiropractic Low Back Consensus
and 80% agreement. Consensus was therefore considered to
have been reached, and no additional Delphi rounds were
conducted. All comments and ratings were sent to the seed
document committee to consider when developing this
document, based on the seed statements.
Journal of Manipulative and Physiological Therapeutics
November/December 2008
Finally, it is the ultimate goal of chiropractic care to
improve patients' functional capacity and educate them to
independently accept the responsibility for their own
health. In an era of costly health care, the greatest savings
can be realized by keeping healthy patients out of doctor's
offices and allowing limited health care resources to be
used by those truly in need of them.
DISCUSSION
The current document incorporates the consensus-based
seed statements with additional explanatory material.
General Considerations
The findings of the CCGPP literature synthesis particularly support, although clinical practice is not limited to, the
use of manual therapeutic techniques (such as manipulation
and mobilization procedures), patient education regarding
reassurance, staying active and avoiding illness behavior,
and also rehabilitative exercise as the therapeutic basis for
care for low back conditions. It is also important to note that
the CCGPP recommendations in support of manipulation for
both acute and chronic low back pain closely mirror many
other systematic reviews of the literature. For example,
Bronfort et al6 have also recently concluded that manual
therapeutic methods, such as spinal manipulation and
mobilization methods, combined with active care/exercises
have been shown to be effective in the management of
chronic back pain.
The current document is intended to further define and
clarify the clinical application of research from a
chiropractic evidence-influenced perspective, using a
consensus process with a national panel of chiropractic
clinical experts.
Most acute pain, typically the result of injury (microor macrotrauma), responds to a short course of conservative treatment. If effectively treated at this stage,
patients often recover with full resolution of pain,
although recurrences are common. Delayed or inadequate
early clinical management may result in increased risk
of chronicity and disability. Furthermore, those responding
poorly in the acute stage and those with increased risk
factors for chronicity must also be identified as early
as possible.
Clinicians must continually be vigilant for the appearance of clinical red flags (see clinical red flags section
below) that may arise at any point during patient care. In
addition, biopsychosocial factors (also known as clinical
yellow flags) should be identified and addressed as early
as possible as part of a comprehensive approach to
clinical management.
Chiropractic doctors are skilled in multiple approaches of
functional assessment and treatment. Depending on the
clinical complexity, DCs can work independently or as part
of a multidisciplinary team approach to functional restoration
of patients with acute and chronic low back pain.
Informed Consent
Informed consent is the process of proactive communication between a patient and physician that results in the
patient's authorization or agreement to undergo a specific
medical intervention. Informed consent should be obtained
from the patient, performed within the local and/or regional
standards of practice.
Examination Procedures
Thorough history and evidence-informed examination
procedures are critical components of chiropractic clinical
management. These procedures provide the clinical
rationale for appropriate diagnosis and subsequent treatment planning. The review of evidence-informed examination procedures is beyond the scope of this document.
The reader is advised that there are many excellent
sources of evidence-based information by which to
conduct a thorough and well-informed examination of
the injured low back patient.
Severity and Duration of Conditions
Conditions of illness and injury are typically classified
by severity and/or duration. Common descriptions of the
stages of illness and injuries are acute, subacute, chronic,
and recurrent, and further subdivided into mild, moderate,
and severe.5
• Acute—symptoms persisting for less than 6 weeks.
• Subacute—symptoms persisting between 6 and 12
weeks.
• Chronic—symptoms persisting for at least 12 weeks'
duration.
• Recurrent/flare-up—return of symptoms perceived to
be similar to those of the original injury at sporadic
intervals or as a result of exacerbating factors.
Treatment Frequency and Duration
Although most patients respond within anticipated timeframes, frequency and duration of treatment may be
influenced by individual patient factors or characteristics
that present as barriers to recovery (eg, comorbidities,
clinical yellow flags). Depending on these individualized
factors, additional time and treatment may be required to
Journal of Manipulative and Physiological Therapeutics
Volume 31, Number 9
observe a therapeutic response. The therapeutic effects of
chiropractic care/treatment should be evaluated by subjective
and/or objective assessments after each course of treatment
(see Outcome Measurement).
Recommended therapeutic trial ranges are representative
of typical care parameters. A typical initial therapeutic trial
of chiropractic care consists of 6 to 12 visits over a 2- to
4-week period, with the doctor monitoring the patient's
progress with each visit to ensure that acceptable clinical
gains are realized.
For acute conditions, fewer treatments may be necessary
to observe a therapeutic effect and to obtain complete
recovery. Chiropractic management is also recommended for
various chronic low back conditions where repeated
episodes (or acute exacerbations) are experienced by the
patient, particularly when a previous course of care has
demonstrated clinical effectiveness and reduced the longterm use of medications.
Initial Course of Treatments for Low Back Disorders
The treatment recommendations that follow (Table 1),
based on clinical experience combined with the best
available evidence, are posited for the “typical” patient and
do not include risk stratification for complicating factors.
An initial course of chiropractic treatment typically
includes 1 or more “passive” (ie, non-exercise) manual
therapeutic procedures (ie, spinal manipulation or mobilization) and physiotherapeutic modalities for pain reduction, in
addition to patient education designed to reassure and instill
optimal concepts for independent management. The initial
visits allow the doctor to explain that the clinician and the
patient must work as a proactive team and to outline the
patient's responsibilities. Although passive care methods for
pain or discomfort may be initially emphasized, “active” (ie,
exercise) care should be increasingly integrated to increase
function and return the patient to regular activities.
Reevaluation and Reexamination
A detailed or focused reevaluation designed to determine
the patient’s progress and response to treatment should be
conducted at the end of each trial of treatment.
In addition, a brief assessment of the patients response
to treatment should be noted after each treatment is
completed, and recorded in the progress notes (ie, SOAP
notes). A patient's condition should be monitored for
progress with each visit. Near the midway point of a trial of
care (ie, end of the second week of 4-week trial), the
practitioner should reassess whether the current course of
care is continuing to produce satisfactory clinical gains
using commonly accepted outcomes assessment methods
(see Outcome Measurement).
When a patient begins to demonstrate a delay in expected
progress (ie, stalled functional gains), the DC should reassess
and consider other clinically appropriate options (ie, other
Globe et al
Chiropractic Low Back Consensus
Table 1. Frequency and duration for initial (trial) course of
chiropractic treatments
Stage of condition
Frequency
Duration
(wk)
Reevaluate
after (wk)
Acute
Subacute
Chronic
Recurrent/flare-up
3× weekly
3× weekly
2-3× weekly
1-3× weekly
2-4
2-4
2-4
1-2
2-4
2-4
2-4
1-2
chiropractic methods, outside referral/treatment, diagnostic
testing, and co-management).
A separate reexamination procedure should be performed
at the end of the trial of care or in the event of an unexpected,
significant change in the patient's condition. Patients who
fail to achieve measurable gains should be considered for a
modified treatment plan, additional diagnostic evaluation
and/or specialist referral, co-management, or an alternative
therapeutic approach. As with the other health care
disciplines, there are chiropractic physicians with additional
postgraduate training and board certifications who may be
optimal choices for consultation, referral, or perhaps comanagement of cases.
After an initial course of treatment has been concluded, a detailed or focused reevaluation should be
performed. The purpose of this reevaluation is to
determine whether the patient has made clinically meaningful improvement. A determination of the necessity for
additional treatment should be based on the response to
the initial trial of care and the likelihood that additional
gains can be achieved.
As patients begin to plateau in their response to treatment,
further care should be tapered or discontinued depending on
the presentation. A reevaluation is recommended to confirm
that the condition has reached a clinical plateau or has
resolved. When a patient reaches complete or partial
resolution of their condition and all reasonable treatment
and diagnostic studies have been provided, then this should
be considered a final plateau (maximal therapeutic benefit).
The DC should perform a final examination to verify that
maximum therapeutic benefit has been achieved and provide
any necessary patient education and instructions in effective
future self-management.
Continuing Course of Treatments
If the criteria to support continuing chiropractic care
(substantive, measurable functional gains with remaining
functional deficits) have been achieved, a follow-up course
of treatment may be indicated. However, one of the goals of
any treatment plan should be to reduce the frequency of
treatments to the point where maximum therapeutic benefit
continues to be achieved while encouraging more active selftherapy, such as independent strengthening and range of
motion exercises, and rehabilitative exercises. Patients also
need to be encouraged to return to usual activity levels
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Chiropractic Low Back Consensus
Journal of Manipulative and Physiological Therapeutics
November/December 2008
Table 2. Frequency and duration for continuing courses of
Fig 1. Contraindications for high-velocity manipulation to the
treatments
lumbar spine (red flags).
Stage of
condition
Frequency
Duration
(wk)
Reevaluate after
(no. of treatments)
Acute
Subacute
Chronic
Recurrence/flare-up
2-3× weekly
2-3× weekly
1-3× weekly
1-3× weekly
2-4
2-4
2-4
1-2
4-12
4-12
2-12
1-6
despite residual pain, as well as to avoid catastrophizing and
overdependence on physicians, including DCs. They need to
be reassured that, “hurt is not the same thing as harm.” The
frequency of continued treatment generally depends on the
severity and duration of the condition.
Upon completion of the initial trial of care, if the
appropriate criteria have been met, the following parameters of continued treatment are recommended, based on
clinical experience combined with the best available
evidence (Table 2). When the patient's condition reaches
a plateau, or no longer shows ongoing improvement from
the therapy, a decision must be made on whether the patient
will need to continue treatment. Generally, progressively
longer trials of therapeutic withdrawal may be useful in
ascertaining whether therapeutic gains can be maintained
absent treatment.
Additional Care
In a case where a patient reaches a clinical plateau in their
recovery (maximum therapeutic benefit) and has been
provided reasonable trials of interdisciplinary treatments,
additional chiropractic care may be indicated in cases of
exacerbation/flare-up, or when withdrawal of care results in
substantial, measurable decline in functional or work status.
Additional chiropractic care may be indicated in cases of
exacerbation/flare-up in patients who have previously
reached MTB, if criteria to support such care (substantive,
measurable prior functional gains with recurrence of
functional deficits) have been established.
Outcome Measurement
For a trial of care to be considered beneficial, it must be
substantive, meaning that a definite improvement in the
patient's functional capacity has occurred. Examples of
measurable outcomes and activities of daily living and
employment include:
1. Pain scales such as the visual analog scale and the
numeric rating scale.
2. Pain diagrams that allow the patient to demonstrate the
location and character of their symptoms.
3. Validated activities of daily living measures, such as the
Oswestry Back Disability Index and the Roland Morris
Osseous conditions
• Region of local unstable fractures
• Severe osteoporosis
• Multiple myeloma
• Osteomyelitis
• Local primary bone tumors where osseous integrity is
in question
• Local metastatic bone tumors
• Paget's disease
Neurologic conditions
• Progressive or sudden (i.e. cauda equine syndrome) neurologic
deficit
• Spinal cord tumors that clinically demonstrate neurological
compromise or require specialty referral. In cases where the
neoplasm has been properly assessed and is considered to be
clinically quiescent and/or perhaps distant to therapeutic target
site, then chiropractic manipulative therapy may be utilized.
Inflammatory conditions
• Rheumatoid arthritis in the active systemic, stage, or locally in
the presence of inflammation or atlantoaxial instability.
• Inflammatory phase of ankylosing spondylitis
Inflammatory phase of psoriatic arthritis
Reactive arthritis (Reiter's syndrome)
Bleeding disorder
• Unstable congenital bleeding disorders, typically requiring
specialty co-management
• Unstable acquired bleeding disorders, typically requiring
specialty co-management
• Unstable abdominal aortic aneurysm
Other
• Structural instability (e.g., unstable spondylolithesis)
• Inadequate physical examination
• Inadequate manipulative training and skills
*Under certain procedures soft tissue low velocity, low amplitude or
mobilization procedures may still be clinically reasonable and safe.
Back Disability Index, RAND 36, Bournemouth
Disability Questionnaire.
4. Increases in home and leisure activities, in addition to
increases in exercise capacity.
5. Increases in work capacity or decreases in prior work
restrictions.
6. Improvement in validated functional capacity testing,
such as lifting capacity, strength, flexibility, and
endurance.
Spinal Range of Motion Assessment
Range of motion is commonly used by practitioners for a
variety of reasons. It has not been shown to be a valid
functional outcome measure; however, it may be used as part
of determining an impairment rating or to determine whether
a patient responded positively to a single treatment session.
Journal of Manipulative and Physiological Therapeutics
Volume 31, Number 9
Cautions and Contraindications
Chiropractic care, including patient education, passive
and active care therapy, is a safe and effective form of
health care for low back disorders. There are certain
clinical situations where high-velocity, low-amplitude
manipulation or other manual therapies may be contraindicated. It is incumbent upon the treating DC to evaluate
the need for care and the risks associated with any
treatment to be applied. Many contraindications are
considered relative to the location and stage of severity
of the morbidity, whether there is co-management with 1 or
more specialists, and the therapeutic methods being used
by the chiropractic physician.
Contraindications for High-Velocity Manipulation Techniques on the
Lumbar Spine (Red Flags). Figure 1 summarizes injuries or
pathologic conditions that present contraindications for highvelocity manipulation to the lumbar spine.
Conditions Contraindicating Certain Chiropractic-Directed Treatments Such
as Spinal Manipulation and Passive Therapy
Generally the procedure or therapy is contraindicated
over the relevant anatomy and not necessarily contraindicated for other areas:
•
•
•
•
•
•
•
•
Local open wound or burn
Prolonged bleeding time/hemophilia
Artificial joint implants
Pacemaker (contraindicated modality—electrotherapy)
Joint infection
Tumors/cancer
Recent/healing fracture
Increasing neurologic deficit.
Conditions Requiring Co-Management
• Cancer pain
• Postoperative surgical pain
Conditions Requiring Referral
Patients should be referred to another specialty health care
practitioner or to emergency care in certain instances, such as
the following:
• The patient's condition is not responding to the treatment rendered, when all reasonable alternative chiropractic methods have been exhausted.
• The patient's condition is worsening with treatment.
• The patient has a serious and/or progressive infectious
condition.
• The patient experiences a medical emergency (eg, myocardial infarct, cerebrovascular accident, severe laceration, pneumothorax).
• Increasing neurologic deficits (ie, cauda equina
syndrome).
Globe et al
Chiropractic Low Back Consensus
CONCLUSION
A broad-based panel of experienced chiropractors were
able to reach a high level (80%) of consensus regarding
specific aspects of the chiropractic approach to care for
patients with low back pain, based on both the scientific
evidence and their clinical experience.
ACKNOWLEDGMENT
The authors thank Alan Adams, DC, MS, MSEd,
for consulting on the design of the Delphi process and
Janet P. Jordan, CAE, for ensuring that the nomination information for Delphi panelists was disseminated
widely and that the nominations were collected efficiently.
The independent reviewers, listed below, provided
rigorous and constructive criticism during development
of the seed document. Finally, the Delphi panelists, listed
below, generously provided their expertise and clinical
judgment, without which this project could not have
been accomplished. The authors also thank the independent reviewers:
Gert Bronfort, DC, PhD; Jeffrey R. Cates, DC, MS;
Mark D. Dehen, DC; Meridel I. Gatterman, MA, DC,
Med; Dana J. Lawrence, DC, MMedEd; Eugene A. Lewis,
DC, MPH; William C. Meeker, DC, MPH; Stephen M.
Perle, DC, MS; Michael J. Schneider, DC; Thomas Souza,
DC; Lawrence H. Wyatt, DC.
The work of the Delphi panelists is also appreciated:
Randall M. Adams, DC, MS; Gregory Baker, DC; Charles L.
Blum, DC; Jeffrey Bonsell, DC; Richard Branson, DC; Gert
Bronfort, DC, PhD; Wayne H. Carr, DC; Jarrod M. Cashion,
DC; Joseph J. Cipriano, DC; Edward Cremata, DC; J.
Donald Dishman, DC, MSc; Gregory H. Doerr, DC; Paul E.
Dougherty, DC; John W. Downes, DC; Vernon E. Englund,
DC; Joseph F. Ferstl, DC; Scott D. Fonda, DC; Meridel I.
Gatterman, MA, DC, Med; Michael W. Hall, DC; Wayne A.
Hogan, DC; Kathryn T. Hoiriis, DC; Lawrence Humberstone, DC; Brian Justice, DC; Davis L. Kinney, DC; William
J. Lauretti, DC; Steven Lindner, DC; Vincent F. Loia, DC;
Marshall T. Lysne, DC; Robert T. Martin, DC; Glen
Nykwest, DC; Ian Paskowski, DC; Reed B. Phillips, DC,
PhD; Jeremy S. Rowse, DC; Brad M.T. Smith, DC; Albert
Stabile, Jr, DC; Michael S. Swank, DC; Quentin Thompson,
DC; John M. Ventura, DC; James A. Wyllie, DC.
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Clar et al. Chiropractic & Manual Therapies 2014, 22:12
http://www.chiromt.com/content/22/1/12
CHIROPRACTIC & MANUAL THERAPIES
SYSTEMATIC REVIEW
Open Access
Clinical effectiveness of manual therapy for the
management of musculoskeletal and nonmusculoskeletal conditions: systematic review
and update of UK evidence report
Christine Clar1, Alexander Tsertsvadze1, Rachel Court1, Gillian Lewando Hundt2, Aileen Clarke1 and Paul Sutcliffe1*
Abstract
Background: This systematic review updated and extended the “UK evidence report” by Bronfort et al. (Chiropr
Osteopath 18:3, 2010) with respect to conditions/interventions that received an ‘inconclusive’ or ‘negative’ evidence
rating or were not covered in the report.
Methods: A literature search of more than 10 general medical and specialised databases was conducted in August
2011 and updated in March 2013. Systematic reviews, primary comparative studies and qualitative studies of
patients with musculoskeletal or non-musculoskeletal conditions treated with manual therapy and reporting clinical
outcomes were included. Study quality was assessed using standardised instruments, studies were summarised, and
the results were compared against the evidence ratings of Bronfort. These were either confirmed, updated, or new
categories not assessed by Bronfort were added.
Results: 25,539 records were found; 178 new and additional studies were identified, of which 72 were systematic
reviews, 96 were randomised controlled trials, and 10 were non-randomised primary studies. Most ‘inconclusive’ or
‘moderate’ evidence ratings of the UK evidence report were confirmed. Evidence ratings changed in a positive
direction from inconclusive to moderate evidence ratings in only three cases (manipulation/mobilisation [with
exercise] for rotator cuff disorder; spinal mobilisation for cervicogenic headache; and mobilisation for
miscellaneous headache). In addition, evidence was identified on a large number of non-musculoskeletal conditions
not previously considered; most of this evidence was rated as inconclusive.
Conclusions: Overall, there was limited high quality evidence for the effectiveness of manual therapy. Most reviewed
evidence was of low to moderate quality and inconsistent due to substantial methodological and clinical diversity.
Areas requiring further research are highlighted.
Keywords: Clinical effectiveness, Manual therapy, Systematic review, Musculoskeletal, Bronfort
Background
Manual therapy is a non-surgical type of conservative
management that includes different skilled hands/fingerson techniques directed to the patient’s body (spine and
extremities) for the purpose of assessing, diagnosing,
and treating a variety of symptoms and conditions [1-4].
Manual therapy constitutes a wide variety of different
* Correspondence: [email protected]
1
Populations, Evidence and Technologies, Division of Health Sciences,
Warwick Medical School, University of Warwick, Coventry CV4 7AL, England
Full list of author information is available at the end of the article
techniques which may be categorised into four major
groups: a) manipulation (thrust manipulation), b) mobilisation (non-thrust manipulation), c) static stretching, and
d) muscle energy techniques. The definition and purpose
of manual therapy varies across health care professionals.
Spinal manipulation and mobilisation are commonly
used treatment modalities for back pain, particularly by
physical therapists, osteopaths, and chiropractors. Back
pain is an important health problem with serious societal
and economic consequences for the developed world. It is
estimated that in the USA 80% of people will experience
© 2014 Clar et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
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reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
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unless otherwise stated.
Clar et al. Chiropractic & Manual Therapies 2014, 22:12
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back problems at some point during their lifetime [5].
Back pain is also very prevalent in the UK, affecting
around 29% of the population annually [6].
The use of chiropractic, osteopathic, and other forms
of services delivering various types of manual therapies
has been steadily increasing in the Western World [7].
For example, in the United States, 33% of people with low
back pain are treated by a chiropractor [8]. A UK-based
study surveyed the prevalence of back pain and the use of
chiropractic/osteopathy services in a randomly selected
sample of adults aged 18–64 years living in four counties
of England [9]. Of the respondents with back pain (15.6%),
13.4% had consulted with osteopaths and/or chiropractic
practitioners.
One descriptive review summarised surveys reporting
rates of use of complementary and alternative medicine
(CAM) therapies for management of low back pain and
other musculoskeletal and non-musculoskeletal conditions
[10]. Results of this review showed that chiropractors were
used by 6% to 12% of the surveyed population, the majority
of which complained of back pain.
Previous research has shown short-term benefit of
spinal manual therapy (i.e., manipulation, mobilisation) especially in reducing back pain [11-20]. There is little and
mostly inconclusive evidence from randomised trials
on the effectiveness of manual therapy including chiropractic manipulation for non-musculoskeletal conditions,
specifically for patients with dysmenorrhoea, hypertension, chronic obstructive lung disease, asthma, infantile
colic, premenstrual syndrome, otitis media, nocturnal
enuresis [7,8,20].
The annual incidence of major harms or complications
associated with the use of manipulative procedures is
low. In general, manipulations using thrust techniques
carry a greater risk of major complications than the
non-thrusting, low-velocity, low-amplitude soft-tissue
approaches [21]. Systematic reviews using a variety of
data sources come to conflicting conclusions regarding
serious adverse events that can result from spinal manipulations, especially cervical manipulations (including stroke
and death) [22-29].
The current review builds on the “UK evidence report”
by Bronfort, Haas, Evans, Leininger and Triano [20] on
the effectiveness of manual therapies commissioned by
the UK General Chiropractic Council (GCC). The UK
evidence report concluded that spinal manipulation/
mobilisation was effective in adults for: acute, sub-acute,
and chronic low back pain; migraine and cervicogenic
headache; cervicogenic dizziness; manipulation/mobilisation was effective for several extremity joint conditions;
and thoracic manipulation/mobilisation was effective for
acute/sub-acute neck pain. The evidence was inconclusive
for cervical manipulation/mobilisation alone for neck pain
of any duration, and for manipulation/mobilisation for
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mid back pain, sciatica, tension-type headache, coccydynia,
temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal
manipulation was not effective for asthma and dysmenorrhoea when compared to sham manipulation, or for stage
1 hypertension when added to an antihypertensive diet. In
children, the evidence was inconclusive regarding the
effectiveness for otitis media and enuresis, and it was
not effective for infantile colic and asthma when compared
to sham manipulation. The evidence was inconclusive for
knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome.
In children, the evidence was inconclusive for asthma and
infantile colic.
Bronfort et al. [20] referred to the limitations of the
available evidence and a range of issues that needed exploring in a more extensive review. The current work
aimed to:
Synthesise evidence in addition to the randomised
controlled trials (RCTs) and systematic reviews
captured by Bronfort et al. [20] such as controlled
cohort studies, non-randomised controlled clinical
trials (CCTs), and qualitative studies, focussing on
evidence rated as ‘inconclusive’ or ‘negative’ by
Bronfort, or not covered in the report
Synthesise evidence additional to Bronfort et al. [20]
(RCTs and systematic reviews published since
Bronfort and additional study types)
Compare conclusions from the additional studies
summarised (new RCTs and systematic reviews and
additional study types) to those of Bronfort et al. [20]
focusing in particular on areas where
it was stated that the available evidence was
inconclusive or that manual therapy was not effective
Methods
The PRISMA checklist for the current paper can be found
in Additional file 1.
Search strategy
We used a varied range of sources to identify relevant
literature. A comprehensive literature search was undertaken in the major medical, health-related, science and
health economic electronic bibliographic databases. We
paralleled the comprehensive searches undertaken by
Bronfort et al. [20] through a clearly defined search strategy using the databases: MEDLINE (Ovid), EMBASE,
Mantis, Index to Chiropractic Literature, CINAHL, the
specialised databases Cochrane Airways Group trial
register, Cochrane Complementary Medicine Field register,
and Cochrane Rehabilitation Field register (via CENTRAL).
We supplemented these searches by using the following
other databases: Science Citation Index, AMED, CDSR,
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NHS DARE, NHS HTA, NHS EED, CENTRAL (full
search), and ASSIA, Social Science Citation Index.
Search terms were restricted to terms related to manual
therapy and broader terms like ‘physiotherapy’ were not
included. The search included both free text and MeSH
terms, as well as terms for the eligible study types (from
pretested search strategies). To keep the search as broad
as possible, no condition terms were included. There was
no language restriction in the searches but due to limited
resources only studies published in English, French,
German, and Spanish were included. The main search was
carried out in August 2011 (see Additional file 2). A
search update was undertaken in March 2013.
interventions including comparators (e.g., intervention
groups, comparison, dose, providers), d) outcomes (e.g.
pain, function, adverse events).
Inclusion criteria
Rating of evidence
Studies were eligible for inclusion if they were full text
reports of systematic reviews, RCTs or controlled clinical
trials (CCTs), cohort studies with a comparison group, or
qualitative studies of patients' views on manual therapy.
Primary studies had to include at least 20 participants.
Studies had to include participants of any age and in
any setting treated for any musculoskeletal or nonmusculoskeletal condition who were treated with any
manual treatment/therapy were included (alone or in
combination). To provide an overall picture, any condition was included for which a trial documenting manual
treatment was available. Interventions had to include an
element of manipulation or mobilisation, and emphasis
was on interventions typically carried out by a manual
therapist/chiropractor/osteopath. Comparison was against
any other therapy. Outcomes assessed included pain intensity, pain-related disability, analgesic use, function, mobility,
activities of daily living, characteristic symptoms or indicators of disease, patient satisfaction, quality of life, views/
themes from qualitative data, adverse events (e.g. strokes,
fractures, pain), and mortality. The focus of the present review was on evidence rated as ‘inconclusive’ or ‘negative’
by Bronfort et al. [20] or not covered in the report.
Using the same criteria as Bronfort et al. [20] (based on
consistency between studies, study size, quality etc.), the
evidence was rated as ‘high quality positive/negative
evidence’, ‘moderate quality positive/negative evidence’, or
‘inconclusive favourable/non-favourable/unclear evidence.
Study selection
Two independent reviewers applied the inclusion/exclusion criteria to the studies identified through the searches,
screened the titles/abstracts and then the full text of any
records appearing to fulfil the inclusion criteria. Any disagreements over the inclusion of records were resolved by
discussion.
Data extraction
Data were extracted by two reviewers using a priori developed data extraction forms. The data extracted included:
a) study characteristics (e.g., author name, year of publication, country, study design, aim, duration, follow-up,
quality rating), b) types of participants (e.g., number,
age, gender, inclusion/exclusion criteria), c) types of
Quality assessment
The following assessment tools were used for appraising
any new and additional evidence: AMSTAR (for systematic
reviews); [30-32] Cochrane Risk of Bias (for RCTs); [33]
CRD checklist (for controlled cohort studies); [34] and
CASP (for qualitative studies) [35]. Based on the quality results, studies were rated as high (more than two thirds of
criteria met), medium (more than a third of criteria met) or
low quality (a third or fewer criteria met).
Data synthesis
To obtain an overview of new and potentially relevant
studies omitted by Bronfort et al. [20], all systematic reviews and RCTs included by Bronfort were tabulated, by
condition as classified in the report. Then eligible studies
identified in our search strategy were entered in an Excel
table and filtered by the relevant condition and any studies
not already included by Bronfort et al. [20] were checked
for their relevance and listed (with systematic reviews,
RCTs and other study types listed in separate columns)
if they were judged to be relevant additional studies.
This process was followed for all conditions, and conditions not included by Bronfort were added. Studies were
only included in the table after obtaining and checking
their full text publication. When summarising systematic
reviews on broader topics than the one considered in this
review (e.g. of complementary therapies or physiotherapy in general), only sections of relevance to the
current review were considered. Meta-analyses were not
carried out as interventions and participant populations
were very heterogeneous.
Results
Search results
The initial database searches yielded 25,539 records
(16,976 after deduplication). Of these, 178 were summarised in more detail (72 systematic reviews, 96 RCTs,
10 non-randomised primary studies), see Figure 1 for
study flow chart. Reasons for exclusion included: absence
of comparison group, irrelevant outcomes, study in healthy
volunteers, ineligible intervention, ineligible condition,
relevant intervention similar in all comparison groups,
conference abstracts or commentaries, non-systematic
Identification
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Records identified through
database searching
(n = 25,539)
Additional records identified
through other sources
(n = 751)
Eligibility
Screening
Records after duplicates removed
(n = 17,727)
Records screened
(n = 17,727)
Full-text articles assessed
for eligibility
(n = 1,765)
Records excluded
(n = 15,962)
Full-text articles excluded,
with reasons
(n = 1,587)
Included
Studies included in
qualitative synthesis
(n = 178)
Studies included in
quantitative synthesis
(meta-analysis)
(n = 0)
Figure 1 PRISMA 2009 flow diagram.
review. The kappa statistic of inter-rater agreement was
calculated for a 20% convenience sample of studies
screened by two reviewers. Kappa was 0.74 (95% CI:
0.70, 0.77, equivalent to 93.9% agreement) indicating
‘substantial’ agreement [36].
Tables 1 and 2 summarise the number of studies rated
by Bronfort et al. [20] to be ‘inconclusive’ or ‘negative’
compared to the new/additional studies identified in the
current review for musculoskeletal conditions, headache
and other disorders (Table 1) and non-musculoskeletal
conditions and adverse events (Table 2).
Update on clinical effectiveness–conditions/interventions
rated ‘inconclusive’, ‘negative’ or not covered in the UK
evidence report
The following section provides a summary of the conditions/interventions rated ‘inconclusive’, ‘negative’ or not
covered in the UK evidence report. Details of study characteristics and study quality can be found in Additional
files 3 and Additional file 4.
Musculoskeletal conditions
Tables 3, 4 and 5 provide a comparison between the
overall evidence ratings included in the UK evidence
report and new/additional studies in the current review
for musculoskeletal conditions.
Sciatica and back-related leg-pain Two new/additional
medium [37] to high quality [38] RCTs relating to sciatica
and back-related leg pain were identified, and a protocol
of an on-going study [39]. The medium quality RCT [37]
randomised 40 patients with sciatica to receive chiropractic
spinal manipulation (high velocity, low-amplitude, short
lever technique) or surgical microdiskectomy. At 12 weeks
of follow-up there was significant improvement in quality
of life, pain and disability in both intervention groups,
with no significant difference between groups. The high
quality RCT [38] randomised 134 patients with nonspecific low back pain (with or without sciatica) to
orthopaedic manual therapy (mobilisation, high velocity
low-force manipulation, translatoric thrust manipulation),
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Table 1 Number of studies in UK evidence report and current review – Musculoskeletal conditions, headache disorders,
fibromyalgia
Condition
UK evidence report
Current review (additional studies)
Systematic
reviews
Systematic
reviews
RCTs
RCTs
Other primary
study types
Conditions/Interventions with inconclusive or negative evidence in the UK evidence report
Musculoskeletal
Sciatica/radiating leg pain
3
Details of RCTs in reviews
not listed
2 & 1 ongoing
Neck pain (cervical manipulation/mobilisation only)
Unclear
Unclear
7
Non-specific mid back pain
0
7 [not all thoracic back pain]
Coccydynia
0
1
Ankle and foot conditions
2
Carpal tunnel syndrome
4
Lateral epicondylitis
1
1 ongoing
16
3
6 & 1 ongoing
2
4
3
3
11
8
9 & 1 ongoing
Temporo-mandibular disorders
2
5
1 ongoing
5
Shoulder conditions
2
6
15
12
Cervicogenic headache
4
7
2
2
Tension-type headache
5
12
1
4
2 controlled clinical
trials & 1 cohort
Headache disorders and fibromyalgia
Miscellaneous headache
1
1
2
2
Fibromyalgia
3
8
3
2
the McKenzie method or advice only. At 12 months
follow-up, all groups showed significant improvement in
pain and disability, but there was no significant difference
between groups.
Summary: Inconclusive (favourable) evidence for spinal
manipulation/mobilisation in treating sciatica and backrelated leg-pain (no change from the UK evidence report).
The evidence suggests that chiropractic or orthopaedic
manipulation may be effective in reducing symptoms of
sciatica in adults, however, it is not clear due to the small
sample size of the trials, if these manual treatment techniques are more beneficial compared to surgery, McKenzie
method, or advice only.
Neck pain (cervical manipulation/mobilisation alone)
One low quality, [40] four medium quality [41-43] and
two high quality RCTs [44,45] examined the effect of
cervical spinal manipulation or mobilisation alone for
neck pain of any duration [40-46].
A medium quality RCT [46] compared the effects of joint
mobilisation applied to either symptomatic or asymptomatic cervical levels in 48 patients with chronic non-specific
neck pain. Outcomes were only measured immediately
following the treatment and while there were some
within-group improvements in pain parameters, there
were no significant differences between groups. In a
medium quality RCT, [42] 47 patients were randomised to
receive a three-week treatment with cervical manipulation
(cervical/upper thoracic segmental high velocity, low amplitude movements), mobilisation (cervical/upper thoracic
segmental low velocity, low amplitude movements), or the
activator instrument. At 12 months post-treatment, the
proportion of patients who improved on the Patient
Global Impression of Change scale was not significantly
different across the three study groups, neither were any
changes in disability, pain, or quality of life. However,
there were significant within-group improvements from
baseline in disability and pain intensity for the manipulation and activator instrument groups. Fifteen patients
in the manipulation and four patients in each group of the
mobilisation and activator experienced minor adverse
events (e.g. mild headache, mild dizziness, mild arm
weakness). Klein et al. [45] compared a single straincounter strain intervention with sham treatment in a
high quality RCT including 61 patients with neck pain.
After the treatment, there was no significant difference
between groups in mobility restriction or pain. Leaver
et al. [44] conducted a high quality RCT comparing the
effectiveness of cervical manipulation (high-velocity, lowamplitude thrust technique) versus mobilisation (lowvelocity, oscillating passive movements) administered
to 182 patients with non-specific neck pain (less than
3 months of duration) for two weeks. At three months
of follow-up, the median number of days to recovery
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Table 2 Number of studies in UK evidence report and current review - Non-musculoskeletal, adverse events
Condition
UK evidence report
Systematic reviews
Current review (additional studies)
RCTs
Systematic reviews
RCTs
Other primary study types
Conditions/Interventions with inconclusive or negative evidence in the UK evidence report and additional conditions not covered by
the UK evidence report
Non-musculoskeletal
Asthma
4
5
3
1
ADHD/Learning disorders
Not reported
Not reported
1
2
Cancer care
Not reported
Not reported
1
4
Cerebral palsy
Not reported
Not reported
1 qualitative
3
Cervicogenic dizziness/balance
2
2
1
Chronic fatigue
Not reported
Not reported
1
1 & 1 ongoing
Chronic pelvic pain
Not reported
Not reported
2
Cystic fibrosis
Not reported
Not reported
Dysfunctional voiding (paediatric)
Not reported
Not reported
Gastrointestinal
Not reported
Not reported
1
Hypertension
1
3
1
Infantile colic
6
8
4
Menopausal symptoms
Not reported
Not reported
Myofascial pain syndrome
1
15
2
4
Otitis media
3
2
2
1 ongoing
Parkinson’s
Not reported
Not reported
Paediatric nocturnal enuresis
2
2
Peripheral arterial disease
Not reported
Not reported
Pneumonia/respiratory disorders
1
1
3
2 & 1 ongoing
Pregnancy/post-natal/neonatal
Not reported
Not reported
2
2 & 1 ongoing
1
Rehabilitation
Not reported
Not reported
3
2 controlled clinical trials
& 1 cohort
Systemic sclerosis
Not reported
Not reported
2
Dysmenorrhoea
2
5
3
1
1
Insomnia
2
1 controlled clinical trial
1
1
1
1
1
1
Premenstrual syndrome
3
3
Adverse events
5
Primary studies: 6
was not significantly different between the manipulation
and mobilisation groups, and there was also no significant
difference between the two groups in the mean posttreatment pain intensity, in disability, in function, and in
global perceived effect. The most frequent adverse events
were minor and included increased neck pain (22%) and
headache (22%). Other less frequent events were dizziness
(7%), nausea (6%), and paraesthesia (7%). The frequency
of adverse events was not significantly different between
the study groups. Martel et al. [43] conducted a medium
quality RCT of 98 patients with non-specific chronic neck
pain, investigating the effectiveness of spinal manipulative
therapy (standardised passive palpation on the cervical
and thoracic spine) compared to spinal manipulative therapy plus home exercise, or no treatment for 10 months.
7
1
7
After the treatment phase, all study groups experienced
significant improvements in disability and lateral flexion.
However, the between-group differences for all outcome
measures were statistically non-significant. Puentedura
et al. [41] conducted a medium quality RCT comparing
the effectiveness of 2-week thoracic thrust joint manipulation (TJM) plus cervical range of motion (ROM) exercises
to that of cervical thoracic thrust joint manipulation plus
cervical ROM exercises in 24 adults with acute neck pain.
At six months of follow-up, the cervical TJM group compared to the thoracic TJM group experienced significantly
improved scores for neck disability and overall success.
Minor transient adverse events (increased neck pain,
fatigue, headache, upper back pain) were reported by
70%-80% of the participants in the thoracic TJM group
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Table 3 Comparison of evidence in UK evidence report and current review for musculoskeletal spinal conditions
Condition
Intervention
UK evidence report evidence
New/additional evidence
Inconclusive Moderate High Inconclusive
New evidence?
Moderate High
Musculoskeletal - Spinal
Sciatica/radiating leg pain Spinal manipulation/mobilisation Favourable
Favourable
Yes
Neck pain (acute/
subacute/chronic)
Favourable
Yes
Favourable
Yes
Cervical spinal manipulation/
mobilisation alone
Favourable
Manipulation and mobilisation
with/without soft tissue
treatment
Mid back pain
Spinal manipulation
Favourable
Favourable
No
Coccydynia
Spinal manipulation
Favourable
Favourable
No
Temporomandibular
disorders
Mobilisation/massage
Favourable
Favourable
No
Mandibular manipulation
Unclear
Yes
Intra-oral myofascial therapy
Favourable
Yes
Osteopathic manual therapy
(cervical and temporomandibular
joint regions)
Favourable
Yes
Myofascial pain syndrome Ischaemic compression
Favourable
Yes
• active upper trapezius
Trigger point release
trigger points, neck pain
Integrated neuromuscular
inhibition technique
Non-favourable
Yes
Favourable
Yes
versus 7% in the cervical TJM group. In a low quality
RCT, Schomacher et al. [40] randomised 126 adult participants with chronic neck pain to receive a single 4-minute
mobilisation technique (intermittent translatoric traction
at the zygopophyseal joint between C2 and C7 with
Kaltenborn’s grade II force) applied to symptomatic
levels (concordant segment) versus asymptomatic levels
(three levels below/above concordant segment) of the cervical spine. The immediate post-treatment between-group
differences for the mean change in pain were not statistically significant.
Summary: Inconclusive (favourable) evidence for
cervical spinal manipulation/mobilisation alone in
treating neck pain (no change from the UK evidence
report). Inconclusive (favourable) evidence for manipulation and mobilisation with/without soft tissue
treatment (not evaluated in the UK evidence report).
The evidence suggests there are similar improvements in
the manipulation and/or mobilisation intervention groups
compared to active treatment, however, some trials also
found no improvement in comparison to a control group.
Non-specific mid-back pain One additional low quality
systematic review [47] and one on-going RCT [48] were
identified on non-specific mid-back pain. The systematic
review included only one RCT [49] eligible for the current
review, but this had already been included in the UK
evidence report.
Summary: Inconclusive (favourable) evidence (no
change from the UK evidence report). It cannot be
established from the current evidence whether manual
therapy is more effective than non-treatment, placebo,
or other treatments for the treatment of non-specific
mid-back pain.
Ankle and foot conditions Three additional systematic
reviews [50-52] (2 high quality, [50,52] 1 medium quality
[51]) and six additional RCTs [53-58] (1 high quality, [58]
2 medium quality [53,56] and 3 low quality [54,55,57]) and
one ongoing RCT [59] were identified on the treatment of
ankle and foot conditions using manual therapy.
A high quality Cochrane review examined the effect of
rehabilitation interventions for ankle fractures [50]. With
respect to manual therapy, one trial with a high risk of
bias [57] and one trial with a low risk of bias [58] were
identified. The trial by Wilson and colleagues included
only 12 participants in total, who had an ankle fracture
treated with or without surgery. The intervention group
received physiotherapy including Kaltenborn-based manual therapy to the talocrural and talocalcaneal joints, both
groups also received an exercise intervention. After five
weeks of treatment, there was no statistically significant
improvement in activity limitation or ankle plantarflexion
range of motion, but the ankle dorsiflexion range of
motion was statistically significant in favour of manual
therapy. Lin et al. compared treatment with manual
therapy (anterior-posterior joint mobilisation over the
talus) plus a standard physiotherapy programme (experimental) with the standard physiotherapy programme only
in 94 patients with ankle fracture within one week of cast
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Table 4 Comparison of evidence in UK evidence report and current review for musculoskeletal upper extremity
disorders
Condition
Intervention
UK evidence report evidence
Inconclusive
New/additional evidence
Moderate High Inconclusive
New evidence?
Moderate High
Musculoskeletal - Upper
extremity disorders
Carpal tunnel syndrome
Lateral epicondylitis
Mobilisation
Favourable
Favourable
No
Trigger point therapy
Favourable
Favourable
Yes
Diversified chiropractic care
Unclear
Yes
Neurodynamic technique
Unclear
Yes
Soft tissue mobilisation (with
or without Graston instrument)
Unclear
Yes
Manipulation
Non-favourable
Non-favourable
No
Manual tender point therapy
Favourable
Favourable
No
Mobilisation with exercise
Favourable
Shoulder disorders
• Shoulder girdle
pain/dysfunction
Manipulation/mobilisation
(mobilisation with movement)
• Rotator cuff disorder
Manipulation/mobilisation
(with exercise)
• Adhesive capsulitis
Favourable
Positive
Favourable
High grade mobilisation
Positive
Positive
No
Positive
Yes
Positive
No
Mobilisation with movement
Favourable
Yes
Osteopathy (Niel-Asher technique)
Favourable
Yes
Manual therapy with exercise
Favourable
Yes
• Minor neurogenic
shoulder pain
Cervical lateral glide mobilisation
and/or high velocity low amplitude
manipulation with soft tissue release
and exercise
Favourable
Yes
• Soft tissue shoulder
disorders
Myofascial treatments (ischaemic
compression, deep friction massage,
therapeutic stretch)
Positive
Yes
Table 5 Comparison of evidence in UK evidence report and current review for musculoskeletal lower extremity
disorders
Condition
Intervention
UK evidence report evidence
New/additional evidence
New evidence?
Inconclusive Moderate High Inconclusive Moderate High
Musculoskeletal - Lower
extremity disorders
Ankle sprains
Ankle fracture rehabilitation
Manipulation/mobilisation Favourable
Favourable
No
Muscle energy technique
Favourable
Yes
Mobilisation
Negative
Kaltenborn-based manual
therapy
Morton’s neuroma/metatarsalgia Manipulation/mobilisation Favourable
Negative
No
Favourable
Yes
Favourable
No
Hallux limitus
Manipulation/mobilisation Favourable
Plantar fasciitis
Manipulation/mobilisation
with exercise
Favourable
Trigger point therapy
Favourable
Yes
Hallux abducto valgus
Manipulation/mobilisation Favourable
Favourable
Yes
Positive
No
Positive
No
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removal. There was no significant difference between
groups in functional, pain or quality of life parameters
at 24 weeks’ follow-up. The review authors concluded
that there is no evidence that manual therapy after a
period of immobilisation may improve ankle range of
motion in patients after ankle fracture. Another high
quality systematic review [52] examined the effects of
manipulative therapy for lower extremity conditions.
The authors identified one high, ten moderate and two
low quality trials concerning manual therapy after ankle
inversion sprain, one high and one moderate quality trial
concerning plantar fasciitis, one moderate and one low
quality trial concerning metatarsalgia, four moderate quality trials concerning decreased proprioception/balance/
function secondary to foot and ankle injury/decreased
range of motion/joint dysfunction, one moderate quality
trial concerning hallux limitus and two moderate quality
trials concerning hallus abducto valgus. They concluded
that there was moderate evidence for manual therapy
(mobilisation/manipulation) of the knee and/or full kinetic
chain and of the ankle and/or foot, combined with multimodal or exercise therapy for ankle inversion sprain and
limited evidence regarding long term effects. There was
also moderate evidence for manual therapy (mobilisation/
manipulation/stretching) of the ankle and/or foot combined with multimodal or exercise therapy for short-term
treatment of plantar fasciitis. There was limited evidence
for manual therapy (manipulation/mobilisation) of the
ankle and/or foot combined with multimodal or exercise
therapy for short-term treatment of metatarsalgia and
hallux limitus/rigidus and for loss of foot and/or ankle
proprioception and balance. There was insufficient evidence for manual therapy (mobilisation/manipulation)
of the ankle and/or foot for hallux abducto valgus. The
authors suggested that further high quality research is
needed.
A low quality RCT [54] examined the effects of a muscle
energy technique versus manipulation in the treatment of
40 patients with chronic recurrent ankle sprain. After six
chiropractic treatments over three weeks, there was significant improvement over time in the One Leg Standing
Test (eyes open and closed), the McGill Pain Questionnaire, the Functional Evaluation Scale, and in dorsiflexion
and plantarflexion; however, there was no significant
difference between the two groups. Adverse events were
reported but no serious adverse events were seen. Du
Plessis et al. [53] conducted a medium quality trial of
chiropractic treatment in patients with hallux abducto
valgus. Thirty patients were included and the intervention
group was treated four times over two weeks with graded
joint mobilisation of the first metatarsophalangeal joint
plus joint manipulation, while the control group received
a night splint. At the end of the intervention, there was no
significant difference between the groups in terms of pain
Page 9 of 34
and foot function scores (with both groups showing
improved values). However, these improvements were
not maintained in the control group, while they were
maintained in the intervention group (significant difference between groups in favour of the manual therapy
group at the one month follow-up, p < 0.01). Hallux dorsiflexion was significantly greater in the manual therapy
group both at the end of the intervention and at the end
of the one month follow-up. Adverse events were reported
but no serious adverse events were seen. Another medium
quality RCT [56] examined the effects of manual therapy
in the treatment of plantar heel pain. The trial included 60
patients treated four times weekly for four weeks. Both
groups received a self-stretching intervention (directed at
the calf muscles and plantar fascia) and the intervention
group also received myofascial trigger point manual
therapy. After the intervention, results for pressure pain
thresholds were significantly better for the manual therapy
than for the stretching only group (p < 0.03) and results
for the physical function and bodily pain subscales on the
SF-36 quality of life questionnaire were also improved in
favour of manual therapy. No significant differences were
seen in any other subscales of the SF-36. Similarly, a low
quality RCT [55] examined the effects of myofascial therapy in 30 patients with plantar fasciitis and found significant pain and foot function values in the intervention
group compared to the control.
Summary: Inconclusive (favourable) evidence that
manipulation, mobilisation, and a muscle energy technique are of benefit in the treatment of ankle sprains
(not evaluated in UK evidence report). Inconclusive
(favourable) evidence for Kaltenborn-based manual
therapy for rehabilitation following ankle fracture (not
evaluated in the UK evidence report). Inconclusive
(favourable) evidence for hallux abducto valgus that
mobilisation/manipulation is more effective in leading
to improvements in the intermediate term than night
splints (no change from UK evidence report). Inconclusive
(favourable) evidence for trigger point therapy in treating
plantar fasciitis treatment (no change from the UK evidence
report). Inconclusive (favourable) evidence for manual
therapy (manipulation/mobilisation) of the ankle and/or
foot combined with multimodal or exercise therapy (no
change from the UK evidence report) in treating Morton’s
neuroma, metatarsalgia, hallux limitus/rigidus.
Carpal tunnel syndrome Three additional medium quality systematic reviews, [60,61] one high quality systematic
review [62] and three additional RCTs [63-65] on the effectiveness of manual therapy in carpal tunnel syndrome
were identified. The medium quality reviews [60,61] and a
high quality review [62] did not include any eligible trials
not already considered by the UK evidence report and
were therefore not considered here. Two medium quality
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RCTs [63,64] were included in one of the additional
systematic reviews [66]. Only one medium quality RCT
[65] was not included in any of the new reviews.
The medium quality systematic review [66] summarised
evidence on the effectiveness of non-surgical treatments
for carpal tunnel syndrome. The authors concluded that
there is limited evidence that carpal bone mobilisation is
more effective with respect to symptom improvement
than no treatment in the short term in the treatment of
carpal tunnel syndrome. There was no evidence found for
the effectiveness of neurodynamic treatment versus carpal
bone mobilisation in the short term, for the effectiveness
of a neurodynamic technique plus splinting compared
with a sham therapy plus splinting group in the short term,
or for the effectiveness of Graston instrument-assisted soft
tissue mobilisation plus home exercises compared with soft
tissue mobilisation plus home exercises in the midterm.
There was no evidence for the effectiveness of chiropractic therapy compared with medical treatment for
in the midterm.
A medium quality RCT [65] was and compared 15
sessions of trigger point therapy over five weeks with
sham treatment in 55 patients with carpal tunnel syndrome. After the end of the intervention, there was significant improvement in the severity of symptoms, functional
status and perceived improvement in the intervention
group compared to control (p < 0.05).
Summary: Inconclusive (favourable) evidence for carpal
bone mobilisation and for trigger point therapy in the
treatment of carpal tunnel syndrome (no change from the
UK evidence report). Inconclusive (unclear) evidence for
neurodynamic treatment, soft-tissue mobilisation (with or
without Graston instrument), and diversified chiropractic
care in the management of carpal tunnel syndrome (not
evaluated in the UK evidence report).
Lateral epicondylitis (tennis elbow) Eight additional
low to moderate quality systematic reviews, [60,67-73]
eight additional RCTs for low to moderate quality, [74-81]
one ongoing RCT, [82] and three low quality nonrandomised comparative studies were identified [83-85].
Four of the additional RCTs [75,77-79] were included in
the new additional reviews.
One systematic review of medium quality [69] evaluated
the effectiveness of manipulative therapy (MT) in treating
adults with lateral epicondylitis. The review identified and
included 13 randomised and non-randomised trials of fair
quality overall. The review results indicated beneficial
effects of Mulligan’s mobilisation with movement (versus
no treatment, placebo, or corticosteroid injection) and
manual therapy applied to the cervical spinal region
(versus placebo). Cyriax physiotherapy was found to be
more effective than conventional therapy (stretching, exercise, and modalities), but less effective than corticosteroid
Page 10 of 34
injection or supervised exercise. Kohia et al. [70] systematically reviewed the effectiveness of various physical
therapy treatments for lateral epicondylitis in adults
(medium quality). In total, 16 RCTs of physical therapy
were included in the review. The findings indicated that in
the short-term (6 months or less), corticosteroid injections
were more beneficial than physical therapy (elbow manipulation and exercise) or Cyriax physiotherapy. However, in
the longer term (six months or longer), there was no difference between physical therapy (elbow manipulation
and exercise) versus corticosteroid injections or no treatment. Moreover, radial head mobilisation was more effective compared to standard treatment (ultrasound, massage,
stretching, exercise for wrist) at a follow-up of 15 weeks.
The physical therapy protocol (pulsed ultrasound, friction
massage, and stretching, exercise for wrist) was more effective than a brace with or without pulsed ultrasound.
Cyriax physiotherapy was more beneficial than light
therapy but less beneficial than supervised exercise of
wrist extensors. And finally, the use of wrist manipulation
led to greater improvements in lateral epicondylitis than a
combination of ultrasound, friction massage, and muscle
strengthening. According to the review authors, no single
treatment technique was shown to be the most effective
in treatment of lateral epicondylitis. In one systematic
review of medium quality, [71] the authors explored the
effectiveness of physiotherapy, steroid injections, and
relative rest for the treatment of adult lateral epicondylitis.
The review identified and included 30 studies with quality
scores ranging from 2 to 9 (out of 11). After 6 weeks of
follow-up, steroid injections and multimodal physiotherapy (arm stretching, strengthening, ultrasound, and
massage) were more effective than relative rest. However,
after 3 months, multimodal physiotherapy was better than
steroid injections but as effective as relative rest. The
authors concluded that early active interventions such
as steroid injections and multimodal physiotherapy may
improve symptoms of lateral epicondylitis in adults. In
a medium quality systematic review, [73] evidence was
summarised on the effectiveness of conservative treatments (e.g., ultrasound, acupuncture, rebox, exercise,
wait and see, mobilisation/manipulation, laser) for lateral
epicondylitis in adults. In total, 31 trials of conservative
treatment were included, of which four trials reported
on effectiveness of mobilisation/manipulation relative
to placebo, standard physiotherapy, corticosteroid injections, or manipulation in combination with treatments.
The results indicated that mobilisation/manipulation led
to greater improvements in symptoms of lateral epicondylitis compared to placebo or standard physiotherapy.
However, at one year of follow-up, there was no difference
between corticosteroid injections and manipulation/
mobilisation (Cyriax group). The authors concluded
that level 2b (Sackett’s evidence rating) evidence indicated
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benefits of mobilisation/manipulation in treating lateral
epicondylitis.
In one pilot study of low quality, [74] the authors
randomised 30 adults with lateral epicondylitis to receive
either the chiropractic mobilisation (augmented soft tissue
technique) or no treatment for five weeks. After three
months of follow-up, the groups demonstrated significant
improvements in the Patient-Rated Tennis Elbow Evaluation scale, in pain and in pain-free grip strength when
compared to baseline. However, no between-group difference for these measures was statistically significant.
In one trial of medium quality, [76] 60 adult participants
with lateral epicondylitis were randomised to 4-week
Cyriax physiotherapy versus phonophoresis with diclofenac gel and supervised exercise. At 4 and 8 weeks,
both groups demonstrated significant improvements in
pain (VAS scale), pain-free grip strength (dynamometer), and functional status when compared to baseline.
At both follow-ups, there were significantly greater
mean improvements in pain, pain-free grip strength,
and functional status with Cyriax physiotherapy compared
to phonophoresis. In a non-randomised controlled experimental trial of low quality, [83] the effect of the Mulligan
technique (mobilisation, movement and taping) plus traditional treatment (thermal treatment, massage, ultrasound,
exercise) was compared to that of traditional treatment
alone given for 4 weeks to 34 participants with lateral
epicondylitis. After 4 weeks, both groups demonstrated
significant improvements in function, pain, and pain-free
grip strength when compared to baseline with the mean
improvements from baseline in pain and function being
significantly greater in the Mulligan technique group compared to traditional treatment alone. A low quality RCT
[80] compared the effects of myofascial release with sham
ultrasound in 68 computer professionals with lateral epicondylitis (12 sessions over 4 weeks). At 12 weeks followup, values on the Patient-rated Tennis Elbow Evaluation
Scale were significantly more improved in the intervention
group than in the control group. A low quality RCT
[81] compared the effectiveness of a supervised exercise
programme with that of Cyriax physiotherapy (12 sessions
over 4 weeks) in 20 patients with lateral epicondylitis.
After the end of the treatment, pain and function (Tennis
Elbow Function Scale) were significantly improved in both
groups, but significantly more in the exercise group than
in the Cyriax physiotherapy group.
In one observational cohort study of low quality, [84]
the authors retrospectively compared the effectiveness of
adding cervical spine manual therapy (passive mobilisation,
mobilisation with movement, muscle energy techniques)
to local management directed at the elbow (pulsed ultrasound, iontophoresis, deep tissue massage, stretching,
strengthening exercise for muscles of the upper extremity,
cold packs, elbow joint mobilisation) administered to
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patients with lateral epicondylitis. The authors reviewed
and divided charts of 112 participants into two groups of
the cervical spine manual therapy plus local management
(n = 51) versus local management alone (n = 61). The selfreported outcome of success (i.e., return to all functional
activities without recurrence of elbow symptoms after
discharge from physical therapy) was ascertained via telephone follow-up interviews (72–74 weeks after discharge)
with a response rate of 85% (95 responders). Compared to
the local management group, the cervical spine manual
therapy group experienced a numerically higher rate of
success in fewer visits. In a non-randomised controlled
experimental trial of low quality [85] manual therapy (soft
mobilisation of the cervical spine/cervicothoracic junction
and flexion mobilisation in the cervical joints) plus
extracorporeal low-energy shockwave therapy (ESWT)
was compared to that of ESWT alone given to 60 participants with chronic lateral epicondylitis. At 12 months of
follow-up, both treatment groups experienced significant
improvements in pain compared to baseline. However,
there was no statistically significant difference between
groups.
Summary: Inconclusive (non-favourable) evidence was
found for the treatment of lateral epicondylitis (tennis
elbow) with manipulation alone (no change from the UK
evidence report). The reviewed evidence indicated some
benefits of manual therapy in reducing symptoms in
patients with lateral epicondylitis, when in combination
with other treatments (exercise, traditional physiotherapy,
local management, standard therapy), when compared to
no treatment, or baseline values (within-group change),
however, the evidence was still rated inconclusive
(favourable) evidence (no change from the UK evidence
report). When comparing manual therapy to other treatments (e.g., placebo, phonophoresis, low-energy shockwave
therapy, relative rest), there was inconclusive or inconsistent (favourable) evidence (no change from the UK
evidence report).
Shoulder conditions Fifteen new or additional systematic
reviews [60,86-99] were identified that included assessments of manual therapy for shoulder pain and disorders
with inconclusive results in the UK evidence report, as
well as twelve new or additional RCTs [100-112]. However, eleven of the reviews were either included in other
more comprehensive reviews or did not include any studies in addition to those in the UK evidence report or to
those included in more specific reviews, [60,89-93,95-99]
and nine of the RCTs were included in relevant new
reviews and will therefore not be described separately
here [100,101,104-110]. The remaining systematic reviews
were rated medium quality [86-88,94]. The new RCTs not
described in any of the reviews were of high [103,111] and
medium [112] quality.
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In one of the new systematic reviews, [86] the authors
examined the effects of manipulative therapy with or
without multimodal therapy for shoulder disorders. They
identified 23 RCTs, five non-randomised trials, and seven
non-controlled primary studies. The included studies used
a variety of intervention techniques including mobilisation, manipulation with and without exercise, combination
with soft tissue treatment in some studies, mobilisation
with movement, myofascial treatments, and cervical lateral glide mobilisation. Each condition category examined
(other than shoulder osteoarthritis) included at least one
high quality study. The authors concluded that for rotator
cuff disorders and for shoulder complaints, dysfunctions,
disorders or pain, there was fair evidence for manual and
manipulative therapy of the shoulder, shoulder girdle and/
or full kinetic chain combined with multimodal or exercise
therapy; similarly for frozen shoulder (adhesive capsulitis),
there was fair evidence for manual and manipulative therapy of the shoulder, shoulder girdle and/or full kinetic
chain combined with multimodal or exercise therapy
(manual therapy included high velocity low amplitude
manipulation, mid-or end-range mobilisation, mobilisation with movement). For shoulder soft tissue disorders
there was fair evidence for using soft tissue or myofascial
treatments (ischaemic compression, deep friction massage,
therapeutic stretch). For minor neurogenic shoulder pain
there was limited evidence for cervical lateral glide mobilisation and/or high velocity low amplitude manipulation
with soft tissue release and exercise. There was insufficient
evidence for the manual treatment of shoulder osteoarthritis (no trials in this patient group). Another medium
quality systematic review [87] examined the effectiveness
of manual therapy for impingement-related shoulder pain.
They considered systematic reviews, RCTs and quasi-RCTs
of manual or exercise therapy in patients with pain arising
locally in a shoulder with grossly abnormal mobility. The
review included eight systematic reviews and six RCTs, of
which three included exercise interventions only and three
included both exercise and manual therapy (mobilisation).
Of the included reviews, five reported evidence to favour
manual therapy plus exercise over exercise alone. The evidence from the three additional RCTs was inconclusive,
but with a tendency towards improved outcomes with
interventions including both manual therapy and exercise.
No evidence was found for the effectiveness of mobilisation alone. None of the systematic reviews and only one of
the RCTs included a specific statement on adverse events;
in the one RCT no adverse events were reported. The authors concluded that there is limited evidence to support
the effectiveness of manual therapy and exercise interventions for impingement-related shoulder pain. This
primarily related to sub-acute and chronic complaints and
short and medium term effectiveness, with the conclusions
being based on research of varying methodological quality,
Page 12 of 34
with varying risk of bias, and affected by weaknesses in
the reporting quality. Cautious interpretation was also
warranted due to the heterogeneity of populations, interventions and outcomes.
A medium quality systematic review [88] examined
the effectiveness of manual physical therapy for painful
shoulder conditions. Treatment had to be by physical
therapists and manual therapy interventions including
low and high velocity mobilisations had to be directed
at the glenohumeral joint only, without mobilisation of
adjacent structures. Seven RCTs with a mean PEDro
quality score of 7.86 of 10 (range 6 to 9) were included,
and interventions included mobilisation with movement,
the Cyriax approach, and static mobilisation performed at
end-range or mid-ranges of motion. Of the included trials,
three examined mobilisation with movement and two of
these found a significant improvement in range of motion
in the intervention group compared to the control, while
the highest percentage change in range of motion was
found in the intervention group in the third study. Significant improvement in pain compared to control was seen
in one of two studies, and significant functional improvement in one study and highest percentage change
in function in a second study. One study on Cyriax
manual therapy found significant improvement in range
of motion compared to the control, while three studies
examining mobilisation at the end-range of motion all
found a significant improvement in range of motion and
end-range mobilisation compared to the control, while
two studies reported no significant change in pain measures
and two of three studies reported significantly improved
function compared to the control. Mid-range mobilisation
appeared to be less effective with no effect on range of
motion or function and only one of four studies reporting
a significant improvement in pain. The review authors
concluded that the included studies demonstrated a benefit of manual therapy for improvements in mobility and a
trend towards improving pain measures, while increases
in function and quality of life were questionable. Similarly,
Pribicevic et al. [94] examined in their medium quality
review the effectiveness of manipulative therapy for the
treatment of shoulder pain (excluding adhesive capsulitis). Treatment had to include a manipulative thrust
technique (chiropractic or physiotherapy). The authors
included 22 case reports, four case series, and four
RCTs. The RCTs had quality scores of 5 to 8 out of 10.
One included chiropractic manipulations and three included physiotherapeutic manipulations. All trials provided some limited evidence that the groups receiving
the manipulation intervention had better outcomes (in
terms of pain, recovery, improvement) than the control
groups. The authors concluded that the evidence was
limited, as only two RCTs of reasonably sound methodology could be identified and that there is need for
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well-designed trials investigating multi-modal chiropractic
treatment.
A low quality RCT examined the effects of manual
therapy (mobilisation of the glenohumeral joint and soft
tissues using Kaltenborn’s roll-glide techniques, Cyriax
deep transverse massage, Mulligan’s mobilisation with
movement and typical techniques of glenohumeral joint
mobilisation in the anteroposterior direction) in 30 patients with chronic rotator cuff injury [102]. The duration
of the treatment was unclear (at least 15 treatments) and
the intervention was combined with standard rehabilitation (TENS, ultrasound, exercise). A range of mobility
parameters as well as pain were significantly more improved in the manual therapy group than in the control
group after the intervention. The authors did not report
on adverse effects. Another RCT [103] was high quality
and examined the effects of myofascial trigger point
treatment in 72 patients with chronic unilateral nontraumatic shoulder pain (excluding adhesive capsulitis).
The treatment involved inactivation of active myofascial
trigger points by manual compression, which was combined with other manual techniques, namely deep stroking or strumming and intermittent cold application.
Patients were also instructed to perform simple gentle
static stretching and relaxation exercises at home several times a day to apply heat and received ergonomic
advice. There was a ‘wait and see’ control group that
received physiotherapy after the trial period. Treatment
was given once a week for up to 12 weeks. After 12 weeks,
the patients in the intervention group had significantly improved values for disability (DASH questionnaire), current
pain, pain in the past seven days and most severe pain in
the past seven days compared to the control. The Global
Perceived Effect was also significantly better in the intervention than in the control group (55% versus 14% with
improvement), as was the number of muscles with active
trigger points. The authors did not report on adverse
effects. A medium quality RCT [112] compared therapy
according to the fascial distortion model with classic manual therapy in 60 patients with frozen shoulder. Patients
received four treatment sessions over four weeks. Six
weeks after the end of treatment function and pain improved in both groups, but significantly more so in the
fascial distortion model group than in the classic manual therapy group. Patients found the fascial distortion
model treatment more uncomfortable than classic manual
therapy, but no serious adverse effects were seen. A high
quality RCT [111] compared the effectiveness of endrange mobilisation/scapular mobilisation treatment in
addition to standard physical therapy, compared to
standard therapy alone in 34 patients with frozen shoulder
syndrome. The main treatment groups included patients
meeting criteria from a kinematics prediction, and an
additional control group included patients not fulfilling
Page 13 of 34
the criteria. Treatment was provided twice weekly for
eight weeks. At eight weeks, results for several range of
motion parameters and function were significantly better
for the intervention group fulfilling the criteria compared
to the control group fulfilling the criteria. However, there
was no difference between the intervention group and
the control group not fulfilling the criteria. These results
supported the use of a prediction method.
Summary: Moderate (positive) evidence for use of
manual therapy combined with exercise in the treatment
of rotator cuff disorders (change from inconclusive
(favourable) evidence in UK evidence report). Inconclusive
(favourable) evidence for the effectiveness of mobilisation
with movement (not evaluated in UK evidence report) or
osteopathy (Niel-Asher technique) (not evaluated in UK
evidence report) or manual therapy with exercise in the
treatment of adhesive capsulitis (not evaluated in UK
evidence report). Inconclusive (favourable) evidence for
the effectiveness of cervical lateral glide mobilisation and/
or high velocity low amplitude manipulation with soft
tissue release and exercise in minor neurogenic shoulder
pain (not evaluated in the UK evidence report). Moderate
(positive) evidence for using myofascial treatments (ischaemic compression, deep friction massage, therapeutic
stretch) for soft tissue disorders of the shoulder (not evaluated in the UK evidence report).
Temporomandibular disorders One systematic review
protocol [113] and five RCTs [114-118] (3 low quality,
[115,116,118] 2 high quality [114,117]) were identified
on manual therapy for temporomandibular disorders.
Craane et al. [114] conducted a high quality RCT of 49
participants with temporomandibular closed lock who
either received physical therapy (including joint mobilisation, exercises, and massage) or a control treatment. Over
a year of follow-up, all pain variables decreased, and all
function variables increased significantly over time for
both groups, but there was no significant difference between the groups. In a low quality RCT, [116] 50 adults
with temporomandibular disorders were randomised
to receive osteopathic manual therapy or conventional
conservative therapy (oral appliance, physical therapy,
hot/cold packs, transcutaneous electrical nerve stimulation) for 6 months. At 8 months of follow-up, the osteopathic group compared to the conventional conservative
therapy group experienced significant improvement in
maximal mouth opening and lateral movement of the
head around its axis, but the mean jaw pain score between
the two groups was not significantly different. In a high
quality RCT, [117] 30 participants with myogenous
temporomandibular disorders were randomly assigned
to receive one of the three treatments for 5 weeks:
intra-oral myofascial therapy (IMT), IMT plus self-care
(mandibular home exercises) and education (lecture on
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basic temporomandibular joint anatomy, biomechanics, disc displacement, dysfunction), or no treatment. At
6 months of post-treatment follow-up, both IMT groups
compared to no treatment group experienced significant
improvements in pain scores at rest, opening, and clenching (p < 0.01). Moreover, the IMT alone group had a
significant improvement in pain at rest (p = 0.04), pain
on opening (p < 0.01), and opening range (p < 0.01) compared to IMT combination with education and self-care. A
low quality randomised trial [118] compared the effectiveness of a single manipulation procedure plus nonsteroidal anti-inflammatory drugs (NSAIDs) to that of
NSAIDs alone in 305 adults with temporomandibular
joint disc displacement (closed lock). The total success
rate for the manual therapy group during the entire
follow-up time was 172/204 (84.3%) while the success
rates in the control group were 0%. No formal comparisons between intervention and control groups were presented. In a low quality RCT, [115] 30 patients with
myofascial pain lasting for at least six months were randomised to a single session of botulinum toxin injections or
multiple session fascial manipulation (three 50 min sessions over two to four weeks). At three months follow-up,
there were significant reductions in pain perception in
both groups, but no significant difference between groups
in most of the parameters measured. There was a tendency towards greater pain reduction in the manipulation
group and greater increase in range of motion in the botulinum toxin group.
Summary: Results on the comparative effectiveness/
safety of manual therapy for temporomandibular disorders
remain inconclusive (favourable) evidence for mobilisation, massage, myofascial or osteopathic manipulation (no
change from the UK evidence report).
Headache and other conditions
Table 6 provides a comparison between the overall evidence ratings included in the UK evidence report and
new/additional studies in the current review for headache and other conditions.
Cervicogenic headache Two new high quality systematic
reviews, [119,120] one high quality RCT [121] and one
medium quality RCT [122] were identified on manual
therapy for cervicogenic headache.
A high quality systematic review [120] evaluated the
effects of spinal manipulative therapy on cervicogenic
headache. The results from six of nine trials suggested
that spinal manipulative therapy was more beneficial in
treating the headaches compared to physical therapy,
light massage, drug therapy, or no intervention. The
remaining three trials showed no significant difference
in headache intensity, duration, or frequency between
spinal manipulative therapy and placebo, physical therapy,
Page 14 of 34
massage, or wait list controls. The systematic review by
Chaibi et al. [119] did not include any new evidence in
addition to the studies already identified and concluded
that while the relevant RCTs suggested that physiotherapy
and spinal manipulative therapy might be an effective
treatment in the management of cervicogenic headache
the studies were difficult to evaluate as only one included
a non-treatment control group and most included participants with infrequent cervicogenic headache. One high
quality RCT [121] compared the effects of temporomandibular manual therapy techniques plus cervical manual
therapy to cervical manual therapy alone in 43 adults with
cervicogenic headache. At 6 months of follow-up, the
experimental group experienced significantly reduced
headache intensity and temporomandibular measures
(pain intensity during mouth opening, presence of deviation, and sounds) compared to the control. In a medium
quality RCT, [122] 38 patients with recurrent headache
and neck pain for at least two months (age 18 to 40 years)
were randomised to mobilisation or massage (12 treatment
sessions over 6 weeks for each treatment). Mobilisation
involved low velocity/high amplitude oscillatory movements to the upper cervical vertebrae. Massage included
myofascial release, manual cervical traction, trigger point
therapy, facilitated stretching techniques. All participants
also followed a programme of stretching and active exercises. In both groups, headache was significantly reduced
after the intervention and function was significantly increased, but for most variables, the improvements were
significantly greater in the cervical mobilisation group.
Summary: Moderate (positive) evidence for mobilisation techniques in cervicogenic headache (change from inconclusive (unclear) evidence in the UK evidence report).
Inconclusive (non-favourable) evidence for friction
massage and trigger points in cervicogenic headache
(no change from the UK evidence report).
Tension-type headache Four new and additional RCTs
[123-127] (3 medium quality, [124-127] 1 low quality [123])
assessed the effects of manual therapy in tension-type headache. A new systematic review [128] did not include any
evidence over and above the studies already considered by
the UK evidence report and concluded that the evidence
that spinal manipulation alleviates tension type headaches
was encouraging, but inconclusive.
A low quality RCT [123] compared the effects of a
direct versus an indirect myofascial release technique
with control (soft stroking) in the treatment of tensiontype headache. Sixty-three patients received one hour
sessions twice a week for 12 weeks. Days with headache
and headache frequency were reduced significantly more
in both interventions groups than in the control group.
There were no statistically significant differences between
the two myofascial release groups and no serious adverse
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Table 6 Comparison of evidence in UK evidence report and current review for headache and other conditions
Condition
Intervention
UK evidence report evidence
New/additional evidence
Inconclusive
Inconclusive
Moderate
High
Moderate
New evidence?
High
Headache and other
Cervicogenic headache
Tension-type headache
Spinal manipulation
Positive
Positive
No
Self-mobilising apophyseal
glides
Positive
Positive
No
Friction massage and trigger
points
Non-favourable
Mobilisation
Unclear
Spinal manipulation
Unclear
Non-favourable
No
Positive
Yes
Unclear
Yes
Osteopathic care
Favourable
Yes
Spinal mobilisation
Favourable
Yes
Miscellaneous headache
Mobilisation
Cervicogenic dizziness
Self-mobilising apophyseal
glides
Favourable
Positive
Manipulation/mobilisation
Balance in elderly people
Diversified chiropractic care
Fibromyalgia
Spinal manipulation
Unclear
Positive
Yes
Positive
No
Favourable
Yes
Unclear
Yes
Unclear
No
Cranio-sacral therapy
Favourable
Favourable
Yes
Massage-myofascial release
therapy
Favourable
Favourable
Yes
events. In their medium quality RCT, Anderson et al.
[124] assessed the effect of adding osteopathic manual
treatment to progressive muscular relaxation exercise
compared to progressive muscular relaxation exercise
alone in 29 patients with tension-type headache. Two
weeks after the four week treatment, patients who received the combination treatment experienced a significantly reduced frequency of headache compared to
patients assigned to progressive muscular relaxation
exercise alone. The between-group differences for other
headache parameters (headache rating, headache index,
and headache intensity) were not statistically significant.
In another medium quality RCT, [125,126] the effectiveness of manual therapy (cervical/thoracic spine mobilisation, exercises, postural correction) was compared to usual
care by the general practitioner in 82 patients with chronic
tension-type headache. Immediately after the end of treatment (at eight weeks), patients in the manual therapy group
experienced significantly greater improvements in headache
frequency, headache pain intensity, headache-related disability, cervical range of movement, and endurance of the
neck flexor muscles, than the control group, but not in
the use of pain medication. At 26 weeks of follow-up, the
between-group differences were maintained significant
only for headache frequency and headache pain intensity
in favour of manual therapy. The medium quality RCT by
Vernon et al. [127] compared the effectiveness of cervical
manipulation, medical treatment (10–25 mg/day amitriptyline), and a combination of the two treatments in 20
adults with tension-type headache. The treatment duration was 14 weeks. There was a significant effect of the
combination treatment compared to each treatment alone
on headache frequency.
Summary: Inconclusive (favourable) evidence for
manual therapy (osteopathic care, spinal mobilisation)
in treating tension-type headache (not evaluated in the
UK evidence report). Inconclusive (unclear) evidence
for spinal manipulation in treating tension-type headache
(no change from the UK evidence report).
Miscellaneous headaches Two medium quality systematic reviews [129,130] and two medium quality RCTs
[131,132] were identified on manual therapy for miscellaneous headaches.
The systematic review by Bryans et al. [129] investigated
evidence on benefits and harms of manual therapy/chiropractic treatment in adults with miscellaneous headaches
(migraine, tension-type headache, cervicogenic headache).
The review included 21 relevant publications including
the following: 11 randomised trials, 5 controlled trials, and
5 systematic reviews. The reviewed evidence indicated
benefits of spinal manipulation for adults with episodic/
chronic migraine and cervicogenic headache, but not for
those with episodic tension-type headache. Evidence
regarding benefits of spinal manipulation for chronic
tension-type headache was inconclusive. Cranio-cervical
mobilisation and joint mobilisation were shown to be of
benefit for episodic/chronic tension-type headaches and
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cervicogenic headache, respectively. Evidence regarding
benefits of manual traction, connective tissue manipulation,
Cyriax’ mobilisation or exercise for tension-type headaches
was inconclusive. Harms were adequately reported in only
six trials and overall risks were low. Another systematic
review [130] investigated if 6–12 visits to a chiropractor to
receive spinal manipulative therapy or mobilisation would
confer benefits for adults with headaches. The review included 47 randomised trials. The results did not support
claims of restricting chiropractic care to 6–12 visits. The
data indicated that a minimum of 24 visits would be
needed to stabilise headaches.
A medium quality RCT [131] compared the effectiveness of 6-week manual therapy (combination of spinal
mobilisation and stabilising exercise) plus usual care
(education, prophylactic and attack medication) to that
of usual care alone in 37 adults with miscellaneous
headaches (tension-type, cervicogenic, migraine). There
were no significant between-group differences in perceived
effect, headache impact test-6, headache frequency, pain
intensity, medication intake, and absenteeism at 26 weeks
of follow-up. A pilot RCT of medium quality [132] compared the effects of manual therapy (Trager approach:
gentle mobilisation of the joint areas of the head, neck,
upper back, and shoulders), attention treatment (visit and
discussion with physician about medication intake, previous week’s headaches, and perception of well-being), or
no treatment (i.e., only medication group) in 33 participants taking pain medication for miscellaneous chronic
headaches (i.e., tension-type, cluster, migraine). At 6 weeks
of follow-up, both the manual therapy and attention
groups experienced a significantly greater mean reduction
(from baseline) in headache duration compared to the no
treatment control group, as well as a greater improvement
in quality of life. There was no significant difference between groups in post-treatment or between-group differences in mean change of medication use, headache
intensity, and the number of headache episodes.
Summary: Moderate (positive) evidence for manipulation and mobilisation for miscellaneous headache (change
from inconclusive (favourable) evidence in the UK evidence report).
Fibromyalgia Three medium quality systematic reviews
[133-135] assessed manual therapy in patients with fibromyalgia. However, two reviews [133,134] did not include
studies not already included in the UK evidence report
and both concluded that there is insufficient evidence
to support the effectiveness of manual therapy in the
treatment of fibromyalgia. The other medium quality
review [135] only included three very small studies
(<25 participants) on manipulative (chiropractic or osteopathic) therapy and concluded that there was not enough
evidence for the effectiveness of manipulative therapy in
Page 16 of 34
fibromyalgia. Two new RCTs (1 medium quality, [136] 1
low quality [137]) not included in any systematic reviews
were identified.
The medium quality RCT assessed the effects of craniosacral therapy in 92 women with fibromyalgia [136]. After
20 weeks of treatment, there was a significant improvement in the clinical global impression of improvement
and the clinical global impression of severity and a significant reduction in pain at 13 of 18 tender points. However,
most of these differences were not maintained one year
after the treatment. The low quality RCT [137] assessed
the effects of massage-myofascial release therapy in 59
patients with fibromyalgia. After 20 weeks of treatment,
there was a significant improvement in pain (VAS), at 8
of 18 tender points, and four of eight quality of life domains
(SF-36). Most of these changes were not maintained six
months after the intervention.
Summary: Inconclusive (favourable) evidence for the
use of chiropractic spinal manipulation in fibromyalgia
(no change from the UK evidence report). Inconclusive
(favourable) evidence for effectiveness of cranio-sacral
therapy and massage-myofascial release therapy for
fibromyalgia.
Non-musculoskeletal conditions
Table 7 provides a comparison between the overall evidence ratings included in the UK evidence report and
new/additional studies in the current review for nonmusculoskeletal conditions.
Asthma We identified three additional systematic reviews
on manual therapy for asthma, [138-140] one additional
medium quality RCT of cranio-sacral therapy for asthma
in adults, [141] and one high quality qualitative study on
complementary therapy use in patients with asthma [142].
Only one medium quality systematic review [139] included
relevant studies over and above those already included in
other reviews.
The review investigated chiropractic treatment for
asthma and included eight studies, of which three were
RCTs and one was a CCT, while the rest were uncontrolled studies. Three of the included studies were in
children. In the comparative studies, no significant differences between comparison groups were seen in respiratory parameters, symptoms or subjective measures. In the
uncontrolled studies, improvements were generally seen
in subjective measures – however, improvements in subjective measures were also seen in the control groups of
comparative studies. Only one study reported on adverse
events (none reported). The review authors concluded
that some patients may experience chiropractic care as
beneficial, but overall there were no significant effects
in any outcomes versus sham treatment. However, the
quality of the evidence was generally poor and more
Condition
Asthma
Intervention
Cancer care
New/additional evidence
Inconclusive
Inconclusive
Spinal manipulation
Osteopathic manual therapy
Attention deficit hyperactivity disorder
UK evidence report evidence
Moderate
Negative
Favourable
High
Moderate
New evidence?
High
Unclear
yes
Favourable
no
Cranio-sacral therapy
Favourable
yes
Osteopathic treatment
Unclear
yes
Chiropractic care
Unclear
Massage including myofascial release/strain/
counterstrain
yes
Positive
Manipulation in osteosarcoma
Negative
yes
yes
Cerebral palsy
Osteopathic manual therapy (cranio-sacral,
cranial, myofascial release)
Unclear
yes
Chronic fatigue syndrome/myalgic encephalomyelitis
Osteopathic manual therapy
Favourable
yes
Chronic pelvic pain
• interstitial cystitis/painful bladder syndrome/chronic
prostatitis
Myofascial therapy
Favourable
yes
• chronic pelvic pain in women
Distension of painful pelvic structures
Favourable
yes
• chronic prostatitis/chronic pelvic pain/female
urination disorders
Osteopathic manual therapy
Favourable
yes
Cystic fibrosis
Mobilisation
Unclear
yes
Paediatric dysfunctional voiding
Osteopathic manual therapy
Favourable
yes
Paediatric nocturnal enuresis
Spinal manipulation
Infant colic
Spinal manipulation
Dysmenorrhoea
Spinal manipulation
Cranial osteopathic manual therapy
Favourable
Negative
Favourable
Favourable
no
Favourable
yes
Favourable
Negative
Unclear
no
Negative
no
Premenstrual syndrome
Spinal manipulation
Unclear
no
Menopausal symptoms
Fox’s low force osteopathic technique plus
cranial techniques
Favourable
yes
Gastrointestinal disorders•reflux disease,
duodenal ulcer
Spinal manipulation
Unclear
yes
• irritable bowel syndrome
Osteopathic manual therapy
Hypertensionstage 1 hypertension
Spinal manipulation added to diet
Favourable
Negative
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Table 7 Comparison of evidence in UK evidence report and current review for non-musculoskeletal conditions
yes
Negative
no
Favourable
Favourable
no
Instrument assisted spinal manipulation
Unclear
Unclear
no
Osteopathic manual therapy
Unclear
yes
Gonstead full spine chiropractic care
Unclear
yes
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Upper cervical (NUCCA) spinal manipulation
Intermittent claudication
Osteopathic manual therapy
Favourable
Venous insufficiency
Myofascial release manual therapy combined
with kinesiotherapy
Favourable
Insomnia
Spinal manipulation
Unclear
yes
Otitis media
Osteopathic manual therapy
Parkinson’s disease
Osteopathic manual therapy
Pneumonia in elderly adults
Osteopathic manual therapy
Chronic obstructive pulmonary disease in
elderly adults
Osteopathic manual therapy
Back pain during pregnancy
Spinal manipulation
Unclear
Favourable
yes
Unclear
no
Favourable
yes
Favourable
no
Favourable
yes
Favourable
yes
Care during labour/delivery
Spinal manipulation
Unclear
yes
Care of preterm infants
Physiotherapeutic/osteopathic manual therapy
Unclear
yes
Surgery rehabilitation
Osteopathic manual therapy
Favourable
yes
Stroke rehabilitation
Mobilisation
Unclear
yes
Systemic sclerosis
McMennell joint manipulation
Unclear
yes
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Table 7 Comparison of evidence in UK evidence report and current review for non-musculoskeletal conditions (Continued)
Page 18 of 34
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evidence is required using valid and reliable outcome
measurements.
The medium quality RCT [141] included 89 adults
with asthma and compared the effects of cranio-sacral
therapy only, acupuncture only, combined cranio-sacral
therapy and acupuncture, attention control and waiting
list control. The study was underpowered for this number
of comparison groups and as no significant difference
could be found between the intervention groups and between the control groups, intervention groups and control
groups lumped together (i.e. no results were presented for
cranio-sacral therapy alone). The intervention groups
(acupuncture and/or cranio-sacral therapy) showed no
significant difference to the control groups in pulmonary
function measures or depression (Beck Depression Scale),
however, medication use was significantly reduced both
post-intervention and at six months follow-up in the
intervention groups (i.e. the same lung function could be
maintained at a lower level of medication use), and the
Asthma Quality of Life score was significantly more improved post-intervention (not at six months follow-up)
than in the control groups. An effect of provider continuity was also found, with the effects on quality of life being
stronger in the groups having had 12 treatment sessions
with a single provider, and with these groups also having a
significantly reduced anxiety level (Beck Anxiety Interventory). No adverse effects were seen.
In the qualitative study, [142] 50 patients with asthma
(21 adults and 29 children with their parents) were interviewed about their use of complementary therapies. Of
these, 13 did not use complementary therapies. Reasons
for non-use of complementary therapies included general
scepticism, trust in conventional doctors, and not having
tried any complementary therapies yet, despite being
interested and open. The main complementary therapies
used by the rest were breathing techniques (e.g. the
Buteyko Method) and homeopathy, with some reported
use of chiropractics, osteopathy and cranial osteopathy.
Reasons for using complementary therapies included concerns about the side effects of conventional medications,
medication dependency, and medication escalation (push
factors). Pull factors included the desire for more natural
or non-invasive treatments, the quality of the consultation
(holistic approach, time taken, listening), a commitment
to alternative philosophies of health, and experiences of
effectiveness. Other important factors included the fact
that complementary therapy use provided a greater scope
for self-help and taking control, and that it allowed an
exploration of a broader range of causes of asthma than
conventional approaches. No specific statements on the
views of manual therapy were offered.
Summary: Inconclusive (unclear) evidence for use of
spinal manipulation in treating asthma (change from
moderate (negative) evidence in the UK evidence report).
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Inconclusive (favourable) evidence for osteopathic manual therapy in treating asthma (no change from UK evidence report). Inconclusive (favourable) evidence for
cranio-sacral therapy in treating asthma (not evaluated
in the UK evidence report).
Attention Deficit/Hyperactivity Disorder (ADHD)/
Learning disabilities One medium quality systematic
review [143] and two low quality RCTs [144,145] were
identified on the use of manual therapy in children or
adolescents with attention deficit/hyperactivity disorder
(ADHD).
One systematic review [143] sought to assess the effects
of chiropractic treatment in children or adolescents with
ADHD. However, the authors found no studies fulfilling
their inclusion criteria. The two low quality RCTs – that
had very limited descriptions of study methodology and
the study populations – both assessed the effects of osteopathic treatment of children with ADHD. Children had
three [145] and four [144] osteopathic treatments separated
by several weeks. Both trials reported improved outcomes
on the ADHD Connors scale for the intervention group
compared to the control group, however, no statistical
analyses were reported.
Summary: Given the severe methodological limitations
of the included studies, there is inconclusive (unclear) evidence regarding the effectiveness of osteopathic treatment
for ADHD (not evaluated in the UK evidence report).
Cancer care One low quality systematic review [146]
assessed chiropractic care of patients with cancer. No
comparative studies were identified. While the review
reports evidence that patients with cancer frequently
consult chiropractors, no evidence regarding the effects
of the chiropractic treatment was reported. Two high
quality RCTs, [147,148] one medium quality, [149] and
one low quality RCT [150] assessed the effects of manual
therapy (myofascial release massage, mobilisation) in
cancer patients. One moderate quality controlled cohort
study [151] assessed adverse effects of manipulative therapy in patients with osteosarcoma.
Cantarero-Villanueva et al. [147] compared an eight
week multimodal programme (core stability exercises
and myofascial release massage, instruction DVD) with
usual care in 78 breast cancer survivors. Immediately
after treatment and at six months, fatigue, mood state,
trunk curl endurance, and leg strength showed greater
improvement in the experimental group compared to
control group. Fernandez-Lao et al. [150] compared
the effect of two 40 min sessions of myofascial release
massage focussed on the neck-shoulder area with usual
care plus 40 minutes attention control in 20 breast cancer
survivors with cancer-related fatigue. After the intervention, a significant improvement was seen in the manual
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therapy group with respect to tension-anxiety, fatigue,
and mood state in general compared to the control.
Lopez-Sendin et al. [148] compared a physiotherapy
intervention (six sessions of about 30 minutes for two
weeks) involving several massage techniques and strain/
counterstrain techniques over the tender points with a
sham touch intervention in 92 patients with terminal cancer and pain. Risk areas were avoided. After the interventions, there was significantly greater improvement in
some pain parameters and in mood in the intervention
group than in the control group. A medium quality RCT
(Pace do Amaral 2012) [149] examined the effects of manual therapy in combination with upper limb exercises with
exercises alone for shoulder rehabilitation in 131 women
after surgery for breast cancer. Manual therapy consisted
in mobilisations and massage. Patients received 12 ± 2 sessions over one month. Shoulder range of motion and
function were significantly improved in both groups, but
there was no significant difference between groups.
With respect to adverse events, one moderate quality
controlled cohort study (Wu 2010) [151] assessed the
prognosis of patients with osteosarcoma who had or had
not had manipulative therapy (patients had sought manipulative therapy because of non-specific symptoms,
not for cancer treatment). Tumour characteristics and
demographic characteristics were similar between the two
groups, however, the patients who had received manipulative therapy had a significantly worse prognosis
over the 42 to 50 month follow-up period than the
non-manipulation group (lower survival rate, more lung
metastases, more local recurrence).
Summary: Moderate (positive) evidence for the effectiveness of massage techniques involving manual therapy
elements in breast cancer survivors and terminal cancer
patients but inconclusive (unclear) evidence for use of
chiropractic care for cancer care (not evaluated in the
UK evidence report). In some types of cancer such as
osteosarcoma, manipulative therapy may have significant
adverse effects and was contraindicated.
Cerebral palsy in children Three RCTs (1 low quality,
[152] two medium quality [153,154]) were identified that
assessed the effects of osteopathy in children with cerebral
palsy. One of the trials was low quality and two were
medium quality. A systematic review [155] on interventions assessing sleep quality in children with cerebral palsy
did not include any studies over and above those already
reviewed.
A low quality trial [152] assessed the effects of osteopathy (cranio-sacral and myofascial release techniques)
versus acupuncture and attention control in 50 children
with cerebral palsy. Outcomes were based on parents’
perceptions only (and parents were not reported to have
been blinded). Statistical differences between groups were
Page 20 of 34
not reported. Most improvements were seen in leg or
hand use and in sleep, and these appeared similar between
the two intervention groups. Improvements in speech/
drooling and cognition appeared to be more for the acupuncture group than the osteopathy group, while there
were similar improvements in mood. The sample number
was small and the significance of any differences between
groups remained unclear. The second trial [153] was
medium quality and again compared osteopathy with
acupuncture or attention control in 55 children with
cerebral palsy. Osteopathy consisted of direct or indirect
techniques in the cranial field and/or myofascial release
(10 sessions over 24 weeks), compared with 30 sessions of
acupuncture (scalp, body and auricular acupuncture).
No significant effects of acupuncture were seen for any
of the gross motor function or disability outcomes, while
osteopathy resulted in a significant effect for two of the six
gross motor and disability outcomes assessed (Gross
Motor Function Measurement percent and Functional
Independence Measure for Children mobility). The medium
quality RCT by Wyatt et. al. [154] compared the effects of
six sessions of cranial osteopathy with an attention control
group in 142 children with cerebral palsy. After six
months, there were no significant differences between
the two groups in gross motor function or quality of life.
Similarly, there were no significant differences regarding
sleep-related parameters, parental assessment of the
child’s pain and main carer’s quality of life. However,
significantly more parents in the osteopathy group rated
their child’s global health as ‘better’ after six months than
in the control group – but parents were not blinded to the
intervention condition.
Summary: Inconclusive (unclear) evidence for the
effectiveness of osteopathic manual therapy in the treatment of cerebral palsy (not evaluated in the UK evidence
report).
Cervicogenic dizziness/balance One high quality systematic review was identified on the effects of manual
therapy with or without vestibular rehabilitation in the
management of cervicogenic dizziness, [156] as well as
one low quality RCT on the effects of chiropractic care
in elderly adults with impaired balance [157] and a
protocol of an ongoing trial on the effects of manual
therapy treatments for people with cervicogenic dizziness
and pain [158].
The high quality systematic review [156] included five
RCTs (three of these were Chinese studies) and eight
non-controlled cohort studies. One of the RCTs was
good quality, while the rest were moderate quality. Six
of the studies (two RCTs) used manipulation/mobilisation
only as an intervention, while the rest used a multimodal
approach. None of the trials used a vestibular rehabilitation intervention. Twelve studies (including all RCTs)
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found an improvement in dizziness and associated symptoms after manual therapy, and two of the RCTs found an
improvement in balance performance. Adverse events
were only reported by three studies, but two of these
found no adverse events and one only minor ones. The
review authors concluded that there is moderate evidence
in a favourable direction to support the use of manual
therapy (spinal mobilisation and/or manipulation) for
cervicogenic dizziness but that research is needed on
combining manual therapy with vestibular rehabilitation.
A low quality RCT [157] compared the effect of a limited or extended course of chiropractic care on balance,
chronic pain, and associated dizziness in 34 older adults
with impaired balance. In the limited chiropractic care
group, patients were treated twice a week for eight weeks
using the diversified technique (manipulation, soft tissue
treatments, hot packs), in the extended schedule group
patients received additional monthly treatments for ten
months. Outcome reporting of falls in this study were
unreliable as patients were asked at each treatment/assessment visit there were unequal numbers of visits between
groups and patients with more visits reported more falls.
There was no significant difference between groups in
scores on the Berg Balance Scale, depression, the Pain
Disability Index, or dizziness.
Summary: Inconclusive (favourable) evidence for the
effectiveness of manipulation/mobilisation for cervicogenic dizziness (not evaluated in the UK evidence report).
Inconclusive (unclear) evidence for diversified chiropractic treatment in the improvement of balance in elderly
people (not evaluated in the UK evidence report).
Chronic fatigue syndrome/myalgic encephalomyelitis
One high quality systematic review was identified that
studied the effects of alternative medical interventions
(including manual therapy) on patients with chronic
fatigue syndrome or fibromyalgia [134]. The authors
identified one low quality RCT assessing the effects of
osteopathic manual therapy in 58 patients with myalgic
encephalomyelitis. In that trial there was a significant
improvement in symptoms in the intervention group
but not in the control group (significant difference between
groups).
Summary: Inconclusive (favourable) evidence for
osteopathic manual therapy improving symptoms of
myalgic encephalomyelitis (not evaluated in the UK
evidence report).
Chronic pelvic pain Two high quality systematic reviews [159,160] and three RCTs (1 medium quality,
[161,162] and 2 low quality [163,164]) were identified
that assessed the effects of manual therapy in chronic
pelvic pain.
Page 21 of 34
A high quality systematic review [159] assessed the
effects of osteopathic manual therapy on female urination disorders. The review included two RCTs and
three CCTs of osteopathic treatment for female urinary
incontinence or voiding disorder. All studies had a high
risk of bias. There was a significant therapeutic effect
of osteopathic treatment (outcome not reported) when
compared with a no treatment control group, but no
difference when compared with pelvic floor muscle
training. Another high quality systematic review [160]
examined the effects of physiotherapy management
(including manual therapy) in women with chronic
pelvic pain. Three RCTs of adequate quality relevant to
manual therapy were included. There was level 1d evidence (high risk of bias) that physiotherapeutic distension of painful pelvic structures combined with pain
counselling improves pain experience compared with
usual treatment.
One medium quality RCT [161,162] compared the effects of 10 weeks of myofascial physical therapy or general
full body Western massage in 47 adults with interstitial
cystitis/painful bladder syndrome or men with chronic
prostatitis/chronic pelvic pain. Overall, significantly more
patients had moderate or marked symptom improvement
with myofascial therapy than with massage therapy
(57% versus 21%, ‘responders’). When considering the
subgroups with interstitial cystitis/painful bladder syndrome or with chronic prostatitis/chronic pelvic pain, a
significant difference between groups was only seen for
the former (50% versus 7%, p = 0.03), while a substantial
proportion of the latter were also ‘responders’ to massage
therapy (64% myofascial therapy, 40% massage therapy).
Significantly more improvement was seen for both the
Interstitial Cystitis Symptom and Problem Index for the
myofascial therapy group than the massage group, while
there was no difference in urinary frequency or urgency,
sexual function, pain, or quality of life (SF-12). A low quality RCT [163] compared the effects of distension of painful pelvic structure (two sessions) in 50 women with
chronic pelvic pain with a counselling control group. At
the end of the treatment, the intervention group had significantly reduced pelvic pain, painful intercourse, low
back pain, sleep disturbance, sleep quality, mental fatigue,
and anger than the control group. There was no significant
difference in depression or mood. Another low quality
RCT [164] compared the effects of eight weeks of osteopathic care with a simple exercise control group in 35 men
with chronic prostatitis/chronic pelvic pain syndrome. Six
weeks after the last treatment, the osteopathy group had
had a significantly improved International Prostate Symptom Score, Chronic Prostatitis Symptom Index, and quality
of life score compared to the control group.
Summary: Inconclusive (favourable) evidence for the
use of osteopathic treatment in female urination disorders
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(not evaluated in UK evidence report). Inconclusive
(favourable) evidence for the use of myofascial therapy
in interstitial cystitis/painful bladder syndrome or chronic
prostatitis/chronic pelvic pain (not evaluated in the UK
evidence report). Inconclusive (favourable) evidence for
distension of painful pelvic structures in chronic pelvic
pain in women and for osteopathic manual therapy in
men with chronic prostatitis/chronic pelvic pain (not evaluated in the UK evidence report).
Cystic fibrosis One small medium quality RCT assessed
the effects of musculoskeletal treatments including mobilisations to the rib cage and thoracic spine in 20 adults
with cystic fibrosis [165]. Patients in the intervention
group received six treatment sessions, patients in the control group received usual care only. After 12 weeks, there
were no significant differences between groups in pain or
FEV1. However, quality of life had increased significantly
more in the intervention group than in the control group.
Summary: Inconclusive (unclear) evidence for the use
of mobilisations (rib cage and thoracic spine) in patients
with cystic fibrosis (not evaluated in the UK evidence
report).
Paediatric dyfunctional voiding One low quality RCT
was identified that assessed manual therapy in paediatric
dysfunctional voiding [166]. Children (n = 21) with vesicoureteral reflux and/daytime incontinence were randomised to standard therapy or standard therapy plus four
sessions of manual physical therapy based on an osteopathic approach. Overall, children who received osteopathic
manual therapy had significantly more (p = 0.008) improvement of symptoms after 10 weeks of treatment than children in the control group, however, significance was not
quite reached in subgroups with vesicoureteral reflux only
or with daytime incontinence only (possibly partially due to
small numbers). Adverse effects were not assessed.
Summary: Inconclusive (favourable) evidence for
osteopathic manual therapy improving symptoms of
paediatric dysfunctional voiding (not evaluated in the
UK evidence report).
Gastrointestinal disorders One additional medium
quality systematic review [167] and two additional low
quality RCTs [168,169] were identified that investigated
manual treatment for gastrointestinal disorders.
The systematic review [167] included one RCT and
one CCT that reported the effects of chiropractic spinal
manipulation in patients with gastroesophageal reflux
disease and duodenal ulcer. Given the paucity and low
quality of the reviewed evidence, the review could not
draw any definitive conclusions regarding the effects of
spinal manipulation versus ischaemic compression or
conventional treatment.
Page 22 of 34
One additional low quality RCT assessed the benefits
and harms of osteopathy compared to standard care at
1, 3, and 6 months of post-baseline follow-up for 39 patients with irritable bowel syndrome [169]. The posttreatment change at 6 months was statistically significant
in favour of osteopathy versus standard care for overall/
global assessment, Functional Bowel Disorder Severity
Index score, and quality of life. Similarly, the end-point
mean symptom score was significantly reduced in favour
of the osteopathy over standard care group. There was no
occurrence of adverse events. A low quality RCT [168]
compared two sessions (at 0 and 7 days) of osteopathy
with sham osteopathy in 30 patients with irritable bowel
syndrome. The severity of irritable bowel syndrome decreased in both groups, but at day 7 the decrease was significantly more marked in the osteopathy group. However,
there was no significant difference between the groups at
the one month follow-up.
Summary: Inconclusive (unclear) evidence for spinal
manipulation for gastrointestinal disorders (not evaluated
in the UK evidence report). Inconclusive (favourable)
evidence for osteopathic manual therapy for irritable
bowel syndrome (not evaluated in the UK evidence
report).
Hypertension We identified one new medium quality
systematic review [170] and one additional medium
quality non-randomised clinical trial not included in any
systematic review [171] on the use of manual therapy in
the treatment of hypertension.
A systematic review [170] examined the effects of spinal
manipulative therapy on hypertension. Results of five
RCTs using a variety of spinal techniques were reported
(Gonstead chiropractic adjusting, NUCCA technique,
“diversified adjustments”, Activator instrument, and osteopathic manipulative therapy). Two included trials with
a low risk of bias found no significant differences for
diversified adjustments plus diet versus diet only or of
Gonstead chiropractic adjusting versus brief massage
or control on systolic or diastolic blood pressure (however,
the trial of Gonstead chiropractic care had a very small
sample size). Of three trials with unclear risk of bias, two
(both using largely only a single adjustment) found a significantly greater reduction of both systolic and diastolic
blood pressure with spinal manipulation using the Activator instrument or the NUCCA technique versus control,
while one trial found no significant difference in a crossover trial between the effects of osteopathic manipulative
therapy and sham massage on blood pressure.
A non-randomised clinical trial [171] examined the
effects of biweekly osteopathic manipulative therapy
plus pharmacological treatment versus pharmacological
treatment only on blood pressure and intima media thickness (femoral and carotid bifurcation) over 12 months in
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63 patients with hypertension. After adjusting for a range
of confounding factors, osteopathic treatment was significantly associated with both a larger decrease in systolic
blood pressure and in intima media thickness than
pharmacological treatment alone.
Summary: Inconclusive (favourable) evidence for upper
cervical NUCCA manipulation for stage 1 hypertension
(no change from the UK evidence report). Inconclusive
(unclear) evidence for instrument assisted spinal manipulation for hypertension (not evaluated in the UK evidence
report). Inconclusive (unclear) evidence for effectiveness
of Gonstead full spine chiropractic care or osteopathic
manipulative therapy for hypertension (not evaluated in
the UK evidence report).
was applied once a week for 10 weeks and follow-up was
at 15 weeks. Four of six menopausal symptoms were
improved in the intervention group after the end of the
intervention period compared to control, and three were
reduced after the five week follow-up period. At the
follow-up, there was also a significant reduction in neck
pain compared to control in those patients who had had
chronic neck pain at the start of the trial; the difference
was nearly significant for back pain (small numbers).
Summary: Inconclusive (favourable) evidence for the
effectiveness of combined use of Fox’s low force osteopathic techniques and cranial techniques in the treatment
of menopausal symptoms (not evaluated in the UK evidence report).
Infantile colic Four potentially relevant new systematic
reviews [138,172-174] including manual treatments for
infant colic were identified. Three of the systematic reviews did not include any new studies not already considered by the UK evidence report or eligible according to
the inclusion criteria of the current review [138,172,174].
A high quality Cochrane review included six relevant
RCTs [173]. Overall, the associated meta-analysis found a
significant reduction in crying time with manipulative
treatment. However, the studies included in the review
were generally small and methodologically prone to bias,
and the authors concluded that it was not possible to arrive at a definitive conclusion about the effectiveness of
manipulative therapies for infantile colic. The review also
included a new high quality RCT [175] of chiropractic
manual therapy that found reduced crying time in the
treated infants, irrespective of parent blinding.
Summary: Inconclusive (favourable) evidence for cranial osteopathic manual therapy in treating infantile colic.
Inconclusive (favourable) evidence for spinal manipulation in treating infantile colic (change from moderate
(negative) evidence reported in the UK evidence report).
Myofascial pain syndrome Two additional medium
quality systematic reviews assessing the effectiveness of
manual therapy in myofascial pain syndrome were identified [178,179]. However, no review included any trials
over and above those mentioned in the UK evidence report. Three additional medium quality RCTs [180-182]
and one low quality RCT [183] were identified on the
effects of manual therapy in people with myofascial pain.
Two trials [180,181] only assessed outcomes immediately after a single treatment and therefore longer term
effects are unclear. In the first trial, [180] the effects of ischaemic compression therapy with trigger point therapy
using the Activator instrument in 52 participants were
compared with active upper trapezius trigger points. Improvements were seen in both groups on pain, pressure
pain threshold and a global impression of improvement,
but there was no significant difference between the two
intervention groups. In the second trial, [181] the effects
of ischaemic compression, trigger point pressure release,
and sham treatment in 45 patients with sub-acute mechanical neck pain were compared with active upper trapezius trigger points. After the intervention, there was no
significant difference between the three groups in neck
pain, pressure pain threshold or lateral cervical flexion.
However, there were significantly more participants in the
ischaemic compression group who reported an improvement (pain reduction of at least 20 mm (VAS)) than in the
sham group. None of the two trials reported on adverse
events. In another trial, [182] 60 patients with nonspecific sub-acute neck pain and active upper trapezius
trigger points were treated 12 times over a period of four
weeks using a muscle energy technique or an integrated neuromuscular inhibition technique (ischaemic
compression plus strain-counterstrain plus muscle energy technique). After the intervention, participants in
the integrated neuromuscular inhibition group had significantly better outcomes for pain, neck disability and
lateral cervical flexion than participants in the muscle
energy group. The authors did not report on adverse
Insomnia One low quality systematic review [176]
assessed the effects of chiropractic spinal manipulative
therapy on primary insomnia. No relevant controlled
studies were identified (the only controlled study mentioned was in fact of healthy volunteers (not mentioned
by the reviewers) and thus no relevant outcomes were
reported).
Summary: Inconclusive (unclear) evidence on the benefits of manual therapy in people with primary insomnia
(not evaluated in the UK evidence report).
Menopausal symptoms One small low quality RCT
[177] assessed the effects of Fox’s low force osteopathic
technique and cranial methods in the treatment of menopausal symptoms in 30 women aged between 50 and
60 years, compared to a placebo procedure. The treatment
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events. Sarrafzadeh et al. [183] compared the effects of
pressure release with those of phonophoresis of hydrocortisone or ultrasonic therapy (six sessions for each
treatment) in 60 women with latent upper trapezius
myofascial trigger points. After the treatment, pain
intensity, pain pressure threshold and active cervical
lateral flexion were significantly more improved in the
pressure release and phonophoresis groups than in the
ultrasound group.
Summary: Inconclusive (favourable) evidence for ischaemic compression (manual or using an Activator instrument) in the deactivation of upper trapezius trigger
points (not evaluated in the UK evidence report). Inconclusive (non-favourable) evidence indicating that trigger
point release is not as effective as ischaemic compression
in deactivating active upper trapezius trigger points and
improving associated neck pain (not evaluated in the UK
evidence report). Inconclusive (favourable) evidence for
an integrated neuromuscular inhibition technique in the
management of neck pain with active upper trapezius trigger points (not evaluated in the UK evidence report).
Otitis media One new high quality systematic review
was identified on the treatment of otitis media in children
with spinal manipulative therapy [184]. One ongoing trial
was identified on a five week standardised osteopathic manipulative medicine protocol plus standard care compared
to standard care only in children between six months and
two years with acute otitis media [185]. One systematic
review [138] did not include any evidence over and above
that already reviewed.
The review by Pohlmann et al. [184] summarised 49
studies of all types (including four clinical trials) but only
limited quality evidence was identified and the authors
concluded that there was currently no evidence to support
or refute using spinal manipulative therapy for otitis
media and no evidence to suggest that spinal manipulative
therapy produces serious adverse effects for children with
otitis media.
Summary: Inconclusive (unclear) evidence for osteopathic manual therapy in treating otitis media (no change
from the UK evidence report).
Parkinson’s disease One small low quality controlled
trial [186] assessed the effect of a single 30 minute session
of osteopathic manual therapy on gait performance in
patients with Parkinson’s disease. Gait parameters were
significantly improved in comparison to the control group,
but no other patient-relevant outcomes were assessed and
long term effects of osteopathic manipulation in Parkinson’s
disease remain unclear. Adverse effects were not assessed.
Additionally, an ongoing trial of different rehabilitation
programmes (involving joint mobilisation) in Parkinson’s
disease was identified [187].
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Summary: Inconclusive (favourable) evidence for the
effectiveness of osteopathic manual therapy in Parkinson’s
disease (not evaluated in the UK evidence report).
Paediatric nocturnal enuresis One high quality new
systematic (Cochrane) review was identified that assessed
the effects of complementary and miscellaneous interventions (including chiropractic) for nocturnal enuresis in
children [188]. However, the review did not include any
new trials fulfilling our inclusion criteria that were not
already considered by the UK evidence report. Another
new high quality systematic review of the use of chiropractic spinal manipulation in paediatric health conditions
[138] also did not include any relevant trials not already
included in the UK evidence report.
Summary: Inconclusive (favourable) evidence for
spinal manipulation in paediatric nocturnal enuresis (no
change from the UK evidence report).
Peripheral arterial disease One medium quality RCT
[189] was identified that assessed the effects of myofascial
release manual therapy combined with kinesiotherapy
compared to kinesiotherapy alone in 65 postmenopausal
women with venous insufficiency. After 10 weeks of treatment (20 sessions of myofascial release manual therapy),
there were significant improvements in basal metabolism,
intracellular water, diastolic blood pressure, venous blood
flow velocity, pain, and emotional role in the myofascial
therapy group compared to control.
One medium quality non-randomised controlled trial
was identified of osteopathic manipulative therapy in patients with intermittent claudication [190]. Thirty male
patients were treated for six months with a variety of
osteopathic manual techniques plus standard pharmacological treatment or standard pharmacological treatment
only. After the six months, patients in the intervention
group had significantly improved values for the anklebrachial pressure index at rest and after exercise, claudication pain time and total walking time on a treadmill, with
no significant changes occurring in the control group
(difference between groups not reported – these were
presumably insignificant). Four of eight quality of life
measures were significantly more improved in the intervention group than in the control group (physical function, role limitations/physical, bodily pain, general
health); there were no significant differences in mental
health, role limitations/emotional, social function or
vitality.
Summary: Inconclusive (favourable) evidence for the
effectiveness of osteopathic manual therapy in the treatment of intermittent claudication and of myofascial release
manual therapy combined with kinesiotherapy in the treatment of venous insufficiency.
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Pneumonia and COPD One high quality Cochrane
review [191] was identified that assessed the effects of
chest physiotherapy in adults with pneumonia, as well as
a medium quality systematic review of manual therapy
for COPD [192] which also included a new medium
quality RCT [193] of osteopathic manipulative treatment
in elderly patients with chronic obstructive pulmonary
disease (COPD). Additionally, we identified a new high
quality RCT of osteopathic manual treatment in severe
COPD [194] which was not included in any of the reviews. There was also an ongoing RCT of osteopathic
manipulative treatment in elderly patients with pneumonia [195]. Another systematic review [140] did not include
any further eligible studies relevant to this section.
A Cochrane review [191] included two RCTs of osteopathic manipulative therapy for adults with pneumonia.
Both included a standardised osteopathic manipulative
treatment protocol versus sham (light touch) treatment
which was applied twice a day for 10 to 15 minutes during
the hospital stay in 21 and 58 patients with a mean age of
77 to 82 years. There was no significant effect of osteopathic treatment on mortality, cure rate, duration of fever,
rate of improvement of chest X-ray, or duration of oral
antibiotic therapy. Hospital stay in the osteopathy group
was significantly reduced by two days compared to control
and both the duration of total antibiotic therapy and intravenous therapy were reduced by about two days in the
osteopathy versus control groups. The review authors
concluded that osteopathic manipulative therapy may
reduce the mean duration of hospital stay and antibiotic
treatment but that further high quality evidence was
needed before chest physiotherapy could be recommended
as an adjunct to conventional therapy in pneumonia in
adults. An ongoing RCT [195] used a second control group
on conventional therapy only. Another systematic review
[192] included seven studies (five RCTS) of manual therapy
for COPD, six of which were rated high risk of bias and
one low risk of bias. Four studies included osteopathic
spinal manipulation, one used massage, one muscle
stretching, and one passive movements. Comparison was
against routine management, light touch or no intervention. After the osteopathic interventions, changes in respiratory parameters were variable, but an improvement
was generally seen in subjective parameters. The authors
concluded that there was no evidence to support or refute
the use of manual therapy techniques in clinical practice
to improve lung function in COPD patients.
The trial by Zanotti et al. [194] compared pulmonary
rehabilitation (exercise training, educational support, psychological counselling, nutritional intervention) plus soft
manipulation with pulmonary rehabilitation plus osteopathic manipulative treatment in 20 patients with stable
severe COPD. Treatment was given five days a week
for four weeks. After the treatment, exercise capacity
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(six minute walk test) improved significantly in both
groups, but significantly more in the group receiving
osteopathic treatment. Furthermore, there was a significant reduction in residual volume in the osteopathy
group (significant difference to control).
Summary: Inconclusive (favourable) evidence for
osteopathic manipulative treatment of pneumonia in
older adults (no change from the UK evidence report).
Inconclusive (favourable) evidence for osteopathic manipulative treatment in patients with COPD (not evaluated
in the UK evidence report).
Pregnancy/obstetric care/neonatal care Two systematic reviews (1 medium quality, [196] 1 high quality [197])
and three medium quality primary controlled studies
[198-200] were identified that reported on the effectiveness of manipulative therapy used in pregnancy, obstetric and/or neonatal care settings, as well as a protocol of
an ongoing trial on osteopathic manipulative treatment
in neonatal intensive care units [201].
One systematic review of medium quality [196] evaluated the evidence on the effects of spinal manipulative
therapy on back pain and other symptoms related to pregnancy. The review identified 32 relevant publications,
most of which were non-randomised and uncontrolled
and their results supported that the use of spinal manipulative therapy during pregnancy was associated with reduced back pain. Evidence regarding labour, delivery and
adverse events were insufficient to be conclusive. The
authors concluded that since there is a limited number
of effective treatments for pregnancy-related back pain,
clinicians might consider spinal manipulative therapy as
a treatment option, if no contraindications are present.
A high quality Cochrane review [197] assessed the effectiveness of massage, reflexology and other manual
methods for pain management in labour. However, all
studies included were of massage therapy and do therefore
not fulfill the inclusion criteria of the current review.
The medium quality RCT [199] randomised 57 pregnant
women with low back pain to exercise, spinal manipulation,
or Neuro-Emotional Technique (treatment once monthly
until 28 weeks gestation, twice monthly until 36 weeks gestation, and weekly thereafter). At least 50% of participants
in each treatment group experienced clinically meaningful
improvement in symptoms for the Roland Morris Disability
Questionnaire. Also at least 50% of the exercise and spinal
manipulation participants experienced clinically meaningful
improvement in pain. However, there were no significant
differences between groups in any of the outcomes. In a
medium quality RCT, [198] 72 very preterm (gestational
age <32 weeks) infants born with very low birth weight
(< 1500 g) were randomised to receive developmental
physical therapy (34 infants) or no physical therapy (38
infants) for 4 months. The Alberta Infant Motor Scale
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(AIMS) was used to assess the effects of physical therapy on motor development in the infants at 4 months
post-randomisation. At the 4-month assessment, there
were no significant differences on AIMS between the
treatment and no treatment groups (the median percentile
rank: 65 versus 72.5, p = 0.191). In a medium quality comparative cohort study of 350 preterm infants during hospitalisation, [200] the authors investigated the effect of
osteopathic manipulative treatment on gastrointestinal
function and length of hospital stay. Osteopathic manipulative treatment in addition to conventional care was compared to conventional care alone. The results indicated
that the infants who had received osteopathic manipulative treatment were at significantly lower risk for having
daily gut symptoms as well as having reduced lengths of
hospital stay compared to the control group.
Summary: Inconclusive (favourable) evidence for spinal
manipulative therapy for back pain during pregnancy
(not evaluated in the UK evidence report). Inconclusive
(unclear) evidence for manual therapy during labour or
delivery (not evaluated in the UK evidence report). Inconclusive (unclear) evidence for manual therapy in
the care of preterm infants (not evaluated in the UK evidence report).
Rehabilitation There were three new and additional
RCTs (1 low quality, [202] 2 medium quality [203,204])
and three non-randomised studies [205-207] (2 low quality
cohort studies, [205,207] 1 medium quality cohort study
[206]) on manual treatments in the rehabilitation of
non-musculoskeletal disorders. Five studies enrolled postsurgery adults receiving manual therapy as part of rehabilitation process. In these studies, participants had
undergone cholecystectomy, [204] abdominal hysterectomy, [202] abdominal surgery, [205] knee/hip arthroplasty [206] and coronary artery bypass graft (CABG)
surgery [207]. In one study, the participants received
manual therapy as a post-stroke rehabilitation treatment [203].
A medium quality RCT [203] randomised 76 adults
after a stroke to receive conventional physiotherapy alone
or with additional three different doses of 30, 60, or
120 minutes of manual therapy (joint/soft tissue mobilisation, massage, tactile stimulation, active-assisted movements, soft tissue stretch, and/or compression) for two
weeks. No statistically significant differences in either
post-treatment Motricity Index or Action Research Arm
Test were observed across the control (conventional
physiotherapy alone) and three treatment groups. There
was no occurrence of adverse events. Sleszynski et al.
[204] randomised 42 adults who had had cholecystectomy to receive a form of spinal manual therapy (i.e.,
thoracic lymphatic pump) or incentive spirometry (IS)
and compared the mean forced vital capacity, forced
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expiratory volume, and incidence of atelectasis (complication of abdominal surgery) between the two treatments
Medium quality trial). The 5-day post-treatment frequency of atelectasis was similar in the two treatment
groups. There was a faster recovery of forced vital capacity
and forced expiratory volume in participants receiving the
manual therapy versus incentive spirometry. A low quality
RCT, [202] randomised 39 women after post-abdominal
hysterectomy to receive placebo (pre- and post-operative),
osteopathic manual therapy (post-operative), morphine
(pre-operative), or the combination of morphine (pre-operative) and osteopathic manual therapy (post-operative).
There were no significant between-group differences in
pain, nausea, or vomiting mean scores at any time of the
48-hour follow-up post-surgery. Total 24-hour postoperative morphine dose was significantly lower in the
pre-operative morphine plus post-operative osteopathic
manual therapy and in the osteopathic manual therapy
groups compared to the pre-operative morphine alone
group.
A retrospective cohort study of low quality explored
the effect of osteopathic manipulative treatment on the
length of hospital stay in adults who had developed ileus
after abdominal surgery [205]. The records of 331 postabdominal surgery participants with diagnosis of ileus
were identified and divided into groups: a) patients who
had received osteopathic manipulative treatment and b)
patients who had not received osteopathic manipulative
treatment. The results indicated a significantly shorter
stay for the osteopathic manipulative treatment recipient
group versus the control group. Yurvati et al. [207] conducted a cohort study to determine the effects of osteopathic manipulative treatment on cardiac haemodynamics
in 29 adults after coronary artery bypass graft surgery.
The treatment group consisted of 10 participants treated
with osteopathic manipulative treatment after surgery and
the control group, identified through a chart review, consisted of 19 subjects who underwent surgery but were not
treated with post-surgery osteopathic manipulative treatment. The treatment and control post-surgery groups
were compared with respect to changes in mixed venous
oxygen saturation and cardiac index. This study was
judged to be of low quality. Mean mixed venous oxygen
saturation and cardiac index improved significantly
more in the osteopathic manipulative treatment group
compared to control. In another cohort study of medium
quality, [206] the authors assessed the effects of osteopathic manipulative treatment on distance walked, days to
independent negotiation of stairs, length of hospital stay,
need for supplemental analgesics, and perception of pain
in 76 adult participants who had knee or hip arthroplasty.
The post-operative mean number of days to independent
negotiation of stairs in the osteopathic manipulative treatment group was significantly shorter compared to the
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control group. There was no statistically significant difference in the distance ambulated, length of hospital stay,
and need for supplemental analgesics.
Summary: Inconclusive (favourable) evidence for
osteopathic manual therapy for surgery rehabilitation (not
evaluated in the UK evidence report – except for knee/hip
arthroplasty). Inconclusive (unclear) evidence for mobilisation for stroke rehabilitation (not evaluated in the UK
evidence report).
Systemic sclerosis Two small low quality RCTs by the
same research group, [208,209] examined the use of
McMennell joint manipulation within the context of a
comprehensive rehabilitation programme for patients
with systemic sclerosis.
The emphasis was on hand involvement, although one
of the studies also examined parameters related to face
involvement. Both trials did not report any formal comparisons between intervention and control groups. In
both trials, some mobility parameters (Hand Mobility in
Scleroderma Test) were improved both after the nine
week intervention and after a nine week post-intervention
follow-up. Some quality of life measures (SF-36) were only
improved after the intervention but not at the nine week
follow-up. In one trial, disability measures were improved
in the intervention group both after the intervention and
at follow-up, while in the other trial the disability improvement did not persist at the follow-up measurement.
However, as these results were not statistically compared
with those of the comparison group (results reported as
unchanged) any benefits of the intervention have to
remain unclear.
Summary: Inconclusive (unclear) evidence for
McMennell joint manipulation used in a complex rehabilitation programme in systemic sclerosis (not evaluated in
the UK evidence report).
No new or additional studies were found for the following conditions: coccydynia, dysmenorrhoea, premenstrual
syndrome.
Adverse events Seven systematic reviews [24,25,28,29,
210-213] and seven primary studies [214-220] were identified specifically concerning adverse events of manual therapy. Mild-to-moderate adverse events of transient
nature (e.g., worsening symptoms, increased pain, soreness, headache, dizziness, tiredness, nausea, vomiting)
were relatively frequent. For example, evidence from high,
medium, and low quality systematic reviews specifically
focussing on adverse events suggested that approximately
half of the individuals receiving manual therapy experienced mild-to-moderate adverse event which had resolved
within 24–74 hours. In agreement with the UK evidence
report, evidence indicated that serious (or major) adverse events after manual therapy were very rare (e.g.,
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cerebrovascular events, disc herniation, vertebral artery
dissection, cauda equine syndrome, stroke, dislocation,
fracture, transient ischemic attack). Evidence on safety of
manual therapies in children or paediatric populations
was scarce; the findings from two low quality cohort studies and one survey were consistent with those for adults
that transient mild to moderate intensity adverse events in
manual treatment were common compared to more serious or major adverse events which were very rare.
However, the evidence on adverse events in manual
therapy warrants caution due to relative paucity of evidence and poor methodological quality of the included
primary studies.
Discussion
The current report summarised new and additional systematic reviews, RCTs and non-randomised primary
studies not included by Bronfort et al. [20] focussing on
conditions/interventions with ‘inconclusive’ or negative’
evidence ratings in the UK evidence report, or those not
included. 178 studies were included. The most common
study design was the RCT. There were relatively few
non-randomised comparative and qualitative studies
meeting the current inclusion criteria.
The majority of conditions previously reported to have
‘inconclusive’ evidence ratings by Bronfort remained the
same. Evidence ratings changed in a positive direction
from inconclusive to moderate (positive) evidence ratings in only three cases (manipulation/mobilisation [with
exercise] for rotator cuff disorder, spinal mobilisation for
cervicogenic and mobilisation for miscellaneous headache). New moderate (positive) evidence was identified
for soft tissue shoulder disorders using myofascial treatments (ischaemic compression, deep friction massage,
therapeutic stretch) not reported in the UK evidence report.
In addition, evidence was identified on a large number
of non-musculoskeletal conditions that had not previously been considered by Bronfort, most of this evidence was rated as inconclusive; although moderate
(positive) evidence was identified for the use of massage including myofascial release/strain/counterstrain
for cancer care.
Despite a noted shortfall in the quality of the evidence,
the current review also supported the “moderate (positive)”
evidence ratings by Bronfort for the use of:
Manipulation/mobilisation (with movement) for
shoulder girdle pain/dysfunction;
High grade mobilisation for adhesive capsulitis;
Myofascial treatments (ischaemic compression, deep
friction massage, therapeutic stretch) for soft tissue
shoulder disorders;
Manipulation/mobilisation (with exercise) for
plantar fasciitis;
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Self-mobilising apophyseal glides for cervicogenic
headache;
Self-mobilising apophyseal glides for cervicogenic
dizziness; and
Massage including myofascial release/strain/
counterstrain for cancer care.
Both Bronfort et al. [20] and the current review considered the evidence for treating a large range of nonmusculoskeletal conditions, but despite finding additional
evidence in some cases, the current review was unable to
change the inconclusive evidence ratings for these conditions including:
Asthma using osteopathic manual therapy;
Paediatric nocturnal enuresis using spinal
manipulation;
Infant colic using cranial osteopathic manual therapy
(although new evidence appeared more favourable
than that reported in the UK evidence report);
Premenstrual syndrome using spinal manipulation;
Stage 1 hypertension using upper cervical (NUCCA)
spinal manipulation;
Stage 1 hypertension using instrumental assisted
spinal manipulation;
Otitis media and pneumonia in elderly adults using
osteopathic manual therapy; and
Pneumonia in elderly adults using osteopathic
manual therapy.
Limitations and strengths
The clinical effectiveness review was limited by the extent
of information provided in the included primary studies
and clinical/methodological diversity of the included evidence. Most studies had small sample sizes and methodological limitations. For the majority of RCTs it was not
clear if the methods for randomization were adequate and
the treatment allocation was appropriately concealed. In
many cases, either the studies were not blinded or the
blinding status of outcome assessors could not be determined. It should be noted that in most situations where
physical treatments were applied, blinding was very difficult or impossible to achieve. The lack of description of
adequacy of randomisation methods, treatment allocation
concealment, and blinding in the studies complicated valid
interpretation of the review results. Furthermore, there
was a substantial clinical and methodological diversity
across the included studies that may have contributed to
the observed inconsistencies in the results. For example,
there has been a large variation in types of manual therapy
and their modes of application across studies, which was
compounded by differences in control treatments thereby
limiting comparability between the study results. Moreover,
the therapy provider’s experience, training, and approaches
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used varied across the trials and this variation may have
additionally impacted on the trial results. The abovementioned clinical diversity limited the extent of statistical
pooling of trial results. Poorly and scarcely reported harms
data limited our ability to make meaningful comparisons
of rates of adverse events between the treatments.
We attempted to take into account a user perspective
by considering qualitative studies, however, we only identified a very limited number of studies reflecting patient
views of manual therapy.
One of the main strengths of the clinical effectiveness
review is its broad scope in terms of reviewed interventions, populations/conditions, and outcome measures.
This review identified, appraised, and summarised a
large amount of relevant literature. The review authors
employed systematic, comprehensive, and independent
strategies to minimise the risk of bias in searching, identifying, selecting, extracting, and appraising the evidence.
The broad search strategy, not restricted by the language
or year of publication, was applied to multiple electronic
and other bibliographic sources.
Research needs/recommendations
The current research has highlighted the need for longterm large pragmatic head-to-head trials reporting clinically relevant and validated efficacy outcomes. If ethically
justifiable, future trials need to include a sham or no treatment arm to allow the assessment and separation of nonspecific effects (e.g., patient’s expectation) from treatment
effects. Furthermore, future research needs to explore
which characteristics of manual therapies (e.g., mode of
administration, length of treatments, number of sessions,
and choice of spinal region/points) are important in terms
of their impact on clinically relevant and patient-centred
outcomes. Also, strong efforts are needed to improve quality of reporting of primary studies of manual therapies.
The following key research needs and recommendations were highlighted from the report findings:
Studies need to be developed that involve qualitative
research methods to explore patient attitudes,
satisfaction with and the acceptability of manual
therapy treatments, this could also take the form of
mixed methods studies exploring both effectiveness
and patient views;
Greater consistency is needed across research groups
in this area in terms of definition of participants,
interventions, comparators and outcomes;
More research is needed on non-musculoskeletal
conditions; and
High quality, long-term, large, randomised trials
reporting effectiveness and cost-effectiveness of
manual therapy are needed for more definitive
conclusions.
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Conclusion
We consider that it is unlikely that the evidence which is
available provides a reliable representation of the likely
success of manual therapy as provided in the UK. The
magnitude of the benefits and harms of all manual therapy interventions across the many conditions reported
on cannot be reliably estimated due to the paucity, poor
methodological quality and clinical diversity of included
studies.
The differences in the therapy providers’ experience,
training, and approaches may have additionally contributed to the inconsistent results. Limited research
has been published on many non-musculoskeletal conditions. There were considerable gaps in the evidence,
inconsistent reporting on techniques and interventions
used (with often a lack of description of techniques),
and many studies failed to consider the generalisability
of the findings to the range of settings in which manual
therapy is practised in the UK.
Additional files
Additional file 1: PRISMA 2009 Checklist.
Additional file 2: Search strategies.
Additional file 3: Data tables for included papers – study
characteristics, results and conclusions.
Additional file 4: Quality assessments of all included papers.
Competing interests
This project is an extension of a report funded by The Royal College of
Chiropractors, available from: http://www2.warwick.ac.uk/fac/med/research/
hscience/pet/reportforcollegeofchiropractors/. The authors declare that they
have no competing interests.
Authors’ contributions
PS and GLH developed the review. CC, AT and PS conducted the review, this
included: screening and retrieving papers, assessing against inclusion criteria,
appraising the quality of papers and abstracting data from papers for
narrative synthesis. RC developed the search strategy and undertook
searches. All authors were involved in writing draft and final versions of the
review. All authors read and approved the final manuscript.
Authors’ information
CC, AT, PS, RC and AC all work in Warwick Evidence at the University of
Warwick and undertake systematic reviews on the clinical and cost
effectiveness of health care interventions for the National Institute for Health
Research Health Technology Assessment Programme on behalf of a range of
policy makers, including the National Institute for Health and Care Excellence
(NICE). AC is a Professor of Public Health Research, Director of Warwick
Evidence and Acting Director of the Division of Health Sciences. GLH is a
Professor of Social Sciences in Health at the University of Warwick.
Acknowledgements
The team would like to thank the following people for their valuable
contributions to the study: Professor Martin Underwood, Mr Simon Briscoe,
Dr Tara Gurung, Ms Sandra Schlager, Ms Amy Grove, Mrs Jas Bains, Ms Bola
Ola, Mrs Hannah Fraser, Dr Beth Hall, Professor Christina Cunliffe, and Dr Gay
Swait. The project was funded by the Royal College of Chiropractors. None
of the authors have other financial relationships with the funders. The
publication of the project results was not continent on the funder’s approval
or censorship of the manuscript.
Page 29 of 34
Author details
1
Populations, Evidence and Technologies, Division of Health Sciences,
Warwick Medical School, University of Warwick, Coventry CV4 7AL, England.
2
Social Science and Systems in Health, Division of Health Sciences, Warwick
Medical School, University of Warwick, Coventry CV4 7AL, England.
Received: 18 October 2013 Accepted: 24 February 2014
Published: 28 March 2014
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doi:10.1186/2045-709X-22-12
Cite this article as: Clar et al.: Clinical effectiveness of manual therapy
for the management of musculoskeletal and non-musculoskeletal
conditions: systematic review and update of UK evidence report.
Chiropractic & Manual Therapies 2014 22:12.
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The Spine Journal 14 (2014) 1106–1116
Clinical Study
Dose-response and efficacy of spinal manipulation for care of chronic
low back pain: a randomized controlled trial
Mitchell Haas, DCa,*, Darcy Vavrek, NDa, David Peterson, DCb, Nayak Polissar, PhDc,
Moni B. Neradilek, MSc
b
a
Center for Outcomes Studies, University of Western States, 2700 NE 132nd Ave., Portland, OR 97230, USA
Division of Chiropractic Sciences, University of Western States, 2700 NE 132nd Ave., Portland, OR 97230, USA
c
The Mountain-Whisper-Light Statistics, 1827 23rd Ave. E., Seattle, WA 98122, USA
Received 26 November 2012; revised 17 July 2013; accepted 22 July 2013
Abstract
BACKGROUND CONTEXT: There have been no full-scale trials of the optimal number of visits
for the care of any condition with spinal manipulation.
PURPOSE: To identify the dose-response relationship between visits to a chiropractor for spinal
manipulation and chronic low back pain (cLBP) outcomes and to determine the efficacy of manipulation by comparison with a light massage control.
STUDY DESIGN/SETTING: Practice-based randomized controlled trial.
PATIENT SAMPLE: Four hundred participants with cLBP.
OUTCOME MEASURES: The primary cLBP outcomes were the 100-point modified Von Korff
pain intensity and functional disability scales evaluated at the 12- and 24-week primary end points.
Secondary outcomes included days with pain and functional disability, pain unpleasantness, global
perceived improvement, medication use, and general health status.
METHODS: One hundred participants with cLBP were randomized to each of four dose levels of
care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated
three times per week for 6 weeks. At sessions when manipulation was not assigned, they received
a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the
no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks.
RESULTS: For the primary outcomes, mean pain and disability improvement in the manipulation
groups were 20 points by 12 weeks and sustainable to 52 weeks. Linear dose-response effects were
small, reaching about two points per six manipulation sessions at 12 and 52 weeks for both variables (p!.025). At 12 weeks, the greatest differences from the no-manipulation control were found
for 12 sessions (8.6 pain and 7.6 disability points, p!.025); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points, p!.025).
CONCLUSIONS: The number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.
Ó 2014 The Authors. Published by Elsevier Inc. Open access under CC BY-NC-SA license.
Keywords:
Chronic low back pain; Dose-response; Spinal manipulation; Chiropractic; Randomized controlled trial
FDA device/drug status: Not applicable.
Author disclosures: MH: Grant: NIH: NCCAM (I, Paid directly to institution). DV: Grant: NIH: NCCAM (I, Paid directly to institution). DP:
Grant: NIH: NCCAM (I, Paid directly to institution). NP: Fees for participation in review activities such as data monitoring boards, statistical analysis, end-point committees, and the like: University of Western States (B).
MBN: Fees for participation in review activities such as data monitoring
boards, statistical analysis, end-point committees, and the like: University
of Western States (B).
The disclosure key can be found on the Table of Contents and at www.
TheSpineJournalOnline.com.
The trial was registered at ClinicalTrials.gov NCT00376350.
* Corresponding author. Center for Outcomes Studies, University of
Western States, 2700 NE 132nd Ave., Portland, OR 97230, USA. Tel.:
(503) 251-5728; fax: (503) 251-2832.
E-mail address: [email protected] (M. Haas)
1529-9430 Ó 2014 The Authors. Published by Elsevier Inc. Open access under CC BY-NC-SA license.
http://dx.doi.org/10.1016/j.spinee.2013.07.468
M. Haas et al. / The Spine Journal 14 (2014) 1106–1116
1107
Introduction
It has long been known that low back pain (LBP) is
a prevalent and costly condition [1,2] and that chiropractors
provide the vast majority of spinal manipulation [3] and
treat a large proportion of LBP in the United States [4].
It is therefore important to determine the optimal quantity
of spinal manipulative therapy (SMT), particularly for
chronic low back pain (cLBP) [5].
Recommendations for duration and frequency of SMT/
chiropractic care for cLBP have varied widely and have long
been based on the clinical experience and opinion [6]. In the
early 1990s, a multidisciplinary RAND panel found that
opinion was too varied to come to a formal evidence-based
consensus (2–24 weeks of care, 1–5 visits per week), but
on average, members expected the typical patient to improve
in 4 to 6 weeks with three visits per week [7]. In contrast, an
all-chiropractic RAND expert panel recommended 30 visits
over 14 weeks [8]. Shekelle et al. [3] noted a range of 1 to 19
visits in the published studies of chiropractic care. Later,
Nyiendo et al. [9] found a mean of 6.7 visits (standard deviation [SD]57.5, range51–56) in a practice-based cohort of
526 nonspecific cLBP patients.
To this day, there is no consensus on the efficacy of SMT
and its role in the care of cLBP. Some systematic reviews
have reported quality evidence in support of SMT [10,11],
whereas others including the latest Cochrane review found
SMT to be no better than other interventions [12]. Results
of systematic reviews, whether meta-analysis or bestevidence synthesis, may depend on the quantity of care used
in the trials included in the reviews. Investigators have had
virtually no evidence from dose-response trials to inform
the number of SMT sessions provided.
Because of the dearth of evidence for duration and frequency of care, we conducted the first pilot randomized
trial evaluating dose-response of SMT (n572) [5]. We
found a clinically important association between number
of visits to a chiropractor (1–4 weekly visits for 3 weeks)
and short-term pain and disability relief showing that
a higher number of visits yielded more favorable results.
We have subsequently conducted the current 5-year study,
the first full-scale dose-response trial with the aim of identifying optimal care of cLBP with SMT and informing the
design of comparative effectiveness studies. We also evaluated the efficacy of the SMT dose levels by testing the hypothesis of no difference between SMT and a hands-on
control. The trial evaluated the unique contribution of
SMT to outcomes beyond the effects of a light massage
to control attention (quantity of visits) and touching the patient, history, and context [13].
Methods
Design
In a prospective open-label randomized controlled trial,
400 participants with nonspecific cLBP were randomized to
Context
The impact of spinal manipulation on chronic low back
pain compared to light massage, serving as a control, is
assessed by the authors.
Contribution
In this well-performed RCT, spinal manipulation for 18
visits was found to result in modestly improved outcomes relative to light massage, but such improvements
may not be clinically significant. They also found that
the best treatment effects for manipulation were at 12
sessions versus the control and no additional benefit
was afforded at 18 sessions.
Implications
This study provides some guidance where there is currently little. Twelve chiropractic sessions are reasonable,
manipulation may be modestly better than light massage
at this endpoint, but not at 24 weeks. As important, the
study serves as a reasonable model for the design of
a practice-based randomized trial.
—The Editors
receive a dose of 0, 6, 12, or 18 SMT sessions from a chiropractor. All participants were assigned 18 treatment visits,
3 per week for 6 weeks. Spinal manipulative therapy was
performed at the assigned number of visits, and a brief light
massage control was performed at non-SMT visits to control provider attention and touching the participants [14].
For example, those receiving 12 visits for SMT received
6 visits for light massage from the chiropractor (Fig. 1).
Follow-up evaluation was by mailed questionnaire or
blinded phone interview at 6, 12, 18, 24, 39, and 52 weeks
after randomization. The primary outcomes were prespecified as self-reported pain intensity and functional disability
at the 12- and 24-week end points. The primary end points
were chosen to emphasize a short- and a long-term posttreatment time point.
Randomization was conducted using computer-generated
design-adaptive allocation [15,16] to balance six baseline
variables across groups: pain and disability scores, age, gender, relative confidence in SMT and massage, and any previous SMT or massage care. Allocation to study groups was
hence concealed from all study personnel and participants
by requiring entry of data into the computer program collected immediately before randomization (pain, disability,
and confidence in treatment success). Patient coordinators
called in the allocation variables over the phone to research
staff who entered the data into the allocation computer program. The patient coordinator then assigned the participant
to group by placing an unmarked sealed envelope identifying care in the patient’s clinic file. Participants and treating
1108
M. Haas et al. / The Spine Journal 14 (2014) 1106–1116
Not eligible = 2306
Not interested = 382
Phone Screen (n = 3353)
Cancelled = 72
No show = 71
Baseline Exam 1 (n = 522)
Not eligible = 101
Not interested = 11
Baseline Exam 2 (n = 403)
Not eligible = 3
Not interested = 0
No show = 6
Randomization (n = 400)
0 SMT + 18 LM
(n = 100)
6 SMT + 12 LM
(n = 100)
12 SMT + 6 LM
(n = 100)
18 SMT + 0 LM
(n = 100)
visits attended
visits attended
visits attended
visits attended
(nonadherent < 75%)
(nonadherent < 75%)
(nonadherent < 75%)
(nonadherent < 75%)
1 – 4: n =
5 – 8: n =
9 – 13: n =
14 – 17: n =
18: n=
Treatment noncompliance
Medical =
Personal =
Unknown =
1 – 4: n = 3
5 – 8: n = 1
9 – 13: n = 5
14 – 17: n = 1
18: n= 90
Treatment noncompliance
Medical = 0
Personal = 8
Unknown = 1
1 – 4: n = 3
5 – 8: n = 2
9 – 13: n = 2
14 – 17: n = 0
18: n= 93
Treatment noncompliance
Medical = 2
Personal = 5
Unknown = 0
1 – 4: n = 2
5 – 8: n = 2
9 – 13: n = 0
14 – 17: n = 1
18: n= 95
Treatment noncompliance
Medical = 0
Personal = 4
Unknown = 0
follow-up
6 wk: n = 97
12 wk: n = 90
18 wk: n = 94
24 wk: n = 86
39 wk: n = 83
52 wk: n = 86
Lost to follow-up
Address = 0
Medical = 0
Personal = 1
Unknown = 0
follow-up
6 wk: n = 96
12 wk: n = 89
18 wk: n = 94
24 wk: n = 89
39 wk: n = 87
52 wk: n = 85
Lost to follow-up
Address = 0
Medical = 2
Personal = 1
Unknown = 0
follow-up
6 wk: n = 99
12 wk: n = 92
18 wk: n = 96
24 wk: n = 93
39 wk: n = 87
52 wk: n = 88
Lost to follow-up
Address = 0
Medical = 0
Personal = 0
Unknown = 0
4
0
3
0
93
0
6
1
follow-up
6 wk: n = 95
12 wk: n = 85
18 wk: n = 86
24 wk: n = 82
39 wk: n = 84
52 wk: n = 81
Lost to follow-up
Address = 1
Medical = 0
Personal = 3
Unknown = 1
Included in analysis
n = 95
Included in analysis
n = 99
Included in analysis
n = 97
Included in analysis
n = 100
Reason for exclusion:
No follow-up data
Non-compliant n = 4
Compliant n = 1
Reason for exclusion:
No follow-up data
Non-compliant n = 1
Reason for exclusion:
No follow-up data
Non-compliant n = 3
Reason for exclusion:
NA
Fig. 1. Study flow diagram. All participants were assigned 18 treatment visits. They received either spinal manipulative therapy (SMT) or light massage
control (LM) at any one visit.
M. Haas et al. / The Spine Journal 14 (2014) 1106–1116
clinicians were not blinded to intervention after randomization. However, patient coordinators, who collected some
outcomes by phone interview, remained blinded to group assignment throughout the study.The study was approved by
the University of Western States Institutional Review Board
(FWA 851). The trial was registered at ClinicalTrials.gov,
NCT00376350.
Protocol overview
Participants were recruited through craigslist, mailers,
and local newspapers. They were informed that the study
was investigating 18 visits for different combinations of
two manual therapies for cLBP. Preliminary screening
was conducted through telephone interview by study staff.
At the first baseline visit, participants signed an informed
consent form and filled out a baseline survey. Eligibility
screening examinations were then conducted at a central
university clinic by one of the two licensed chiropractors
(faculty with O20 years of experience) using history, physical examination, and lumbar X-rays [17].
Eligible participants selected a convenient clinic for
study care. Care was provided by one of the 12 licensed chiropractors with 4 to 24 years of experience in 9 Portland-area
clinics. The treating chiropractors were selected because
their abilities were known to the authors, and some had
previous experience on our trials. After a second baseline
survey at the clinic, participants were given a brief confirmatory screening examination by the treating clinician. They
were then randomized and received their first treatment. Participants were compensated for each treatment visit, mailed
questionnaires, and phone interviews ($10–$20). Participants signed an informed consent form.
Participants
Participants were required to be at least 18 years old and
have a current episode of cLBP [18] of mechanical origin
[19] of at least 3 months duration [3]. They were further required to have had some LBP on 30 days in the previous 6
weeks and a minimum LBP index of 25 on a 100-point
scale to prevent floor effects. Participants were excluded
if they received manual therapy within the previous 90 days
or for contraindications to study interventions [17,20] and
complicating conditions such as active cancer, spine pathology, inflammatory arthropathies, autoimmune disorders,
anticoagulant conditions, neurodegenerative diseases, pain
radiating below the knee, organic referred pain, pregnancy,
and disability compensation.
Intervention
Each visit was 15 minutes long with a treating chiropractor, consistent with chiropractic practice [21]. Participants received a hot pack for 5 minutes to relax spinal
muscles followed by 5 minutes for the SMT or control intervention. The visit was completed with 5 minutes of very
1109
low-dose pulsed ultrasound (20% duty cycle with 0.5 watts/
cm2). This was used as a quasi-sham to enhance treatment
credibility and adherence to care [13].
Spinal manipulative therapy consisted of manual thrust
(high velocity, low amplitude) spinal manipulation in the
lumbar and transition thoracic regions, predominantly in
the side-posture position [22]. Specific manipulations to be
performed were determined at each visit by the chiropractor
through ongoing evaluation of the participants including patient progress, self-reported and provocative pain, spinal
range of motion, and palpation of the spine and paraspinal
soft tissue [17,22]. Manipulation was not performed at a visit,
if the treating chiropractor failed to find any indication.
Lighter thrust manipulation including the use of mechanical
assistance of a spring-loaded table and segmental lowvelocity mobilization were permitted in the case of acute
exacerbation of the lumbar spine pain [22].
The light massage control consisted of 5 minutes of gentle effleurage and petrissage of the low back (lumbar and
lower thoracic) paraspinal muscles [22,23], focused on
the symptomatic areas. The massage used was gentler
and of shorter duration than recommended for therapeutic
massage practice [21,24]. As such, it was a minimalist
intervention to control touching the patient; it was not
a formal sham. The treating chiropractors were also asked
to render SMT and control intervention with equal enthusiasm to help balance expectations of treatment success imparted by the practitioner. Protocol standardization and
provider equipoise across treatment groups were maintained through quarterly training and monitored by office
observation and patient phone interview [14,25].
Outcome and baseline variables
This report emphasizes the prespecified primary outcomes, the self-reported modified Von Korff pain and disability scales validated by Underwood et al. [26]. The
pain score is the average of three 11-point numeric rating
scales converted to a 100-point scale: back pain today,
worst back pain in the last 4 weeks, and average back pain
in the last 4 weeks. The disability score is also the average
of three scales: interference with daily activities, social and
recreational activities, and the ability to work (outside or
around the house).
Secondary outcomes included pain unpleasantness [27],
Physical and Mental Component Summary Scales of the
short-form 12 [28], Health State Visual Analog Scale
from EuroQol [29], perceived pain and disability improvement, and the number of the following in the previous 4
weeks: days with pain and disability and medication use.
Additional baseline variables included demographics,
Fear-Avoidance Beliefs Questionnaire [30], confidence in
treatment success [14], and any from a list of comorbid
conditions (arthritis, asthma or allergies, gastrointestinal
problems, gynecological problems, hypertension, or other
chronic condition) [31].
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M. Haas et al. / The Spine Journal 14 (2014) 1106–1116
comparisons were adjusted for the six baseline balancing
variables used to randomize the participants [15,16]: pain
and disability scores, age, gender, relative confidence in
SMT and massage, and any previous SMT or massage care.
The baseline value of the outcome measure was added as
a covariate if not already included among the six balancing
variables.
In a prespecified secondary ‘‘responder’’ analysis, the
two primary outcomes were dichotomized to show the
proportion of participants with 50% improvement. The
analysis mentioned previously was then repeated using
binomial regression to identify slopes and group differences
in proportion of responders [33].
The sample size was determined a priori to have at least
80% power to detect a between-group effect of 10 of
100 points in the two primary outcomes using a twotailed test. It took into consideration a 10% dropout rate.
The .025 level of significance was used to adjust for having
two primary outcomes. Detection of a 10-point between-
Statistical analysis
An intention-to-treat analysis was conducted with each
participant included in the original allocation group; missing data were imputed using linear interpolation and then
last datum was carried forward. Nine participants were
omitted from the analysis because they had no follow-up
data. A sensitivity analysis with all missing data excluded
was conducted for the two primary outcomes.
The prespecified primary analysis consisted of regression models to identify the linear effect of SMT dose
(slope5outcome increment/six SMT sessions) and to compare each SMT group to the no-SMT control group (adjusted
mean differences). Seemingly unrelated (simultaneous) regression by Zellner [32] was used to model outcomes
for the individual time points [33]. In addition, for the primary outcomes only, longitudinal effects across all followups were modeled with generalized estimating equations
using unstructured correlation to account for within-person
correlation between time points [33]. Slopes and group
Table 1
Baseline characteristics
Sociodemographic information
Age (y)
Female (%)
Non-white or Hispanic (%)
Married (%)
College degree (%)
Income !$20,000/y (%)
Smoker (%)
Expectations
Confidence in treatment success
Spinal manipulation (1–6 scale)*
Light massage (1–6 scale)*
Previous treatment
Spinal manipulation (%)
Light massage (%)
LBP complaint
Pain intensity (0–100 scale)y
Functional disability (0–100 scale)y
Pain unpleasantness (0–100 scale)y
Days with pain (last 4 wk)
Days with disability (last 4 wk)
Duration (y)
Health status
SF-12 physical health componentz
SF-12 mental health componentz
Health state (0–100 Visual Analog Scale)z
Other comorbidity (%)
Fear-Avoidance Beliefs Questionnaire
Work beliefs (0–100 scale)z
Activity beliefs (0–100 scale)z
Oral medication use (times in last 4 wk)
Prescription
Nonprescription
SMT 0
(n595)
SMT 6
(n599)
SMT 12
(n597)
SMT 18
(n5100)
All
(n5391)
40.9 (14.1)
49
14
37
58
31
17
41.4 (14.8)
49
18
28
63
27
13
41.8 (14.0)
49
11
41
51
19
6
41.2 (13.8)
52
16
36
53
28
8
41.3 (14.1)
50
15
36
56
26
11
3.6 (1.2)
3.4 (1.2)
3.8 (1.1)
3.5 (1.2)
3.7 (1.2)
3.4 (1.2)
3.8 (1.1)
3.5 (1.2)
3.7 (1.2)
3.5 (1.2)
71
52
52.2
45.2
41.7
24.8
7.4
11.6
70
56
(16.3)
(21.8)
(19.5)
(4.8)
(8.1)
(9.5)
51.0
44.8
41.1
24.1
6.7
11.2
74
43
(18.2)
(24.0)
(21.1)
(5.5)
(7.5)
(9.8)
51.6
46.1
40.3
23.3
6.8
11.7
72
54
(17.5)
(23.4)
(22.8)
(5.7)
(7.5)
(10.4)
51.5
45.2
42.4
24.1
6.5
12.5
72
51
(16.8)
(21.8)
(22.2)
(4.6)
(7.2)
(9.5)
51.6
45.3
41.4
24.1
6.8
11.8
(17.2)
(22.7)
(21.4)
(5.2)
(7.6)
(9.8)
43.0 (9.5)
50.2 (10.5)
70.1 (17.2)
58
43.8 (8.9)
48.6 (10.5)
72.1 (13.8)
57
44.3 (8.4)
47.6 (11.2)
73.5 (14.4)
52
42.3 (8.8)
49.4 (9.6)
68.2 (17.4)
54
43.3 (8.9)
48.9 (10.5)
70.9 (15.8)
55
36.6 (23.2)
55.0 (20.1)
32.0 (23.4)
53.8 (23.1)
31.0 (18.9)
56.4 (17.7)
32.2 (21.4)
58.8 (19.8)
32.9 (21.8)
56.0 (20.3)
0.9 (3.6)
7.6 (10.0)
0.3 (1.1)
8.9 (10.8)
0.6 (2.6)
9.5 (10.0)
0.3 (1.5)
7.6 (9.4)
0.5 (2.4)
8.4 (10.1)
SMT, spinal manipulation; SF-12, short-form 12; LBP, low back pain.
Values are mean (standard deviation) or percentage.
* Six-point Likert scale with 1 indicating lowest and 6 indicating highest confidence.
y
Lower scores favorable. Low back pain intensity and functional disability evaluated with modified Von Korff scales.
z
Higher scores favorable. Short-form 12 health survey scores are standardized to the US general population (mean550, standard deviation510).
M. Haas et al. / The Spine Journal 14 (2014) 1106–1116
1111
Table 2
Primary outcomes
Observed unadjusted mean (SD)
Time
SMT 0
Pain intensity (0–100 scale)
0 wk
52.2 (16.3)
6 wk
34.5 (18.4)
12 wk
37.9 (20.4)
18 wk
35.7 (19.5)
24 wk
34.9 (20.6)
39 wk
36.2 (21.0)
52 wk
36.5 (21.8)
6–52 wky —
Functional disability (0–100
0 wk
45.2 (21.8)
6 wk
27.0 (20.2)
12 wk
29.2 (23.7)
18 wk
26.1 (21.4)
24 wk
27.1 (25.2)
39 wk
26.2 (22.8)
52 wk
28.0 (23.7)
6–52 wky —
SMT 6
51.0 (18.2)
32.3 (15.8)
32.7 (19.4)
31.4 (18.4)
32.5 (19.8)
32.8 (21.5)
30.7 (22.4)
—
scale)
44.8 (24.0)
28.5 (20.3)
24.8 (18.6)
23.5 (19.4)
25.6 (21.7)
24.5 (22.6)
22.6 (22.4)
—
Slope (95% CI)
Adjusted mean difference (95% CI)
SMT 12
SMT 18
Per six SMT sessions
SMT 0 vs. 6
SMT 0 vs. 12
SMT 0 vs. 18
51.6
27.1
29.0
30.3
33.7
30.2
31.9
—
(17.5)
(14.7)
(20.8)
(19.3)
(20.5)
(21.7)
(22.5)
51.5
30.2
31.4
29.3
32.1
31.6
28.7
—
(16.8)
(19.0)
(19.8)
(19.7)
(20.5)
(21.5)
(20.5)
—
1.8
2.2
2.0
0.6
1.6
2.2
1.7
(0.3, 3.2)*
(0.6, 3.8)*
(0.4, 3.5)*
(1.0, 2.3)
(0.2, 3.3)
(0.4, 4.0)*
(0.4, 3.0)*
—
1.7
4.5
3.6
1.7
2.8
5.4
3.1
(2.6,
(0.6,
(1.3,
(3.4,
(2.8,
(0.4,
(1.0,
5.9)
9.6)
8.5)
6.9)
8.4)
11.1)
7.1)
—
7.2
8.6
5.1
0.8
5.8
4.6
5.3
(2.8, 11.6)*
(3.2, 14.0)*
(0.2, 10.0)
(4.4, 6.0)
(0.5, 11.2)
(1.2, 10.3)
(1.2, 9.3)*
—
4.1
6.1
6.1
2.4
4.3
7.6
5.0
(0.5, 8.6)
(1.0, 11.2)*
(1.2, 11.0)*
(2.9, 7.6)
(1.2, 9.9)
(2.0, 13.2)*
(0.8, 9.2)*
46.1
25.8
22.0
22.1
24.0
21.7
22.4
—
(23.4)
(19.3)
(20.7)
(21.5)
(20.4)
(20.5)
(21.2)
45.2
30.1
23.4
22.4
24.1
24.1
19.1
—
(21.8)
(20.9)
(20.5)
(19.2)
(20.3)
(22.7)
(18.7)
—
0.6
2.0
1.3
1.1
0.9
2.7
0.9
(2.3, 1.0)
(0.3, 3.8)*
(0.4, 2.9)
(0.7, 2.9)
(0.9, 2.8)
(1.0, 4.4)*
(0.3, 2.2)
—
1.7
4.2
2.2
1.4
1.4
5.2
1.5
(6.8,
(1.0,
(2.8,
(4.5,
(4.3,
(0.5,
(2.1,
3.4)
9.4)
7.2)
7.2)
7.1)
10.9)
5.1)
—
1.5
7.5
4.1
3.4
4.7
5.9
3.9
(3.7, 6.6)
(1.7, 13.3)*
(1.5, 9.7)
(2.4, 9.3)
(0.7, 10.2)
(0.1, 11.8)
(0.0, 7.7)
—
3.1
5.8
3.6
2.9
2.0
8.8
2.4
(8.3, 2.1)
(0.2, 11.3)
(1.5, 8.7)
(2.9, 8.8)
(3.9, 7.9)
(3.3, 14.4)*
(1.5, 6.3)
SMT, spinal manipulative therapy; SD, standard deviation; CI, confidence interval.
Primary end points were prespecified as pain intensity and functional disability at 12 and 24 weeks. Unadjusted group means are from original data without imputation; slopes and group differences are computed from imputed data adjusted for the baseline covariates. Positive signs of slopes and mean differences were computed to favor higher doses of manipulation. A two-tailed test of statistical significance was prespecified at the .025 to account for
two primary outcomes and used for all statistical tests.
* p!.025.
y
Longitudinal profile using generalized estimating equations.
group difference was chosen to be consistent with our past
studies [31,34]. All analyses were conducted with Stata
11.2 (StataCorp, College Station, TX, USA).
Results
Participants were enrolled from March 2007 to May
2010 and followed for 1 year with the last follow-up ending
May 2011. Allocation was equally spread out across clinics
and providers with group assignments averaging 25%
Fig. 2. Pain time profile. Pain intensity was evaluated on a 0 to 100 scale.
The graphs show pain development for each group at baseline and the six
follow-up time points. The primary end points were 12 and 24 weeks.
SMT, spinal manipulative therapy.
(SD56%) per group per clinic and 25% (SD512%) per
group per treating physician.
The study flowchart in Fig. 1 shows strong adherence to
care with 90% to 95% of participants attending all 18 study
visits. Four participants, allocated to 18 SMT sessions and
who attended all 18 visits, collectively had 5 treatment
visits where SMT was deemed inappropriate and withheld
per protocol. Three had SMT withheld at one visit because
Fig. 3. Pain dose-response curves. The dose-response plots demonstrate
small gradients in pain intensity (0- to 100-point scale) across dose groups
for four time points: end of care (6 weeks), primary end points (12 and 24
weeks), and the final follow-up (52 weeks). Note that a line illustrates differences across the dose groups at a particular time point, rather than
change over time for a particular dose. SMT, spinal manipulative therapy.
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M. Haas et al. / The Spine Journal 14 (2014) 1106–1116
interventions was approximately equal and balanced across
groups.
Baseline characteristics (Table 1) were balanced across
groups with the exception of smoking; inclusion of smoking in the analysis produced no substantive changes in effect sizes. The mean age was 41.3 years, and most
participants were white non-Hispanic. Half of the participants reported the following characteristics: female, college
degree, comorbidity, and experience with a study intervention. The mean duration of LBP was 11.8 years. The average participant experienced LBP 6 days per week and took
medication for it twice per week.
Pain
Fig. 4. Responders: percentage of individuals attaining 50% pain improvement. SMT, spinal manipulative therapy.
it was not indicated, and two received mobilization at one
visit because of acute exacerbation. There was one violation of protocol where a patient accidentally received 13
SMT visits instead of 12. Compliance with data collection
was greater than 80% for all follow-up time points. Nine
participants were completely lost to follow-up.
Medication use and care from a nonstudy provider for
cLBP were balanced across groups at each time point. During the treatment phase, 93% to 97% of participants in each
treatment arm refrained from professional care outside the
study and 94% to 95% abstained from prescription medication. Thereafter, approximately three-fourths reported no
outside professional care at each follow-up; the maximum
difference between groups ranged from 4% to 11% of participants. Also, 90% refrained from prescription medication
at each follow-up with maximum group differences ranging
from 1% to 8%. Nonprescription analgesics were balanced
across groups. Confidence in the success of the two
Pain improved by the end of treatment and was durable
up to 52 weeks after randomization for all groups (Table 2
and Fig. 2). Mean pain reduction within groups reached
more than 20 points for SMT treatment arms.
Adjusted slopes and mean differences (AMD) with confidence intervals are presented in Table 2 for the primary
analysis. A small statistically significant linear doseresponse effect in pain intensity across the treatment levels
was observed at the 12-week primary end point (2.2 points
per six visits, p5.007) but not at the 24-week primary end
point (0.6 points per six visits). Slopes were small at the
other time points (1.6–2.0). Overall, there were minimal
differences between adjacent dose groups at all time points
(Fig. 3).
At 12 weeks, the maximum pain difference between
treatment and no-SMT control was observed for 12 SMT
visits (AMD58.6, p5.002); at 24 weeks, there were no
meaningful differences from the control (AMD !2.5).
For the secondary time points, a notable effect was observed at 52 weeks; here, 18 SMT visits showed the greatest advantage over the control (AMD57.6, p5.011).
Table 3
Responders ($50% individual improvement)
Observed unadjusted % of responders
Time
SMT 0
Pain intensity
6 wk
32.6
12 wk 28.4
18 wk 32.6
24 wk 36.8
39 wk 32.6
52 wk 37.9
Functional disability
6 wk
49.5
12 wk 43.2
18 wk 50.5
24 wk 49.5
39 wk 51.6
52 wk 58.9
Slope (95% CI)
Adjusted difference in percentage of responders (95% CI)
Per six SMT sessions
SMT 0 vs. 6
SMT 0 vs. 12
SMT 0 vs. 18
(1.3, 9.8)*
(0.5, 8.1)
(0.5, 9.2)
(2.9, 5.7)
(0.5, 9.1)
(1.9, 6.9)
3.7
10.0
4.3
3.7
9.0
10.2
(16.2, 8.8)
(3.2, 23.1)
(9.1, 17.6)
(10.0, 17.4)
(4.5, 22.5)
(3.5, 23.9)
13.7
21.1
10.3
3.2
13.0
3.9
(0.6, 26.9)
(7.7, 34.6)*
(3.3, 23.9)
(10.5, 16.9)
(0.7, 26.6)
(9.8, 17.6)
13.0
8.9
14.2
4.9
14.6
10.6
(0.4, 26.5)
(4.2, 21.9)
(0.5, 27.9)
(8.7, 18.4)
(1.1, 28.1)
(3.2, 24.4)
(0.5, 0.3)
(0.0, 8.8)
(1.9, 6.9)
(2.2, 6.6)
(3.2, 5.6)
(3.5, 5.2)
2.0
6.2
3.7
2.5
4.9
1.1
(16.1, 12.0)
(7.7, 20.0)
(10.4, 17.9)
(11.5, 16.5)
(9.0, 18.8)
(14.8, 12.6)
0.9
16.8
13.5
10.4
10.4
1.4
(13.2, 15.1)
(2.9, 30.6)*
(0.3, 27.2)
(3.4, 24.3)
(3.4, 24.2)
(15.4, 12.6)
7.5
11.5
3.5
4.8
2.5
2.7
(21.4, 6.5)
(2.4, 25.4)
(8.8, 19.3)
(9.1, 18.6)
(11.5, 16.4)
(11.0, 16.5)
SMT 6
SMT 12
SMT 18
28.3
38.4
37.4
40.4
41.4
47.5
46.4
49.5
43.3
40.2
45.4
41.2
45.0
37.0
47.0
42.0
47.0
48.0
5.5
3.8
4.8
1.4
4.8
2.5
47.5
49.5
54.5
51.5
56.6
57.6
50.5
59.8
63.9
59.8
61.9
57.7
42.0
55.0
56.0
54.0
54.0
62.0
0.1
4.4
2.5
2.2
1.2
0.8
SMT, spinal manipulative therapy; CI, confidence interval.
Unadjusted group percentages are from original data without imputation; slopes and group differences in responders are computed from imputed data
adjusted for the baseline covariates. Positive signs of slopes and mean differences were computed to favor higher doses of SMT.
* p!.025.
M. Haas et al. / The Spine Journal 14 (2014) 1106–1116
1113
Table 4
Secondary outcomes
Observed unadjusted mean (SD)
Time
SMT 0
SMT 6
SMT 12
Pain unpleasantness (0–100 scale)
0 wk
41.7 (19.5) 41.1 (21.1) 40.3 (22.8)
6 wk
24.7 (21.7) 20.3 (17.5) 15.6 (17.3)
12 wk 29.7 (22.3) 24.5 (20.6) 22.2 (22.3)
18 wk 26.8 (22.3) 21.9 (21.2) 20.4 (20.4)
24 wk 27.4 (21.7) 24.8 (21.8) 25.0 (21.9)
39 wk 28.3 (21.6) 25.5 (21.3) 23.2 (20.8)
52 wk 27.8 (22.1) 22.1 (21.7) 24.0 (24.0)
Days with pain (last 4 wk)
0 wk
24.8 (4.8)
24.1 (5.5)
23.3 (5.7)
6 wk
18.9 (10.0) 17.6 (10.6) 15.0 (10.1)
12 wk 18.1 (9.5)
17.4 (9.2)
15.5 (9.7)
18 wk 17.4 (10.2) 17.6 (10.3) 15.5 (10.3)
24 wk 16.9 (10.0) 16.5 (10.3) 15.4 (9.5)
39 wk 17.7 (9.8)
15.6 (9.9)
15.1 (10.4)
52 wk 17.0 (10.2) 15.3 (10.3) 14.0 (10.6)
Days with disability (last 4 wk)
0 wk
7.4 (8.1)
6.7 (7.5)
6.8 (7.5)
6 wk
2.4 (5.5)
1.6 (3.0)
1.3 (2.7)
12 wk
3.4 (5.9)
2.6 (4.9)
2.0 (3.3)
18 wk
2.1 (5.3)
2.2 (5.0)
1.8 (4.1)
24 wk
3.5 (6.7)
2.7 (5.1)
2.8 (4.6)
39 wk
2.8 (5.1)
3.0 (5.5)
2.4 (4.7)
52 wk
3.4 (6.0)
3.4 (6.9)
1.9 (3.7)
Perceived pain change (six-point Likert)y
6 wk
3.7 (0.9)
4.1 (0.9)
4.3 (1.0)
12 wk
3.7 (0.9)
3.8 (0.9)
4.0 (1.0)
18 wk
3.7 (0.9)
4.0 (1.0)
4.1 (1.0)
24 wk
3.8 (1.0)
3.9 (1.0)
3.9 (1.0)
39 wk
3.7 (1.0)
3.8 (1.1)
4.0 (1.0)
52 wk
3.7 (0.9)
4.0 (1.1)
3.9 (1.1)
Perceived disability change (six-point Likert)y
6 wk
3.6 (0.9)
3.9 (0.9)
4.0 (1.0)
12 wk
3.5 (0.9)
3.8 (0.9)
3.8 (1.0)
18 wk
3.6 (0.8)
3.7 (1.0)
3.8 (1.0)
24 wk
3.6 (0.9)
3.7 (0.9)
3.7 (0.9)
39 wk
3.6 (0.9)
3.7 (1.0)
3.9 (1.0)
52 wk
3.6 (0.9)
3.8 (1.0)
3.8 (1.1)
SF-12 physical health component
0 wk
43.0 (9.5)
43.8 (8.9)
44.3 (8.4)
12 wk 45.5 (10.3) 47.1 (8.2)
49.6 (8.5)
24 wk 50.0 (11.1) 50.5 (10.1) 51.4 (9.1)
39 wk 50.6 (11.5) 51.1 (10.3) 52.7 (9.6)
52 wk 50.7 (12.0) 50.8 (11.0) 52.6 (10.3)
SF-12 mental health component
0 wk
50.2 (10.5) 48.6 (10.5) 47.6 (11.2)
12 wk 50.2 (10.8) 50.4 (9.4)
47.8 (11.0)
24 wk 51.8 (10.9) 52.8 (10.2) 50.8 (11.8)
39 wk 51.7 (11.3) 51.5 (11.6) 49.2 (13.6)
52 wk 51.3 (12.0) 50.4 (11.4) 50.6 (12.7)
EuroQol Health State (0–100 scale)
0 wk
70.1 (17.2) 72.1 (13.8) 73.5 (14.4)
12 wk 73.5 (17.3) 78.4 (14.1) 77.9 (15.0)
24 wk 73.9 (17.5) 77.8 (15.5) 77.0 (15.4)
39 wk 73.1 (20.0) 76.8 (17.2) 76.6 (15.6)
52 wk 74.8 (17.0) 77.1 (17.0) 77.3 (15.3)
Nonprescription medication (times in last 4 wk)
0 wk
7.6 (10.0)
8.9 (10.8)
9.5 (10.0)
6 wk
4.3 (6.8)
4.1 (6.9)
4.0 (6.7)
12 wk
7.8 (11.0)
7.1 (23.0)
5.8 (7.6)
Slope (95% CI)
Adjusted mean difference (95% CI)
SMT 18
Per six SMT sessions
SMT 0 vs. 6
42.4
18.4
23.9
21.3
24.8
23.0
21.5
(22.2)
(18.1)
(21.3)
(21.8)
(22.4)
(21.1)
(19.9)
—
2.4
2.0
1.8
0.7
1.8
1.7
(0.9, 4.0)*
(0.2, 3.7)
(0.1, 3.6)
(1.1, 2.5)
(0.1, 3.6)
(0.1, 3.5)
—
4.2
4.8
4.6
2.1
2.4
5.4
(0.8,
(1.0,
(1.0,
(3.5,
(3.3,
(0.3,
24.1
16.3
14.7
14.9
13.5
14.3
13.6
(4.6)
(10.8)
(10.2)
(10.6)
(9.6)
(10.6)
(10.4)
—
0.8
1.1
0.8
1.0
0.9
1.0
(0.0, 1.7)
(0.2, 1.9)*
(0.0, 1.7)
(0.2, 1.8)*
(0.1, 1.7)
(0.1, 1.8)*
—
0.9
0.4
0.6
0.1
1.7
1.3
6.5
1.2
2.3
2.1
2.8
2.5
2.4
(7.2)
(3.4)
(3.7)
(4.9)
(4.2)
(4.8)
(4.7)
—
0.3
0.4
0.1
0.1
0.1
0.4
(0.0,
(0.0,
(0.4,
(0.3,
(0.3,
(0.1,
0.7)
0.7)
0.5)
0.6)
0.5)
0.8)
—
0.8
0.6
0.1
0.7
0.3
0.1
4.3
4.0
4.0
3.9
4.0
4.0
(1.0)
(0.9)
(1.0)
(1.0)
(0.9)
(0.9)
0.1
0.1
0.1
0.0
0.1
0.1
(0.1, 0.2)*
(0.0, 0.2)
(0.0, 0.2)
(0.1, 0.1)
(0.0, 0.2)
(0.0, 0.1)
4.0
3.8
3.8
3.7
3.9
3.9
(0.9)
(0.9)
(0.9)
(1.0)
(0.9)
(0.9)
0.1
0.1
0.1
0.0
0.1
0.1
42.3
47.5
50.9
51.8
52.5
(8.8)
(8.5)
(9.4)
(9.3)
(8.5)
49.4
48.0
51.3
49.0
50.4
68.2
75.7
74.5
75.3
77.2
SMT 0 vs. 12
SMT 0 vs. 18
9.1)
10.5)
10.3)
7.8)
8.2)
11.2)
—
8.7
7.1
5.8
2.0
4.8
3.7
(3.5, 14.0)*
(1.1, 13.0)*
(0.4, 11.2)
(3.6, 7.5)
(0.6, 10.3)
(2.4, 9.7)
—
6.6
5.8
5.8
2.5
5.4
6.4
(1.7, 11.6)*
(0.1, 11.5)
(0.4, 11.2)
(3.2, 8.3)
(0.2, 10.9)
(0.7, 12.1)
(1.8,
(2.0,
(3.2,
(2.5,
(0.8,
(1.4,
3.5)
2.8)
2.1)
2.7)
4.2)
3.9)
—
3.0
1.9
1.2
0.7
1.7
2.1
(0.3, 5.6)
(0.7, 4.5)
(1.5, 3.9)
(1.8, 3.3)
(0.8, 4.3)
(0.7, 4.9)
—
2.2
3.0
2.2
3.1
3.0
3.0
(0.6, 4.9)
(0.5, 5.6)*
(0.6, 4.9)
(0.5, 5.7)*
(0.4, 5.6)
(0.3, 5.7)
(0.4,
(0.7,
(1.4,
(0.7,
(1.7,
(1.7,
1.9)
1.9)
1.3)
2.1)
1.1)
1.4)
—
1.0
1.3
0.3
0.6
0.4
1.5
(0.1, 2.2)
(0.0, 2.5)
(0.9, 1.6)
(0.8, 2.1)
(0.9, 1.6)
(0.2, 2.8)
—
1.1
1.0
0.0
0.5
0.2
0.8
(0.1,
(0.3,
(1.3,
(0.9,
(1.1,
(0.6,
0.2
0.1
0.2
0.1
0.1
0.3
(0.0, 0.5)
(0.1, 0.4)
(0.0, 0.5)
(0.2, 0.4)
(0.2, 0.4)
(0.0, 0.6)
0.4
0.3
0.4
0.1
0.3
0.2
(0.2, 0.7)*
(0.0, 0.5)
(0.1, 0.7)*
(0.2, 0.4)
(0.0, 0.6)
(0.1, 0.5)
0.4
0.3
0.2
0.1
0.3
0.2
(0.1, 0.7)*
(0.0, 0.5)
(0.0, 0.5)
(0.2, 0.3)
(0.0, 0.5)
(0.0, 0.5)
(0.0, 0.2)*
(0.0, 0.2)*
(0.0, 0.2)
(0.1, 0.1)
(0.0, 0.2)*
(0.0, 0.2)
0.3
0.2
0.1
0.1
0.1
0.2
(0.0, 0.5)
(0.0, 0.5)
(0.2, 0.3)
(0.2, 0.3)
(0.2, 0.4)
(0.0, 0.5)
0.4
0.3
0.2
0.1
0.3
0.2
(0.1, 0.6)*
(0.0, 0.5)
(0.1, 0.4)
(0.2, 0.3)
(0.1, 0.6)*
(0.1, 0.5)
0.4
0.3
0.2
0.1
0.3
0.3
(0.2, 0.6)*
(0.0, 0.5)
(0.0, 0.5)
(0.2, 0.4)
(0.0, 0.5)*
(0.0, 0.3)
—
1.0
0.5
0.6
0.8
(0.3, 1.6)*
(0.3, 1.2)
(0.2, 1.4)
(0.1, 1.6)
—
1.2
0.0
0.1
0.3
(0.8,
(2.3,
(2.3,
(2.7,
3.3)
2.4)
2.4)
2.1)
—
3.5
0.8
1.5
1.4
(1.3, 5.7)*
(1.6, 3.2)
(0.9, 4.0)
(1.2, 4.0)
—
2.4
1.3
1.6
2.2
(0.3, 4.6)
(1.1, 3.6)
(0.9, 4.0)
(0.2, 4.5)
(9.6)
(9.8)
(11.2)
(11.7)
(11.7)
—
0.7
0.1
0.8
0.0
(1.3,0.0)
(0.8, 0.6)
(1.5,0.0)
(0.8, 0.8)
—
1.3
2.1
1.1
0.2
(0.7,
(0.0,
(1.3,
(2.3,
3.3)
4.2)
3.4)
2.7)
—
0.5
0.7
0.4
1.1
(2.6,
(1.3,
(2.9,
(1.6,
1.5)
2.8)
2.1)
3.7)
—
1.5
0.1
2.0
0.3
(3.5,
(2.1,
(4.3,
(2.9,
0.4)
2.2)
0.3)
2.3)
(17.4)
(14.5)
(16.7)
(16.8)
(14.9)
—
0.8
0.3
0.9
1.0
(0.4,
(1.0,
(0.5,
(0.3,
—
3.9
2.9
2.6
1.3
(0.0, 7.7)
(1.0, 6.9)
(1.9, 7.0)
(2.7, 5.4)
—
2.7
1.4
1.8
0.9
(1.3,
(2.6,
(2.6,
(3.1,
6.7)
5.5)
6.2)
4.9)
—
3.1
1.5
3.2
3.3
(0.8,
(2.7,
(1.3,
(0.5,
6.9)
5.8)
7.6)
7.2)
7.6 (9.4)
4.0 (8.3)
7.8 (25.8)
2.0)
1.6)
2.3)
2.2)
—
0.1 (0.5, 0.7)
0.1 (1.6, 1.8)
—
0.6 (1.2, 2.4)
1.4 (2.7, 5.6)
—
0.9 (0.8, 2.6)
3.2 (0.4, 5.9)*
2.3)
2.2)
1.4)
1.9)
1.5)
2.1)
—
0.3 (1.5, 2.1)
0.1 (5.5, 5.3)
(Continued)
1114
M. Haas et al. / The Spine Journal 14 (2014) 1106–1116
Table 4
(Continued )
Observed unadjusted mean (SD)
Time
18
24
39
52
SMT 0
wk
wk
wk
wk
5.7
8.1
7.2
6.5
(7.4)
(13.7)
(14.2)
(8.0)
SMT 6
6.0
7.7
7.4
6.6
(10.4)
(15.8)
(12.2)
(13.7)
SMT 12
5.3
6.5
6.6
6.7
(9.1)
(8.6)
(8.9)
(9.3)
SMT 18
5.5
6.4
7.7
6.8
(9.1)
(10.8)
(13.5)
(12.7)
Slope (95% CI)
Adjusted mean difference (95% CI)
Per six SMT sessions
SMT 0 vs. 6
0.2
0.7
0.0
0.1
(0.5,
(0.4,
(1.1,
(0.9,
0.8)
1.7)
1.1)
0.8)
0.1
0.9
0.3
0.3
(2.4,
(3.3,
(3.4,
(2.7,
SMT 0 vs. 12
2.6)
5.1)
4.0)
3.4)
1.0
2.4
1.4
0.6
(1.1,
(0.7,
(1.9,
(1.5,
3.2)
5.5)
4.7)
2.6)
SMT 0 vs. 18
0.2
1.8
0.5
0.3
(1.8,
(1.5,
(4.0,
(2.9,
2.2)
5.0)
3.1)
2.4)
SMT, spinal manipulative therapy; SD, standard deviation; CI, confidence interval; SF-12, short-form 12.
Unadjusted group means are from original data without imputation; slopes and group differences are computed from imputed data adjusted for the baseline covariates. Positive signs of slopes and mean differences were computed to favor higher doses of SMT.
* p!.025.
y
Likert scale: much worse51, worse52, about the same53, better54, much better55, and completely recovered56.
Analyses of the three pain score components gave similar
results and are available from the authors.
Repeated-measures analysis of the full 6- to 52-week
pain profile demonstrated a small advantage of treatment
over control. The largest effect was observed for 12 SMT
visits versus control (AMD55.3, p5.011).
Functional disability
Mean functional disability reduction reached 20 points.
Trends in slopes and group comparisons were similar to
those for pain but smaller in magnitude with fewer statistically significant results (Table 2). At the 12-week primary
end point, the greatest advantage for SMT over control
was also found for 12 SMT visits (AMD57.5, p5.011),
and at the 24-week primary end point, there were no clinically meaningful effects (AMD !3.4). At 52 weeks, 18
SMT visits were observed to have the greatest effect
(AMD58.8, p5.002). As for pain, there were no clinically
meaningful differences in disability profiles between 12 and
18 SMT visits.
Sensitivity analysis
There were no material changes in the results for pain
and disability outcomes when imputed data were excluded
from the analysis. For the primary end points, changes were
0.3 or less in slope and 1.4 or less/100 points in group differences. The changes at other time points were similarly
negligible. Clustering by care provider or clinic produced
no substantive changes in effect sizes.
Responder analysis
The responder profile in Fig. 4 and Table 3 shows that
about 30% to 50% of individuals in each group achieved
50% pain improvement at each time point. Only one statistically significant difference between treatment and control
was found. At 12 weeks, a substantial proportion of response to care was attributable to manipulation for 12
SMT visits (21.1%, p5.002). This difference corresponds
to a number needed to treat equal to 5. For functional disability, about 40% to 60% of individuals were responders
for all groups and time points. There was only one statistically significant group difference.
Secondary outcomes
Generally, there was within-group improvement in secondary outcomes recorded at the end of care showing the
same durability for these outcomes as for pain outcomes.
However, the improvement in the no-SMT control group
was of such magnitude that there were few sizable statistically significant differences between treatment and control
groups (Table 4).
Days with pain and disability were reduced from baseline by 1 to 2 per week. Perceived pain and disability
improvement were typically rated as ‘‘better.’’ The standardized short-form 12 physical health component improved about 7 to 10 points (up to 1 SD), returning to US
population norms in 3 to 6 months. The mental health component deviated little from population norms at baseline.
EuroQol Health State Visual Analog Scale showed little
change from baseline. There was a small decrease in medication use after end of care. The mean reductions in pain
unpleasantness scores were similar to pain score reduction,
about 20 points.
Adverse events
There were no notable adverse events. Three persons
reported seeking care for symptomatic relief of LBP exacerbation related to the study. One ineligible person subsequently reported increase of pain after the screening
examination. One participant in the 12-SMT group lost several days of work followed by complete resolution or the
episode during the treatment phase. One participant in the
12-SMT group dropped out after an exacerbation associated with lifting a child.
Discussion
This first full-scale dose-response study of SMT had several notable findings. Based on the pain and functional
disability primary outcomes, 12 sessions of SMT yielded
the overall best, albeit modest, treatment effects (group
M. Haas et al. / The Spine Journal 14 (2014) 1106–1116
differences). This was particularly noted in the short term at
the 12-week primary end point. Group differences were negligible at the 24-week primary end point and favored 18
SMT sessions to a small degree in the long term, at 52 weeks.
In general, the data were consistent with a dose-response relationship being saturated at 12 sessions with little or no additional benefit attributable to additional SMT visits, even at
52 weeks. Analysis of the full-time profile supported no additional benefit overall of 18 over 12 sessions. In addition,
responder analysis gave additional support for some advantage of 12 visits but only in the short term.
The linear dose-response gradients for the primary outcomes were small in general, reaching approximately
2/100 scale points per six sessions of SMT at 12 and 52
weeks. Even excluding the highest dose group for shortterm results, the gradient would only double to about
4/100 scale points per six SMT sessions. The fact that there
was little difference between adjacent dose groups makes it
difficult to recommend one treatment dose over another.
However, two considerations come into play. First, the effects across dose accumulate to modest benefit of SMT
above the hands-on control. Second, an aim of the study
was to find a saturation dose level for use in future studies.
The time profiles, dose-response gradients, and comparisons with the control group suggest in aggregate that 12
visits would be the best choice, particularly for short-term
improvement.
Interpretation of the dose-response effects requires consideration of several factors. This was a fastidious randomized trial designed to isolate the effects of SMT. We
controlled number of visits, time with the participant, effects of touching the patient, patient-provider interaction,
and intervention credibility. This was accomplished with
18 visits of hands-on therapy and electronic modality (minimal ultrasound) for all groups. The specific and contextual
effects of light massage at non-SMT visits, ultrasound, or
simply 18 visits to a health-care provider potentially obfuscated a larger dose-response gradient that might be found in
clinical practice. For example, such larger effects were seen
in our pilot study where participants attended only visits for
the active intervention [5].
In terms of efficacy, the light massage control is technically a comparison intervention rather than a true sham.
Many sessions with even a minimal massage may have
more effect than one might expect. As such, the differences
between SMT and the control may be somewhat smaller
than for a comparison with a sham manipulation. We did
not attempt to use a sham for two reasons. First, it would
be virtually impossible to blind participants because half received visits for both treatment and control and could compare interventions. Second, we wanted to avoid some
disappointment that can arise when participants think they
may be receiving sham intervention.
All participants were scheduled to receive their assigned
dose of SMT. There were no treatment stoppage rules based
on improvement during the care period. The effects of care
1115
stoppage are unknown and could be either beneficial or detrimental to outcomes in the short and long terms.
Another issue is the threshold of a clinically important
difference between groups for the continuous variable primary outcomes. Studies on patient-rated minimal important
change have led some authors to conclude that 30%
improvement (about 15–20/100 points) can be considered
a robust indicator of within-person minimal clinically important change for these outcomes [35]. A 50% improvement has been recommended as a success threshold for the
individual [36]. However, Dworkin et al. [37] point out that
these numbers do not apply to between-group effects, and
identifying meaningful group differences is a multifactorial
process that is far from straightforward. The between-group
differences of 8.6 in pain and 7.5 in disability scores at a
primary end point are certainly marginal, but it is not clear
yet whether effects of this magnitude constitute a degree
of clinical relevance. The associated number needed to treat
for pain (55) may actually indicate a meaningful effect
[12,38].
Conclusions
Overall, 12 sessions of spinal manipulation in 6 weeks
from a chiropractor yielded the most favorable pain and
functional disability improvement for chronic nonspecific
LBP. Mean participant improvement for this group was substantial at the end of care and sustainable to 52 weeks. Approximately, half of patients would be expected to achieve
50% improvement in pain/disability. Therefore, 12 sessions
of SMT is the current best estimate for use in comparative
effectiveness trials. However, the recommendation is made
with caution because the gradient of treatment effects across
dose groups was too small to clearly distinguish 12 visits
from adjacent dose levels. Even with 12 visits, the contribution of SMT to outcomes beyond that of a focused light massage delivered by a chiropractor (hands-on control) was at
best modest at the 12-week primary end point and negligible
at the 24-week primary end point.
Acknowledgments
This study was funded by the National Center for Complementary and Alternative Medicine (NCCAM), National
Institutes of Health (U01 AT001908). The contents of this
publication are the sole responsibility of the authors and
do not necessarily reflect the official views of NCCAM.
The authors declare no conflicts of interest.
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Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
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REVIEW
Open Access
Effectiveness of manual therapies: the UK
evidence report
Gert Bronfort1*, Mitch Haas2, Roni Evans1, Brent Leininger1, Jay Triano3,4
Abstract
Background: The purpose of this report is to provide a succinct but comprehensive summary of the scientific
evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and
non-musculoskeletal conditions.
Methods: The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs),
widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs
not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was
based on an adapted version of the grading system developed by the US Preventive Services Task Force and a
study risk of bias assessment tool for the recent RCTs.
Results: By September 2009, 26 categories of conditions were located containing RCT evidence for the use of
manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal
conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an
additional 46 RCTs not yet included in systematic reviews and guidelines.
Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments.
Conclusions: Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back
pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several
extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The
evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for
manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint
disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective
for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1 hypertension when added to
an antihypertensive diet. In children, the evidence is inconclusive regarding the effectiveness for otitis media and
enuresis, and it is not effective for infantile colic and asthma when compared to sham manipulation.
Massage is effective in adults for chronic low back pain and chronic neck pain. The evidence is inconclusive for
knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome. In
children, the evidence is inconclusive for asthma and infantile colic.
Background
The impetus for this report stems from the media
debate in the United Kingdom (UK) surrounding the
scope of chiropractic care and claims regarding its effectiveness particularly for non-musculoskeletal conditions.
The domain of evidence synthesis is always embedded
within the structure of societal values [1]. What constitutes evidence for specific claims is framed by the
experience, knowledge, and standards of communities
[2,3]. This varies substantially depending on jurisdictional restrictions by country and region. However, over
the last several decades a strong international effort has
been made to facilitate the systematic incorporation of
standardized synthesized clinical research evidence into
health care decision making [4].
Evidence-Based Healthcare (EBH)
* Correspondence: [email protected]
1
Northwestern Health Sciences University, 2501 W 84th St, Bloomington, MN,
USA
EBH is about doing the right things for the right people
at the right time [5]. It does so by promoting the
© 2010 Bronfort et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
examination of best available clinical research evidence
as the preferred process of decision making where
higher quality evidence is available [6]. This reduces the
emphasis on unsystematic clinical experience and pathophysiological rationale alone while increasing the likelihood of improving clinical outcomes [7]. The fact that
randomized clinical trial (RCT) derived evidence of
potentially effective interventions in population studies
may not be translated in a straight forward manner to
the management of individual cases is widely recognized
[8-10]. However, RCTs comprise the body of information best able to meet existing standards for claims of
benefit from care delivery. The evidence provided by
RCTs constitutes the first line of recommended action
for patients and contributes, along with informed patient
preference, in guiding care [11]. Practice, as opposed to
claims, is inherently interpretative within the context of
patient values and ethical defensibility of recommendations [8,12]. Indeed, the need to communicate research
evidence, or its absence, to patients for truly informed
decision-making has become an important area of
health care research and clinical practice [13,14].
While some may argue that EBH is more science than
art [7], the skill required of clinicians to integrate research
evidence, clinical observations, and patient circumstances
and preferences is indeed artful [6]. It requires creative,
yet informed improvisation and expertise to balance the
different types of information and evidence, with each of
the pieces playing a greater or lesser role depending on
the individual patient and situation [15].
It has become generally accepted that providing evidence-based healthcare will result in better patient outcomes than non-evidence-based healthcare [7]. The
debate of whether or not clinicians should embrace an
evidence-based approach has become muted. Put simply
by one author: “...anyone in medicine today who does
not believe in it (EBH) is in the wrong business [7].”
Many of the criticisms of EBH were rooted in confusion
over what should be done when good evidence is available versus when evidence is weak or nonexistent. From
this, misunderstandings and misperceptions arose,
including concerns that EBH ignores patient values and
preferences and promotes a cookbook approach [16].
When appropriately applied, EBH seeks to empower
clinicians so they can develop fact-based independent
views regarding healthcare claims and controversies.
Importantly, it acknowledges the limitations of using
scientific evidence alone to make decisions and emphasizes the importance of patients’ values and preferences
in clinical decision making [6].
The question is no longer “should” we embrace EBH
but “how"? With EBH comes the need for new skills
including: efficient literature search strategies and the
application of formal rules of evidence in evaluating the
Page 2 of 33
clinical literature [6]. It is important to discern the role of
the health care provider as an advisor who empowers
informed patient decisions. This requires a healthy
respect for which scientific literature to use and how to
use it. “Cherry-picking” only those studies which support
one’s views or relying on study designs not appropriate
for the question being asked does not promote doing the
right thing for the right people at the right time.
Perhaps most critical is the clinician’s willingness to
change the way they practice when high quality scientific
evidence becomes available. It requires flexibility born of
intellectual honesty that recognizes one’s current clinical
practices may not really be in the best interests of the
patient. In some cases this will require the abandonment
of treatment and diagnostic approaches once believed to
be helpful. In other cases it will require the acceptance
and training in new methods. The ever-evolving scientific
knowledge base demands that clinicians be accepting of
the possibility that what is “right” today might not be
“right” tomorrow. EBH requires that clinicians’ actions are
influenced by the evidence [17]. Importantly a willingness
to change must accompany the ability to keep up to date
with the constant barrage of emerging scientific evidence.
Purpose
The purpose of this report is to provide a brief and succinct summary of the scientific evidence regarding the
effectiveness of manual treatment as a therapeutic
option for the management of a variety of musculoskeletal and non-musculoskeletal conditions based on the
volume and quality of the evidence. Guidance in translating this evidence to application within clinical practice settings is presented.
Methods
For the purpose of this report, manual treatment includes
spinal and extremity joint manipulation or mobilization,
massage and various soft tissue techniques. Manipulation/mobilization under anaesthesia was not included in
the report due to the procedure’s invasive nature. The
conclusions of the report are based on the results of the
most recent and most updated (spans the last five to ten
years) systematic reviews of RCTs, widely accepted evidence-based clinical guidelines and/or technology assessment reports (primarily from the UK and US if available),
and all RCTs not yet included in the first three categories. While critical appraisal of the included reviews
and guidelines would be ideal, it is beyond the scope of
the present report. The presence of discordance between
the conclusions of systematic reviews is explored and
described. The conclusions regarding effectiveness are
based on comparisons with placebo controls (efficacy) or
commonly used treatments which may or may not have
been shown to be effective (relative effectiveness), as well
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
as comparison to no treatment. The strength/quality of
the evidence relating to the efficacy/effectiveness of manual treatment is graded according to an adapted version
of the latest grading system developed by the US Preventive Services Task Force (see http://www.ahrq.gov/clinic/
uspstf/grades.htm). The evidence grading system used for
this report is a slight modification of the system used in
the 2007 Joint Clinical Practice Guideline on low back
pain from the American College of Physicians and the
American Pain Society [18].
Through a search strategy using the databases MEDLINE (PubMed), Ovid, Mantis, Index to Chiropractic
Literature, CINAHL, the specialized databases Cochrane
Airways Group trial registry, Cochrane Complementary
Medicine Field, and Cochrane Rehabilitation Field, systematic reviews and RCTs as well as evidence-based
clinical guidelines were identified. Search restrictions
were human subjects, English language, peer-reviewed
and indexed journals, and publications before October
2009. In addition, we screened and hand searched reference citations located in the reviewed publications. The
description of the search strategy is provided in Additional file 1 (Medline search strategy).
Although findings from studies using a nonrandomized design (for example observational studies, cohort
studies, prospective clinical series and case reports) can
yield important preliminary evidence, the primary purpose of this report is to summarize the results of studies
designed to address efficacy, relative efficacy or relative
effectiveness and therefore the evidence base was
restricted to RCTs. Pilot RCTs not designed or powered
to assess effectiveness, and RCTs designed to test the
immediate effect of individual treatment sessions were
not part of the evidence base in this report.
The quality of RCTs, which have not been formally
quality-assessed within the context of systematic reviews
or evidence based guidelines, was assessed by two
reviewers with a scale assessing the risk of bias recommended for use in Cochrane systematic reviews of RCTs.
Although the Cochrane Collaboration handbook http://
www.cochrane.org/resources/handbook/ discourages that
scoring be applied to the risk of bias tool, it does provide
suggestion for how trials can be summarized. We have
been guided by that suggestion and the adapted evidence
grading system used in this report requires that we assess
the validity and impact of the latest trial evidence. These
additional trials are categorized as higher, moderate, or
lower-quality as determined by their attributed risk of
bias. For details, see Additional file 2 (The Cochrane Collaboration tool for assessing risk of bias and the rating of
the bias for the purpose of this report).
The overall evidence grading system allows the
strength of the evidence to be categorized into one of
three categories: high quality evidence, moderate
Page 3 of 33
quality evidence, and inconclusive (low quality) evidence. The operational definitions of these three categories follow below:
High quality evidence
The available evidence usually includes consistent
results from well-designed, well conducted studies in
representative populations which assess the effects on
health outcomes.
The evidence is based on at least two consistent
higher-quality (low risk of bias) randomized trials. This
conclusion is therefore unlikely to be strongly affected
by the results of future studies.
Moderate quality evidence
The available evidence is sufficient to determine the
effectiveness relative to health outcomes, but confidence
in the estimate is constrained by such factors as:
● The number, size, or quality of individual studies.
● Inconsistency of findings across individual studies.
● Limited generalizability of findings to routine
practice.
● Lack of coherence in the chain of evidence.
The evidence is based on at least one higher-quality randomized trial (low risk of bias) with sufficient statistical
power, two or more higher-quality (low risk of bias) randomized trials with some inconsistency; at least two consistent, lower-quality randomized trials (moderate risk of
bias). As more information becomes available, the magnitude or direction of the observed effect could change, and
this change may be large enough to alter the conclusion.
Inconclusive (low quality) evidence
The available evidence is insufficient to determine
effectiveness relative to health outcomes. Evidence is
insufficient because of:
● The limited number or power of studies.
● Important flaws in study design or methods (only
high risk of bias studies available).
● Unexplained inconsistency between higher-quality
trials.
● Gaps in the chain of evidence.
● Findings not generalizable to routine practice.
● Lack of information on important health outcomes
For the purpose of this report a determination was
made whether the inconclusive evidence appears favorable or non-favorable or if a direction could even be
established (unclear evidence).
Additionally, brief evidence statements are made
regarding other non-pharmacological, non-invasive
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
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physical treatments (for example exercise) and patient
educational interventions, shown to be effective and
which can be incorporated into evidence-based therapeutic management or co-management strategies in
chiropractic practices. These statements are based on
conclusions of the most recent and most updated
(within last five to ten years) systematic reviews of randomized clinical trials and widely accepted evidencebased clinical guidelines (primarily from the UK and US
if available) identified through our search strategy.
Page 4 of 33
summary statements at the end of the section for each
condition and in briefer summary form in Figures 3, 4,
5, 6, and 7. Additionally, definitions and brief diagnostic
criteria for the conditions reviewed are provided. Diagnostic imaging for many conditions is indicated by the
presence of “red flags” suggestive of serious pathology.
Red flags may vary depending on the condition under
consideration, but typically include fractures, trauma,
metabolic disorders, infection, metastatic disease, and
other pathological disease processes contraindicative to
manual therapy.
Translating Evidence to Action
Translating evidence requires the communication of salient take-home messages in context of the user’s applications [3]. There are two message applications for
information derived from this work. First, the criteria for
sufficiency of evidence differ depending on the context of
the considered actions [8,19]. Sufficient evidence to proffer claims of effectiveness is defined within the sociopolitical context [20] of ethics and regulation. Separate is
the second application of evidence to inform decision
making for individual patients. Where there is strength of
evidence and the risk of bias is small, the preferred
choices require little clinical judgment. Alternatively,
when evidence is uncertain and/or there is higher risk of
bias, then greater emphasis is placed on the patient as an
active participant [11]. This requires the clinician to
effectively communicate research evidence to patients
while assisting their informed decision-making [19].
In summary, the information derived within this
report are directed to two applications 1) the determination of supportable public claims of treatment effectiveness for chiropractic care within the context of social
values; and 2) the use of evidence information as a basis
for individualized health care recommendations using
the hierarchy of evidence (Figure 1).
Results
By September 2009, 26 categories of conditions were
located containing RCT evidence for the use of manual
therapy: 13 musculoskeletal conditions, four types of
chronic headache and nine non-musculoskeletal conditions (Figure 2). We identified 49 recent relevant systematic reviews and 16 evidence-based clinical
guidelines plus an additional 46 RCTs not yet included
within the identified systematic reviews and guidelines.
A number of other non-invasive physical treatments and
patient education with evidence of effectiveness were
identified including exercise, yoga, orthoses, braces, acupuncture, heat, electromagnetic field therapy, TENS,
laser therapy, cognitive behavioral therapy and relaxation. The report presents the evidence of effectiveness
or ineffectiveness of manual therapy as evidence
Non-specific Low Back Pain (LBP)
Definition
Non-specific LBP is defined as soreness, tension, and/or
stiffness in the lower back region for which it is not
possible to identify a specific cause of pain [21].
Diagnosis
Diagnosis of non-specific LBP is derived from the
patient’s history with an unremarkable neurological
exam and no indicators of potentially serious pathology.
Imaging is only indicated in patients with a positive
neurological exam or presence of a “red flag” [21-24].
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2004, five systematic reviews made a comprehensive evaluation of the benefit of spinal manipulation for
non-specific LBP [25-30]. Approximately 70 RCTs were
summarized. The reviews found that spinal manipulation was superior to sham intervention and similar in
effect to other commonly used efficacious therapies
such as usual care, exercise, or back school. For sciatica/
radiating leg pain, three reviews [18,25,27] found manipulation to have limited evidence. Furlan et al [30] concluded massage is beneficial for patients with subacute
and chronic non-specific low-back pain based on a
review of 13 RCTs.
Evidence-based clinical guidelines
Since 2006, four guidelines make recommendations
regarding the benefits of manual therapies for the care
of LBP: NICE [21,31], The American College of Physicians/American Pain Society [18,22], European guidelines for chronic LBP [23], and European guidelines for
acute LBP [24]. The number of RCTs included within
the various guidelines varied considerably based on their
scope, with the NICE guidelines including eight trials
and The American College of Physicians/American Pain
Society guidelines including approximately 70 trials.
These guidelines in aggregate recommend spinal manipulation/mobilization as an effective treatment for acute,
subacute, and chronic LBP. Massage is also recommended for the treatment of subacute and chronic LBP.
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
Figure 1 Translating Evidence to Action.
Figure 2 Categories of Conditions included in this report.
Page 5 of 33
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Page 6 of 33
Figure 3 Evidence Summary - Adults - Spinal Conditions.
Recent randomized clinical trials not included in above
Hallegraeff et al [32] compared a regimen of spinal
manipulation plus standard physical therapy to standard
physical therapy for acute LBP. Overall there were no
differences between groups for pain and disability post
treatment. Prediction rules may have affected outcomes.
This study had a high risk of bias.
Rasmussen et al [33] found patients receiving extension exercise or receiving extension exercise plus spinal
manipulation experienced a decrease in chronic LBP,
but no differences were noted between groups. This
study had a high risk of bias.
Little et al [34] found Alexander technique, exercise,
and massage were all superior to control (normal care)
at three months for chronic LBP and disability. This
study had a moderate risk of bias.
Wilkey et al [35] found chiropractic management was
superior to NHS pain clinic management for chronic
LBP at eight weeks for pain and disability outcomes.
This study had a high risk of bias.
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
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Figure 4 Evidence Summary - Adults - Extremity Conditions.
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Figure 5 Evidence Summary - Adults - Headache and Other Conditions.
Bogefeldt et al [36] found manual therapy plus advice
to stay active was more effective than advice to stay
active alone for reducing sick leave and improving
return to work at 10 weeks for acute LBP. No differences between the groups were noted at two years. This
study had a low risk of bias.
Hancock et al [37] found spinal mobilization in addition to medical care was no more effective than medical
care alone at reducing the number of days until full
recovery for acute LBP. This study had a low risk of
bias.
Ferreira et al [38] found spinal manipulation was
superior to general exercise for function and perceived
effect at eight weeks in chronic LBP patients, but no differences were noted between groups at six and 12
months. This study had a moderate risk of bias.
Eisenberg et al [39] found that choice of complementary therapies (including chiropractic care) in addition
to usual care was no different from usual care in bothersomeness and disability for care of acute LBP. The trial
did not report findings for any individual manual therapy. This study had a low risk of bias.
Hondras et al [40] found lumbar flexion-distraction
was superior to minimal medical care at 3,6,9,12, and 24
weeks for disability related to subacute or chronic LBP,
but spinal manipulation was superior to minimal medical care only at three weeks. No differences between
spinal manipulation and flexion-distraction were noted
for any reported outcomes. Global perceived improvement was superior at 12 and 24 weeks for both manual
therapies compared to minimal medical care. This study
had a low risk of bias.
Mohseni-Bandpei et al [41] showed that patients
receiving manipulation/exercise for chronic LBP
reported greater improvement compared with those
receiving ultrasound/exercise at both the end of the
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Page 9 of 33
Figure 6 Evidence Summary - Adults - Non-Musculoskeletal Conditions.
treatment period and at 6-month follow-up. The study
had a high risk of bias.
Beyerman et al [42] evaluated the efficacy of chiropractic spinal manipulation, manual flexion/distraction,
and hot pack application for the treatment of LBP of
mixed duration from osteoarthritis (OA) compared with
moist heat alone. The spinal manipulation group
reported more and faster short term improvement in
pain and range of motion. The study had a high risk of
bias.
Poole et al [43] showed that adding either foot
reflexology or relaxation training to usual medical
care in patients with chronic LBP is no more
effective than usual medical care alone in either the
short or long term. The study had a moderate risk of
bias.
Zaproudina et al [44] found no differences between
groups (bonesetting versus exercise plus massage) at
one month or one year for pain or disability. The global
assessment score of improvement was superior for the
bonesetting group at one month. This study had a high
risk of bias.
Evidence Summary (See Figure 3)
◦ High quality evidence that spinal manipulation/
mobilization is an effective treatment option for
subacute and chronic LBP in adults [18,21,23].
◦ Moderate quality evidence that spinal manipulation/mobilization is an effective treatment option
for subacute and chronic LBP in older adults [40].
◦ Moderate quality evidence that spinal manipulation/mobilization is an effective treatment option
for acute LBP in adults [18,24].
◦ Moderate evidence that adding spinal mobilization
to medical care does not improve outcomes for
acute LBP in adults [37].
◦ Moderate quality evidence that massage is an effective treatment for subacute and chronic LBP in
adults [22,30].
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
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Figure 7 Evidence Summary - Pediatrics - Non-Musculoskeletal Conditions.
◦ Inconclusive evidence in a favorable direction
regarding the use of manipulation for sciatica/
radiating leg pain [22,25,27].
◦ Inconclusive evidence in a non-favorable direction
regarding the addition of foot reflexology to usual
medical care for chronic LBP [43].
Other effective non-invasive physical treatments or patient
education
Advice to stay active, interdisciplinary rehabilitation,
exercise therapy, acupuncture, yoga, cognitive-behavioral
therapy, or progressive relaxation for chronic LBP and
superficial heat for acute LBP [18,22].
Non-specific mid back pain
Definition
Non-specific thoracic spine pain is defined as soreness,
tension, and/or stiffness in the thoracic spine region for
which it is not possible to identify a specific cause of
pain [45].
Diagnosis
Diagnosis of non-specific thoracic spine pain is derived
from the patient’s history with an unremarkable neurological exam and no indicators of potentially serious
pathology. Imaging is only indicated in patients with a
positive neurological exam or presence of a “red flag”
[45,46].
Evidence base for manual treatment
Systematic reviews (most recent)
No systematic reviews addressing the role of manual
therapy in thoracic spine pain that included randomized
clinical trials were located.
Evidence-based clinical guidelines
The Australian acute musculoskeletal pain guidelines
group concludes there is evidence from one small pilot
study [47] that spinal manipulation is effective compared
to placebo for thoracic spine pain.
Recent randomized clinical trials not included in above
Multiple randomized clinical trials investigating the use
of thoracic spinal manipulation were located [48-53];
however, most of the trials assessed the effectiveness of
thoracic manipulation for neck or shoulder pain.
Evidence Summary (See Figure 3)
◦ Inconclusive evidence in a favorable direction
regarding the use of spinal manipulation for mid
back pain [47].
Other effective non-invasive physical treatments or patient
education
None
Mechanical neck pain
Definition
Mechanical neck pain is defined as pain in the anatomic
region of the neck for which it is not possible to identify
a specific pathological cause of pain [54,55]. It generally
includes neck pain, with or without pain in the upper
limbs which may or may not interfere with activities of
daily living (Grades I and II). Signs and symptoms indicating significant neurologic compromise (Grade III) or
major structural pathology (Grade IV including fracture,
vertebral dislocation, neoplasm, etc.) are NOT included.
Diagnosis
Diagnosis of mechanical neck pain is derived from the
patient’s history. Imaging is only indicated in patients
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
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with a positive neurological exam or presence of a “red
flag” [54,56].
Evidence base for manual treatment
Systematic reviews (most recent)
The recently published best evidence synthesis by the Bone
and Joint Decade 2000-2010 Task Force on Neck Pain and
Its Associated Disorders represents the most recent and
comprehensive systematic review of the literature for noninvasive interventions, including manual treatment, for
neck pain [55]. For whiplash associated disorders, they concluded that mobilization and exercises appear more beneficial than usual care or physical modalities. For Grades I
and II neck pain, they concluded that the evidence suggests
that manual treatment (including manipulation and mobilization) and exercise interventions, low-level laser therapy
and perhaps acupuncture are more effective than no treatment, sham or alternative interventions. No one type of
treatment was found to be clearly superior to any other.
They also note that manipulation and mobilization yield
comparable results. Conclusions regarding massage could
not be made due to lack of evidence.
Since 2003, there were five other systematic reviews
[29,57-60]. One found that spinal manipulation was
effective for non-specific neck pain alone and in combination with exercise [29], while two found effectiveness
only for the combination of spinal manipulation and
exercise [58,60]. Differences between review conclusions
are expected. It is likely they can be attributed to additional primary studies and diversity in review strategies,
including inclusion criteria, methodological quality scoring, and evidence determination.
Evidence-based clinical guidelines
The American Physical Therapy Association’s guidelines on
neck pain recommends utilizing cervical manipulation and
mobilization procedures to reduce neck pain based on
strong evidence [56]. They found cervical manipulation and
mobilization with exercise to be more effective for reducing
neck pain and disability than manipulation and mobilization alone. Thoracic spine manipulation is also recommended for reducing pain and disability in patients with
neck and neck-related arm pain based on weak evidence.
Recent randomized clinical trials not included in above
Häkkinen et al used a cross-over design to compare manual therapy and stretching for chronic neck pain [61].
Manual therapy was more effective than stretching at
four weeks, but no difference between the two therapies
was noted at 12 weeks. This study had a high risk of bias.
González-Iglesias et al examined the effectiveness of
adding general thoracic spine manipulation to electrotherapy/thermal therapy for acute neck pain. In two separate trials they found an advantage for the manipulation
group in terms of pain and disability [62,63]. The trials
had moderate to low risk of bias.
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Walker et al compared manual therapy with exercise
to advice to stay active and placebo ultrasound [64].
The manual therapy group reported less pain (in the
short term) and more improvement and less disability
(in the long term) than the placebo group. This study
had a low risk of bias.
Cleland et al [65] showed that thoracic spine thrust
mobilization/manipulation results in a significantly
greater short-term reduction in pain and disability than
does thoracic non-thrust mobilization/manipulation in
people with mostly subacute neck pain. The study had a
low risk of bias.
Fernandez et al [66] found that adding thoracic
manipulation to a physical therapy program was effective in treating neck pain due to whiplash injury. The
study had a high risk of bias.
Savolainen et al [49] compared the effectiveness of
thoracic manipulations with instructions for physiotherapeutic exercises for the treatment of neck pain in occupational health care. The effect of the manipulations was
more favorable than the personal exercise program in
treating the more intense phase of pain. The study had
a moderate risk of bias.
Zaproudina et al [67] assessed the effectiveness of traditional bone setting (mobilization) of joints of extremities and the spine for chronic neck pain compared with
conventional physiotherapy or massage. The traditional
bone setting was superior to the other two treatments
in both in the short and long term. The study had a
moderate risk of bias.
Sherman et al compared massage therapy to self-care for
chronic neck pain. Massage was superior to self-care at 4
weeks for both neck disability and pain [68]. A greater proportion of massage patients reported a clinically significant
improvement in disability than self-care patients at four
weeks, and more massage patients reported a clinically significant improvement in pain at four and 10 weeks. No statistically significant differences between groups were noted
at 26 weeks. This study had a low risk of bias.
Evidence Summary (See Figure 3)
◦ Moderate quality evidence that mobilization combined with exercise is effective for acute whiplashassociated disorders [55].
◦ Moderate quality evidence that spinal manipulation/mobilization combined with exercise is effective for chronic non-specific neck pain [55,58].
◦ Moderate quality evidence that thoracic spinal
manipulation/mobilization is effective for acute/
subacute non-specific neck pain [62,63,65,66].
◦ Moderate quality evidence that spinal manipulation
is similar to mobilization for chronic non-specific
neck pain [55,58].
◦ Moderate quality evidence that massage therapy is
effective for non-specific chronic neck pain [68].
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
◦ Inconclusive evidence in a favorable direction for
cervical spinal manipulation/mobilization alone for
neck pain of any duration [29,55,58].
Other effective non-invasive physical treatments or patient
education
Exercise, low-level laser therapy, acupuncture [55]
Coccydynia
Definition
Coccydynia is defined as symptoms of pain in the region
of the coccyx [69].
Diagnosis
Diagnosis of coccydynia is derived from the patient’s
history and exam with no indicators of potentially serious pathology. Imaging is only indicated in patients
with a presence of a “red flag” [46,69].
Evidence base for manual treatment
Systematic reviews (most recent)
None located
Evidence-based clinical guidelines
None located
Recent randomized clinical trials not included in above
Maigne et al [70] found manipulation was more effective
than placebo for pain relief and disability in the treatment of coccydynia at one month. This study had a
moderate risk of bias.
Evidence Summary (See Figure 3)
◦ Inconclusive evidence in a favorable direction for
the use of spinal manipulation in the treatment of
coccydynia [70].
Other effective non-invasive physical treatments or patient
education
None
Shoulder pain
Definition
Shoulder pain is defined as soreness, tension, and/or
stiffness in the anatomical region of the shoulder and
can be secondary to multiple conditions including, but
not limited to rotator cuff disease and adhesive
capsulitis.
Diagnosis
Diagnosis of shoulder pain is derived mainly from the
patient’s history and physical exam with no indicators of
potentially serious pathology. Imaging studies are confirmatory for diagnoses of rotator cuff disorders, osteoarthritis, glenohumeral instability, and other pathologic
causes of shoulder pain [71].
Evidence base for manual treatment
Systematic reviews (most recent)
Two systematic reviews evaluated the benefit of manual
therapy for shoulder pain [72,73]. Six RCTs evaluating
Page 12 of 33
the effectiveness of manual therapy for the treatment of
shoulder pain were included [74-79]. Five of the trials
evaluated mobilization [74-77,79] while one trial evaluated the use of manipulation and mobilization [78]
for shoulder pain. The review concluded there is weak
evidence that mobilization added benefit to exercise for
rotator cuff disease.
Evidence-based clinical guidelines
The Philadelphia Panel’s evidence based clinical practice
guidelines on selected rehabilitation interventions for
shoulder pain concluded there is insufficient evidence
regarding the use of therapeutic massage for shoulder
pain [80].
Recent randomized clinical trials not included in above
Vermeulen et al [81] found that high-grade mobilization
techniques were more effective than low-grade mobilization techniques for active range of motion (ROM), passive ROM, and shoulder disability for adhesive capsulitis
at three to 12 months. No differences were noted for
pain or mental and physical general health. Both groups
showed improvement in all outcome measures. This
study had low risk of bias.
van den Dolder and Roberts [82] found massage was
more effective than no treatment for pain, function, and
ROM over a two week period in patients with shoulder
pain. This study had moderate risk of bias.
Bergman et al [51] found no differences between groups
during the treatment period (6 wks). More patients
reported being “recovered” in the usual care plus manipulative/mobilization group at 12 and 52 weeks compared to
usual care alone. This study had low risk of bias.
Johnson et al [83] found no differences in pain or disability between anterior and posterior mobilization for the care
of adhesive capsulitis. This study had a high risk of bias.
Guler-Uysal et al [84] concluded that deep friction
massage and mobilization exercises was superior in the
short term to physical therapy including diathermy for
adhesive capsulitis. The study had a high risk of bias.
Evidence Summary (See Figure 4)
◦ Moderate quality evidence that high-grade mobilization is superior to low-grade mobilization for
reduction of disability, but not for pain, in adhesive
capsulitis [81].
◦ Inconclusive evidence in an unclear direction for a
comparison of anterior and posterior mobilization
for adhesive capsulitis [83].
◦ Moderate evidence favors the addition of manipulative/mobilization to medical care for shoulder
girdle pain and dysfunction [51].
◦ Inconclusive evidence in a favorable direction for
massage in the treatment of shoulder pain [82].
◦ Inconclusive evidence in a favorable direction for
mobilization/manipulation in the treatment of
rotator cuff pain [72].
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
Other effective non-invasive physical treatments or patient
education
Exercise therapy [80]
Lateral epicondylitis
Definition
Lateral epicondylitis is defined as pain in the region of
the lateral epicondyle which is exacerbated by active and
resistive movements of the extensor muscles of the forearm [85].
Diagnosis
Page 13 of 33
in the short term and superior in the long term for
lateral epicondylitis [98].
◦ Inconclusive evidence in a favorable direction
regarding the use of manual oscillating tender point
therapy of the elbow for lateral epicondylitis [99].
Other effective non-invasive physical treatments or patient
education
Laser therapy, acupuncture [86,100,101]
Carpal tunnel syndrome
Definition
Diagnosis is made solely from the patient’s history and
clinical examination [71].
Carpal tunnel syndrome is defined as compression of
the median nerve as it passes through the carpal tunnel
in the wrist [102].
Evidence base for manual treatment
Systematic reviews (most recent)
Diagnosis
Three systematic reviews evaluating the benefit of manual
therapy for lateral epicondylitis have been identified
[86-88]. Eight RCTs were included [89-96] in the systematic reviews examining the effect of various manual therapies including elbow [89] and wrist manipulation [92],
cervical spine [90] and elbow mobilization [91,93,95], and
cross-friction massage [94-96]. Bisset et al [86] concluded
there is some evidence of positive initial effects of manual
techniques (massage/mobilization) for lateral epicondylitis,
but no long term evidence. Smidt et al [88] concluded
there is insufficient evidence to draw conclusions on the
effectiveness of mobilization techniques for lateral
epicondylitis.
Diagnosis of carpal tunnel syndrome is made from the
patient’s history, physical exam, and confirmatory electrodiagnostic tests [102].
Evidence base for manual treatment
Systematic reviews (most recent)
Evidence-based clinical guidelines
Since 2003, four systematic reviews evaluated the benefit
of manual therapy for carpal tunnel syndrome
[87,103-105]. Two RCTs evaluating the effectiveness of
manual therapy were included [106,107]. One of the
trials examined the use of spinal and upper extremity
manipulation [106], while the other trial examined the
use of wrist manipulation [107] for carpal tunnel syndrome. The reviews concluded uncertain or limited evidence for manipulation/mobilization.
None located
Evidence-based clinical guidelines
Recent randomized clinical trials not included in above
The American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of carpal tunnel
syndrome [102] made no recommendations for or
against the use of manipulation or massage therapy due
to insufficient evidence.
Verhaar et al [97] showed that corticosteroid injection
was superior to Cyriax physiotherapy for the number of
pain free subjects at six weeks. No differences between
groups were noted at one year. This study had a high
risk of bias.
Bisset et al [98] found corticosteroid injections were
superior to elbow mobilization with exercise which was
superior to wait and see approaches for pain-free grip
strength, pain intensity, function, and global improvement at six weeks. However, both elbow mobilization
with exercise and the wait and see approach were superior to corticosteroid injections at six months and one
year for all of the previously reported outcomes. This
study had a low risk of bias.
Nourbakhsh and Fearon [99] found oscillating energy
manual therapy (tender point massage) was superior to
placebo manual therapy for pain intensity and function.
This study had a high risk of bias due to sample size
(low risk of bias otherwise).
Evidence Summary (See Figure 4)
◦ Moderate quality evidence that elbow mobilization
with exercise is inferior to corticosteroid injections
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figure 4)
◦ Inconclusive evidence in a favorable direction for
manipulation/mobilization in the treatment of carpal tunnel syndrome [87,103,105].
Other effective non-invasive physical treatments or patient
education
Splinting [102]
Hip pain
Definition
Hip pain is defined as soreness, tension, and/or stiffness
in the anatomical region of the hip and can be secondary to multiple conditions including hip osteoarthritis.
Diagnosis
Diagnosis of hip pain is derived from the patient’s history
and physical exam with an unremarkable neurological
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
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Page 14 of 33
exam and no indicators of potentially serious pathology.
Imaging studies are confirmatory for diagnoses of moderate or severe osteoarthritis [108,109].
neurological exam and no indicators of potentially serious pathology. Imaging studies are confirmatory for
diagnoses of moderate or severe osteoarthritis [109,112].
Evidence base for manual treatment
Systematic reviews (most recent)
Evidence base for manual treatment
Systematic reviews (most recent)
One systematic review evaluating manual therapy for
hip pain has been published [110]. One RCT evaluating
the effectiveness of hip manipulation for the treatment
of hip osteoarthritis was included in the published systematic review [111]. The review concluded there is limited evidence for manipulative therapy combined with
multimodal or exercise therapy for hip osteoarthritis.
As of September 2009, one systematic review evaluating
the benefit of manual therapy for knee pain has been
identified [110]. Ten RCT’s evaluating the effectiveness
of manual therapy for the treatment of knee pain were
included in the published systematic review [115-124].
Both osteoarthritis knee pain and patellofemoral pain
syndrome were included in the conditions reviewed. Various manual therapy techniques including spinal mobilization [115,116,119], spinal manipulation [118,123], knee
mobilization [115-117,120-124], and knee manipulation
[121] were examined within the review. The review concludes there is fair evidence for manipulative therapy of
the knee and/or full kinetic chain (Sacro-iliac to foot),
combined with multimodal or exercise therapy for knee
osteoarthritis and patellofemoral pain syndrome.
Evidence-based clinical guidelines
The NICE national clinical guidelines for care and management of adults with osteoarthritis [112] recommends
manipulation and stretching should be considered as an
adjunct to core treatment, particularly for osteoarthritis
of the hip. This recommendation is based on the results
of one RCT.
The orthopaedic section of the American Physical
Therapy Association’s guidelines on hip pain and mobility deficits [108] recommends clinicians should consider
the use of manual therapy procedures to provide shortterm pain relief and improve hip mobility and function
in patients with mild hip osteoarthritis based on moderate evidence.
Recent randomized clinical trials not included in above
Licciardone et al found decreased rehabilitation efficiency with osteopathic manipulative therapy (OMT)
compared to sham OMT following hip arthroplasty. No
other significant differences were found between the
two groups [113]. This study had a high risk of bias.
Evidence Summary (See Figure 4)
◦ Moderate quality evidence that hip manipulation is
superior to exercise for the treatment of the symptoms of hip osteoarthritis [111].
◦ Inconclusive evidence in a non-favorable direction
regarding osteopathic manipulative therapy for
rehabilitation following total hip arthroplasty [113].
Other effective non-invasive physical treatments or patient
education
Exercise therapy, advice about weight loss, and appropriate footwear [108,112,114]
Knee pain
Definition
Knee pain is defined as soreness, tension, and/or stiffness in the anatomical region of the knee and can be
secondary to multiple conditions including knee
osteoarthritis or patellofemoral pain syndrome.
Diagnosis
Diagnosis of knee pain is derived from the patient’s history and physical exam with an unremarkable
Evidence-based clinical guidelines
The NICE national clinical guidelines for care and management of adults with osteoarthritis [112] recommends
manipulation and stretching should be considered as an
adjunct to core treatment.
Recent randomized clinical trials not included in above
Pollard et al [125] assessed a manual therapy protocol
compared to non-forceful manual contact (control).
They concluded that a short term of manual therapy
significantly reduced pain compared to the control
group. This study had a high risk of bias.
Perlman et al [126] found massage therapy was more
effective than wait list control for osteoarthritis related
knee pain, stiffness, and function. This study had a high
risk of bias.
Licciardone et al [113] assessed osteopathic manipulative treatment following knee arthroplasty. This study
found decreased rehabilitation efficiency with OMT
compared to sham OMT; otherwise, no significant differences were found between the two groups. This study
had a high risk of bias.
Evidence Summary (See Figure 4)
◦ Moderate quality evidence that manual therapy of
the knee and/or full kinetic chain (SI to foot) combined with multimodal or exercise therapy is effective for the symptoms of knee osteoarthritis [110].
◦ Moderate quality evidence that manual therapy of
the knee and/or full kinetic chain (SI to foot) combined with multimodal or exercise therapy is effective for patellofemoral pain syndrome [110].
◦ Inconclusive evidence in a favorable direction that
massage therapy is effective for the symptoms of
knee osteoarthritis [126].
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
◦ Inconclusive evidence in a non-favorable direction
for the effectiveness of osteopathic manipulative
therapy for rehabilitation following total hip or
knee arthroplasty [113].
Other effective non-invasive physical treatments or patient
education
Exercise therapy, advice about weight loss, appropriate
footwear, pulsed electromagnetic field therapy, acupuncture, and TENS [112,127-131]
Ankle and foot conditions
Definition
A variety of conditions are included under ankle and
foot conditions including ankle sprains, plantar fasciitis,
morton’s neuroma, hallux limitus/rigidus, and hallux
abducto valgus.
Diagnosis
The diagnosis of ankle/foot conditions relies mainly on
the patient’s history and physical examination. Imaging
studies are indicated for morton’s neuroma or in the
presence of potential pathology [109].
Evidence base for manual treatment
Systematic reviews (most recent)
As of September 2009, two systematic reviews evaluating the benefit of manual therapy for ankle and foot
conditions have been published [110,132]. The ankle
and foot conditions reviewed included ankle sprain,
plantar fasciitis, morton’s neuroma, hallux limitus, and
hallux abducto valgus. Thirteen RCTs evaluating the
effectiveness of manual therapy for the treatment of various ankle and foot conditions were included in the
published systematic reviews [133-145]. Of the thirteen
trials, six examined the use of ankle/foot manipulation
[134,136,137,139-141], six examined the use of ankle/
foot mobilization [133,135,138,143-145], and one trial
examined the combined use of manipulation and mobilization [142].
The review by Brantingham et al concluded there is
fair evidence for manipulative therapy of the ankle and/
or foot combined with multimodal or exercise therapy
for ankle inversion sprain [110]. The same authors
found limited evidence for manipulative therapy combined with multimodal or exercise therapy for plantar
fasciitis, metatarsalgia, and hallux limitus and insufficient evidence for the use of manual therapy for hallux
abducto valgus.
The review by van der Wees et al concluded it is
likely that manual mobilization has an initial effect on
dorsiflexion range of motion after ankle sprains [132].
Evidence-based clinical guidelines
None making recommendations based on RCTs were
located
Page 15 of 33
Recent randomized clinical trials not included in above
Wynne et al found an osteopathic manipulative therapy
group had greater improvement in plantar fasciitis
symptoms versus placebo control. This study had a high
risk of bias [146].
Cleland et al compared manual therapy with exercise
to electrotherapy with exercise for patients with plantar
heel pain [147]. They found manual therapy plus exercise was superior. This study had a low risk of bias.
Lin et al found the addition of manual therapy (mobilization) to a standard physiotherapy program provided
no additional benefit compared to the standard physiotherapy program alone for rehabilitation following
ankle fracture [148]. This study had a low risk of bias.
Evidence Summary (See Figure 4)
◦ Moderate quality evidence that mobilization is of
no additional benefit to exercise in the rehabilitation following ankle fractures [148].
◦ Moderate quality evidence that manual therapy of
the foot and/or full kinetic chain (SI to foot) combined with exercise therapy is effective for plantar
fasciitis [147].
◦ Inconclusive evidence in a favorable direction for
the effectiveness of manual therapy with multimodal or exercise therapy for ankle sprains [110].
◦ Inconclusive evidence in a favorable direction
regarding the effectiveness of manual therapy for
morton’s neuroma, hallux limitus, and hallux
abducto valgus [110].
Other effective non-invasive physical treatments or patient
education
Stretching and foot orthoses for plantar fasciitis [149],
ankle supports for ankle sprains [150]
Temporomandibular disorders
Definition
Temporomandibular disorders consist of a group of
pathologies affecting the masticatory muscles, temporomandibular joint, and related structures [151].
Diagnosis
Diagnosis of temporomandibular disorders is derived
from the patient’s history and physical exam with no
indicators of potentially serious pathology [151,152].
Evidence base for manual treatment
Systematic reviews (most recent)
As of September 2009, two systematic reviews evaluating the benefit of manual therapy for temporomandibular dysfunction have been published [153,154]. Three
RCTs evaluating the effectiveness of manual therapy
were included in the published systematic reviews
[155-157]. Two of the trials examined the effectiveness
of mobilization [155,156] and one trial assessed massage
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
[157]. The reviews conclude there is limited evidence for
the use of manual therapy in the treatment of temporomandibular dysfunction.
Evidence-based clinical guidelines
None located
Recent randomized clinical trials not included in above
Monaco et al [158] examined the effects of osteopathic
manipulative treatment on mandibular kinetics compared to a no treatment control group; however, no
between group analysis was performed. This study had a
high risk of bias.
Ismail et al [159] found physical therapy including
mobilization in addition to splint therapy was superior
to splint therapy alone after three months of treatment
for active mouth opening. No differences were found
between groups for pain. This study had a moderate
risk of bias.
Evidence Summary (See Figure 5)
◦ Inconclusive evidence in a favorable direction
regarding mobilization and massage for temporomandibular dysfunction [154].
Other effective non-invasive physical treatments or patient
education
None
Fibromyalgia
Definition
Fibromyalgia syndrome (FMS) is a common rheumatological condition characterized by chronic widespread
pain and reduced pain threshold, with hyperalgesia and
allodynia [160].
Diagnosis
Diagnosis of fibromyalgia is made primarily from the
patient’s history and physical exam. The American College of Rheumatology have produced classification criteria for fibromyalgia including widespread pain
involving both sides of the body, above and below the
waist for at least three months and the presence of 11
out of 18 possible pre-specified tender points [161].
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2004, three systematic reviews evaluating the benefit of manual therapy for fibromyalgia have been published [162-164]. Six RCTs evaluating the effectiveness
of manual therapy for the treatment of fibromyalgia
were included in the published systematic reviews
[165-170]. Five of the studies assessed the effectiveness
of spinal manipulation for fibromyalgia [165-169], while
one assessed the effectiveness of massage [170].
Schneider et al [162] conclude there is moderate level
evidence from several RCTs and a systematic review
[171] that massage is helpful in improving sleep and
reducing anxiety in chronic pain; however, few of the
Page 16 of 33
studies included in the systematic review [162] specifically investigated fibromyalgia.
Ernst [163] states that the current trial evidence is
insufficient to conclude that chiropractic is an effective
treatment of fibromyalgia.
Goldenberg et al [164] conclude there is weak evidence of efficacy for chiropractic, manual, and massage
therapy in the treatment of fibromyalgia.
Evidence-based clinical guidelines
The 2007 a multidisciplinary task force with members
from 11 European countries published evidence based
recommendation for FMS [160]. The task force notes
the clinical trial evidence for manual therapy is lacking.
Randomized clinical trials not included in above
Ekici et al [172] found improvement was higher in the
manual lymph drainage group compared to connective
tissue massage on the fibromyalgia impact questionnaire,
but no differences were noted between groups for pain,
pain pressure threshold, or health related quality of life.
This study had a moderate risk of bias.
Evidence Summary (See Figure 5)
◦ Inconclusive evidence in a favorable direction
regarding the effectiveness of massage and manual
lymph drainage for the treatment of fibromyalgia
[162,172].
◦ Inconclusive evidence in an unclear direction
regarding the effectiveness of spinal manipulation
for the treatment of fibromyalgia [162].
Other effective non-invasive physical treatments or patient
education
Heated pool treatment with or without exercise, supervised aerobic exercise [160,173]
Myofascial Pain Syndrome
Definition
Myofascial pain syndrome is a poorly defined condition
that requires the presence of myofascial trigger points.
Diagnosis
Diagnosis of myofascial pain syndrome is made exclusively from the patient’s history and physical exam.
Evidence base for manual treatment
Systematic reviews (most recent)
As of September 2009, one systematic review evaluating
the benefit of manual therapy for myofascial pain syndrome was identified, which concludes there is limited
evidence to support the use of some manual therapies
for providing long-term relief of pain at myofascial trigger points [174]. Fifteen RCTs evaluating the effectiveness of manual therapy for the treatment of myofascial
pain syndrome were included in the published systematic review [90,175-188]. Only two of the truly randomized trials assessed the effectiveness of manual therapy
beyond the immediate post-treatment period [175,178].
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
One trial assessed the effectiveness of massage combined with other therapies, while the other trial assessed
the effectiveness of self-treatment with ischemic
compression.
Page 17 of 33
Recent randomized clinical trials not included in above
Evidence-based clinical guidelines
Lawler and Cameron [196] found that massage therapy
significantly reduced migraine frequency in the short
term compared to filling out a diary with no other treatment. This study had a high risk of bias.
None
Evidence Summary (See Figure 5)
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figure 5)
◦ Inconclusive evidence in a favorable direction
regarding the effectiveness of massage for the
treatment of myofascial pain syndrome [174].
Other effective non-invasive physical treatments or patient
education
Laser, acupuncture [174]
Migraine Headache
Definition
Migraine headache is defined as recurrent/episodic
moderate or severe headaches which are usually unilateral, pulsating, aggravated by routine physical activity,
and are associated with either nausea, vomiting, photophobia, or phonophobia [189,190].
Diagnosis
Diagnosis of migraine headaches is made primarily from
the patient’s history and a negative neurological exam.
Neuroimaging is only indicated in patients with a positive neurological exam or presence of a “red flag” [190].
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2004, two systematic reviews evaluated the benefit
of manual therapy for migraine headache [191,192]. The
reviews evaluated three RCTs on spinal manipulation
[193-195]. Astin and Ernst [191] concluded that due to
methodological limitations of the RCTs, it is unclear
whether or not spinal manipulation is an effective treatment for headache disorders. In contrast, the conclusion
from a Cochrane review [192] was that spinal manipulation is an effective option for the care of migraine headache. The conclusions of the two reviews differed in
methodology for determining RCT quality and the
strength of evidence. Astin and Ernst [191] evaluated
study quality using a scale that is no longer recommended by the Cochrane Collaboration and did not
apply evidence rules for their conclusions. The
Cochrane review [192] used a pre-specified, detailed
protocol for synthesizing the evidence from the quality,
quantity, and results of RCTs.
Evidence-based clinical guidelines
The SIGN guidelines [190] for the diagnosis and management of headache in adults concludes the evidence
of effectiveness for manual therapy is too limited to lead
to a recommendation.
◦ Moderate quality evidence that spinal manipulation
has an effectiveness similar to a first-line prophylactic prescription medication (amitriptyline) for
the prophylactic treatment of migraine [195].
◦ Inconclusive evidence in a favorable direction comparing spinal manipulation to sham interferential
[194].
◦ Inconclusive evidence in a favorable direction
regarding the use of massage therapy alone [196].
Other effective non-invasive physical treatments or patient
education
Trigger avoidance, stress management, acupuncture,
biofeedback [190,197,198]
Tension- Type Headache
Definition
Tension-type headache is defined as a headache that is
pressing/tightening in quality, mild/moderate in intensity, bilateral in location, and does not worsen with routine physical activity [189,190].
Diagnosis
Diagnosis of tension-type headaches is made primarily
from the patient’s history and a negative neurological
exam [190]. Neuroimaging is only indicated in patients
with a positive neurological exam or presence of a “red
flag” [190].
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2002, five systematic reviews evaluated the benefit
of manual therapy for tension-type headache
[191,192,199-201]. Eleven RCTs were included in the
published systematic reviews [202-212]. Three of the
RCTs assessed the effectiveness of spinal manipulation
[202,206,210], six of the trials evaluated the use of combined therapies including a form of manual therapy
[203,207-209,211,212], one trial evaluated a craniosacral
technique [204], and the remaining trial compared connective tissue manipulation to mobilization [205]. The
reviews generally conclude there is insufficient evidence
to draw inference on the effectiveness of manual therapy
in the treatment of tension-type headache. An exception
is the Cochrane review [192] which found that some
inference regarding spinal manipulation could be made
from two trials with low risk of bias. One trial [202]
showed that for the prophylactic treatment of chronic
tension-type headache, amitriptyline (an effective drug)
is more effective than spinal manipulation during
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
treatment. However, spinal manipulation is superior in
the short term after cessation of both treatments, but
this could be due to a rebound effect of the medication
withdrawal. The other trial [203] showed that spinal
manipulation in addition to massage is no more effective
than massage alone for the treatment of episodic tension-type headache.
Evidence-based clinical guidelines
The SIGN guideline [190] for the diagnosis and management of headache in adults draws no conclusions.
Recent randomized clinical trials not included in above
Anderson and Seniscal [213] found that participants
receiving osteopathic manipulation in addition to relaxation therapy had significant improvement in headache
frequency compared to relaxation therapy alone. This
study had a moderate risk of bias.
Evidence Summary (See Figure 5)
◦ Moderate quality evidence that spinal manipulation
in addition to massage is no more effective than
massage alone for the treatment of episodic tension-type headache [192,203].
◦ Inconclusive evidence in an unclear direction regarding the use of spinal manipulation alone or in combination with therapies other than massage for most
forms of tension-type headache [191,192,199-202].
Other effective non-invasive physical treatments or patient
education
Acupuncture, biofeedback [198,214]
Cervicogenic Headache
Definition
Cervicogenic headache is defined as unilateral or bilateral pain localized to the neck and occipital region
which may project to regions on the head and/or face.
Head pain is precipitated by neck movement, sustained
awkward head positioning, or external pressure over the
upper cervical or occipital region on the symptomatic
side [189,190,215].
Diagnosis
Page 18 of 33
limitations of the RCTs, it is unclear whether or not
spinal manipulation is an effective treatment for headache disorders. In contrast, a Cochrane review [192]concluded that spinal manipulation is an effective option for
the care of cervicogenic headache. The conclusions of
the two reviews differed in methodology for determining
RCT quality and the strength of evidence. Ernst [191]
evaluated study quality using a scale that is no longer
recommended by the Cochrane Collaboration and did
not apply evidence rules for their conclusions. The
Cochrane review [192] used a pre-specified, detailed protocol for synthesizing the evidence from the quality,
quantity, and results of RCTs.
Evidence-based clinical guidelines
The SIGN guidelines [190] for the diagnosis and management of headache in adults concluded spinal manipulation should be considered in patients with
cervicogenic headache.
Recent randomized clinical trials not included in above
Hall et al [223] evaluated the efficacy of apophyseal glide
of the upper cervical region in comparison to a sham
control. They found a large clinically important and statistically significant advantage of the intervention over
sham for pain intensity. The study had a low risk of
bias.
Evidence Summary (See Figure 5)
◦ Moderate quality evidence that spinal manipulation
is more effective than placebo manipulation, friction massage, and no treatment [192].
◦ Moderate quality evidence that spinal manipulation
is similar in effectiveness to exercise [220].
◦ Moderate quality evidence that self-mobilizing natural apophyseal glides are more effective than placebo [223].
◦ Inclusive evidence that deep friction massage with
trigger point therapy is inferior to spinal manipulation [221].
◦ Inconclusive evidence in an unclear direction for
the use of mobilization [192].
Diagnosis of cervicogenic headaches is made primarily
from the patient’s history and a negative neurological
exam. Neuroimaging is only indicated in patients with a
positive neurological exam or presence of a “red flag”
[190].
Other effective non-invasive physical treatments or patient
education
Evidence base for manual treatment
Systematic reviews (most recent)
Headaches not classified as tension-type, migraine, or
cervicogenic in nature according to the International
Headache Society’s 2004 diagnostic criteria [189].
Since 2002, four systematic reviews have been published
on manual therapy for cervicogenic headache
[55,191,192,216]. The reviews made inference based on
six RCTs that evaluated a range of manual therapy treatments including spinal manipulation [217-222], mobilization [217,220], and friction massage [220,222]. Astin and
Ernst [191] concluded that due to methodological
Neck exercises [192]
Miscellaneous Headache
Definition
Evidence base for manual treatment
Systematic reviews (most recent)
One systematic review (2004) evaluated the benefit of
manual therapy for other types of chronic headache
[192]. One RCT evaluating the use of mobilization for
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
Page 19 of 33
post-traumatic (post-concussive) headache was included
[224]. The review found the evidence to be inconclusive.
Recent randomized clinical trials not included in above
Evidence-based clinical guidelines
Evidence Summary (See Figures 6 &7)
None
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figure 5)
◦ Inconclusive evidence in a favorable direction
regarding mobilization for post-traumatic headache
[224].
Other effective non-invasive physical treatments or patient
education
None
Asthma
Definition
Asthma is a common, complex chronic disorder of the
airways that is characterized by variable and recurring
symptoms, airflow obstruction, bronchial hyperresponsiveness, and an underlying inflammation [225].
Diagnosis
The diagnosis is made through the combination of the
patient’s history, upper respiratory physical exam, and
pulmonary function testing (spirometry). Patient administered peak flow measurement is often used to monitor effects of treatment [225,226].
Evidence base for manual treatment
Systematic reviews
Since 2002, four systematic reviews, one a Cochrane
review, on manual therapy for asthma have been published [227-230]. Of the total of five RCTs on the effectiveness of manual therapy [231-235] available from the
searched literature, two investigated chiropractic spinal
manipulation for chronic asthma, one in adults [231] and
the other in children [232]. Two trials assessed the effectiveness on chronic asthma in children, one examined
osteopathic manipulative/manual therapy [233], and the
other massage [234]. The fifth trial evaluated the effect of
foot manual reflexology for change in asthma symptoms
and lung function in adults [235]. The four systematic
reviews collectively concluded that the evidence indicates
that none of the manual therapy approaches have been
shown to be superior to a suitable sham manual control
on reducing severity and improving lung function but
that clinically important improvements occur over time
during both active and sham treatment.
Evidence-based clinical guidelines
The asthma guidelines by The US National Heart, Lung,
and Blood Institutes [225] and by The British Thoracic
Society [226] both conclude that there is insufficient evidence to recommend the use of chiropractic or related
manual techniques in the treatment of asthma.
None
◦ There is moderate quality evidence that spinal
manipulation is not effective (similar to sham
manipulation) for the treatment of asthma in children and adults on lung function and symptom
severity [227,228].
◦ There is inconclusive evidence in a non-favorable
direction regarding the effectiveness of foot manual
reflexology for change in asthma symptoms and
lung function in adults [235].
◦ There is inconclusive evidence in a favorable direction regarding the effectiveness of osteopathic
manipulative treatment for change in asthma
symptoms and lung function in children [233].
◦ There is inconclusive evidence in an unclear direction regarding the effectiveness of massage for
change in asthma symptoms and lung function in
children [234].
Other effective non-invasive physical treatments or patient
education
Education and advice on self-management, maintaining
normal activity levels, control of environmental factors
and smoking cessation [225,226]
Pneumonia
Definition
Pneumonia is defined as an acute inflammation of the
lungs caused by infection [236,237].
Diagnosis
Diagnosis of pneumonia relies primarily on chest radiography in conjunction with the patient’s history, examination, and laboratory findings [236,237].
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2007, one systematic review evaluating the benefit
of manual therapy for pneumonia has been published
[230]. One RCT evaluating the effectiveness of manual
therapy for the treatment of pneumonia was included in
the published systematic review [238]. The included trial
assessed the effectiveness of osteopathic spinal manipulation for acute pneumonia in hospitalized elderly adults.
The review concluded there is promising evidence for
the potential benefit of manual procedures for hospitalized elderly patients with pneumonia. Our risk of bias
assessment places this trial in the moderate risk of bias
category.
Evidence-based clinical guidelines
None addressing the use of manual therapy
Randomized clinical trials not included in above
None
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
Evidence Summary (See Figure 6)
◦ There is inconclusive evidence in a favorable direction regarding the effectiveness of osteopathic
manual treatment for the treatment of acute pneumonia in elderly hospitalized patients [238].
Page 20 of 33
Other effective non-invasive physical treatments or patient
education
Particle repositioning maneuvers for benign paroxysmal
positional vertigo, vestibular rehabilitation [239,243]
Other effective non-invasive physical treatments or patient
education
Infantile Colic
Definition
Cases of pneumonia that are of public health concern
should be reported immediately to the local health
department. Respiratory hygiene measures, including the
use of hand hygiene and masks or tissues for patients
with cough, should be used in outpatient settings as a
means to reduce the spread of respiratory infections
[236,237].
Colic is a poorly defined condition characterized by
excessive, uncontrollable crying in infants.
Vertigo
Definition
Vertigo is defined as a false sensation of movement of
the self or the environment. Vertigo is a sensation and
not necessarily a diagnosis as there are multiple underlying pathologies responsible for vertigo [239,240].
Diagnosis
Diagnosis of vertigo relies primarily on the patient’s history and clinical examination. Potential causes of vertigo
include both pathological disorders such as vertebrobasilar insufficiency or central nervous system lesions as
well as more benign causes such as cervicogenic vertigo
or benign paroxysmal positional vertigo [239].
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2004, two systematic reviews evaluating the benefit of manual therapy for vertigo have been published
[230,240]. One RCT evaluating the effectiveness of
mobilization and soft-tissue massage for the treatment
of cervicogenic vertigo was included in both published
systematic reviews [241]. One review concluded limited
evidence of effectiveness [240]. The other concluded
effectiveness, but the inference was on the inclusion of
other types of evidence [230].
Evidence-based clinical guidelines
None addressing the use of manual therapy
Recent randomized clinical trials not included in above
Reid et al [242] compared sustained natural apophyseal
glides (SNAGs), delivered manually by a therapist, to
detuned laser treatment for the treatment of cervicogenic dizziness. Patients receiving SNAGs reported less
dizziness, disability and cervical pain after six weeks, but
not at 12 weeks. This study had a low risk of bias.
Evidence Summary (See Figure 5)
◦ Moderate quality evidence that manual treatment
(specifically sustained natural apophyseal glides) is
an effective treatment for cervicogenic dizziness, at
least in the short term [242].
Diagnosis
The diagnosis of colic is based solely on the patient’s
history and the absence of other explanations for the
excessive crying. The “rule of threes” is the most common criteria used in making a diagnosis of colic. The
rule of three’s is defined as an otherwise healthy and
well fed infant with paroxysms of crying and fussing
lasting for a total of three hours a day and occurring
more than three days a week for at least three weeks
[244,245].
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2003, six systematic reviews evaluating the benefit
of manual therapy for infantile colic have been published
[230,245-249]. Two of the systematic reviews evaluated
the effectiveness of manual therapy for non-musculoskeletal [247] and pediatric [248] conditions as a whole but
fail to draw specific conclusions regarding the use of
manual therapy for infantile colic. Of the eight RCTs
evaluating the effectiveness of manual therapy for the
treatment of colic, five were included in the published
systematic reviews [250-254]. All five of the trials
assessed the effectiveness of chiropractic spinal manipulation for infantile colic. All four systematic reviews concluded there is no evidence manual therapy is more
effective than sham therapy for the treatment of colic.
Evidence-based clinical guidelines
No clinical guidelines located
Randomized clinical trials not included in above
Hayden et al [255] found cranial osteopathy was more
effective than no treatment for crying duration. This
study had a high risk of bias
Huhtala et al [256] found no difference between
groups treated with massage therapy or given a crib
vibrator for crying duration. This study had a high risk
of bias.
Arikan et al [257] found all four interventions (massage, sucrose solution, herbal tea, hydrolysed formula)
showed improvement compared to a no treatment control group. This study had a moderate risk of bias.
Evidence Summary (See Figure 7)
◦ Moderate quality evidence that spinal manipulation
is no more effective than sham spinal manipulation
for the treatment of infantile colic [254].
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
◦ Inconclusive evidence in a favorable direction
regarding the effectiveness of cranial osteopathic
manual treatment and massage for the treatment
of infantile colic [255,257].
Other effective non-invasive physical treatments or patient
education
Reduce stimulation, herbal tea, and trial of hypoallergenic formula milk [258,259]
Nocturnal Enuresis
Definition
Nocturnal enuresis is defined as the involuntary loss of
urine at night, in the absence of organic disease, at an
age when a child could reasonably be expected to be dry
(typically at the age of five) [260].
Diagnosis
The diagnosis of nocturnal enuresis is derived
mainly from the patient’s history given the absence of
other organic causes including congenital or
acquired defects of the central nervous system. Psychological factors can be contributory in some
children requiring proper assessment and treatment
[261].
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2005, two systematic reviews, one a Cochrane
review, evaluating the benefit of manual therapy
for nocturnal enuresis were published [230,262]. The
systematic reviews included a total of two randomized
clinical trials [263,264]. Both of the included
trials examined the use of spinal manipulation for nocturnal enuresis. Both reviews concluded there is insufficient evidence to make conclusions about the
effectiveness of spinal manipulation for the treatment of
enuresis.
Evidence-based clinical guidelines
None addressing manual therapy as a treatment option
Page 21 of 33
Diagnosis
Diagnosis of otitis media relies on otoscopic signs and
symptoms consistent with a purulent middle ear effusion in association with systemic signs of illness [266].
Evidence base for manual treatment
Systematic reviews (most recent)
Hawk et al [230] found promising evidence for the
potential benefit of spinal manipulation/mobilization
procedures for children with otitis media. This was
based on one trial [267]. Two other reviews specifically
addressed spinal manipulation by chiropractors for nonmusculoskeletal [247] and pediatric [248] conditions.
Both found insufficient evidence to comment on manual
treatment effectiveness or ineffectiveness for otitis
media.
Evidence-based clinical guidelines
The American Academy of Pediatrics 2004 guidelines on
the diagnosis and management of acute otitis media
[268] concluded no recommendation for complementary
and alternative medicine for the treatment of acute otitis
media can be made due to limited data.
Recent randomized clinical trials not included in above
Wahl et al investigated the efficacy of osteopathic
manipulative treatment with and without Echinacea
compared to sham and placebo for the treatment of otitis media [269]. The study found that a regimen of up
to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media episodes. This study had a high risk of bias.
Evidence Summary (See Figure 7)
◦ Inconclusive evidence in an unclear direction
regarding the effectiveness of osteopathic manipulative therapy for otitis media [267,269].
Other effective non-invasive physical treatments or patient
education
Patient education and “watch and wait” approach for 72
hours for acute otitis media [266,268]
Randomized clinical trials not included in above
None
Evidence Summary (See Figure 7)
◦ Inconclusive evidence in a favorable direction
regarding the effectiveness of chiropractic care for
the treatment of enuresis [230,262].
Other effective non-invasive physical treatments or patient
education
Education, simple behavioral interventions, and alarm
treatment [265]
Otitis Media
Definition
Otitis media is characterized by middle ear inflammation which can exist in an acute or chronic state and
can occur with or without symptoms [266].
Hypertension
Definition
Hypertension is defined as the sustained elevation of
systolic blood pressure over 140 mmHg, diastolic blood
pressure over 90 mm Hg, or both [270,271].
Diagnosis
Diagnosis of hypertension is made by the physical exam,
specifically sphygmomanometry. The patient’s history,
clinical exam and laboratory tests help identify potential
etiologies [270,271].
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2007, one systematic review evaluating the benefit
of manual therapy for hypertension has been published
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
(Hawk et al) [230]. Two RCTs evaluating the effectiveness of manual therapy for the treatment of stage I
hypertension were included in this systematic review
[272,273]. One of the included trials evaluated the use
of spinal manipulation [272] and the other evaluated the
use of instrument assisted spinal manipulation [273].
The review found no evidence of effectiveness for spinal
manipulation.
Evidence-based clinical guidelines
None addressing the use of manual therapy
Recent randomized clinical trials not included in above
A study by Bakris et al [274] found NUCCA upper cervical manipulation to be more effective than sham
manipulation in lowering blood pressure in patients
with Stage I hypertension. This study had a high risk of
bias.
Evidence Summary (See Figure 6)
◦ Moderate quality evidence that diversified spinal
manipulation is not effective when added to a diet
in the treatment of stage I hypertension [272].
◦ Inconclusive evidence in a favorable direction
regarding upper cervical NUCCA manipulation for
stage I hypertension [274].
◦ Inconclusive evidence in an unclear direction
regarding instrument assisted spinal manipulation
for hypertension [273].
Other effective non-invasive physical treatments or patient
education
Advice on lifestyle interventions including diet, exercise,
moderate alcohol consumption and smoking cessation
[270,271]
Relaxation therapies including biofeedback, meditation, or muscle relaxation [271]
Dysmenorrhea
Definition
Dysmenorrhea is defined as painful menstrual cramps of
uterine origin. Dysmenorrhea is grouped into two categories, primary and secondary dysmenorrhea. Secondary
dysmenorrhea is painful menstruation associated with a
pelvic pathology like endometriosis, while primary dysmenorrhea is painful menstruation in the absence of
pelvic disease [275].
Page 22 of 33
therapy for the treatment of dysmenorrhea were
included in the systematic reviews [277-281]. Four of
the included trials examined the use of spinal manipulation [278-281] and one examined the use of osteopathic
manipulative techniques [277]. Based on these trials, the
Cochrane review by Proctor et al concluded there is no
evidence to suggest that spinal manipulation is effective
in the treatment of primary and secondary dysmenorrhea [276]. The review by Hawk et al concluded the evidence was equivocal regarding chiropractic care for
dysmenorrhea [230].
Evidence-based clinical guidelines
We identified consensus guidelines from the Society of
Obstetricians and Gynecologists of Canada (SOGC)
published in 2005 which included an assessment of
manual treatment for primary dysmenorrhea. The
authors concluded there is no evidence to support spinal
manipulation as an effective treatment for primary dysmenorrhea [275].
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figure 7)
◦ Moderate quality evidence that spinal manipulation
is no more effective than sham manipulation in the
treatment of primary dysmenorrhea [276,281].
Other effective non-invasive physical treatments or patient
education
High frequency TENS [275]
Premenstrual Syndrome
Definition
Premenstrual syndrome is defined as distressing physical, behavioral, and psychological symptoms, in the
absence of organic or underlying psychiatric disease,
which regularly recurs during the luteal phase of the
menstrual cycle and disappears or significantly regresses
by the end of menstruation and is associated with
impairment in daily functioning and/or relationships
[282,283].
Diagnosis
Diagnosis of premenstrual syndrome is made through
patient history and the use of a patient diary over two
menstrual cycles [282,283].
Diagnosis
Diagnosis of primary dysmenorrhea is made from the
patient’s history. Diagnosis of secondary dysmenorrhea
requires further investigation including a pelvic exam
and potential ultrasound or laparoscopy [275].
Evidence base for manual treatment
Systematic reviews (most recent)
We identified two systematic reviews evaluating the
benefit of manual therapy for dysmenorrhea [230,276].
Five studies evaluating the effectiveness of manual
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2007, three systematic reviews evaluating the benefit of manual therapy for premenstrual syndrome have
been published [230,284,285]. Three RCTs evaluating
the effectiveness of manual therapy for the treatment of
premenstrual syndrome were included in the reviews
[286-288]. The included trials examined different forms
of manual therapy including spinal manipulation [286],
massage therapy [287], and reflexology [288]. Overall,
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
the reviews concluded that the evidence is “not promising” [284], “equivocal” [230], and that high quality studies are needed to draw firm conclusions [284,285].
Evidence-based clinical guidelines
None discussing manual therapy
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figure 7)
◦ Inconclusive evidence in a favorable direction
regarding the effectiveness of reflexology and massage therapy for the treatment of premenstrual
syndrome [230].
◦ Inconclusive evidence in an unclear direction
regarding the effectiveness of spinal manipulation
for the treatment of premenstrual syndrome [230].
Other effective non-invasive physical treatments or patient
education
Cognitive behavioral therapy [282]
Discussion
Making claims
There are two important questions underlying the medical and media debate surrounding the scope of chiropractic care and claims regarding its effectiveness
particularly for non-musculoskeletal conditions: 1)
should health professionals be permitted to use generally
safe but as yet unproven methods? 2) What claims, if
any, can and should be made with respect to the potential value of unproven treatments?
In response to the first question, a reasonable answer
is “yes” given that professionals operate within the context of EBH, where it is acknowledged what is known
today, might change tomorrow. It requires flexibility
born of intellectual honesty that recognizes one’s current clinical practices may not really be in the best
interests of the patient and as better evidence emerges,
clinicians are obligated to change. Further, where evidence is absent, they are open to promoting the development of new knowledge that expands understanding
of appropriate health care delivery.
In response to the second question, no claims of efficacy/effectiveness should be made for which there isn’t
sufficient evidence. Unsubstantiated claims can be dangerous to patient health [289]. We maintain the best evidence for efficacy/effectiveness that meets society’s
standards comes from well-designed RCTs. While other
study designs and clinical observations do offer insight
into the plausibility and potential value of treatments, the
concepts of plausibility and evidence of efficacy/effectiveness should not be confused when making claims.
Clinical Experience versus Clinical effectiveness
Why is it that the results of RCTs often do not confirm
the results observed in clinical practice? There are
Page 23 of 33
several reasons. One of the problems is that both the
provider and the patient are likely to interpret any
improvement as being solely a result of the intervention
being provided. However this is seldom the case. First,
the natural history of the disorder (for example. acute
LBP) is expected to partially or completely resolve by
itself regardless of treatment. Second, the phenomenon
of regression to the mean often accounts for some of
the observed improvement in the condition. Regression
to the mean is a statistical phenomenon associated with
the fact that patients often present to the clinic or in
clinical trials at a time where they have relatively high
scores on severity outcome measures. If measured
repeatedly before the commencement of treatment the
severity scores usually regress towards lower more normal average values [290].
Additionally, there is substantial evidence to show that
the ritual of the patient practitioner interaction has a
therapeutic effect in itself separate from any specific
effects of the treatment applied. This phenomenon is
termed contextual effects [1,291]. The contextual or, as
it is often called, non-specific effect of the therapeutic
encounter can be quite different depending on the type
of provider, the explanation or diagnosis given [292], the
provider’s enthusiasm, and the patient’s expectations
[293-298]. Some researchers have suggested that relying
on evidence from RCTs and systematic reviews of RCTs
is not adequate to determine whether a treatment is
effective or not. The main issue, they contend, is that
the intervention when studied in RCTs is too highly
protocolized and does not reflect what is going on in
clinical practice [230]. They advocate a whole systems
research approach that more accurately represents the
entire clinical encounter. When using this perspective
and systematically synthesizing the literature regarding
chiropractic treatment of non-musculoskeletal conditions, also reviewed in this report, they conclude, for
example that chiropractic is beneficial to patients with
asthma and to children with infantile colic [230]. This
conclusion is at odds with the evidence summaries
found in this report. We submit that whole systems
research approach in this instance is clouding the interpretation of the literature regarding effectiveness as it
relates to making claims, and incorrectly giving the consumer the impression that chiropractic care shows effectiveness over and above the contextual effects as it
relates to the two examples above.
In a placebo-controlled RCT the question is: does the
treatment provided have a specific effect over and above
the contextual or non-specific effects. The result of such
a trial may show that there is no important difference
between the active intervention and the sham intervention. However, the patients may exhibit clinically important changes from baseline in both groups and thus the
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
outcome would be consistent with what clinicians
observe in their practice. An example of this is the
results of the pragmatic placebo controlled RCT on
chiropractic co-management of chronic asthma in adults
(care delivered by experienced chiropractors consistent
with normal clinical practice), which showed that
patients improved equally during both the active and
the sham intervention phases of the trial [231].
The Pieces of The Evidence-Based Healthcare Puzzle
It is essential to recognize what each piece of the EBH
puzzle offers. Patient values and preferences do not provide sound evidence of a treatment’s effectiveness and
may be misleading. A patient can be satisfied with a
treatment, but it still may not be effective. The clinician’s observations, if well documented, can attest to
patient improvement while under care and encourage
perception of a treatment’s clinical plausibility. However,
the narrow focus of attention under non-systematic
observations common to practice experience tends to
obscure other factors influencing case outcome. Similarly, EBH can be flawed, not because it fails to be scientific, but because-like all sciences-it imports the biases of
researchers and clinicians [299]. Well-performed clinical
research however, does provide evidence for claims that
a treatment is effective when the results are consistently
applied to relevant patients. This is because of its reliance on methods for systematic observation and efforts
to minimize bias.
Other authors’ work has been used to argue that a
range of study types should be included when evaluating
a treatment’s efficacy/effectiveness (case series, etc.)
[230,300]. We maintain the best evidence that rises to
societal standards to support claims of efficacy/effectiveness comes from well-designed RCTs. This is largely
due to the powerful effect of successful randomization
and design factors intended to minimize bias (all which
help ensure that the results are due to the intervention
and not some other known or unknown factor). Other
evidence may be useful to inform treatment options
when conditions for individual patients are not consistent with the best evidence or when better evidence is
unavailable [11]. Other types of research are more
appropriate for answering related questions including,
but not limited to, safety or mechanistic plausibility.
This can lead to the refinement of interventions, inform
the design of clinical trials, and aid in the interpretation
of clinical observations. Similarly, clinical data from epidemiological studies, case reports, and case series can
suggest that a treatment is clinically plausible. That is,
clinical observations demonstrate that it is possible that
an intervention is effective. However, a gain in plausibility, biological or clinical, does NOT constitute proof of
a treatment’s efficacy in human populations. Conversely
Page 24 of 33
lack of proof (as demonstrated through well performed
randomized clinical trials) does not exclude plausibility
[301,302].
Research on systematic reviews have taught us that
individual studies can often lead to a conclusion very
different from that of a systematic analysis of all available studies [3]. Moreover, the scientific process is a systematic means of self-correcting investigations that
classically begin with observations and hypotheses that
support plausibility and/or mechanisms. Ideally, these
precede and inform the conduct of RCTs under conditions most likely to yield clear results, often referred to
as efficacy studies. Separately, studies that emulate general practice conditions may be used to develop an
understanding of effectiveness. Historically, the modern
investigation of manual treatment methods represents
an aberration in this process. With the advent of social
support and funding for research at the end of the 20th
Century, there was an underlying presumption that the
long-term practice of these methods provided a sound
clinical wisdom on which to ground RCTs, bypassing
mechanistic studies. The early emphasis on clinical trials
has illuminated the gaps in understanding of appropriate
indications for treatment, dosage and duration of care,
consistency of treatment application, and the appropriate outcome measures to monitor results [11]. In
response, funding agencies in North America have
renewed research emphasis on the potential mechanisms
of effect [303]. Data from this work is expected to
inform future clinical research questions, and subsequently lead to well-grounded studies that are likely to
yield more complete evidence regarding appropriate and
effective care.
Safety of Manual Treatment
Choosing an intervention should always be tempered by
the risk of adverse events or harm. Adverse events associated with manual treatment can be classified into two
categories: 1) benign, minor or non-serious and 2) serious. Generally those that are benign are transient, mild
to moderate in intensity, have little effect on activities,
and are short lasting. Most commonly, these involve
pain or discomfort to the musculoskeletal system. Less
commonly, nausea, dizziness or tiredness are reported.
Serious adverse events are disabling, require hospitalization and may be life-threatening. The most documented
and discussed serious adverse event associated with
spinal manipulation (specifically to the cervical spine) is
vertebrobasilar artery (VBA) stroke [304,305]. Less commonly reported are serious adverse events associated
with lumbar spine manipulation, including lumbar disc
herniation and cauda equina syndrome [304].
Estimates of serious adverse events as a result of
spinal manipulation have been uncertain and varied.
Bronfort et al. Chiropractic & Osteopathy 2010, 18:3
http://www.chiroandosteo.com/content/18/1/3
Much of the available evidence has been relatively poor
due to challenges in establishing accurate risk estimates
for rare events. Such estimates are best derived from
sound population based studies, preferably those that
are prospective in nature [304,306].
Estimates of VBA stroke subsequent to cervical spine
manipulation range from one event in 200,000 treatments to one in several million [307,308]. In a subsequent landmark population-based study, Cassidy et al
[309] revisited the issue using case-control and casecrossover designs to evaluate over 100 million personyears of data. The authors confirmed that VBA stroke is
a very rare event in general. They stated, “We found no
evidence of excess risk of VBA stroke associated with
chiropractic care compared to primary care.” They
further concluded, “The increased risk of VBA stroke
associated with chiropractic and PCP (primary care physician) visits is likely due to patients with headache and
neck pain from VBA dissection seeking care before their
stroke.” In regards to benign adverse reactions, cervical
spine manipulation has been shown to be associated
with an increased risk when compared to mobilization
[55,310,311].
Appropriately, the risk-benefit of cervical spine manipulation has been debated [304,305]. As anticipated, new
research can change what is known about the benefit of
manual treatment for neck pain. Currently, the evidence
suggests that it has some benefit [55]. It has been suggested that the choice between mobilization and manipulation should be informed by patient preference [55].
Estimates of cervical or lumbar disc herniation are
also uncertain, and are based on case studies and case
series. It has been estimated that the risk of a serious
adverse event, including lumbar disc herniation is
approximately 1 per million patient visits [312]. Cauda
equina syndrome is estimated to occur much less frequently, at 1 per several million visits [312-314].
Safety of Manual Treatment in Children
The true incidence of serious adverse events in children
as a result of spinal manipulation remains unknown. A
systematic review published in 2007 identified 14 cases
of direct adverse events involving neurologic or musculoskeletal events, nine of which were considered serious
(eg. subarachnoid hemorrhage, paraplegia, etc.) [315].
Another 20 cases of indirect adverse events were identified (delayed diagnosis, inappropriate application of
spinal manipulation for serious medical conditions). The
review authors note that case reports and case series are
a type of “passive” surveillance, and as such don’t provide information regarding incidence. Further, this type
of reporting of adverse events is recognized to underestimate true risk [315-317].
Page 25 of 33
Importantly, the authors postulate that a possible reason for incorrect diagnosis (for example. delayed diagnosis, inappropriate treatment with spinal manipulation) is
due to lack of sufficient pediatric training. They cite
their own survey [318] which found that in a survey of
287 chiropractors and osteopaths, 78% reported one
semester or less of formal pediatric education and 72%
received no pediatric clinical training. We find this particularly noteworthy.
Limitations of the Report Conclusions
The conclusions in this report regarding the strength of
evidence of presence or absence of effectiveness are predicated on the rules chosen for which there are no absolute standards. Different evidence grading systems and
rules regarding impact of study quality may lead to different conclusions. However, we have applied a synthesis methodology consistent with the latest
recommendations from authoritative organizations
involved in setting standards for evidence synthesis.
Although we used a comprehensive literature search
strategy we may not have identified all relevant RCTs,
guidelines, and technology reports. Conditions for which
this report concludes the evidence currently shows manual treatment to be effective or even ineffective, sometimes rests on a single RCT with adequate statistical
power and low risk of bias. Additional high quality
RCTs on the same topics have a substantial likelihood
of changing the conclusions. Including only English language reviews and trials may be considered another limitation of this report leading to language bias; however,
the impact of excluding non-English trials from metaanalyses and systematic reviews is conflicting [319,320],
and the incidence of randomized trials published in
non-English journals is declining [321]. Another potential limitation of this report is the lack of critical appraisal of the systematic reviews and clinical guidelines
included in the report. Systematic reviews and clinical
guidelines can differ widely in methodologic quality and
risk of bias [322]. While critical appraisal of the included
reviews and guidelines would be ideal, it was beyond the
scope of the present report. When drawing conclusions
about relative effectiveness of different forms of manual
treatments it is acknowledged that it has usually not
been possible to isolate or quantify the specific effects of
the interventions from the non-specific (contextual)
effect of patient-provider interaction [291]. It was
beyond the scope of this report to assess the magnitude
of the effectiveness of the different manual therapies
relative to the therapies to which comparisons were
made. However, if moderate or high quality evidence of
effectiveness was established the therapy was interpreted
as a viable treatment option, but not necessarily the
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http://www.chiroandosteo.com/content/18/1/3
most effective treatment available.We recognize that
findings from studies using a nonrandomized design (for
example. observational studies, cohort studies, prospective clinical series and case reports) can yield important
preliminary evidence on potential mechanisms and plausibility of treatment effects. However, the primary purpose of this report is to summarize the results of studies
designed to specifically address treatment efficacy and
effectiveness from which claims of clinical utility, consistent with that literature, may be considered defensible.
Therefore, the evidence base on the effects of care was
restricted to RCTs.
Conclusions
Spinal manipulation/mobilization is effective in adults
for acute, subacute, and chronic low back pain; for
migraine and cervicogenic headache; cervicogenic dizziness; and a number of upper and lower extremity joint
conditions. Thoracic spinal manipulation/mobilization is
effective for acute/subacute neck pain, and, when combined with exercise, cervical spinal/manipulation is
effective for acute whiplash-associated disorders and for
chronic neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of
any duration, and for any type of manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders,
fibromyalgia, premenstrual syndrome, and pneumonia in
older adults. Spinal manipulation is not effective for
asthma and dysmenorrhea when compared to sham
manipulation, or for Stage 1 hypertension when added
to an antihypertensive diet. For children, the evidence is
inconclusive regarding the effectiveness of spinal manipulation/mobilization for otitis media and enuresis, but
shows it is not effective for infantile colic and for
improving lung function in asthma when compared to
sham manipulation.
The evidence regarding massage shows that for adults
it is an effective treatment option for chronic LBP and
chronic neck pain. The evidence is inconclusive for knee
osteoarthritis, fibromyalgia, myofascial pain syndrome,
migraine headache, and premenstrual syndrome. For
children, the evidence is inconclusive for asthma and
infantile colic.
Additional file 1: The literature search strategy.
Click here for file
[ http://www.biomedcentral.com/content/supplementary/1746-1340-18-3S1.DOC ]
Additional file 2: Includes the criteria used for evaluating risk of bias
from randomized controlled trials not included within systematic reviews,
evidence based guidelines, or health technology assessments.
Click here for file
[ http://www.biomedcentral.com/content/supplementary/1746-1340-18-3S2.DOC ]
Page 26 of 33
Acknowledgements
The UK General Chiropractic Council provided the funding for this scientific
evidence report.
Della Shupe, librarian at NWHSU, is acknowledged for helping design and
perform the detailed search strategy used for the report.
Author details
1
Northwestern Health Sciences University, 2501 W 84th St, Bloomington, MN,
USA. 2University of Western States, 2900 NE 132nd Ave, Portland, OR, USA.
3
Canadian Memorial Chiropractic College, 6100 Leslie St, North York, ON,
Canada. 4McMaster University, 1280 Main St W, Hamilton, ON, Canada.
Authors’ contributions
GB was responsible for the methodology used to select and summarize the
evidence, for organizing and participating in the analysis of the evidence
and formulating conclusions and drafting and finalizing the report.
MH participated in analyzing the evidence and formulating conclusions for
the majority of the musculoskeletal conditions and the different types of
headache.
RE participated in analyzing the evidence and formulating conclusion for
part of the musculoskeletal and non-musculoskeletal conditions and
providing substantial input to the background and discussion sections.
BL was responsible for retrieving the research articles and providing draft
summary statements for all conditions as well as participating in drafting
and proof reading the manuscript.
JT was responsible for conceiving and drafting the section on translation of
research into action and providing substantial input to the background and
discussion sections.All authors have read and approved the final manuscript.
Competing interests
All authors are trained as doctors of chiropractic but are now full time
professional researchers.
Received: 26 November 2009
Accepted: 25 February 2010 Published: 25 February 2010
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ABSTRACT
Long-term outcomes of lumbar fusion among workers' compensation
subjects: a historical cohort study.
Nguyen TH1, Randolph DC, Talmage J, Succop P, Travis R.
STUDY DESIGN:
Historical cohort study.
OBJECTIVE:
To determine objective outcomes of return to work (RTW), permanent disability, postsurgical complications,
opiate utilization, and reoperation status for chronic low back pain subjects with lumbar fusion. Similarly, RTW
status, permanent disability, and opiate utilization were also measured for nonsurgical controls.
SUMMARY OF BACKGROUND DATA:
A historical cohort study of workers' compensation (WC) subjects with lumbar arthrodesis and randomly
selected controls to evaluate multiple objective outcomes has not been previously published.
METHODS:
A total of 725 lumbar fusion cases were compared to 725 controls who were randomly selected from a pool of
WC subjects with chronic low back pain diagnoses with dates of injury between January 1, 1999 and December
31, 2001. The study ended on January 31, 2006. Main outcomes were reported as RTW status 2 years after the
date of injury (for controls) or 2 years after date of surgery (for cases). Disability, reoperations, complications,
opioid usage, and deaths were also deter-mined.
RESULTS:
Two years after fusion surgery, 26% (n = 188) of fusion cases had RTW, while 67% (n = 483) of nonsurgical
controls had RTW (P ≤ 0.001) within 2 years from the date of injury. The reoperation rate was 27% (n = 194)
for surgical patients. Of the lumbar fusion subjects, 36% (n = 264) had complications. Permanent disability
rates were 11% (n = 82) for cases and 2% (n = 11) for nonoperative controls (P ≤ 0.001). Seventeen surgical
patients and 11 controls died by the end of the study (P = 0.26). For lumbar fusion subjects, daily opioid use
increased 41% after surgery, with 76% (n = 550) of cases continuing opioid use after surgery. Total number of
days off work was more prolonged for cases compared to controls, 1140 and 316 days, respectively (P <
0.001). Final multi-variate, logistic regression analysis indicated the number of days off before surgery odds
ratio [OR], 0.94 (95% confidence interval [CI], 0.92-0.97); legal representation OR, 3.43 (95% CI, 1.58-7.41);
daily morphine usage OR, 0.83 (95% CI, 0.71-0.98); reoperation OR, 0.42 (95% CI, 0.26-0.69); and
complications OR, 0.25 (95% CI, 0.07-0.90), are significant predictors of RTW for lumbar fusion patients.
CONCLUSION:
This Lumbar fusion for the diagnoses of disc degeneration, disc herniation, and/or radiculopathy in a WC
setting is associated with significant increase in disability, opiate use, prolonged work loss, and poor RTW
status.
Spine (Phila Pa 1976). 2011 Feb 15;36(4):320-31. doi: 10.1097/BRS.0b013e3181ccc220.
ORIGINAL ARTICLES
MANAGEMENT OF CHRONIC SPINE-RELATED CONDITIONS:
CONSENSUS RECOMMENDATIONS OF A
MULTIDISCIPLINARY PANEL
Ronald J. Farabaugh, DC,a,b Mark D. Dehen, DC,c,d and Cheryl Hawk, DC, PhD e,f
ABSTRACT
Objective: Chronic spine-related conditions are very problematic in terms of treatment and indemnity costs,
diagnostic complexity, and appropriate case management. Currently no chiropractic-directed guideline exists related to
chiropractic management of the chronic spine pain patient. The purpose of this project was to develop a broad-based
multidisciplinary consensus of medical and chiropractic clinical experts representing mainstream medical and
chiropractic practice to produce a document designed to provide standardized parameters of care and documentation.
Methods: Background materials were provided to the panelists prior to the consensus process and served as the basis
for the 29 seed statements. Delphi rounds were conducted electronically, and the Nominal Group Panel was
conducted via conference call. The RAND/UCLA methodology was used to reach consensus, which was considered
present if both the median rating was 7 or higher and at least 80% of panelists rated the statement 7 or higher.
Consensus was reached through a combination of Delphi rounds and Nominal Group Panel. Of 29 panelists, 5 were
non–doctors of chiropractic.
Results: Specific recommendations regarding treatment, frequency and duration, as well as outcome assessment and
contraindications for manipulation, were agreed upon by the panel.
Conclusions: A multidisciplinary panel of experienced practitioners was able to reach a high level (80%) of consensus
regarding specific aspects of the chiropractic approach to care for complex patients with chronic spine-related conditions,
based on both the scientific evidence and their clinical experience. (J Manipulative Physiol Ther 2010;33:484-492)
Key Indexing Terms: Chiropractic; Chronic Spine Pain; Manipulation
SCOPE
OF THE
CHRONIC PAIN PROBLEM
Chronic pain is considered the most underestimated
health care problem impacting quality of life. Today, chronic
pain is one of the most common reasons for patients to seek
medical care; it is estimated that 35% of the US population in
general, 25% of children younger than 18 years, and 50%
of community-dwelling older adults experience chronic
pain.1,2 The majority of chronic pain is spine-related.3
Health care costs associated with spine problems, including
low back pain (LBP) and neck pain, were estimated at $102
a
Chair, Council on Chiropractic Guidelines and Practice
Parameters, Lexington, SC.
b
Clinic Director, Farabaugh Chiropractic Clinic, Columbus,
Ohio.
c
Immediate Past Chair, Council on Chiropractic Guidelines
and Practice Parameters, Lexington, SC.
d
Clinic Director, Back to Wellness Clinic, North Mankato,
Minn.
e
Chair, Scientific Commission of Council on Chiropractic
Guidelines and Practice Parameters, Lexington, SC.
484
billion in the United States in 2004.4Total estimated
expenditures among individuals with spine problems
increased 65% (adjusted for inflation) from 1997 to 2005,
more rapidly than overall health expenditures.5
PHARMACOLOGICAL MANAGEMENT AND ASSOCIATED COSTS
Frequent use of opioids in managing chronic non-cancer
pain has been a major issue for health care in the United
States, with significant concerns related to adverse effects,
f
Director of Clinical Research, Logan College of Chiropractic,
Chesterfield, Mo.
Submit requests for reprints to: Cheryl Hawk, DC, PhD,
Director of Clinical Research, Logan College of Chiropractic,
1851 Schoettler Rd, Chesterfield, MO 63017
(e-mail: [email protected]).
Paper submitted July 2, 2010; in revised form July 26, 2010;
accepted July 28, 2010.
0161-4754/$36.00
Copyright © 2010 by National University of Health Sciences.
doi:10.1016/j.jmpt.2010.07.002
Journal of Manipulative and Physiological Therapeutics
Volume 33, Number 7
misuse, abuse, and addiction.3 While these medications serve
as powerful pain killers, they have also been implicated for
potential drug abuse. A 2006 Centers for Disease Control and
Prevention report showed that the rise in drug overdose
mortality was due to increasing deaths from prescription
drugs, rather than from illicit drugs such as heroin and
cocaine.6 Furthermore, approximately 21% of people with
chronic pain find their care unsatisfactory, and only 30% find
that prescription medications adequately address their pain.1
Most chronic pain sufferers initially try to self-manage
their symptoms with over-the-counter analgesic drugs.
Perhaps because of their ready availability to the general
public, over-the-counter drugs are a significant source of
morbidity and mortality in the United States, especially
acetaminophen, salicylates, and nonsteroidal anti-inflammatory drugs such as ibuprofen and naproxen.7
CHIROPRACTIC MANAGEMENT
Chiropractic practice has long been associated with
managing neuromusculoskeletal conditions, predominantly
back pain. There is a substantial body of literature to
support the effectiveness of this care.8 A synthesis of
recommendations for acute LBP suggests that clinicians
should educate patients about its etiology (eg, unknown and
nonspecific), prognosis (eg, likely to improve within weeks
with or without care), recurrence (eg, future occurrences are
common). They should also recommend that patients stay
active despite discomfort and rely mostly on acetaminophen, nonsteroidal anti-inflammatory drugs or spinal
manipulative therapy for short-term symptomatic relief.
Those recommendations also held true for the management
of chronic LBP, with the judicious addition of one or more
interventions, such as back exercises, behavioral therapy,
acupuncture, yoga, massage therapy, multidisciplinary
rehabilitation, and adjunctive or strong opioid analgesics.4,9
There is also moderate quality evidence that spinal
manipulation/mobilization combined with exercise is effective for chronic non-specific neck pain.8 There is low-quality
evidence supporting the clinical benefit of mobilization and
manipulation for pain, function and global perceived effect
for patients with chronic cervicogenic headache, compared to
controls at intermediate and long-term follow-up.10
In 2007 the American College of Physicians and the
American Pain Society released a joint guideline related to
the diagnosis and treatment of low back pain. According to
their review of the literature, spinal manipulation was
recommended for both acute and chronic low back pain.9
Due to the scope of chronic pain problem in the United
States and the lack of clear guidelines related to chronic pain
treatment rendered by chiropractic physicians, the Council on
Chiropractic Guidelines and Practice Parameters (CCGPP)
conducted a formal consensus process with a multidisciplinary panel of experts to develop rational, appropriate patientcentered treatment guidelines for patients with chronic spine-
Farabaugh et al
Chronic Spine-Related Pain Consensus
related pain who prefer an alternative/complementary
management strategy to pharmaceutical use.
METHODS
Background Materials and Seed Documents
Several documents were provided to the panelists prior
to the consensus process. These included (1) guidelines on
the management of chronic spinal pain through interventional techniques (injections), by the American Society of
Interventional Pain Physicians,11 to provide context and
comparisons for the current project; (2) “Chiropractic
Management of Low Back Disorders,” which reported on
a previous consensus project conducted by CCGPP12; (3)
the introductory article to an issue of The Spine Journal
dedicated to management of chronic low back pain13; (4)
“Evidence-Informed Management of Chronic Low Back
Pain with Spinal Manipulation and Mobilization;”14 5)
“Consensus Terminology for Stages of Care: Acute,
Chronic Recurrent and Wellness,” an article with consensus
definitions of these stages arrived at through another
CCGPP project.15 The core committee, composed of
CCGPP Executive Committee members, developed 29
seed statements, based on the background documents.
Consensus Panel
Delphi panelists were solicited through a press release
and word of mouth. Every attempt was made to include not
only experienced chiropractors but also other health
professionals involved in the conservative management of
chronic pain.
Conduct of Delphi Rounds
All Delphi rounds were conducted electronically, by email. The panelists' rating forms were identified only by an
ID number, which was only connected to the panelist's
name by the project coordinator, in order to distribute and
collect the forms. The panelists did not know one another's
identity until the consensus process was concluded. We
used the consensus process methodology established by
RAND/UCLA to seek consensus on the seed statements.16
Statements were rated on an ordinal rating scale of 1 to 9
(highly inappropriate to highly appropriate); as specified by
RAND/UCLA, “appropriateness” indicated that the
expected health benefit to the patient exceeds the expected
negative consequences by a sufficiently wide margin that it
is worth doing, exclusive of cost.16 To score the ratings, we
considered ratings of 1 to 3 to indicate “inappropriate;” 4 to
6 to indicate “undecided,” and 7 to 9 to indicate
“appropriate.” Inappropriate ratings required that the
panelist provide a specific reason and, if possible, a
supporting citation from the peer-reviewed literature. The
ratings were entered into an SPSS v 17.0 database (SPSS,
Chicago, IL). Consensus on a statement's appropriateness
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Chronic Spine-Related Pain Consensus
Journal of Manipulative and Physiological Therapeutics
September 2010
was considered to be present if both the median rating was
7 or higher and a minimum of 80% of panelists rated the
statement 7 or higher. Panelists were allowed to make
comments of any length on each statement. The core
committee then reviewed all comments and then, based on
these comments, revised statements on which consensus
was not reached. The revised statements, accompanied by
the deidentified comments, were circulated in the next
round. Although consensus was reached after 3 rounds, 2
panelists requested that they be allowed to give a minority
statement because they strongly disagreed with 2 statements. In order to gain full consensus, we conducted an
additional two Delphi rounds, in conjunction with
the Nominal Group Panel, at which time all disagreement
was resolved.
Definition of “Chronic Pain Patients”
Composition of the Delphi Panel
Application of Chronic Pain Management
Of the 29 panelists, 24 were doctors of chiropractic
(DCs); the 5 non-DC panelists consisted of an acupuncturist, massage therapist, medical physician (pain management specialist), physical therapist and massage therapist.
Geographically, 2 countries (US and UK) and 14 states
(CA, CT, FL, GA, HI, IA, IL, MA, MN, NV, NY, OH, UT,
WI) were represented. The mean number of years in
practice for the 29 panelists was 24. Of the 23 US DCs, 14
(61%) were members of the American Chiropractic
Association; 2 (9%) of the International Chiropractors
Association, and the rest did not belong to any national
chiropractic organization.
Chronic pain management occurs after the appropriate
application of active and passive care including lifestyle
modifications. It may be appropriate when rehabilitative
and/or functional restorative and other care options, such as
psychosocial issues, home-based self-care and lifestyle
modifications, have been considered and/or attempted, yet
treatment fails to sustain prior therapeutic gains and
withdrawal/reduction results in the exacerbation of the
patient's condition and/or adversely affects their activities
of daily living (ADLs).
Ongoing care may be inappropriate when it interferes
with other appropriate care or when the risk of supportive
care outweighs its benefits, that is, physician dependence,
somatization, illness behavior, or secondary gain. However,
when the benefits outweigh the risks, ongoing care may be
both medically necessary and appropriate.
Appropriate chronic pain management of spine-related
conditions includes addressing the issues of physician
dependence, somatization, illness behavior, and secondary
gain. Those conditions that require ongoing supervised
treatment after having first achieved MTI should have
appropriate documentation that clearly describes them as
persistent or recurrent conditions. Once documented as
persistent or recurrent, these chronic presentations should
not be categorized as “acute” or uncomplicated.
Conduct of Nominal Group Panel
Similarly to Delphi panels, Nominal Group Panels
(NGPs) are used for problem solving and also for
developing consensus.17
We conducted the NGP electronically, an innovative
method we had used successfully in a previous consensus
project.15 Nominal Group Panel participants self-selected
from the Delphi panel. The NGP was used to clarify issues
that arose during the Delphi panel that would have been
difficult to resolve without real-time participant interactions. There were 12 panelists, all but one DCs; the other
panelist was an MD (pain management specialist).
Chronic pain patients are those for whom ongoing
supervised treatment/care has demonstrated clinically
meaningful improvement with a course of management
and have reached MTI, but in whom significant residual
deficits in activity performance remain or recur upon
withdrawal of treatment. The management for chronic pain
patients ranges from home-directed self-care to episodic
care to scheduled ongoing care. Patients who require
provider-assisted ongoing care are those for whom self-care
measures, while necessary, are not sufficient to sustain
previously achieved therapeutic gains; these patients may
be expected to progressively deteriorate as demonstrated by
previous treatment withdrawals. Additional relevant definitions in common use are provided in Table 1.
Prognostic Factors
RESULTS
The following statements were the result of the
consensus process.
Definition of Maximum Therapeutic Improvement
Maximum therapeutic improvement (MTI) is defined as
the point at which a patient's condition has plateaued and
is unlikely to improve further.
Prognostic factors that may provide a partial basis for the
necessity for chronic pain management of spine-related
conditions after MTI has been achieved include:
• Older age (pain and disability)
• History of prior episodes (pain, activity limitation,
disability)
• Duration of current episode N1 month (activity
limitation, disability)
Journal of Manipulative and Physiological Therapeutics
Volume 33, Number 7
Table 1. Definitions of chronic pain-related terminology
Term
Definition
Acute episode/disorder
…return to pre-episode status:
six to eight weeks18
Complicated case
A case where the patient, because of
one or more identifiable factors,
exhibits regression or retarded
recovery in comparison with
expectations from the
natural history.18
Chronic episode/disorder
…symptoms have been prolonged
beyond 16 weeks18
Chronic low back pain
…back related limitations
lasting longer than 3 months19
Chronicity
Acute: 6-8 weeks
Subacute: 8-16 weeks
Chronic: N16 weeks18
Disability
An umbrella term for activity
limitations and/or participation
restrictions in an individual with a
health condition, disorder
or disease.20
Exacerbation
Temporary worsening of a
pre-existing condition. Following
a transient increase in symptoms,
signs, disability, and/or impairment,
the person recovers to his or her
baseline status, or what it would have
been had the exacerbation never
occurred. Given a condition whose
natural history is one of progressive
worsening, following a prolonged but
still temporary worsening, return to
pre-exacerbation status would not be
expected, despite the absence of
permanent residuals from the
new cause.20
Impairment
A significant deviation, loss, or loss of
use of any body structure or function
in an individual with a health
condition, disorder, or disease.20
Permanent impairment
An impairment extant at the point of
maximal medical improvement.20
Recurrence
Reappearance of the symptoms and/or
signs of a disease after a remission
(period during which the
manifestations were absent or
significantly diminished).20
• Leg pain [for patients having LBP] (pain, activity
limitation, disability)
• Psychosocial factors [depression (pain); high fearavoidance beliefs, poor coping skills (activity limitation); expectations of recovery]
Farabaugh et al
Chronic Spine-Related Pain Consensus
• High pain intensity (activity limitation; disability)
• Occupational factors [higher job physical or psychological demands (disability)]
The list above is not all-inclusive and is provided to
represent prognostic factors most commonly seen in the
literature. Other factors or comorbidities not listed above
may adversely affect a given patient's prognosis and
management. These should be documented in the clinical
record and considered on a case-by-case basis.
Each of the following factors may complicate the
patient's condition, extend recovery time, and result in the
necessity of ongoing care:
• Nature of employment/work activities or ergonomics
The nature and psychosocial aspects of a patient's
employment must be considered when evaluating the
need for ongoing care (e.g. prolonged standing
posture, high loads, and extended muscle activity).
• Impairment/disability
The patient who has reached MTI, but has failed to
reach pre-injury status has an impairment/disability
even if the injured patient has not yet received a
permanent impairment/disability award.
• Medical history
Concurrent condition(s) and/or use of certain medications may affect outcomes.
• History of prior treatment
Initial and subsequent care (type and duration), as well
as patient compliance and response to care, can assist
the physician in developing appropriate treatment
planning. Delays in the initiation of appropriate care
may complicate the patient's condition and extend
recovery time.
• Lifestyle habits
Lifestyle habits may impact the magnitude of treatment
response, including outcomes at MTI.
• Psychological factors
A history of depression, anxiety, somatoform disorder
or other psychopathology may complicate treatment
and/or recovery.
Treatment Withdrawal Fails to Sustain MTI
Documented flare-ups/exacerbations, that is, phases of
increased pain, which may or may not be related to specific
incidents, superimposed on a recurrent or chronic course,
may be an indication of chronicity and/or need for ongoing
care. A flare-up or exacerbation is characterized by a return
of atypical pain and/or other symptoms and/or pain-related
difficulty performing tasks and actions equivalent to the
appropriate minimal clinicially important change value for
the outcome of interest.
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Table 2. Complicating factors that may document the necessity of
ongoing care for chronic conditions
• Severity of symptoms and objective findings
• Patient compliance and/or non-compliance factors
• Factors related to age
• Severity of initial mechanism of injury
• Number of previous injuries (N3 episodes)
• Number and/or severity of exacerbations
• Psycho-social factors (pre-existing or arising during care)
• Pre-existing pathology or surgical alteration
• Waiting N7 days before seeking some form of treatment
• Ongoing symptoms despite prior treatment
• Nature of employment / work activities or ergonomics
• History of lost time
• History of prior treatment
• Lifestyle habits
• Congenital anomalies
• Treatment withdrawal fails to sustain MTI
Complicating/Risk Factors for Failure to Sustain MTI
Table 2 lists complicating factors that may document the
necessity of ongoing care for chronic spine-related conditions. Such lists of complicating/risk factors are not allinclusive. Individual factors from this list may adequately
explain the condition chronicity, complexity and instability
in some cases. However, most chronic cases that require
ongoing care are characterized by multiple complicating
factors. These factors should be carefully identified and
documented in the patient's file to support the characterization of a condition as chronic.
Risk factors for the transition of acute/subacute spine-related conditions
to chronicity (yellow flags)
A number of prognostic variables have been identified as
increasing the risk of transition from acute/subacute to
chronic nonspecific spine-related pain. However, their
independent prognostic value is low. A multi-dimensional
model, that is, a number of clinical, demographic, psychological and social factors are considered simultaneously,
has been recommended. This model emphasizes the interaction among these factors, as well as the possible overlap
between variables such as pain beliefs and pain behaviors.
Chronicity may be described in terms of pain, and/or activity
limitation (function), and/or work disability. Risk factors for
chronicity have been categorized by similar domains:
Journal of Manipulative and Physiological Therapeutics
September 2010
demonstrate better functional outcomes if they
received that treatment
• Significant others' support: overprotectiveness and
encouraging avoidance may contribute to the risk of
chronicity. In contrast, the risk of chronicity may be
reduced when significant others encourage participation in social and recreational activities
• Healthcare practitioners' attitudes and beliefs –
clinicians' beliefs about activity seem to influence
their self-reported practice behaviors
Diagnosis
The diagnosis should never be used exclusively to
determine need for care (or lack thereof). The diagnosis must
be considered with the remainder of case documentation to
assist the physician or reviewer in developing a comprehensive
clinical picture of the condition/patient under treatment.
Clinical Re-Evaluation Information
Clinical information obtained during re-evaluation that
may be used to document the necessity of chronic pain
management for persistent or recurrent spine-related
conditions includes, but is not limited to:
• Response to date of care management for the current
and previous episodes.
• Response to therapeutic withdrawal (either gradual or
complete withdrawal) or absence of care.
• MTI has been reached and documented.
• Patient-centered outcome assessment instruments.
• Analgesic use patterns.
• Other health care services used.
Once the need for additional care has been documented,
findings of diagnostic/assessment procedures that may
influence treatment selection include:
Factors directly associated with the clinician/patient
encounter may influence (increase or decrease the likelihood) the transition toward chronicity:
• neurological/provocative testing (standard neurological testing, orthopedic tests, manual muscle testing);
• diagnostic imaging (x-ray, computed tomography,
magnetic resonance imaging);
• electrodiagnostics;
• functional movement/assessment (eg, ambulatory
assessment/limp, etc);
• chiropractic analysis procedures;
• biomechanical analysis (pain, asymmetry, range of
motion, tissue tone changes);
• palpation (static, motion);
• nutritional/dietary assessment with respect to factors
related to pain management (such as vitamin
D intake21,22 ).
• Treatment expectations: patients with high expectations for a specific treatment have been shown to
This list is provided for guidance only and is not allinclusive. All of these items are not required to justify the
•
•
•
•
Symptoms
Psychosocial factors
Function
Occupational factors
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Volume 33, Number 7
Table 3. Clinical information often relied on to document the
necessity of ongoing care for chronic conditions
In addition to standard documentation elements (ie, date, history,
physical evaluation, diagnosis and treatment plan,23 the clinical
information typically relied upon to document the necessity of
ongoing chronic pain management includes:
• Documentation of having achieved a clinically meaningful favorable
response to initial treatment, or documentation that the plan of care is
to be amended
• Documentation the patient has reached MTI
• Significant residual deficits in activity limitations are present at MTI
• Documented attempts of transition to primary self-care
• Documented attempts and/or consideration of alternative treatment
approaches
• Documentation of those factors influencing the likelihood that selfcare alone will be insufficient to sustain or restore MTI
need for ongoing care. Each appropriate item of clinical
information should be documented in the case file to
describe the patient's clinical status, present and past.
Table 3 summarizes the clinical information that may be
used to document the necessity of ongoing care for
patients with chronic conditions.
In the absence of documented flare-up/exacerbation the
ongoing treatment of persistent or recurrent spine-related
disorders is not expected to result in any clinically
meaningful change. In the event of a flare-up or
exacerbation, a patient may require additional supervised
treatment to facilitate return to MTI status. Individual
circumstances including patient preferences and previous
response to specific interventions guide the appropriate
services to be used in each case.
Chronic pain management components
A variety of functional and physiological changes may
occur in chronic conditions. Therefore, a variety of
treatment procedures, modalities, and recommendations
may be applied to benefit the patient. These include but are
not limited to the items indicated in Table 4.
Chronic pain management treatment planning/dosaging
The necessity for ongoing chronic pain management of
spine-related conditions for individual patients is established when there is a return of pain and/or other symptoms
and/or pain-related difficulty performing tasks and actions
equivalent to the appropriate minimal clinically important
change value for more than 24 hours, for example,
change in numeric rating scale of more than 2 points for
chronic LBP.24
Although the visit frequency and duration of supervised treatment vary, and are influenced by the rate of
recovery toward MTI values and the individual's ability
to self-manage the recurrence of complaints, a reasonable
therapeutic trial for managing patients requiring ongoing
Farabaugh et al
Chronic Spine-Related Pain Consensus
Table 4. Components which may be included in physiciandirected case management
Active Care
• Supervised rehabilitative/therapeutic exercise
• General exercise programs
• Specific exercise approaches
• Mind/body programs, eg, yoga, Tai Chi, etc.
• Multi-disciplinary rehabilitation
• Cognitive behavioral programs
Counseling
• ADL recommendations/counseling
• Co-management/coordination of care with other physicians/
healthcare providers
• Ergonomic recommendations/counseling
• Exercise recommendations/counseling and instruction
• Home care recommendations
• Lifestyle modifications/counseling
• Pain management recommendations
• Psycho-social counseling/behavioral modification
• Risk avoidance counseling
• Monitoring patient compliance with self-care recommendations
Passive Care
• Manual therapy procedures
• Adjustment/manipulation of joint structures
• Mobilization of joint structures
• Mobilization of soft-tissue
• Massage therapy
• Physical modalities
• Thermal
• Acoustic
• Light
• Mechanical
• Electrical
• Acupuncture
• Bracing/orthoses
care is up to 4 visits after a therapeutic withdrawal.
See Table 5 for a summary of dosaging and reevaluation recommendations.
If re-evaluation indicates further care, this may be
delivered at up to 4 visits per month. Clinicians should
routinely monitor a patient's change in pain/function to
determine appropriateness of continued care. An appropriate re-evaluation should be completed at minimum every 12
visits. Re-evaluation may be indicated more frequently in
the event a patient reports a significant or unanticipated
change in symptoms and/or there is a basis for determining
the need for change in the treatment plan/goals.
Scheduled ongoing chronic pain management treatment planning
When pain and/or ADL dysfunction exceeds the
patient's ability to self-manage, the medical necessity of
care should be documented and the chronic care treatment
plan altered appropriately.
Patient recovery patterns vary depending on degrees of
exacerbations. Mild exacerbation episodes may be
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Table 5. Chronic care dosaging recommendations a
Stage
Dosaging
Re-evaluation
Mild exacerbation
1-6 visits
per episode
1-4 visits
per month
At beginning of each
episode of care
At minimum every
12 visits, or as
necessary to document
condition changes.
Every 2-4 weeks,
following acute
care guidelines12
Every 2-4 weeks,
following acute
care guidelines12
Scheduled
ongoing care
Moderate exacerbation
Follow acute
care guidelines12
Severe exacerbation
Follow acute
care guidelines12
Table 6. Red flags that are contraindications to ongoing high
velocity low amplitude (HVLA) spinal manipulation
• Progressive neurological disorders
• Cauda Equina syndrome
• Bone weakening disorders, ie, acute spinal fracture, spinal infection,
spinal or extra-vertebral bony malignancies
• Tumor
• Articular derangements indicating instability, ie, active avascular
necrosis in weight-bearing joints
likelihood of patient harm. Table 6 summarizes red flags
that present contraindications to ongoing high velocity, low
amplitude spinal manipulation.
a
The ultimate goal is providing the least frequent level of direct
physician care to maintain the highest level of documented physical
functioning. When an individual case warrants it, the clinical necessity to
exceed guidelines parameters must be documented adequately.
manageable with 1-6 office visits within a chronic care
treatment plan. There is not a linear effect between the
intensity of exacerbation and time to recovery.25
Moderate and severe exacerbation episodes within a
chronic care treatment plan require acute care recommendations and case management.12
Chronic Care Goals
Chronic care goals are to:
•
•
•
•
•
•
•
Minimize lost time on the job
Support patient's current level of function/ADL
Pain control/relief to tolerance
Minimize further disability
Minimize exacerbation frequency and severity
Maximize patient satisfaction
Reduce and/or minimize reliance on medication
Complex cases that require modification of manipulative technique
In some complex cases where biomechanical, neurological or vascular structure or integrity is compromised, the
clinician may need to modify or omit the delivery of
manipulative procedures. Chiropractic co-management
may still be appropriate using a variety of treatments and
therapies commonly utilized by doctors of chiropractic. It is
prudent to document the steps taken to minimize the
additional risk that these conditions may present.
During the course of ongoing chronic pain management
of spine related conditions, the provider must remain alert
to the emergence of well-known and established “red flags”
that could indicate the presence of serious pathology.
Patients presenting with “red flag” signs and/or symptoms
require prompt diagnostic workup which can include
imaging, laboratory studies, and/or referral to another
provider. Ignoring these “red flag” indicators increases the
DISCUSSION
It is important for the reader to recognize that these
guidelines are intended to be flexible and may need to be
modified. They are not standards of care. Adherence to
them is voluntary. Alternative practices are possible and
may be preferable under certain clinical conditions. The
ultimate judgment regarding the propriety of any specific
procedure must be made by the practitioner in light of
individual circumstances presented by each patient.18
There is substantial agreement on the management of
acute, and episodic chronic pain related to mild, moderate,
and/or severe exacerbations for the typical patient presentation. Relative to low back pain, CCGPP's project,
described in the 2008 publication, “Chiropractic Management of Low Back Disorders: A Consensus Report” has
addressed those patients.12 Therefore, this project focused
on the problematic category of patients whose chronic pain
is not successfully controlled without ongoing care.
Management of this category of patient contributes
substantially to overall medico-legal complications and
costs. Since no chiropractic guideline currently exists to
address this problem, these patients may be inappropriately
denied chiropractic care and must therefore turn to more
expensive, more invasive, and often less effective therapies.
Although this document may provide some assistance to
third party payers in the evaluation of care, it is not by itself
a proper basis for evaluation. Many factors must be
considered in determining clinical or medical necessity,
including the best available scientific evidence, the clinical
experience of the involved practitioners and the patient's
personal preferences. Furthermore, guidelines require
periodic re-evaluations as additional scientific and clinical
information becomes available.
Limitations
The chief limitation of this project was the lack of
diversity in the consensus panel, which included only 5
non-DCs and only 2 International Chiropractors Association members. CCGPP had hoped to attract a broader,
more multidisciplinary panel. Our inability to do so may
Journal of Manipulative and Physiological Therapeutics
Volume 33, Number 7
reflect the longstanding isolation of the profession, as well
as the factionalism within it. Another limitation may be
related to the number of source documents available to
provide to the panel as background chronic pain in use
throughout the medical and research communities. Additional sources may have been useful for the panel to gain a
broader understanding of common medical lexicon. We
reviewed only a limited number of terms and perspectives
centered on “chronic spine-related conditions.” There may
be other terminology, definitions or perspectives which
were not considered, although efforts were made to
include those most commonly used in the health care
arena. Limitations imposed by the Delphi process, as well
as the limited diversity of the panel members may also
have contributed to a bias in consideration of other
definitions or terminology.
CONCLUSION
There is increasing evidence in the scientific literature
supporting the long tradition of patients seeking chiropractic
care when dealing with chronic spinal pain. As demonstrated above, there is also an obvious need for a safe, low-cost
alternative to pharmaceutical chronic pain management.
Therefore, it appears the time is right for chiropractic
management of chronic pain for spine-related conditions to
be embraced by the mainstream health care system.
The CCGPP has endeavored, through this consensus
process, to provide a responsible care guide to assist
healthcare providers in providing appropriate, evidence
based chronic pain management to their patients while
recommending appropriate documentation to allow reasonable evaluation by third-party payors.
Practical Applications
• The consensus process utilizing a multidisciplinary panel was successful in developing a set of
case management recommendations.
• This document provides a case management
compass for an evidence-based and reasonable
approach to the chiropractic management of chronic
spine pain patients who require ongoing care.
• This is an iterative process and case management
recommendations will be updated as new evidence
emerges.
ACKNOWLEDGMENT
The authors thank Cathy Evans for successfully
conducting the complex communications for the consensus process. The following experts generously donated
their time in participating as Delphi and/or Nominal
Group panelists:
Farabaugh et al
Chronic Spine-Related Pain Consensus
Carol Sauer Albright, PT; Greg Baker, DC; Vijaykumar B.
Balraj, MA, PhD; Charles Blum, DC; Jeffrey Bonsell, DC;
Frederick Carrick, DC, PhD; Mark E. Cotney, DC; Edward
Cremata, DC; Kedar Deshpande, MD; Paul Dougherty,
DC; Joseph F. Ferstl, DC, FACO; Ronald Fudala, DC,
DACAN; Hugh Gemmell, DC, MSc, EdD; Paul J. Greteman, DC, DICCP; Kevin D. Hagerty, DC, CICE, CPUR;
Anthony Hall, DC; Catherine Ho, LAc, Dipl. AC; Robert
Klein, DC, FACO; Thomas Kosloff, DC; Kurt Kuhn, DC,
MS, PhD; Anthony Lisi, DC; John Lockenour, DC,
DABCO; Lawrence Nordhoff, DC; Mariangela Penna,
DC; Gregory Snow, DC, CCSP; John S. Stites, DC,
DACBR; David N. Taylor, DC, DABCN; Jeffrey E. Weber,
MA, DC, DCBCN, FACCN; Ruth Werner, LMT.
FUNDING SOURCES AND POTENTIAL CONFLICTS OF INTEREST
All authors and panelists participated without compensation from any organization. The CCGPP provided
funding for Ms. Evans's salary. Cleveland Chiropractic
College made an in-kind contribution to the project by
allowing Dr. Hawk to devote a portion of her work time to
this project. There were no conflicts of interest.
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Article
Annals of Internal Medicine
Manual Therapy, Physical Therapy, or Continued Care by a General
Practitioner for Patients with Neck Pain
A Randomized, Controlled Trial
Jan Lucas Hoving, PT, PhD; Bart W. Koes, PhD; Henrica C.W. de Vet, PhD; Danielle A.W.M. van der Windt, PhD; Willem J.J. Assendelft, MD, PhD;
Henk van Mameren, MD, PhD; Walter L.J.M. Devillé, MD, PhD; Jan J.M. Pool, PT; Rob J.P.M Scholten, MD, PhD; and Lex M. Bouter, PhD
Background:
Neck pain is a common problem, but the effectiveness of frequently applied conservative therapies has never
been directly compared.
Objective:
To determine the effectiveness of manual therapy,
physical therapy, and continued care by a general practitioner.
Design:
Randomized, controlled trial.
Setting:
Outpatient care setting in the Netherlands.
Patients:
183 patients, 18 to 70 years of age, who had had
nonspecific neck pain for at least 2 weeks.
Intervention:
6 weeks of manual therapy (specific mobilization
techniques) once per week, physical therapy (exercise therapy)
twice per week, or continued care by a general practitioner (analgesics, counseling, and education).
on an ordinal six-point scale. Physical dysfunction, pain intensity,
and disability were also measured.
Results:
At 7 weeks, the success rates were 68.3% for manual
therapy, 50.8% for physical therapy, and 35.9% for continued
care. Statistically significant differences in pain intensity with
manual therapy compared with continued care or physical therapy
ranged from 0.9 to 1.5 on a scale of 0 to 10. Disability scores also
favored manual therapy, but the differences among groups were
small. Manual therapy scored consistently better than the other
two interventions on most outcome measures. Physical therapy
scored better than continued care on some outcome measures, but
the differences were not statistically significant.
Conclusion:
In daily practice, manual therapy is a favorable
treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner.
Measurements: Treatment was considered successful if the pa-
Ann Intern Med. 2002;136:713-722.
For author affiliations, see end of text.
tient reported being “completely recovered” or “much improved”
See editorial comment on pp 758-759.
N
therapists can specialize in passive manual (or “handson”) techniques, including mobilization or manipulation (high-velocity thrust techniques), also referred to as
manual therapy (14 –19). According to the International
Federation of Orthopedic Manipulative Therapies, “Orthopedic manipulative (manual) therapy is a specialization within physical therapy and provides comprehensive conservative management for pain and other
symptoms of neuro-musculo-articular dysfunction in
the spine and extremities” (unpublished data). Today,
many different manual therapy approaches are applied
by various health professionals, including medical doctors, physical therapists, massage therapists, manual
therapists, chiropractors, and osteopathic doctors. Reviews of trials involving manual therapy or physical therapy show that most interventions in these categories are
characterized by a combination of passive and active
components (20 –23). Although a combination of manual therapy or physical therapy that includes exercises
appears to be effective for neck pain, these therapies
have not been studied in sufficient detail to draw firm
eck pain is a common problem in the general population, with point prevalences between 10% and
15% (1–3). It is most common at approximately 50
years of age and is more common in women than in
men (1, 2, 4 – 6). Neck pain can be severely disabling
and costly, and little is known about its clinical course
(7–9). Limited range of motion and a subjective feeling
of stiffness may accompany neck pain, which is often
precipitated or aggravated by neck movements or sustained neck postures. Headache, brachialgia, dizziness,
and other signs and symptoms may also be present in
combination with neck pain (10, 11). Although history
taking and diagnostic examination can suggest a potential cause, in most cases the pathologic basis for neck
pain is unclear and the pain is labeled nonspecific.
Conservative treatment methods that are frequently
used in general practice include analgesics, rest, or referral to a physical therapist or manual therapist (12, 13).
Physical therapy may include passive treatment, such as
massage, interferential current, or heat applications, and
active treatment, such as exercise therapies. Physical
www.annals.org
© 2002 American College of Physicians–American Society of Internal Medicine 713
Article
Effects of Three Therapies for Neck Pain
Context
Neck pain is common among primary care patients.
Evidence on the effectiveness of therapies for neck pain is
limited.
A previous randomized, controlled trial suggested benefits
from manual therapy and physical therapy.
Contribution
This randomized, controlled trial of manual therapy, physical therapy, and continued care by a doctor confirms the
superiority of manual therapy and physical therapy over
continued care.
At 7 weeks, 68.3% of patients in the manual therapy
group reported resolved or much improved pain, compared with 50.8% of patients in the physical therapy
group and 35.9% of patients in the continued care group.
Clinical Implications
Primary care physicians should consider manual therapy
when treating patients with neck pain.
–The Editors
conclusions, and the methodologic quality of most trials
on neck pain is rather low (20 –23).
Koes and colleagues (24, 25) performed a randomized trial on back and neck pain and found promising
results for manual therapy and physical therapy in subgroup analyses of patients with neck pain. In our randomized, controlled trial, we compared the effectiveness
of manual therapy, physical therapy, and continued care
by a general practitioner in patients with nonspecific
neck pain.
METHODS
Patients
Patients with nonspecific neck pain whose clinical
presentation did not warrant referral for further diagnostic screening were referred to one of four research centers by 42 general practitioners for study selection. We
excluded patients whose history, signs, and symptoms
suggested a potential nonbenign cause (including previous surgery of the neck) or evidence of a specific pathologic condition, such as malignancy, neurologic disease,
fracture, herniated disc, or systemic rheumatic disease.
Two research assistants who were experienced physical
therapists and were blinded to treatment allocation performed physical examinations at baseline and follow-up.
714 21 May 2002 Annals of Internal Medicine Volume 136 • Number 10
They used standardized inclusion and exclusion criteria
and performed a short neurologic examination (Appendix Table 1, available at www.annals.org) and range-ofmotion assessment. The eligibility criteria were age between 18 and 70 years, pain or stiffness in the neck for
at least 2 weeks, neck symptoms reproducible during
physical examination, willingness to adhere to treatment
and measurement regimens, no physical therapy or
manual therapy for neck pain during the previous 6
months, no involvement in litigation, and written informed consent. Patients with concurrent headaches,
nonradicular pain in the upper extremities, and low
back pain were not excluded, but neck pain had to be
the main symptom for all patients.
Random Assignment and Data Collection
All patient data were collected before randomization. Patients were assigned to a treatment group on the
basis of block randomization after prestratification for
symptom severity (severity scores ⬍7 points or ⱖ7
points on a scale of 0 to 10); age (⬍40 years or ⱖ40
years); and, mainly for practical reasons, research center
(four local centers). Randomized permuted blocks of six
patients were generated for each stratum by using a
computer-generated random-sequence table. A researcher who was not involved in the project prepared
opaque, sequentially numbered sealed envelopes that
contained folded cards indicating one of the three interventions.
Interventions
The intervention period lasted 6 weeks. Patients
were allowed to perform exercises at home and to continue medication prescribed at baseline or use over-thecounter analgesics. Other co-interventions were discouraged but were registered if they occurred. Within the
boundaries of the protocol, treatment could be reassessed and adapted to the patient’s condition. The specific treatment characteristics were registered at each
visit. A maximum number of visits was set for each
intervention group; however, the patients did not have
to complete this maximum number if symptoms had
resolved.
Manual Therapy
Our approach to manual therapy was eclectic and
incorporated several techniques used in western Europe,
www.annals.org
Effects of Three Therapies for Neck Pain
North America, and Australia, including those described
by Cyriax, Kaltenborn, Maitland, and Mennel (15, 16,
19). In our trial, manual therapy (defined as the use of
passive movements to help restore normal spinal function) included “hands-on” muscular mobilization techniques (aimed at improving soft tissue function), specific
articular mobilization techniques (to improve overall
joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine), and coordination or stabilization techniques
(to improve postural control, coordination, and movement patterns by using the stabilizing cervical musculature) (26). Joint mobilization “is a form of manual therapy that involves low-velocity passive movements within
or at the limit of joint range of motion” (27). Manual
therapists must undergo extensive training to be able to
skillfully perform mobilization techniques (15, 19). Spinal manipulations (low-amplitude, high-velocity thrust
techniques) were not included in this protocol. Fortyfive minute treatment sessions were scheduled once per
week, for a maximum of six treatments. Six experienced
manual therapists acknowledged by the Netherlands
Manual Therapy Association performed the treatment.
Physical Therapy
The physical therapists used a combination of several treatment options, but active exercise therapies were
the cornerstone of their strategy. Active exercise therapy
involves participation by the patient and includes active
exercises (to improve strength or range of motion), postural exercises, stretching, relaxation exercises, and functional exercises.
Manual traction or stretching, massage, or physical
therapy methods, such as interferential current or heat
applications, could precede the exercise therapy. Specific
manual mobilization techniques were not included in
this protocol. Thirty-minute treatment sessions were
scheduled twice per week for a maximum of 12 treatments. The treatment was performed by five experienced physical therapists. We prevented cross-contamination with manual therapy by choosing physical
therapists who were not manual therapy specialists.
Continued Care by a General Practitioner
Each patient in this group received standardized
care from his or her general practitioner, including adwww.annals.org
Article
vice on prognosis, advice on psychosocial issues, advice
on self-care (heat application, home exercises), advice on
ergonomics (for example, size of pillow, work position),
and encouragement to await further recovery. The treatment protocol was similar to the practice guidelines for
low back pain issued by the Dutch College of General
Practitioners (28). Patients received an educational
booklet containing ergonomic advice and exercises (29).
Medication, including paracetamol or nonsteroidal antiinflammatory drugs, was prescribed on a time-contingent basis if necessary. Ten-minute follow-up visits,
scheduled every 2 weeks, were optional, and referral during the intervention period was discouraged.
Outcome Measures
Data were collected at the research center after 3
and 7 weeks. At 7 weeks, treatment results were expected to be maximal. The patients were repeatedly
asked not to reveal any information about their treatment allocation to the research assistants. The success of
blinding was evaluated at 7 weeks.
Primary outcome measures focused on perceived recovery, pain, and functional disability. Patients rated
perceived recovery on a 6-point ordinal transition scale,
ranging from “much worse” to “completely recovered.”
Success was defined a priori as “completely recovered” or
“much improved” (30). In addition, on the basis of the
systematic assessment of spinal mobility, palpation, and
pain reported by the patient, the research assistant rated
the severity of physical dysfunction on a numeric 11point scale ranging from 0 (no physical dysfunction) to
10 (maximal dysfunction). Likewise, the patient measured pain severity in the previous week in three ways on
a numeric 11-point scale (higher scores indicate more
severe pain): “bothersomeness” of pain (affective pain),
average pain, and most severe pain (31, 32). Functional
disability was measured according to the Neck Disability
Index (33), which scores 10 activities of daily living on a
scale of 0 to 5. Higher scores indicate more disability
(maximum score, 50 points). Other studies have shown
that the reliability and validity of the Neck Disability
Index are acceptable (34, 35).
Secondary outcome measures included the severity
of the most important functional limitation, rated by
the patient on a numeric 11-point scale. Range of motion of the cervical spine was measured by using the
Cybex Electronic Digital Inclinometer 320 (Lumex,
21 May 2002 Annals of Internal Medicine Volume 136 • Number 10 715
Article
Effects of Three Therapies for Neck Pain
Figure 1. Flow chart describing the progress of patients through the trial.
Inc., Ronkonkoma, New York) (36). General health was
measured according to the self-rated health index (scale,
0 to 100) of the Euro Quality of Life scale (37, 38).
Patients recorded absences from work and analgesic use
in a diary.
Statistical Analyses
We calculated sample sizes on the basis of the dichotomized score of the primary outcome measure “perceived recovery.” A difference of 25% or more in success
rate was considered to be clinically significant. With a
power of 0.8 and a significance level of 0.05, a minimum of 60 patients per treatment group was required
(39). Analyses were performed according to the intentionto-treat principle, using SPSS statistical software (SPSS
Inc., Chicago, Illinois) (40). We also performed an al716 21 May 2002 Annals of Internal Medicine Volume 136 • Number 10
ternative analysis that excluded patients who had received any interventions other than the allocated treatments.
The differences in success rates for perceived recovery (risk differences) were analyzed by applying chisquare tests (univariate analysis). Likewise, differences in
improvement rates for absence from work and use of
analgesics were analyzed. For the continuous outcome
measures, univariate analyses of variance were applied to
the differences between the baseline measurement and
each of the follow-up measurements (the mean improvement).
Multivariate analyses (multiple logistic regression
and analyses of covariance) were performed to examine
the influence of the following covariates: baseline value
of an outcome measure, therapist, age, severity, research
www.annals.org
Effects of Three Therapies for Neck Pain
center, sex, duration of the current episode, previous
episodes of neck pain, headache of cervical origin, radiating pain below the elbow, and patient preference for
treatment. For all comparisons, a two-tailed P value of
0.05 was considered statistically significant. A statistician who had no knowledge of the randomization code
performed all analyses.
The Scientific Committee and Medical Ethical
Committee of the Vrije Universiteit Medical Center in
Amsterdam, the Netherlands, approved the protocol.
Article
Role of the Funding Sources
The two grant agencies approved the design of the
trial but had no influence on the conduct and reporting
of the study.
RESULTS
Patient Selection and Follow-up
During a period of 21 months (February 1997 to
October 1998), 223 patients were referred by their gen-
Table 1. Prognostic Indicators and Baseline Values of Outcome Measures
Variable
Prognostic indicator
Mean age ⫾ SD, y
Women, %
Duration of neck pain, %
2–6 wk
7–12 wk
ⱖ13 wk
Previous episodes of neck pain, %
Assumed cause of neck pain, %
Unknown
Trauma
Not trauma
Previous treatment for neck pain, %
Radiating pain below elbow, %
“Pins and needles” sensation below elbow, %
Concomitant symptoms, %
Headache of cervical origin
Dizziness
Concentration problems
Nausea
Low back pain
Waking up because of neck pain, %
No
Sometimes
Every night
Employed, n (%)
Baseline values of outcome measures
Mean score for severity of general physical dysfunction ⫾ SD (scale, 0–10)*
Mean score for pain severity in the previous week ⫾ SD (scale, 0–10)
“Bothersomeness” of pain
Average pain
Most severe pain
Mean disability score ⫾ SD
Neck Disability Index (scale, 0–50)
Main functional limitation (scale, 0–10)
Mean cervical range of motion ⫾ SD, degrees
Flexion–extension
Lateral flexion
Rotation
Mean self-rated general health ⫾ SD (Euro Quality of Life index, 0–100)
Use of analgesics in the previous 2 weeks, %
Absence from work, %†
Manual Therapy Group
(n ⴝ 60)
Physical Therapy Group
(n ⴝ 59)
Continued Care Group
(n ⴝ 64)
44.6 ⫾ 12.4
56.7
45.9 ⫾ 11.9
69.5
45.9 ⫾ 10.5
56.3
48.3
21.7
30.0
63.3
45.8
25.4
28.8
59.3
50.0
31.3
18.8
71.9
38.4
18.3
43.3
70.0
15.0
23.3
42.4
16.9
40.7
57.6
15.3
20.3
37.5
14.1
48.4
67.2
17.3
18.8
50.0
26.7
26.7
21.7
20.0
59.3
42.4
32.2
37.3
33.9
64.1
40.6
28.1
20.3
18.8
53.3
30.0
16.7
47 (78.3)
44.1
32.2
23.7
42 (71.2)
50.0
23.4
26.6
46 (71.9)
6.0 ⫾ 1.7
6.1 ⫾ 2.0
6.4 ⫾ 2.0
7.6 ⫾ 1.9
5.9 ⫾ 1.7
8.0 ⫾ 1.8
7.3 ⫾ 2.2
5.7 ⫾ 1.8
7.6 ⫾ 1.8
7.8 ⫾ 2.2
6.3 ⫾ 2.1
8.1 ⫾ 1.9
13.6 ⫾ 7.0
7.1 ⫾ 1.8
13.9 ⫾ 6.8
6.5 ⫾ 1.9
15.9 ⫾ 7.1
7.3 ⫾ 2.1
101.8 ⫾ 21.7
70.5 ⫾ 20.6
132.9 ⫾ 32.9
69.3 ⫾ 17.2
56.7
12.8
102.2 ⫾ 21.4
68.1 ⫾ 18.2
141.8 ⫾ 28.6
75.3 ⫾ 15.4
55.9
9.5
105.1 ⫾ 21.5
66.3 ⫾ 17.2
137.6 ⫾ 27.2
69.1 ⫾ 16.1
53.1
19.6
* Scored by a research assistant.
† Patients employed at baseline who reported absenteeism from work on 1 or more days in the previous 2 weeks.
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21 May 2002 Annals of Internal Medicine Volume 136 • Number 10 717
Article
Effects of Three Therapies for Neck Pain
Table 2. Frequency of Adverse Reactions in the Three Treatment Groups
Adverse Reaction
Increased neck pain for ⬎2 d
Headache
Pain or paresthesia of the arms
Dizziness
Manual Therapy Group
(n ⴝ 60)
Physical Therapy Group
(n ⴝ 59)
Continued Care Group
(n ⴝ 64)
4OOOOOOOOOOOOOOOOOOOOOO n (%) OOOOOOOOOOOOOOOOOOOOOO3
11 (18.4)
4 (6.8)
3 (4.7)
17 (28.3)
19 (32.2)
11 (17.2)
8 (13.3)
9 (15.3)
4 (6.3)
6 (10.0)
7 (11.9)
4 (6.3)
eral practitioners. Of these, 40 did not meet the selection criteria (Figure 1). A total of 183 patients were
randomly assigned: 60 to manual therapy, 59 to physical
therapy, and 64 to continued care. One patient withdrew from the manual therapy group because of lack of
time and also missed the baseline pain measurements.
Values were occasionally missing for some variables in a
few other patients.
Adverse Reactions
Minor, benign, short-term adverse reactions were
reported (Table 2). Headache, pain and tingling in the
upper extremities, and dizziness occurred more frequently in patients who received manual and physical
therapy than in those who received continued care. Patients in the manual therapy group were more likely to
report a temporary increase in neck pain that lasted
more than 2 days after receiving therapy.
Patient Characteristics and Baseline Similarity
All patients had multiple symptoms and signs (Table 1). Mean patient age was 45 years, and approximately 60% were women. Most patients had had neck
pain for 12 weeks or fewer, and many had had previous
episodes of neck pain. Patients rated the “bothersomeness” of their pain, on average, as 7.6 on a numeric
11-point scale. The mean score for the Neck Disability
Index was 14.5 points (“minimally disabled,” according
to Vernon and Mior [33]). Only minor baseline differences were found among the three groups (Table 1).
Interventions
The study design allowed the manual therapists,
physical therapists, and general practitioners to vary the
number of treatments up to a maximum, to perform
their own evaluations, and to treat individual patients
according to their own findings. However, the specific
treatment options were limited to those listed in the
protocol and the specific treatment characteristics were
recorded (Appendix Table 2, available at www.annals
.org). The median number of visits was 6 (interquartile
range, 5 to 6) in the manual therapy group, 9 (interquartile range, 7 to 12) in the physical therapy group,
and 2 (interquartile range, 1 to 4) in the continued care
group. Figure 1 shows the protocol deviations and additional treatments in each group.
718 21 May 2002 Annals of Internal Medicine Volume 136 • Number 10
Evaluation of Blinding
Research assistants remained unaware of the allocated treatment for 93.4% of patients (n ⫽ 170). At 7
weeks, blinding was not successful in 12 patients (2 in
the manual therapy group, 3 in the physical therapy
group, and 7 in the continued care group). In most of
these 12 cases, the patient accidentally mentioned the
treatment.
Intention-to-Treat Analysis
In general, the outcome measures showed distinct
differences both within groups (compared with baseline)
and among groups. These differences usually favored
manual therapy more than physical therapy and physical
therapy more than continued care (Figure 2). Adjustment for covariates (research center, severity, age, sex,
headache, duration of neck pain, previous episodes, and
baseline outcomes of the outcome measure) did not
greatly influence the results. Because only small differences in outcome were seen among the manual therapists and among the physical therapists, multilevel analysis was not necessary. For the continuous outcomes, we
present the adjusted means and confidence intervals. We
did not adjust the percentages of binary outcomes (Table 3) because we preferred to present risk differences
instead of odds ratios.
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Effects of Three Therapies for Neck Pain
The success rate at 7 weeks was twice as high for the
manual therapy group (68.3%) as for the continued care
group (35.9%) (difference, 32.4 percentage points [95%
CI, 15.8 to 49.0 percentage points]). Physical dysfunction, pain, and functional disability were less severe in
the manual therapy group than in the continued care
and physical therapy groups. Some differences in outcome measures were already statistically significant at 3
weeks.
At 7 weeks, the success rate was higher for physical
therapy (50.8%) than for continued care (35.9%), but
this difference was not statistically significant. For the
other outcome measures, small but mostly nonsignificant differences were found in favor of physical therapy
compared with continued care by a general practitioner.
At 3 weeks, more patients worsened with continued care
(n ⫽ 9) than with physical therapy (n ⫽ 3) or manual
therapy (n ⫽ 0). The success rates for manual therapy
were statistically significantly higher than those for phys-
Article
ical therapy. Manual therapy scored better than physical
therapy on all outcome measures, although not all differences were significant.
Although disability on the Neck Disability Index
improved in all three groups by at least 5.9 points (continued care group), the differences among groups were
not statistically significant. Range of motion improved
more markedly for those who received manual therapy
or physical therapy than for those who received continued care. General health perception on the self-rated
health index of the Euro Quality of Life scale showed a
statistically significant difference in favor of manual
therapy compared with continued care and physical
therapy.
Patients receiving manual therapy had fewer absences from work than patients receiving physical therapy or continued care. Respectively, 13% (6 of 47),
29% (12 of 42), and 26% (12 of 46) of patients were
absent due to neck pain; differences among groups were
Figure 2. Results of primary care outcome measures during the 7-week follow-up.
www.annals.org
21 May 2002 Annals of Internal Medicine Volume 136 • Number 10 719
Article
Effects of Three Therapies for Neck Pain
Table 3. Mean Improvement from Baseline and Difference of Mean Improvement between Groups after 7 Weeks
(Intention-to-Treat Analysis)*
Variable
General improvement from baseline
Perceived recovery, %
Severity of physical dysfunction
(scale, 0–10)
Improvement in pain severity from
the previous week (scale, 0–10)
“Bothersomeness” of pain
Average pain
Most severe pain
Improvement in disability from baseline
Neck Disability Index (scale, 0–50)
Main functional limitation (scale, 0–10)
Improvement in range of motion from
baseline, degrees
Flexion–extension
Lateral flexion
Rotation
Improvement in general health from
baseline according to the Euro
Quality of Life self-rated health
index (scale, 0–100)
Manual
Therapy
Group*
Physical
Therapy
Group*
Continued
Care
Group*
Manual Therapy vs.
Continued Care
(95% CI)
Physical Therapy vs.
Continued Care
(95% CI)
Manual Therapy vs.
Physical Therapy
(95% CI)
68.3
50.8
35.9
32.4 (15.8 to 49.0)†
14.9 (⫺2.4 to 32.3)†
17.5 (0.1 to 34.8)†
3.4 ⫾ 2.3
2.9 ⫾ 2.3
1.8 ⫾ 2.4
1.7 (0.9 to 2.5)
1.1 (0.3 to 1.9)
0.6 (⫺0.2 to 1.4)
4.8 ⫾ 3.1
3.5 ⫾ 2.3
4.5 ⫾ 3.1
3.7 ⫾ 3.1
2.8 ⫾ 2.3
3.3 ⫾ 3.1
3.3 ⫾ 3.2
2.6 ⫾ 2.4
3.1 ⫾ 3.2
1.5 (0.4 to 2.5)
0.9 (0.1 to 1.7)
1.4 (0.4 to 2.4)
0.4 (⫺0.6 to 1.4)
0.1 (⫺0.7 to 0.9)
0.2 (⫺0.9 to 1.2)
1.0 (⫺0.02 to 2.1)
0.8 (⫺0.03 to 1.6)
1.2 (0.2 to 2.3)
7.8 ⫾ 7.0
4.4 ⫾ 3.8
6.0 ⫾ 7.0
3.4 ⫾ 3.1
5.9 ⫾ 7.2
3.4 ⫾ 3.2
1.9 (⫺0.3 to 4.1)
1.0 (⫺0.1 to 2.0)
0.1 (⫺2.1 to 2.3)
0.02 (⫺1.0 to 1.1)
1.8 (⫺0.4 to 4.0)
0.9 (⫺0.1 to 2.0)
15.3 ⫾ 20.2
13.4 ⫾ 16.3
21.8 ⫾ 21.7
11.0 ⫾ 20.9
8.8 ⫾ 16.3
13.1 ⫾ 22.5
6.7 ⫾ 20.8
6.8 ⫾ 16.8
8.9 ⫾ 22.4
8.6 (2.3 to 14.9)
6.6 (1.6 to 11.6)
13.0 (6.3 to 19.6)
4.3 (⫺2.0 to 10.6)
2.0 (⫺3.0 to 7.0)
4.2 (⫺2.5 to 10.9)
4.3 (⫺2.0 to 10.7)
4.6 (⫺0.5 to 9.6)
8.8 (2.0 to 15.5)
15.0 ⫾ 15.5
8.8 ⫾ 15.5
7.0 ⫾ 15.2
8.0 (3.4 to 12.7)
1.8 (⫺2.8 to 6.5)
6.2 (1.4 to 11.0)
* Values presented with a plus/minus sign are the mean ⫾ SD. Continuous outcome variables were adjusted for design, location, sex, headache, duration of neck pain,
previous episodes, and baseline outcomes of the outcome measure.
† Values are in percentage points.
not statistically significant. A similar trend was seen for
patients who used analgesics (51% [30 of 59] in the
manual therapy group, 53% [31 of 59] in the physical
therapy group, and 80% [51 of 64] in the continued
care group). Manual therapy and physical therapy each
resulted in statistically significantly less analgesic use
than continued care.
Alternative Analysis
We performed an alternative analysis that excluded
14 patients who received treatment other than that allocated. Results were similar to those of the intentionto-treat analyses. For example, at 7 weeks, the success
rates were 70.7% for manual therapy, 50.8% for physical therapy, and 34.6% for continued care.
DISCUSSION
We compared the effectiveness of frequently used
treatments for nonspecific neck pain in general practice.
We found that manual therapy was more effective than
continued care, and our results consistently favored
manual therapy on almost all outcome measures. Although physical therapy scored slightly better than con720 21 May 2002 Annals of Internal Medicine Volume 136 • Number 10
tinued care, most of the differences were not statistically
significant. In addition, although manual therapy
seemed to be more effective than physical therapy, differences were small for all outcome measures except perceived recovery and were not always statistically significant. The magnitude of the differences between manual
therapy and physical therapy, but also between manual
therapy and continued care, were most pronounced for
perceived recovery. Because perceived recovery combines
other outcomes, such as pain, disability, and patient satisfaction, it may be the most responsive outcome measure. For pain intensity, statistically significant differences among the treatment groups ranged from 0.9 to
1.5 on a scale of 0 to 10. Although smaller differences
could have been detected with larger sample sizes, they
would not have been clinically relevant.
It is of interest that the postulated objective of manual therapy, that is, the restoration of normal joint motion, was achieved, as indicated by the relatively large
increase in the range of motion of the cervical spine.
The differences among groups in scores on the Neck
Disability Index were small (⬍2 points) and are not
considered clinically important (35). The low disability
www.annals.org
Effects of Three Therapies for Neck Pain
scores on the Neck Disability Index at baseline may have
left only a small margin for improvement. Other studies
using the Neck Disability Index have also found that
function may not be severely limited in patients with
nonspecific neck pain (8, 41). We recommend further
investigation of disease-specific outcome measures for
neck pain. Only Koes and colleagues (24, 25) have compared the effectiveness of manual therapy (manipulation
and mobilization) and physical therapy (exercise, traction, and other methods) with that of continued care
and a placebo treatment. Our study confirms their findings that manual therapy and physical therapy are superior to continued care.
The general practitioners performed a routine examination, which is common in general practice. Although
we tried to enroll all eligible patients who consulted
their general practitioner with a new episode of neck
pain during the recruitment period, the numbers of patients recruited by each general practitioner suggest that
potential participants were lost at this point. However,
we feel that our study sample reflects patients with nonspecific neck pain who were seen in everyday practice.
The natural course of neck pain in everyday practice
might best be reflected by the progress in the continued
care group. Borghouts and colleagues (9), in a systematic
summary of the available evidence, found that patients
with chronic neck pain who received a variety of common interventions experienced between 37% and 95%
improvement when assessed from 3 weeks to 1 year. In
the physical therapy and manual therapy groups, the
“hands-on approach,” frequent visits, and opportunities
for intensive patient–therapist interaction may have contributed to the observed effects. The differences in effect
between the physical therapy and manual therapy
groups, however, suggest that the superiority of manual
therapy cannot be explained by nonspecific effects alone.
In this trial, manual therapy was performed by
physical therapists with formal training. We believe that
manual therapy has added value because therapists are
knowledgeable about spinal problems, are skilled in performing specific manual techniques, and are educated
about the potential risks. (42). Active treatment components, such as those used in the physical therapy strategy, tend to become more dominant over time as the
patient improves (41, 43). In our study, mobilization,
the passive component of the manual therapy strategy,
formed the main contrast with physical therapy or conwww.annals.org
Article
tinued care and was considered to be the most effective
component.
Our results suggest that in everyday practice, for
every 3 patients referred to manual therapy and every 7
patients referred to physical therapy, 1 additional patient will completely recover within 7 weeks than would
have recovered after continued care by a general practitioner (number needed to treat on the basis of perceived
recovery). Although differences were not particularly
large for all outcome measures, manual therapy seems to
be a favorable treatment option for patients with neck
pain.
From Institute for Research in Extramural Medicine, Vrije Universiteit
Medical Centre, Amsterdam, the Netherlands; Cabrini Medical Centre,
Malvern, and Monash University, Melbourne, Victoria, Australia; Erasmus University Rotterdam, Rotterdam, the Netherlands; University of
Maastricht, Maastricht, the Netherlands; and Dutch College of General
Practitioners and Nivel Netherlands Institute for Health Services Research, Utrecht, the Netherlands.
Acknowledgments: The authors thank Anita Gross for critical review of
the manuscript; Eva Stokx, Luite van Assen, Vera Veldman, and Ingeborg Korthals-de Bos for data collection and data entry; Frans Krapels for
advice on usual care; and Brigitte Kapteijn and Raymond Swinkels for
advice on physical and manual therapy. They also thank the participating
physical therapists, manual therapists, general practitioners, and patients.
Grant Support: By Netherlands Organization for Scientific Research
(904-66-068) and the Fund for Investigative Medicine of the Health
Insurance Council (OG95-008).
Requests for Single Reprints: Jan Lucas Hoving, PhD, Department of
Clinical Epidemiology, Cabrini Hospital, and Monash University Department of Epidemiology and Preventive Medicine, Cabrini Medical
Centre, Suite 41, 183 Wattletree Road, Malvern, 3144 Victoria, Australia;
e-mail, [email protected].
Current author addresses and author contributions are available at www
.annals.org.
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www.annals.org
ORIGINAL ARTICLES
OUTCOMES FROM MAGNETIC RESONANCE
IMAGING–CONFIRMED SYMPTOMATIC CERVICAL DISK
HERNIATION PATIENTS TREATED WITH HIGH-VELOCITY,
LOW-AMPLITUDE SPINAL MANIPULATIVE THERAPY:
A PROSPECTIVE COHORT STUDY WITH
3-MONTH FOLLOW-UP
Cynthia K. Peterson, RN, DC, M.Med.Ed, a Christof Schmid, DC, b Serafin Leemann, DC, b
Bernard Anklin, DC, b and B. Kim Humphreys, DC, PhD c
ABSTRACT
Objective: The purpose of this study was to investigate outcomes of patients with cervical radiculopathy from
cervical disk herniation (CDH) who are treated with spinal manipulative therapy.
Methods: Adult Swiss patients with neck pain and dermatomal arm pain; sensory, motor, or reflex changes
corresponding to the involved nerve root; and at least 1 positive orthopaedic test for cervical radiculopathy were
included. Magnetic resonance imaging–confirmed CDH linked with symptoms was required.
Baseline data included 2 pain numeric rating scales (NRSs), for neck and arm, and the Neck Disability Index (NDI).
At 2 weeks, 1 month, and 3 months after initial consultation, patients were contacted by telephone, and the NDI,
NRSs, and patient's global impression of change data were collected. High-velocity, low-amplitude spinal
manipulations were administered by experienced doctors of chiropractic. The proportion of patients responding
“better” or “much better” on the patient's global impression of change scale was calculated. Pretreatment and
posttreatment NRSs and NDIs were compared using the Wilcoxon test. Acute vs subacute/chronic patients' NRSs and
NDIs were compared using the Mann-Whitney U test.
Results: Fifty patients were included. At 2 weeks, 55.3% were “improved,” 68.9% at 1 month and 85.7% at 3 months.
Statistically significant decreases in neck pain, arm pain, and NDI scores were noted at 1 and 3 months compared with
baseline scores (P b .0001). Of the subacute/chronic patients, 76.2% were improved at 3 months.
Conclusions: Most patients in this study, including subacute/chronic patients, with symptomatic magnetic resonance
imaging–confirmed CDH treated with spinal manipulative therapy, reported significant improvement with no adverse
events. (J Manipulative Physiol Ther 2013;36:461-467)
Key Indexing Terms: Spine; Neck Pain; Manipulation; Chiropractic; Intervertebral Disk Displacement
ymptomatic compression of a cervical nerve root
occurs in approximately 83.2 of every 100 000
persons and is caused by disk herniations, degenerative spondylosis, or a combination of the 2. Degenerative
S
stenosis leading to narrowing of the intervertebral foramen
is reported to be the most common cause of nerve root
compression. 1 The C6 and C7 nerve roots are most
frequently involved, often resulting in severe pain and
a
Professor, Department of Chiropractic Medicine, Faculty of
Medicine, Orthopedic University Hospital Balgrist, University of
Zürich, Zürich, Switzerland.
b
Doctor, Private Practice, Zürich, Switzerland.
c
Professor and Head of Chiropractic Medicine Department,
Department of Chiropractic Medicine, Faculty of Medicine,
Orthopedic University Hospital Balgrist, University of Zürich,
Zürich, Switzerland.
Submit requests for reprints to: Cynthia K. Peterson RN, DC,
M.Med.Ed, Professor, Department of Chiropractic Medicine,
Faculty of Medicine, Orthopedic University Hospital Balgrist,
University of Zürich, Zürich, Switzerland
(e-mail: [email protected]).
Paper submitted May 31, 2013; in revised form June 24, 2013;
accepted June 27, 2013.
0161-4754/$36.00
Copyright © 2013 by National University of Health Sciences.
http://dx.doi.org/10.1016/j.jmpt.2013.07.002
461
462
Peterson et al
Spinal Manipulation for Cervical Disk Herniation
Journal of Manipulative and Physiological Therapeutics
October 2013
disability. 1,2 Symptoms can arise from the nerve root
compression, inflammation, or both and include pain in a
radicular distribution, paresthesias in a dermatomal pattern,
decreased relevant reflex, and weakness of the muscles
innervated by the nerve root. 3
Patients with radiculopathy from cervical disk herniations (CDHs), the second most common cause of
cervical nerve root compression, typically have acute
neck pain with associated arm pain following the
distribution of the involved nerve root, although the
arm pain may be the predominant symptom. 3,4 However,
it is important to recognize that disk protrusions are also
a common finding on magnetic resonance imaging (MRI)
scans of asymptomatic people. 5–7 One study found that
63% of asymptomatic athletic males older than 40 years
had protruding disks in the cervical spine. 5 In another
study, disk protrusion with demonstrable spinal cord
compression was noted in 7.6% of asymptomatic subjects
over the age of 50 years. 6 However, extruded disk
herniations and cord compression are unusual findings in
asymptomatic individuals. 7
The treatment of patients with cervical radiculopathy
is often surgical if conservative therapies fail. 2–4,8
Conservative treatments of patients with CDH are not
well described or studied but may include lifestyle
changes, pain medications, physiotherapy, epidural steroid injections, or spinal manipulative therapy
(SMT). 2,3,8–12 Like most of the conservative treatments
other than epidural steroid injections, the research
evidence supporting SMT as a treatment for CDHs is
lacking. Three systematic reviews on manipulation for
various neck disorders found insufficient evidence to
support this therapy for patients with neck pain and
radiculopathy. 9–11 However, it is known that some
doctors of chiropractic (DCs) and other manual therapists
treat CDH patients with SMT in spite of the lack of
supporting evidence. 11,13 Therefore, the purpose of this
study is to investigate the clinical outcomes of patients
with cervical radiculopathy from MRI-confirmed CDH
who are treated with high-velocity, low-amplitude SMT
in an outpatient chiropractic practice.
METHODS
Ethics approval was obtained from the Orthopaedic
University Hospital of Balgrist and Canton of Zürich ethics
committees before the start of the study.
Fig 1. Left parasagittal T2-weighted and T1-weighted as well as
T2-weighted axial MRI slices showing C6-7 left posterolateral
disk herniation with posterior displacement of the spinal cord and
left C7 nerve root.
Journal of Manipulative and Physiological Therapeutics
Volume 36, Number 8
Peterson et al
Spinal Manipulation for Cervical Disk Herniation
Inclusion Criteria
Consecutive German-speaking patients from a single
chiropractic practice in Switzerland were recruited from
(January 2010) to (April 2013). Subjects were between 18
and 65 years of age with no contraindications to cervical
SMT and with neck pain and moderate to severe arm pain in
a dermatomal pattern, sensory, motor, or reflex changes
corresponding to the involved nerve root. In addition, at
least one of the following positive orthopaedic tests for
cervical radiculopathy was required: (a) positive upper limb
tension test, (b) positive cervical distraction test, (c) positive
Spurling test, (d) cervical rotation less than 60° (3).
Magnetic resonance imaging–proven CDH at the corresponding spinal segment was also required (Fig 1). The
neurologic examination was repeated at each follow-up
visit by 1 of the 3 DCs practicing at this site. The inclusion
criteria remained constant throughout the study. All patients
provided consent to participate in this study.
Exclusion Criteria
Patients with specific pathologies of the cervical spine that
are contraindications to chiropractic manipulative treatment,
such as tumors, infections, inflammatory spondylarthropathies, acute fractures, Paget disease, and severe osteoporosis,
were excluded. Also excluded were patients with previous
spinal surgery, a history of strokes, signs of cervical
spondylotic myelopathy, spinal stenosis, and pregnancy.
BASELINE DATA
AND
OUTCOME MEASURES
Before the first treatment, the treating DC completed a
questionnaire consisting of demographic information on the
patient (age, sex, chronicity of complaint, specific nerve
root level involved). The patients completed a baseline
questionnaire consisting of numeric rating scales (NRS) for
pain where 0 is no pain and 10 is the worst pain imaginable
for both the neck and the arm pain separately. In addition,
they completed the Neck Disability Index (NDI). 14 At 2
weeks, 1 month, and 3 months after the initial consultation,
a trained research assistant from the university hospital who
was unknown to the patient and independent from the
treating practice contacted the patients via telephone and the
NDI, both NRSs and patient's own global impression of
change (PGIC) data were collected. The PGIC scale is a
7-point verbal scale, including the responses much worse,
worse, slightly worse, no change, slightly better, better, and
much better. 15 Only the responses “much better” and
“better” were considered clinically relevant “improvement,”
as determined by previous studies and used in other cohort
research. 13,16–18 This was considered the primary outcome.
TREATMENT PROCEDURE
The treatment procedure was a standardized, single,
high-velocity, low-amplitude cervical manipulation with
Fig 2. Doctor and patient position for high-velocity, lowamplitude SMT in a patient with symptomatic MRI-confirmed
CDH. (Color version of figure is available online.)
rotation to the opposite side and lateral flexion to the same
side of the affected arm. The DC stood on the affected side
of the supine patient's neck, with an index contact on the
articular pillar of the most symptomatic vertebral motion
segment on the side of the patient's complaint and at the
spinal level clinically assessed to correspond with the
MRI findings. The assisting hand stabilized the head of
the patient. Rotation to the opposite and lateral flexion
to the ipsilateral side was used to take out skin and joint slack
(Fig 2). Once the patient was positioned, a high-velocity,
low-amplitude thrust was applied, with the goal of moving
the affected segment and producing an audible release.
Because an audible release was achieved in most cases, the
presence or absence of an audible release was not recorded.
In the rare case where an audible release did not occur
during the procedure, the DC might repeat the manipulation
up to 2 additional times. When a patient reported bilateral
neck and/or arm pain (extremely rare), the procedure could
be reproduced on the opposite side as well. Treatments were
repeated 3 to 5 times per week for the first 2 to 4 weeks and
carried on 1 to 3 times per week thereafter until the patient
was asymptomatic. All patients were treated by 1 of the 3
DCs who work together in the same clinic. All 3 of these
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Spinal Manipulation for Cervical Disk Herniation
Journal of Manipulative and Physiological Therapeutics
October 2013
Table 1. Baseline and outcome data for all patients at the various time points
Baseline data
(50 pts)
PGIC
NRS neck, mean (SD)
NRS arm, mean (SD)
NDI, mean (SD)
5.71 (2.98)
6.43 (2.77)
18.17 (8.71)
2 wk
(39 pts)
1m
(45 pts)
3 mo
(50 pts)
55.3%, much better or better
0%, worse
68.9%, much
better or better
2.2%, slightly worse
2.58 a (1.97)
2.71 a (2.19)
9.15 a (5.15)
85.7%, much better or better
0%, worse
3.54 a (2.17)
4.12 a (2.58)
14.12 a (8.52)
1.68 a (1.72)
1.64 a (1.84)
4.95 a (4.29)
NDI, neck disability index; NRS, numeric rating scale; PGIC, patient's global impression of change.
a
P b .0001 compared with baseline score using the Mann-Whitney U test.
DCs had completed the mandatory 2-year full-time
postgraduate residency program in Switzerland and had
between 6 and 30 years of chiropractic clinical experience.
The senior DC had trained the 2 younger practitioners,
which standardized the manipulative procedure.
Patients were allowed to take over-the-counter pain
medications as needed, but no other treatments were
administered to these patients in the practice. The type and
quantity of pain medication were not monitored in this study.
If a patient wished to have surgery or a nerve root infiltration,
these options would have been discussed with the patient, and
they would have been referred directly for these procedures, as
Swiss DCs are legally allowed to make these direct referrals.
The patient would then be deleted from the study. This did not
occur in any of the patients however.
Statistical Analysis
Only patients responding better or much better on the
PGIC scale were categorized as “improved,” and this was
the primary outcome measure. These 2 options have been
shown to reflect clinically relevant improvement. 17,18
“Slightly better” was not considered to be improved,
consistent with previous studies. 13,16 However, responses
of “slightly worse,” “worse,” and “much worse” were all
counted as worsening of the condition to error on the side
of caution. 13,16 The proportion (%) of patients improved
or worse was calculated. In addition to descriptive
statistics, scores on the pretreatment and posttreatment
NRSs and NDI were compared using the Wilcoxon test
for matched pairs. Patients with symptoms 4 weeks or
less (acute) were compared with patients with symptoms
more than 4 weeks (subacute/chronic) using the MannWhitney U test to assess for differences. P b .05 was
considered statistically significant.
RESULTS
A total of 50 patients had baseline and 3-month data
available. The mean patient age was 44.38 (SD, 7.6) years,
and 34 (68%) of the patients were male. There was no
significant age difference between the males and females
nor were there significant differences in their baseline NRS
neck pain, NRS arm pain, or NDI scores. Thirty-nine
patients had 2-week data, and 45 patients had 1-month data
available. The reason for the smaller patient numbers at the
2-week and 1-month data collection time points was due to
the narrow windows in the study protocol in which these
follow-up telephone calls could occur. If a patient was not
reached within the allocated time frame, that telephone call
was missed but the patient remained in the study unless the
patient could not be reached for 3 consecutive phone calls.
This only occurred for 1 patient. An additional 2 patients
had baseline, 2-week, and 1-month data, but the 3-month
telephone call was missed, and for 3 patients with baseline,
2-week, and 1-month data, the time for the 3-month
telephone call had not yet arrived. Thus, 56 patients were
enrolled in the study to obtain the 50 patients with both
baseline and 3-month data.
By 2 weeks after the first treatment, 55.3% of all patients
reported that they were significantly improved (Table 1),
and none reported being worse. At 1 month, 68.9% were
significantly improved (1 patient was slightly worse), and
by 3 months, after the first treatment, this figure rose to
85.7% with no patients being worse. When comparing the
follow-up NRS and NDI scores to the baseline scores,
statistically significant reductions at all data collection time
points were noted (Table 1).
When comparing acute patients (symptoms ≤ 4 weeks,
n = 26) with patients whose symptoms were longer than 4
weeks (n = 24), a higher proportion of the acute patients
reported clinically relevant improvement, and this improvement was faster compared with those patients who
were subacute or chronic (Table 2). However, at 3 months
after the first treatment, 76.2% of the subacute/chronic
patients reported clinically relevant improvement with no
patients reporting that they were worse. The mean duration
of symptoms for the subacute/chronic patients was 298.73
days (SD, 766.45). The acute patients had statistically
significant reductions in their NRS neck, NRS arm, and
NDI scores compared with baseline at all data collection
time points. The subacute/chronic patients also had
statistically significant reductions in their NRS and NDI
scores at all time points with 1 exception—the baseline to
2-week NRS arm pain score (P = .052) was not
significantly reduced.
Journal of Manipulative and Physiological Therapeutics
Volume 36, Number 8
Peterson et al
Spinal Manipulation for Cervical Disk Herniation
Table 2. Comparison of CDH patients with symptoms 4 weeks or less with those having symptoms more than 4 weeks (acute and
nonacute)
Baseline
(mean + SD)
2 wk
(mean + SD)
1 mo
(mean + SD)
3 mo
(mean + SD)
61.9% (n = 20),
much better or
better (0% worse)
47.1% (n = 19),
much better or better
(0% worse)
76.9%
(n = 24), much
better or better
(0%worse)
57.9% (n = 21),
much better or better
(5.3% slightly worse)
92.9%
(n = 26),
much better or
better (0% worse)
76.2%
(n = 24),
much better or better
(0% worse)
3.50 a (2.43)
2.02 a (1.55)
1.37 a (1.45)
3.47 a (1.81)
2.97 a (2.21)
2.07 a (1.97)
6.90 (2.36)
5.71 (2.99)
3.85 a (2.70)
4.47 (2.50)
2.60 a (2.26)
2.79 a (2.22)
1.23 a (1.48)
2.00 a (2.18)
19.36 (8.01)
15.56 (8.95)
13.60 a (9.49)
15.15 a (7.89)
9.20 a (4.66)
9.10 a (6.07)
4.38 a (3.64)
5.62 a (5.11)
PGIC
Sx ≤ 4 wk
Sx N 4 wk
NRS neck
Sx ≤ 4 wk
Sx N 4 wk
NRS arm
Sx ≤ 4 wk
Sx N 4 wk
NDI
Sx ≤ 4 wk
Sx N 4 wk
6.15 (2.79)
(n = 26)
5.00 (3.04)
(n = 24)
NDI, neck disability index; NRS, numeric rating scale; PGIC, patient's global impression of change; Sx, symptoms.
a
Statistically significant compared with the baseline figures at P b .05.
Although 1 patient reported being “slightly” worse at 1
month, at 3 months, no patients were worse, and there were
no adverse events in this cohort of patients.
DISCUSSION
Most patients in this study with MRI-proven symptomatic CDHs who were treated with high-velocity, lowamplitude spinal manipulation reported clinically significant improvement at all time points, particularly at 3
months. The PGIC responses of much better and better have
previously been shown to indicate clinically relevant
improvement, whereas slightly better is not clinically
relevant. 16,17 In addition, the large reductions in NRS
neck and arm pain scores as well as the NDI scores at 3
months of approximately between 66% and 75% far exceed
the threshold of 30% to 35% pain reduction considered
clinically relevant. 18 Because of the paucity of research into
SMT for patients with CDHs, comparisons with other
studies cannot be directly made. However, a recent large
prospective outcomes study on Swiss neck pain patients
undergoing chiropractic treatment found that the presence
of radiculopathy was not a negative predictor of improvement. 13 In that study, however, the specific treatment
method was not determined, and the diagnosis of radiculopathy was made by numerous different treating DCs and not
necessarily linked to MRI findings.
It is important to point out that even the subacute/chronic
patients in this study with symptoms lasting longer than 4
weeks (mean duration, 298.73 days) reported high levels of
clinically significant improvement. This is clinically important as the chronic patients are the ones who are usually the
most costly in terms of health care use and quality-of-life
disruption. 19–21 Although the natural history of acute
patients with radiculopathy from CDHs has been reported
to be quite favorable, this only applies to patients with
symptoms of less than 4 to 8 weeks. 22,23 The most recent
review on the natural history of radiculopathy states that the
clinical course of cervical radiculopathy is poorly documented. 24 Indeed, it is virtually impossible to extract reliable
figures on the natural history of this condition from the few
published studies for acute CDH patients with radiculopathy
who have not had any type of treatment at all. 2,24 The results
of this current study can, therefore, only be compared with
those published, which involved another treatment for
patients with CDH and radiculopathy. Kolstad et al 23
studied 21 chronic (symptoms N 3 months) CDH patients
with radiculopathy who received 2 cervical nerve root blocks
consisting of a corticosteroid and anesthetic. They reported
that 24% of these patients (5/21) had clinically relevant
reduction in their symptoms, that is, a 25% reduction in their
NRS score, at 6 weeks and 4 months after injection. The
results of this current study using SMT for the subacute/
chronic patients had substantially better results with more
than 76% reporting clinically relevant improvement and a
65% reduction in arm pain as well as a 59% reduction in neck
pain NRS scores at 3 months. However, the patients in this
current study included those with symptoms between 4 and
12 weeks as well as those whose symptoms were longer than
3 months, and this may have favorably influenced the results.
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Peterson et al
Spinal Manipulation for Cervical Disk Herniation
The mean duration of the symptoms in this subacute/chronic
cohort was over 298 days however.
One patient reported being slightly worse at 1 month, but
by 3 months, no patients were worse. No cases of serious
adverse events occurred. Risks of SMT to the cervical spine
in general include fainting/dizziness/light-headedness (at
worse 16/1000 treatment consultations), headache (at worse
4/100 treatments), and numbness/tingling in upper limbs (at
worse 15/1000 treatments). 25 Serious adverse events such
as dissection of the vertebral artery or serious neurologic
deficits are so rare that accurate estimations of the
frequency cannot be calculated but are estimated at 1 of
200 000 to 1 of several million treatments. 25,26 The most
common adverse events are transient local pain and
stiffness. 27,28 Other uncommon adverse events include
tiredness, dizziness, nausea, and ringing in the ears. 27,28
An advantage to this study is that the treatment was
standardized to a high-velocity, low-amplitude manipulative procedure, based on the location of the disk herniation
as seen on the MRI scans and correlated with the clinical
signs and symptoms. In addition, patients whose herniation
had penetrated through the peripheral annular fibers, the
posterior longitudinal ligament, or were sequestered were
not excluded from being treated with SMT. However, no
studies have been conducted to determine whether there is a
difference in outcome based on the choice of the specific
manipulative procedure or the type and location of disk
herniation. Future studies should address these issues.
Limitations
There are several limitations to this study. As a cohort
outcomes study and not a randomized controlled clinical
trial, the outcomes reported here cannot be directly
attributed to the SMT treatment. Additional research
comparing SMT with other treatments, for example,
therapeutic nerve root infiltrations using the randomized
controlled clinical trial methodology, needs to be done.
Furthermore, all patients in this study were examined and
treated in a single chiropractic practice in Zürich,
Switzerland, by any 1 of the 3 DCs working there
using a standardized treatment approach. Thus, the results
obtained may not be representative of other chiropractic
practices or other practitioners using SMT. The relatively
small sample size for the subgroup of CDH patients
whose symptoms were “subacute/chronic” (24 patients) is
another limitation.
Additional limitations include the fact that all outcomes were self-reported, consistent with many other
research studies. No attempt was made to confirm the
reality of the information given to the research assistants.
However, the DCs themselves monitored and documented the patients' progress, including their neurologic
evaluations as outlined in the methodology. Furthermore,
the fact that the follow-up outcomes were obtained by
Journal of Manipulative and Physiological Therapeutics
October 2013
telephone interviews, whereas the baseline data were
completed by the patient in a written format, may also
influence the results. However, all patients were handled
in the same way, and there was no mixture of telephone
and written questionnaire follow-up data collection. 29 In
addition, the primary outcome measure of the PGIC can
only be collected after treatment, and thus, there was no
“baseline” data for this scale. By conducting the
telephone interviews at the university hospital by
research assistants unknown to the patients rather than
collecting the data at the practice site itself, an attempt
was made to avoid a positive bias.
CONCLUSIONS
A high proportion of acute and most importantly
subacute/chronic patients with MRI-confirmed symptomatic
CDHs treated with high-velocity, low-amplitude cervical
spine manipulation reported clinically relevant improvement
at 1 and 3 months after the first treatment. There were no
adverse events reported for patients in this study.
Practical Applications
• Patients with symptomatic MRI-confirmed
cervical disk herniations treated with SMT to
the level of herniation reported high levels of
clinically relevant improvement at 2 weeks, 1
month, and 3 months after the first treatment.
• A higher proportion of acute patients improve, and this improvement is faster than
those patients who are subacute or chronic.
• Of the subacute/chronic patients, 76.2%
reported clinically relevant improvement at
3 months.
• There were no adverse events.
FUNDING SOURCES AND POTENTIAL CONFLICTS OF INTEREST
The Uniscientia Foundation, the European Academy for
Chiropractic, and the Balgrist Hospital Foundation provided funding support for this study. No conflicts of interest
were reported for this study.
CONTRIBUTORSHIP INFORMATION
Concept development (provided idea for the research):
SL, CS, BA
Design (planned the methods to generate the results):
CP, BKH, SL, CS, BA
Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript):
CP, BKH
Journal of Manipulative and Physiological Therapeutics
Volume 36, Number 8
Data collection/processing (responsible for experiments,
patient management, organization, or reporting data):
SL, CS, BA, CP, BKH
Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): CP
Literature search (performed the literature search): CP
Writing (responsible for writing a substantive part of the
manuscript): CP, SL, CS
Critical review (revised manuscript for intellectual
content, this does not relate to spelling and grammar
checking): CP, BKH, SL, CS, BA
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Kurland LT. Epidemiology of cervical radiculopathy. A
population-based study from Rochester, Minnesota, 1976
through 1990. Brain 1994;117:325-35.
2. Murphy DR, Hurwitz EL, Gregory A, Clary R. A nonsurgical
approach to the management of patients with cervical
radiculopathy: a prospective observational cohort study. J
Manipulative Physiol Ther 2006;29:279-87.
3. Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A,
Allison S. Reliability and diagnostic accuracy of the clinical
examination and patient self-report measures for cervical
radiculopathy. Spine 2003;28:52-62.
4. Murphy DR. Herniated disc with radiculopathy following
cervical manipulation: nonsurgical management. Spine J 2006;
6:459-63.
5. Healy JF, Healy BB, Wong WHM, Olson EM. Cervical and
lumbar MRI in asymptomatic older male lifelong athletes:
frequency of degenerative findings. J Comput Assist Tomogr
1996;20:107-12.
6. Matsumoto M, Fujimura Y, Suzuki N, et al. MRI of cervical
intervertebral discs in asymptomatic subjects. J Bone Joint Surg
Br 1998;80-B:19-24.
7. Ernst CW, Stadnik TW, Peeters E, Breucq C, Osteaux MJC.
Prevalence of annular tears and disc herniations on MR
images of the cervical spine in symptom free volunteers. Eur J
Radiol 2005;55:409-14.
8. Lin EL, Lieu V, Halevi L, Shamie AN, Wang JC. Cervical
epidural steroid injections for symptomatic disc herniations. J
Spinal Disord Tech 2006;19:183-6.
9. Vernon HT, Humphreys BK, Hagino CA. A systematic
review of conservative treatments for acute neck pain not due
to whiplash. J Manipulative Physiol Ther 2005;28:443-8.
10. Brontfort G, Haas M, Evans RL, Bouter LM. Efficacy of
spinal manipulation and mobilization for low back pain and
neck pain: a systematic review and best evidence synthesis.
Spine J 2004;4:335-56.
11. BenEliyahu DJ. Magnetic resonance imaging and clinical
follow-up: study of 27 patients receiving chiropractic care for
cervical and lumbar disc herniations. J Manipulative Physiol
Ther 1996;19:597-606.
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12. Gross AR, Hoving JL, Haines RA, et al. A Cochrane review of
manipulation and mobilization for mechanical neck disorders.
Spine 2004;29:1541-8.
13. Peterson C, Bolton J, Humphreys BK. Predictors of outcome
in neck pain patients undergoing chiropractic care: comparison of acute and chronic patients. Chiropr Man Ther 2012;
20:27.
14. Vernon H. The Neck Disability Index: state-of-the-art, 19912008. J Manipulative Physiol Ther 2008;31:491-502, http://
dx.doi.org/10.1016/j.jmpt.2008.08.006.
15. Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D,
Holman H. Capturing the patient's view of change as a clinical
outcome measure. JAMA 1999;282:1157-62.
16. Peterson CK, Bolton J, Humphreys BK. Predictors of
improvement in patients with acute and chronic low back
pain undergoing chiropractic treatment. J Manipulative
Physiol Ther 2012;35:525-33.
17. Newell D, Bolton JE. Responsiveness of the Bournemouth
questionnaire in determining minimal clinically important change
in subgroups of low back pain patients. Spine 2010;35:1801-6.
18. Hurst H, Bolton J. Assessing the clinical significance of
change scores recorded on subjective outcome measures. J
Manipulative Physiol Ther 2004;27:26-35.
19. Dietl M, Korczak D. Over-, under-and misuse of pain
treatment in Germany. Health Technol Assess 2011;7:
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20. Teasell R, McClure JA, Walton D, et al. A research synthesis
of therapeutic interventions for whiplash-associated disorder
(WAD): Part 4—noninvasive interventions for chronic WAD.
Pain Res Manage 15:313–22.
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of chronic low back pain. Spine 2012;37:E668-77.
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23. Kolstad F, Leivseth G, Nygaard OP. Transforaminal steroid
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467
Soft Tissue
Trigger points and myofascial pain syndrome
Evidence level B (moderately strong evidence) – manual therapies
provide immediate pain relief for trigger points (TrPs)1
Evidence level C (limited evidence) – supporting manual therapies for long term use in
management of TrPs and myofascial pain syndrome (MPS)1
Level A (substantial evidence) – laser therapy is effective for TrPs and MPS1
Level B – TENS may be effective for immediate relief for TrPs1
Level C – (frequency modulated neural stimulation) FREMS, (high-voltage galvanic stimulation)
HVGS, (electrical muscle stimulation) EMS and Interfential current (IFC)1
Level C – ultrasound no more effective than placebo1
Level B - magnets may be effective for TrPs and MPS1
Level B – deep acupuncture for TrPs for up to 3 months1
Tendinopathy
Clinically important benefit - therapeutic US for calcific shoulder tendinopathy2
Lack of evidence – “thermotherapy, therapeutic exercise, massage, transcutaneous electrical
stimulation and other forms of electrical stimulation, mechanical traction, combined
rehabilitation approaches”2
No recommendations – manipulation/mobilization alone or in combination with other
interventions2
Fibromyalgia
Fibromyalgia syndrome “is not a peripheral disorder of the soft tissues, but rather a disorder of
aberrant pain processing and central sensitization”3
Strong evidence – low-dose antidepressants; light aerobic exercise and Cognitive Behavioral
Treatment (CBT)3
Moderate evidence – massage, muscle strength training, acupuncture and spa therapy
(balneotherapy)3
Limited evidence – spinal manipulation; movement/body awareness; and vitamins, herbs and
dietary modifications3
“No single therapy or intervention that can be considered a cure”3
Combination of therapies is most helpful3
More research is necessary3
References
1. Vernon H, Schneider M. Chiropractic management of myofascial trigger points and myofascial pain syndrome: a
systematic review of the literature. J Manipulative Physiol Ther. Jan 2009;32(1):14-24.
2. Pfefer MT, Cooper SR, Uhl NL. Chiropractic management of tendinopathy: a literature synthesis. J Manipulative
Physiol Ther. Jan 2009;32(1):41-52.
3. Schneider M, Vernon H, Ko G, Lawson G, Perera J. Chiropractic management of fibromyalgia syndrome: a
systematic review of the literature. J Manipulative Physiol Ther. Jan 2009;32(1):25-40.
Rapid Response
Resource Center
http://clinicalcompass.org/resources/rapid-response-resource-center
CCGPP
Logan University
Michigan Chiropractic Association
Updated June 2014
Spinal manipulative therapy for chronic low-back pain
(Review)
Rubinstein SM, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2011, Issue 2
http://www.thecochranelibrary.com
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 2.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 3.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 4.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 5.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 6.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 7.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 8.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ADDITIONAL SUMMARY OF FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACKNOWLEDGEMENTS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 SMT vs. inert interventions, Outcome 1 Pain. . . . . . . . . . . . . . . .
Analysis 1.2. Comparison 1 SMT vs. inert interventions, Outcome 2 Perceived recovery. . . . . . . . . . .
Analysis 1.3. Comparison 1 SMT vs. inert interventions, Outcome 3 Return to work. . . . . . . . . . . .
Analysis 2.1. Comparison 2 SMT vs. sham SMT, Outcome 1 Pain. . . . . . . . . . . . . . . . . .
Analysis 2.2. Comparison 2 SMT vs. sham SMT, Outcome 2 Functional status. . . . . . . . . . . . . .
Analysis 3.1. Comparison 3 SMT vs. any other intervention, Outcome 1 Pain. . . . . . . . . . . . . .
Analysis 3.2. Comparison 3 SMT vs. any other intervention, Outcome 2 Functional status. . . . . . . . . .
Analysis 3.3. Comparison 3 SMT vs. any other intervention, Outcome 3 Perceived recovery. . . . . . . . . .
Analysis 3.4. Comparison 3 SMT vs. any other intervention, Outcome 4 Return to work. . . . . . . . . . .
Analysis 3.5. Comparison 3 SMT vs. any other intervention, Outcome 5 Health-related Quality of Life. . . . . .
Analysis 4.1. Comparison 4 Subset of comparison 3. SMT vs. ineffective interventions, Outcome 1 Pain. . . . .
Analysis 4.2. Comparison 4 Subset of comparison 3. SMT vs. ineffective interventions, Outcome 2 Functional status.
Analysis 4.3. Comparison 4 Subset of comparison 3. SMT vs. ineffective interventions, Outcome 3 Perceived recovery.
Analysis 4.4. Comparison 4 Subset of comparison 3. SMT vs. ineffective interventions, Outcome 4 Return to work.
Analysis 5.1. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 1 Pain. . . . . .
Analysis 5.2. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 2 Functional status. .
Analysis 5.3. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 3 Perceived recovery.
Analysis 5.4. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 4 Return to work. .
Analysis 5.5. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 5 Health-related Quality of
Life. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 6.1. Comparison 6 SMT + intervention vs. intervention alone, Outcome 1 Pain. . . . . . . . . . .
Analysis 6.2. Comparison 6 SMT + intervention vs. intervention alone, Outcome 2 Functional status. . . . . .
Analysis 6.3. Comparison 6 SMT + intervention vs. intervention alone, Outcome 3 Perceived recovery. . . . . .
Analysis 7.1. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only, Outcome
1 Pain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 7.2. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only, Outcome
2 Functional status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Analysis 7.3. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only, Outcome
3 Perceived recovery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 7.4. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only, Outcome
4 Return to work. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 7.5. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only, Outcome
5 Health-related Quality of Life. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 8.1. Comparison 8 Subset of comparisons 1, 2 & 3. SMT vs. ineffective/sham/inert interventions, Outcome 1
Pain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 8.2. Comparison 8 Subset of comparisons 1, 2 & 3. SMT vs. ineffective/sham/inert interventions, Outcome 2
Functional status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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[Intervention Review]
Spinal manipulative therapy for chronic low-back pain
Sidney M Rubinstein1 , Marienke van Middelkoop2 , Willem JJ Assendelft3 , Michiel R de Boer4 , Maurits W van Tulder5
1
Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center,
Amsterdam, Netherlands. 2 Department of General Practice, Erasmus Medical Center, Rotterdam, Netherlands. 3 Department of Public
Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands. 4 Institute of Health Sciences, Faculty of Earth and
Life Sciences, VU University Medical Center, Amsterdam, Netherlands. 5 Department of Health Sciences, Faculty of Earth and Life
Sciences, VU University, Amsterdam, Netherlands
Contact address: Sidney M Rubinstein, Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research,
VU University Medical Center, PO Box 7057, Room D518, Amsterdam, 1007 MB, Netherlands. [email protected].
Editorial group: Cochrane Back Group.
Publication status and date: New, published in Issue 2, 2011.
Review content assessed as up-to-date: 4 December 2009.
Citation: Rubinstein SM, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW. Spinal manipulative
therapy for chronic low-back pain. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD008112. DOI:
10.1002/14651858.CD008112.pub2.
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
Background
Many therapies exist for the treatment of low-back pain including spinal manipulative therapy (SMT), which is a worldwide, extensively
practiced intervention.
Objectives
To assess the effects of SMT for chronic low-back pain.
Search strategy
An updated search was conducted by an experienced librarian to June 2009 for randomised controlled trials (RCTs) in CENTRAL
(The Cochrane Library 2009, issue 2), MEDLINE, EMBASE, CINAHL, PEDro, and the Index to Chiropractic Literature.
Selection criteria
RCTs which examined the effectiveness of spinal manipulation or mobilisation in adults with chronic low-back pain were included.
No restrictions were placed on the setting or type of pain; studies which exclusively examined sciatica were excluded. The primary
outcomes were pain, functional status and perceived recovery. Secondary outcomes were return-to-work and quality of life.
Data collection and analysis
Two review authors independently conducted the study selection, risk of bias assessment and data extraction. GRADE was used to
assess the quality of the evidence. Sensitivity analyses and investigation of heterogeneity were performed, where possible, for the metaanalyses.
Spinal manipulative therapy for chronic low-back pain (Review)
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Main results
We included 26 RCTs (total participants = 6070), nine of which had a low risk of bias. Approximately two-thirds of the included
studies (N = 18) were not evaluated in the previous review. In general, there is high quality evidence that SMT has a small, statistically
significant but not clinically relevant, short-term effect on pain relief (MD: -4.16, 95% CI -6.97 to -1.36) and functional status (SMD:
-0.22, 95% CI -0.36 to -0.07) compared to other interventions. Sensitivity analyses confirmed the robustness of these findings. There
is varying quality of evidence (ranging from low to high) that SMT has a statistically significant short-term effect on pain relief and
functional status when added to another intervention. There is very low quality evidence that SMT is not statistically significantly
more effective than inert interventions or sham SMT for short-term pain relief or functional status. Data were particularly sparse for
recovery, return-to-work, quality of life, and costs of care. No serious complications were observed with SMT.
Authors’ conclusions
High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and
improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Further research
is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and
data related to recovery.
PLAIN LANGUAGE SUMMARY
Spinal manipulative therapy for chronic low-back pain
Spinal manipulative therapy (SMT) is an intervention that is widely practiced by a variety of health care professionals worldwide. The
effectiveness of this form of therapy for the management of chronic low-back pain has come under dispute.
Low-back pain is a common and disabling disorder, which represents a great burden to the individual and society. It often results in
reduced quality of life, time lost from work and substantial medical expense. In this review, chronic low-back pain is defined as low-back
pain lasting longer than 12 weeks. For this review, we only included cases of low-back pain that were not caused by known underlying
conditions, for example, infection, tumour, or fracture. We also included patients whose pain was predominantly in the lower back,
but may also have radiated (spread) into the buttocks and legs.
SMT is known as a “hands-on” treatment of the spine, which includes both manipulation and mobilisation. In manual mobilisations,
the therapist moves the patient’s spine within their range of motion. They use slow, passive movements, starting with a small range and
gradually increasing to a larger range of motion. Manipulation is a passive technique where the therapist applies a specifically directed
manual impulse, or thrust, to a joint, at or near the end of the passive (or physiological) range of motion. This is often accompanied
by an audible ‘crack’.
In this updated review, we identified 26 randomised controlled trials (represented by 6070 participants) that assessed the effects of
SMT in patients with chronic low-back pain. Treatment was delivered by a variety of practitioners, including chiropractors, manual
therapists and osteopaths. Only nine trials were considered to have a low risk of bias. In other words, results in which we could put
some confidence.
The results of this review demonstrate that SMT appears to be as effective as other common therapies prescribed for chronic low-back
pain, such as, exercise therapy, standard medical care or physiotherapy. However, it is less clear how it compares to inert interventions
or sham (placebo) treatment because there are only a few studies, typically with a high risk of bias, which investigated these factors.
Approximately two-thirds of the studies had a high risk of bias, which means we cannot be completely confident with their results.
Furthermore, no serious complications were observed with SMT.
In summary, SMT appears to be no better or worse than other existing therapies for patients with chronic low-back pain.
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]
Spinal manipulative therapy compared to inert interventions for chronic low-back pain
Patient or population: patients with chronic low-back pain
Settings: Rather diverse
Intervention: spinal manipulative therapy
Comparison: inert interventions
Outcomes
Illustrative comparative risks* (95% CI)
Assumed risk
Corresponding risk
inert interventions
spinal
therapy
Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
manipulative
Pain
The mean pain in the conVAS. Scale from 0-100 trol groups was
(worse pain). Follow-up: 27 points
1 month
The mean Pain in the intervention groups was
6.00 lower
(15.82 lower to 3.82
higher)
72
(1 study)
⊕
very low1,2,3
Pain
The mean pain in the conVAS. Scale from 0-100 trol groups was
(worse pain). Follow-up: 6 points
3 months
The mean Pain in the intervention groups was
7.00 higher
(3.58 lower to 17.58
higher)
70
(1 study)
⊕
very low1,2,3
72
(1 study)
⊕
very low1,2,4
Recovery at 1 month
Study population
273 per 1000
Medium risk population
RR 1.03
(0.49 to 2.19)
281 per 1000
(134 to 598)
Comments
3
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Recovery at 3 months
Study population
438 per 1000
RR 0.96
(0.56 to 1.65)
70
(1 study)
⊕
very low1,2,4
420 per 1000
(245 to 723)
Medium risk population
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the
assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1
2
3
4
High risk of bias
Less than 400 subjects, total.
Effect includes the possibility of better or worse pain relief with SMT.
Effect includes the possibility of better or worse chance of recovery with SMT.
4
BACKGROUND
Low-back pain is a common and disabling disorder in western society, which represents a great financial burden in the form of direct costs resulting from loss of work and medical expenses, as well
as indirect costs (Dagenais 2008). Therefore, adequate treatment
of low-back pain is an important issue for patients, treating clinicians, and healthcare policy makers. Spinal manipulative therapy
(SMT) is widely used for acute and chronic low-back pain, which
has been examined in many randomised controlled trials (RCTs).
These trials have been summarized in numerous recent systematic reviews (Brønfort 2004a; Brown 2007; Brox 1999; Cherkin
2003), which have formed the basis for recommendations in clinical guidelines (Airaksinen 2006; Chou 2007; Manchikanti 2003;
Staal 2003; van Tulder 2006; Waddell 2001). Most notably, these
guidelines are largely dependent upon an earlier version of this
Cochrane review (Assendelft 2003; Assendelft 2004). That review
concluded that SMT was moderately superior to sham manipulation and therapies thought to be ineffective or harmful for acute
or chronic low-back pain; however, the effect sizes were small and
arguably not clinically relevant. Furthermore, SMT was found to
be no more effective than other standard therapies (e.g. general
practitioner care, analgesics, exercise, or back schools) for short
or long-term pain relief or functional improvement for acute or
chronic low-back pain.
Recommendations regarding SMT vary across national guidelines
on the management of back pain (Koes 2001; van Tulder 2004).
For example, SMT is considered to be a therapeutic option in the
acute phase of low-back pain in many countries, while in other
countries, such as the Netherlands, Australia, and Israel, it is not
recommended (Koes 2001). Similarly, SMT is considered to be a
useful option in the subacute or chronic phase in the Danish and
Dutch guidelines, but is either not recommended or is absent in
the other national guidelines.
The purpose of this review is to update the previous Cochrane review, using the most recent guidelines developed by the Cochrane
Collaboration in general (Handbook 5 2008) and by the Cochrane
Back Review Group in particular (Furlan 2009). In contrast to the
previous Cochrane review, the review has been split into two parts
by duration of the complaint, namely acute (Rubinstein 2010)
and chronic low-back pain. The present review reports on chronic
low-back pain only, based on the published protocol (Rubinstein
2009).
Description of the condition
Low-back pain is defined as pain and discomfort, localised below the costal margin and above the inferior gluteal folds, with
or without referred leg pain. Chronic low-back pain is typically
defined as pain persisting for more than 12 weeks (Spitzer 1987).
Non-specific low-back pain is further defined as low-back pain
not attributed to a recognizable, known specific pathology (e.g.
infection, tumour, fracture or radicular syndrome).
Description of the intervention
SMT is considered here as any “hands-on” treatment, including
both manipulation and mobilisation of the spine (Assendelft 2003;
Assendelft 2004). Mobilisations use low-grade velocity, small or
large amplitude passive movement techniques within the patient’s
range of motion and control. Manipulation, on the other hand,
uses a high velocity impulse or thrust applied to a synovial joint
over a short amplitude at or near the end of the passive or physiologic range of motion, which is often accompanied by an audible
“crack” (Sandoz 1969). The cracking sound is caused by cavitation
of the joint, which is a term used to describe the formation and
activity of bubbles within the fluid (Evans 2002; Unsworth 1971).
Various practitioners, including chiropractors, manual therapists
(physiotherapists trained in manipulative techniques), orthomanual therapists (medical doctors trained in manipulative techniques)
or osteopaths use this intervention in their practices. However, the
diagnostic techniques and philosophy of the various professions
differ. The focus of orthomanual medicine is on abnormal positions of the skeleton and symmetry in the spine, while manual
therapy focuses on functional disorders of the musculoskeletal system, and chiropractic focuses on the musculoskeletal and nervous
systems in relation to the general health of the patient (van de
Veen 2005).
How the intervention might work
Many hypotheses exist regarding the mechanism of action for
spinal manipulation and mobilization (Brønfort 2008; Khalsa
2006; Pickar 2002), and some have postulated that given their theoretically different mechanisms of action, mobilisation and manipulation should be assessed as separate entities (Evans 2002). The
modes of action might be roughly divided into mechanical and
neurophysiologic. The mechanistic approach suggests that SMT
acts on a manipulable lesion (often called the functional spinal
lesion or subluxation) which proposes that forces to reduce internal mechanical stresses will result in reduced symptoms (Triano
2001). However, given the non-nociceptive behaviour of chronic
low-back pain, a purely mechanistic theory alone cannot explain
clinical improvement (Evans 2002). Much of the literature focuses
on the influence on the neurological system, where it is suggested
that spinal manipulation therapy impacts the primary afferent neurons from paraspinal tissues, the motor control system and pain
processing (Pickar 2002), although the actual mechanism remains
debatable (Evans 2002; Khalsa 2006).
Why it is important to do this review
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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SMT is a worldwide, extensively practiced intervention provided
by a variety of professions. However, the efficacy of this therapy
for chronic low-back pain is not without dispute. This review,
with its comprehensive and rigorous methodology, is thought to
provide better insight into this problem. Although numerous systematic reviews have examined the efficacy of SMT for low-back
pain (Airaksinen 2006; Chou 2007), very few have conducted a
meta-analysis, especially for chronic low-back pain. Also, many of
the reviews were narrative rather than systematic and the results
were not consistent (Assendelft 1998). The previous version of the
Cochrane review was published in 2004 and since then many new
trials have been published, including some with large numbers of
participants. In addition, the methodology of systematic reviews
has recently been updated (Handbook 5 2008), as well as the specific guidelines for reviews of back and neck pain (Furlan 2009).
OBJECTIVES
The objective of this review was to examine the effectiveness of
SMT on pain, functional status and recovery at the short-, intermediate- and long-term follow-up measurements as compared to
control treatments (e.g. no treatment, sham and all other treatments) for adults with chronic low-back pain.
METHODS
Criteria for considering studies for this review
Types of studies
Only randomised studies were included. Studies using an inadequate randomisation procedure (e.g. alternate allocation, allocation based upon birth date) were excluded.
Types of participants
Inclusion criteria
• Adult participants (> 18 years of age) with low-back pain
with a mean duration for the current episode (for the study
population) longer than 12 weeks, meaning more than 50% of
the study population had pain that had lasted longer than three
months.
• Studies with patients from primary, secondary or tertiary
care
• Patients with or without radiating pain
Exclusion criteria
Subjects with:
• Post-partum low-back pain or pelvic pain due to pregnancy
• Pain not related to the low-back, e.g. coccydynia
• Post-operative studies or subjects with “failed-back
syndrome”
or studies which
• Examined “maintenance care“ or prevention
• Were designed to test the immediate post-intervention
effect of a single treatment only, with no additional follow-up
(because we were interested in the effect of SMT beyond one
day).
• Exclusively examined specific pathologies, e.g. sciatica.
Note: Studies of sciatica were excluded because it has been
identified by many as a prognostic factor associated with a poor
outcome (Bouter 1998; Brønfort 2004b), especially with SMT
(Axen 2005; Malmqvist 2008). Sciatica was defined here as
radiating pain following the sciatic distribution and exhibiting
signs of a radiculopathy.
Types of interventions
Experimental intervention
The experimental intervention examined in this review includes
both spinal manipulation and mobilisation for chronic low-back
pain. Unless otherwise indicated, SMT refers to both ”hands-on“
treatments.
Types of comparison
Studies were included for consideration if the study design used
suggested that the observed differences were due to the unique
contribution of SMT. This excludes studies with a multi-modal
treatment as one of the interventions (e.g. standard physician care
+ spinal manipulation + exercise therapy) and a different type of
intervention or only one intervention from the multi-modal therapy as the comparison (e.g. standard physician care alone), thus
rendering it impossible to decipher the effect of SMT. However,
studies comparing SMT in addition to another intervention compared to that same intervention alone were included.
Comparison therapies were combined into the following main
clusters:
1) SMT versus inert interventions
2) SMT versus sham SMT
3) SMT versus all other interventions
4) SMT in addition to any intervention versus that intervention
alone
Inert interventions included, for example, detuned diathermy and
detuned ultrasound. ”All other interventions“ included both presumed effective and ineffective interventions for treatment of
chronic low-back pain. Determination of what interventions were
Spinal manipulative therapy for chronic low-back pain (Review)
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6
considered ineffective and effective was based upon the literature
and our interpretation of those results (Airaksinen 2006; Chou
2007).
Types of outcome measures
Only patient-reported outcome measures were evaluated. Physiological measures, such as spinal flexibility or degrees achieved
with a straight leg raise test (i.e. Lasègue sign) were not considered
clinically-relevant outcomes and were not included.
Primary outcomes
Searching other resources
In addition to the aforementioned, we also 1) screened the reference lists of all included studies and systematic reviews pertinent
to this topic; and 2) searched the main electronic sources of ongoing trials (National Research Register, meta-Register of Controlled
Trials; Clinical Trials).
Data collection and analysis
Selection of studies
• pain expressed on a self-reported scale (e.g. visual analogue
scale (VAS), numerical rating scale (NRS))
• functional status expressed on a back-pain specific scale
(e.g. Roland-Morris Disability Questionnaire, Oswestry
Disability Index)
• global improvement or perceived recovery (recovered is
defined as the number of patients reported to be recovered or
nearly recovered)
Two review authors with a background in chiropractic (SMR) and
movement science (MvM) independently screened the titles and
abstracts from the search results. Potentially relevant studies were
obtained in full text and independently assessed for inclusion. Disagreements were resolved through discussion. A third review author (MWvT) was contacted if an arbiter was necessary. Only full
papers were evaluated. Abstracts and proceedings from congresses
or any other ”grey literature“ were excluded. There were no language restrictions.
Secondary outcomes
Data extraction and management
• health-related quality of life (e.g. SF-36 (as measured by the
general health sub-scale), EuroQol, general health (e.g. as
measured on a VAS scale) or similarly validated index)
• return-to-work
A standardised form was used to extract data from the included
papers. The following data were extracted: study design (RCT),
study characteristics (e.g. country where the study was conducted,
recruitment modality, source of funding, risk of bias), patient characteristics (e.g. number of participants, age, gender), description
of the experimental and control interventions, co-interventions,
duration of follow-up, types of outcomes assessed, and the authors’
results and conclusions. Data were extracted independently by the
same two review authors who conducted the selection of studies.
Any disagreements were discussed and an arbiter (MWvT) consulted when necessary. Key findings were summarized in a narrative format. Data relating to the primary outcomes were assessed
for inclusion in the meta-analyses and final value scores (means
and standard deviations) were extracted. Change scores were converted to a mean value for the respective follow-up measurement.
Outcomes were assessed at one, three, six and twelve months and
data included according to the time closest to these intervals. Only
one study examined data beyond 12 months (Goldby 2006).
Search methods for identification of studies
Electronic searches
We identified RCTs and systematic reviews by electronically
searching the following databases:
• CENTRAL (The Cochrane Library 2009, issue 2)
(Appendix 1)
• MEDLINE from Jan. 2000- June 2009 (Appendix 2)
• EMBASE from Jan. 2000- June 2009 (Appendix 3)
• CINAHL from Jan. 2000- June 2009 (Appendix 4)
• PEDro up to June 2009
• Index to Chiropractic Literature up to June 2009
The search strategy developed by the Cochrane Back Review
Group was followed, using free text words and MeSH headings
(Furlan 2009). A search was not conducted for studies published
before 2000 because they were included in the previous Cochrane
review (Assendelft 2003; Assendelft 2004).
Assessment of risk of bias in included studies
The risk of bias (RoB) assessment for RCTs was conducted using the twelve criteria recommended by the Cochrane Back Review Group and evaluated independently by same two review authors mentioned above (SMR, MvM). These criteria are standard for evaluating effectiveness of interventions for low-back pain
(Appendix 5; Furlan 2009). The criteria were scored as ”yes“, ”no“
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7
or ”unclear“ and reported in the Risk of Bias table. Any disagreements between the review authors were resolved by discussion, including input from a third independent review author (MWvT).
In virtually all cases, an attempt was made to contact authors for
clarification of methodological issues if the information was unclear. A study with a low RoB was defined as one fulfilling six or
more of the criteria items, which is supported by empirical evidence (van Tulder 2009), and with no fatal flaw, which is defined
as those studies with 1) a drop-out rate greater than 50% at the
first and subsequent follow-up measurements; or 2) statistically
and clinically-relevant important baseline differences for one or
more primary outcomes (i.e. pain, functional status) indicating
unsuccessful randomisation. Quantitative data from studies with
a fatal flaw were excluded from the meta-analyses (see risk of bias
in the included studies). Since the review authors were already familiar with the literature, they were not blinded to authors of the
individual studies, institution or journal.
Blinding the patient and practitioner to treatment allocation is
nearly impossible in trials of SMT. Given that the primary outcomes assessed in this review are all subjective measures (i.e. pain,
functional status, perceived recovery), any attempt to blind the
outcome assessor was considered irrelevant because the patient is
viewed to be the outcome assessor when evaluating subjective measures. Therefore, if the patient is not blinded, the outcome assessor was also considered not blinded. However, to drop these items
from the assessment is to negate the observation that “blinding”
of research personnel and participants provides less biased data.
Measures of treatment effect
Treatment effect was examined through meta-analyses, but these
were only conducted if studies were thought to be clinically homogenous. Clinical homogeneity was defined a priori by setting,
population and comparison group. A mean difference (MD) was
calculated for pain and when necessary, VAS or NRS scales were
converted to a 100-point scale. Other scales were allowed if it
was thought that the construct measured was consistent with the
outcome being evaluated. For functional status, a standardized
mean difference (SMD) was calculated because many different instruments were used (e.g. Roland-Morris Disability Questionnaire
(RMDQ), Oswestry Disability Index (ODI), disability sub-scale
of the von Korff scale, Disability Rating Index (DRI)). A negative
effect size indicates that SMT is more beneficial than the comparison therapy, meaning subjects have less pain and better functional
status. Quality of life was analysed by a standardized mean difference. Where necessary, scores were transformed, so that a higher
score indicates a better outcome, which is how this was typically
measured; therefore, a negative effect size indicates that the contrast therapy is more beneficial. For dichotomous outcomes (i.e.
recovery, return-to-work), a risk ratio (RR) was calculated and the
event defined as the number of subjects recovered or returnedto-work. A positive RR indicates that SMT results in a greater
chance of recovery or return-to-work. A random-effects model was
used for all analyses because a substantial amount of heterogeneity
remained unexplained by the subgroup and sensitivity analyses.
Funnel plots were only examined for publication bias for the comparison, SMT versus all other interventions, due to the fact that the
other comparisons included too few studies. For each treatment
comparison, an effect size and a 95% confidence interval (CI) were
calculated. All analyses were conducted in Review Manager 5.0.
Assessment of clinical relevance. The determination of clinical relevance was evaluated by one question, ”Is the size of the effect
clinically relevant?“. Levels of clinical relevance were defined as:
1) Small: MD < 10% of the scale (e.g. < 10 mm on a 100-mm
VAS); SMD or “d” scores < 0.2; Relative risk, < 1.25 or > 0.8; 2)
Medium: MD 10% to 20% of the scale, SMD or “d” scores = 0.5,
Relative risk between 1.25 to 2.0 or 0.5 to 0.8; 3) Large: MD >
20% of the scale, SMD or “d” scores ≥ 0.8, Relative risks > 2.0
or < 0.5 (Cohen 1988; Handbook 5 2008).
Unit of analysis issues
We attempted to combine data in studies with multiple comparisons where it was thought that similar contrasts were used and
the outcomes were thought to be clinically similar. This was conducted for one study (Ferreira 2007), which included two similar forms of exercise as the contrast to SMT, general exercise and
motor control exercise. In all other cases, when multiple contrasts
were examined in the same comparison (e.g. SMT versus physiotherapy versus standard medical care), the number of subjects in
the shared comparison, SMT, were halved. This step corrects for
error introduced by ”double-counting“ of subjects for the ”shared
comparison“ in the meta-analyses. Another study presented data
from a cross-over trial (Evans 1978), in which case, data were presented prior to the crossover of the intervention.
Dealing with missing data
In cases where data were reported as a median and interquartile
range (IQR), it was assumed that the median was equivalent to
the mean and the width of the IQR equivalent to 1.35 times
the standard deviation (Handbook 5 2008, section 7.7.3.5). In
one study (Gibson 1985), a range was presented along with the
median instead of a IQR, in which case, the standard deviation
was estimated to be one-quarter of the range, although we recognize that this method is not robust and potentially subject to
error Handbook 5 2008, section 7.7.3.6). In another study (Koes
1992), data were presented together for neck and low-back pain.
A subsequent stratified analysis had been performed for the lowback pain data, but was no longer available. However, we were
able to extract the results from a recent systematic review (Brønfort
2008), which presented these data as between-group differences.
Where data were reported in a graph and not in a table, the means
and standard deviations were estimated. When standard deviations
were not reported, an attempt was made to contact the author. In
the absence of additional information, these were calculated from
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
8
the confidence intervals, where possible. If the standard deviation
for follow-up measurements was missing, its baseline measure was
used for the subsequent follow-ups. Finally, if no measure of variation was reported anywhere in the text, the standard deviation
was estimated based upon other studies with a similar population
and RoB.
Assessment of heterogeneity
Heterogeneity was explored in two manners, informally by vision
(eye-ball test) and formally tested by the Q-test (chi-square) and
I²; however, the decision regarding heterogeneity was dependent
upon the I² (Handbook 5 2008). Substantial heterogeneity is defined as > 50%, and where necessary, the effect of the interventions
are described if the results are too heterogenous.
Data synthesis
The overall quality of the evidence and strength of recommendations was evaluated using GRADE (Guyatt 2008). The quality of
the evidence for a specific outcome was based upon performance
against five principal domains: 1) limitations in design (downgraded when > 25% of the participants were from studies with a
high RoB), 2) inconsistency of results (downgraded in the presence of significant statistical heterogeneity (I² > 50%) and inconsistent findings (in the presence of widely differing estimates of the
treatment effect, that is, individual studies favouring either the intervention or control group)), 3) indirectness (i.e. generalisability
of the findings; downgraded when > 50% of the participants were
outside the target group, for example, studies which exclusively
examined older subjects or included inexperienced treating physicians), 4) imprecision (downgraded when the total number of participants was less than 400 for each continuous outcome and 300
for dichotomous outcomes) and 5) other (e.g. publication bias).
Single studies (N < 400 for continuous outcomes,< 300 for dichotomous outcomes) were considered inconsistent and imprecise
and provide “low quality evidence”, which could be further downgraded to ”very low quality evidence“ if there were also limitations
in design or indirectness. Summary of Findings tables were generated for the primary analyses and for the primary outcome measures only, regardless of statistical heterogeneity, but when present,
this was noted. The quality of the evidence is described as:
High quality: Further research is very unlikely to change our confidence in the estimate of effect. There are sufficient data with
narrow confidence intervals. There are no known or suspected reporting biases.
Moderate quality: Further research is likely to have an important
impact on confidence in the estimate of effect and may change the
estimate; one of the domains is not met.
Low quality: Further research is very likely to have an important
impact on confidence in the estimate of effect and is likely to
change the estimate; two of the domains are not met
Very low quality: Great uncertainty about the estimate; three of the
domains are not met.
No evidence: No evidence from RCTs.
Subgroup analysis and investigation of heterogeneity
Regardless of possible heterogeneity of the included studies, the
following stratified analyses were conducted: 1) By control groups
as defined in Types of intervention (see Types of comparisons); and 2)
by time, that is, short-term (closest to one to three months), intermediate (closest to six months) and long-term follow-up (closest
to 12 months).
Sensitivity analysis
The following sensitivity analyses were planned a priori and conducted in order to explain possible sources of heterogeneity between studies: 1) for RoB; 2) for studies with an adequate allocation procedure; 3) by duration of the low-back pain (studies
which included subacute and chronic versus studies of exclusively
chronic low-back pain); 4) by type of technique (high-velocity low
amplitude manipulation); 5) by type of manipulator (chiropractor
versus manual therapist or physiotherapist); and 6) by type of comparison therapy ((presumed ineffective therapies (e.g. diathermy,
ultrasound, single counselling session with advice on back pain)
and presumed effective therapies (e.g. exercise, standard medical
care, physiotherapy)). In addition, a specific type of contrast (i.e.
exercise therapy) was examined posteriori because it was thought
to be an important contrast, but not earlier defined in the protocol. Summary forest plots were constructed in STATA v.10, which
depict these results.
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of
excluded studies; Characteristics of studies awaiting classification;
Characteristics of ongoing studies.
See Characteristics of included studies; Characteristics of excluded
studies; Characteristics of ongoing studies.
Results of the search
Since the publication of the previous review, 18 new trials were
identified which fulfilled the inclusion criteria (Chown 2008;
Ferreira 2007; Ghroubi 2007; Goldby 2006; Gudavalli 2006;
Hondras 2009; Hsieh 2002; Hurwitz 2002; Licciardone 2003;
Mohseni-Bandpei 2006; Muller 2005; Paatelma 2008; Rasmussen
2008; Rasmussen-Barr 2003; Skillgate 2007; UK BEAM trial
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9
2004; Wilkey 2008; Zaproudina 2009, thus this review represents
a majority of studies published in the past decade. Eight trials
from the previous review are included (Brønfort 1996; Evans
1978; Gibson 1985; Koes 1992; Pope 1994; Postacchini 1988;
Waagen 1986), one of which recently published long-term results
(Hemmila 2002) Figure 1.
Figure 1. Summary of selection process. Spinal manipulative therapy for chronic low-back pain.
The countries in which the studies were conducted varied, but
were largely limited to North America and Europe. Eight studies were conducted in the USA (Brønfort 1996; Gudavalli 2006;
Hondras 2009; Hsieh 2002; Hurwitz 2002; Licciardone 2003;
Pope 1994; Waagen 1986), seven studies in the UK (Chown 2008;
Evans 1978; Gibson 1985; Goldby 2006; Mohseni-Bandpei 2006;
UK BEAM trial 2004; Wilkey 2008), five in Finland (Hemmila
2002; Paatelma 2008; Rasmussen-Barr 2003; Skillgate 2007;
Zaproudina 2009), two in Australia (Ferreira 2007; Muller 2005),
one in Denmark (Rasmussen 2008), one in Italy (Postacchini
1988), one in the Netherlands (Koes 1992) and one in Tunesia
(Ghroubi 2007). All trials were published in English except the
trial conducted in Tunesia, which was published in French.
Included studies
In total, 6070 patients were examined in the trials. Study sample
sizes ranged from 29 to 1,334 (median (IQR) = 149 (86 to 244).
Types of studies. In total, four studies were identified which compared SMT to a placebo in the form of an anti-oedema gel spread
over the lumbar region (Postacchini 1988) or other inert interventions (i.e. detuned short-wave diathermy (Gibson 1985); detuned ultrasound (Koes 1992); corset and transcutaneous muscle
stimulation (Pope 1994)); three studies which compared SMT to
sham SMT (Ghroubi 2007; Licciardone 2003; Waagen 1986); 21
studies which compared SMT to any other intervention - both
presumed effective or ineffective (i.e. acupuncture (Muller 2005),
back school (Hsieh 2002; Postacchini 1988), educational back
booklet with or without additional counselling (Goldby 2006;
Paatelma 2008), exercise therapy (Brønfort 1996; Chown 2008;
Ferreira 2007; Goldby 2006; Gudavalli 2006; Hemmila 2002;
Paatelma 2008; Rasmussen-Barr 2003; UK BEAM trial 2004),
myofascial therapy (Hsieh 2002), massage (Pope 1994), pain clinic
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10
(Wilkey 2008), pharmaceutical/analgesic therapy only (Muller
2005; Postacchini 1988), short-wave diathermy (Gibson 1985),
standard medical care, consisting of among other things, analgesic
therapy and advice/reassurance (Hondras 2009; Hurwitz 2002;
Koes 1992; Skillgate 2007), standard physiotherapy (Hemmila
2002; Hurwitz 2002; Koes 1992; Postacchini 1988; Zaproudina
2009), and ultrasound (Mohseni-Bandpei 2006)); and five studies which compared SMT plus another intervention to the intervention alone (i.e. analgesic therapy (Evans 1978), exercise
(Rasmussen 2008), myofascial therapy (Hsieh 2002), standard
medical care and in combination with exercise (UK BEAM trial
2004) and usual care (Licciardone 2003)).
Study population. The included studies represent a rather heterogenous population with regard to duration of pain, presence
or absence of radiating pain, and distribution of age (Table 1).
Most studies included middle-aged subjects with or without radiating pain. One study included subjects over 55 years (Hondras
2009), and two studies included subjects without radiating pain
(Ghroubi 2007; Muller 2005). However, in a number of studies it
was not clear if subjects with radiating pain were included or not
(Gibson 1985; Goldby 2006; Mohseni-Bandpei 2006; Skillgate
2007; Waagen 1986). Relatively few studies examined exclusively
chronic low-back pain (that is, an inclusion criteria which specified that the symptoms must have been present for three months
or longer) (Chown 2008; Ferreira 2007; Goldby 2006; Gudavalli
2006; Licciardone 2003; Mohseni-Bandpei 2006; Muller 2005;
Rasmussen 2008; Wilkey 2008); however, most studies indicated
that patients had a current episode of low-back pain consisting of
months to years.
Table 1. Specific clinical and treatment characteristics of the included studies
Author
Type radiating Duration LBP: Duration LBP:
pain
According to in- Current episode
clusion criteria for the population
Type manipula- Type manipulator
tion
(N=number of
manipulators)
Max.
no. tx’s SMT allowed and duration
Brønfort 1996
With or without > 6 wks
radiation to one
or both legs to
the knee
median: 2.5 yrs
Chiropractor (N Manipulation
= 5)
10 over 5 wks
Chown 2008
Without radia- > 3 mo
tion
unclear
Osteopathy & Manipulative therapy (N =
?)
Evans 1978
With or without > 3 wks
femoral or sciatic
radiation
median: 10 mo
Medical manip- Manipulation
ulator (N = 1)
Ferreira 2007
With or without > 3 mo
75% > 1 year
Physical
MOB
12 over 8 wks
therapists (N = ? or manipulation;
)
Maitland
Ghroubi 2007
Without
> 6 mo
range: 16 to 19 Manual or phys- Unclear;
pre- 4 over 4 wks
mo
ical therapist? (N sumably manip= 1)
ulation?
Gibson 1985
unclear
> 2 mo to < 12 range: 4 to 4 ½ Osteopath (N = Manipulation
mo
mo
1)
and MOB
4 over 4 wks
Goldby 2006
unclear
> 3 mo
10 over 10 wks?
mean: 11.7 yrs
Manual
therapist (N = ?)
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Manipulation or 5 over 3 mo
MOB (depending upon grp. assignment)
Unclear
3 over 3 wks
11
Table 1. Specific clinical and treatment characteristics of the included studies
(Continued)
Gudavalli 2006
With or without > 3 mo
radiculopathy
unclear
Chiropractor (N MOB (flexion- 16 over 4 wks
= ?)
distraction)
Hemmila 2002
With or without > 7 wks
radiation below
knee
range: 6.8 to 7.5 Bone-setter (N = Primarily MOB? 10 over 6 wks
yrs
4)
No
Manipulation
Hondras 2009
Primarily (85%) > 4 wks
with or without
radiation to the
knee
range: 9.6
15.1 yrs
Hsieh 2002
With or with- > 3 wks to < 6 mo range: 10.7 to Chiropractor (N Manipulation
out leg pain, but
11.8 wks
= ?)
no neurological
signs
9 over 3 wks
Hurwitz 2002
With or without No restriction
leg pain
58% >3mo
Chiropractor (N Manipulation
= 4)
? - at discretion of
therapist
Koes 1992
With or without > 6 wks
radiation to the
knee
median: 1 yr
Manual
Manipulation
therapist (N = 7) and MOB
avg. 5 over 9 wks
Licciardone
2003
With or with- > 3 mo
out sciatica, but
no neurological
signs
range: 39% to Osteopath (N = ? Manipulation or 7 over 5 mo
63% > 1 yr
)
MOB
MohseniBandpei 2006
Unclear
> 3 mo
range: 31 to 56 Manual
Manipulation
mo
therapist (N = 1) (Maitland)
7 over 4 wks?
Muller 2005
Without
> 3 mo
range: 4 mo to 45 Chiropractor (N Manipulation
yrs
= 1?)
? - but equal per
therapy grp.
Paatelma 2008
With or without No restriction
sciatica
Pope 1994
Without sciatica
to Chiropractor (N Manipulation or 12 over 6 wks
= 4)
MOB (flexiondistraction)
(depending upon grp. assignment)
> 50% symp- Orthopedic
Manipulation or 7 over ? wks
toms > 3 mo
manual therapist MOB
mean: 6 tx’s/grp
(N = 1)
3 wks to 6 mo, 29% < 6 mo; Chiropractor (N Manipulation
preceded by 3 wk 35% between 6 = 5)
pain free episode mo to 2 yrs; 36%
> 2 years
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
3 or more sessions/wk for 3
wks
12
Table 1. Specific clinical and treatment characteristics of the included studies
Postacchini
1988
(Continued)
2 grps. = with Grp.C = > 9 wks Grp.C range: 9 Chiropractor (N Manipulation?
and without rato11 mo
= ?)
diation to knee
12 over 6 wks
Rasmussen 2008 With or without > 3 mo
radiation to the
knee
range: 8 to 17 mo Medical manip- Manipulation
ulator (N = 1?)
3 over 4 wks
Rasmussen-Barr
2003
With or without > 6 wks
radiation to the
knee
90% > 3 mo
6 over 6 wks
Skillgate 2007
Unclear
range: 72% to Naprapath (N = Manipulation or 6 over 6 wks
78% > 3 mo
8)
MOB
> 2 wks
UK BEAM trial (Primarily) with (Essentially) > 3 59% > 3mo
2004
or without radia- wks
tion to the knee
Waagen 1986
With or without
to the knee
Wilkey 2008
Zaproudina
2009
> 3 wks
Manual
therapist (N = ?)
MOB
ChiropracManipulation or 8 over 12 wks
tor, osteopath or MOB
physiotherapist
(N = 84)
range: 2.5 to 2.8 Chiropractor (N Manipulation
yrs
= ?)
6 over 2 wks
With or without >3 mo
radiation to the
legs
range: 0.5 to 20 Chiropractor (N Manipulation
yrs
= ?)
16 over 8 wks
With or without > 3 mo
radiation to the
legs
unclear
5 over 10 wks
Bone-setters (N MOB
= ?)
grp(s) = group(s); MOB = mobilization; wks = week(s); mo = month(s); yr = year(s); ? = unclear
Technique: type, practitioner, number and duration of treatment.
The type of technique, type of treating physician/therapist, and
number and duration of the treatments also varied. In ten studies, treatment was delivered by a chiropractor (Brønfort 1996;
Gudavalli 2006; Hondras 2009; Hsieh 2002; Hurwitz 2002;
Muller 2005; Pope 1994; Postacchini 1988; Waagen 1986; Wilkey
2008), in five, by a manual or physical therapist (Ferreira 2007;
Goldby 2006; Koes 1992; Mohseni-Bandpei 2006; RasmussenBarr 2003), in three, by an osteopath (Chown 2008; Gibson
1985; Licciardone 2003), in three, by a medical manipulator or
orthomanual therapist (Evans 1978; Paatelma 2008; Rasmussen
2008), in two, by a bone-setter (Hemmila 2002; Zaproudina
2009), in one, by a naprapath (Skillgate 2007), and in one, by a
number of different disciplines (UK BEAM trial 2004). In another
study, it was unclear what type of SMT treatment was delivered
and what the level or skill of the treating physicians was (Ghroubi
2007). In virtually all studies, treatment was delivered by a few
select experienced physicians/therapists, with the exception of the
UK BEAM study (UK BEAM trial 2004), where participants were
treated in the manipulative-arm of the study in 45 clinics by as
many as 84 practitioners of various professions. In another study,
treatment was delivered by a few select pre-doctoral osteopathic
manipulative medicine fellows, who could be considered inexperienced in manipulative treatments (Licciardone 2003).
The primary type of (thrust) technique used in the SMT arm
of the studies varied highly and was defined as a high-velocity
low-amplitude thrust (Brønfort 1996; Chown 2008; Hondras
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13
2009; Hsieh 2002; Hurwitz 2002; Licciardone 2003; Muller
2005; Paatelma 2008; Pope 1994; Rasmussen 2008; UK BEAM
trial 2004; Waagen 1986), Maitland mobilization (Ferreira 2007;
Mohseni-Bandpei 2006), mobilization consisting of flexion-distraction (Gudavalli 2006; Hondras 2009), unspecified mobilization (Hemmila 2002; Rasmussen-Barr 2003), unspecified rotational thrust technique (Evans 1978; Gibson 1985), unspecified
technique (Ghroubi 2007; Goldby 2006; Koes 1992; Postacchini
1988; Skillgate 2007; Zaproudina 2009) or allowed various types
of thrust and/or non-thrust techniques to be used within the study
(Wilkey 2008).
It is unclear how many treatments the participants received on average because studies did not typically report this. The maximum
number of treatments allowed by protocol was, on average, eight
(SD = 4; data from 24 studies). In other studies, this was at the
discretion of the therapist/physician and terminated sooner if the
patient recovered (Table 1). Similarly, the treatment period was
also quite varied. The duration of the treatment was protocolized
for, on average, seven weeks (SD = 4; data from 23 studies).
Outcome measures: types, timing. All but one study reported on
pain (Chown 2008). All studies measured this construct via a
VAS or NRS, with the exception of two (Skillgate 2007; UK
BEAM trial 2004), which used the pain sub-scale from the modified von Korff scale. Most studies reported back-pain specific
functional status, consisting of either the Roland-Morris Disability Questionnaire (Brønfort 1996; Ferreira 2007; Gudavalli 2006;
Hondras 2009; Hsieh 2002; Hurwitz 2002; Licciardone 2003;
Paatelma 2008;UK BEAM trial 2004; Wilkey 2008) or Oswestry
Disability Index (Chown 2008; Goldby 2006; Hemmila 2002;
Mohseni-Bandpei 2006; Muller 2005; Rasmussen-Barr 2003;
Zaproudina 2009); however, other scales were also used, such as the
modified von Korff scale (Skillgate 2007) (disability data presented
separately), Disability Rating Index (Rasmussen-Barr 2003) and a
four-point non-validated scale (Postacchini 1988). Slightly more
than one-third of the studies reported on some aspect of perceived
recovery (Brønfort 1996; Evans 1978; Ferreira 2007; Gibson
1985; Gudavalli 2006; Hondras 2009; Hurwitz 2002; Koes 1992;
Skillgate 2007; Zaproudina 2009); however, these data were not
always able to be extracted because it was expressed for example, as
a continuous variable (Ferreira 2007;Hondras 2009; Koes 1992)
or was not presented separately for the low back (Skillgate 2007).
Relatively few studies reported on the secondary outcomes, such
as return-to-work or aspects thereof, such as number of sick-leave
days (Brønfort 1996; Gibson 1985; Hemmila 2002; Hsieh 2002;
Licciardone 2003), costs associated with care (Gudavalli 2006;
Hemmila 2002; UK BEAM trial 2004), or health-related quality
of life (HRQoL) such as via the SF-36 (Gudavalli 2006; Hondras
2009; Hsieh 2002; Licciardone 2003; Muller 2005; UK BEAM
trial 2004), EuroQoL (Chown 2008; UK BEAM trial 2004),
HRQoL - 15D questionnaire (Zaproudina 2009), Nottingham
Health Profile (Goldby 2006), general health status (expressed on
a 10 cm VAS scale) (Rasmussen-Barr 2003) and other (Dartmouth
Primary Care Cooperative Information Project chart system (i.e.
COOP)) (Brønfort 1996). In addition, when the SF-36 was measured, data were not always available for the general health subscale, as some studies reported either an overall score (Hondras
2009; Hsieh 2002; Licciardone 2003) or presented other subscales (UK BEAM trial 2004). One study (Koes 1992) examined
a mixed population (neck and low-back); data are presented for
the low-back only.
Timing of the outcome measures ranged from two weeks to two
years post-randomisation. The majority reported short- and intermediate-term outcomes, although many reported long-term outcomes as well.
Safety. Slightly more than one-third of the studies reported on
adverse events (Brønfort 1996; Evans 1978; Gudavalli 2006;
Hondras 2009; Hsieh 2002; Muller 2005; Rasmussen 2008;
Skillgate 2007; UK BEAM trial 2004). Adverse events in the SMT
group were limited to muscle soreness, stiffness, and/or transient
increase in pain. None of the studies registered any serious complications in either the experimental or control group.
Excluded studies
Many studies were excluded because either the proportion of
subjects with chronic low-back pain was unclear or unspecified
(Andersson 1999; Beyerman 2006 Coxhead 1981; Doran 1975;
Glover 1974; Herzog 1991; Kinalski 1989; MacDonald 1990;
Meade 1990/1995; Rupert 1985; Shearar 2005; Sims-Williams
1978; Triano 1995; Zylbergold 1981); the mean duration of symptoms for the population was less than 12 weeks (i.e. 50% of the
population with less than 12 weeks of low-back pain) (Brønfort
1989; Cherkin 1998; Hoehler 1981; Mathews 1987; Skagren
1997); the contribution of SMT to the treatment effect could
not be discerned (Aure 2003; Haas 2004; Niemisto 2003/2005;
Ongley 1987); the procedure of randomisation and allocation
was clearly inappropriate (Arkuszewski 1986; Coyer 1955; Hough
2007; Nwuga 1982; Petty 1995); the study evaluated exclusively
subjects with specific pathology, such as sciatica (Brønfort 2004;
Burton 2000; Coxhead 1981), the study included post-surgical
patients (Timm 1994) or the study did not evaluate SMT as defined here (Geisser 2005).
Risk of bias in included studies
The results of the RoB for the individual studies are summarized
in Figure 2. In total, nine of the 26 trials met the criteria for a
low RoB (Brønfort 1996; Ferreira 2007; Hemmila 2002; Hondras
2009; Hsieh 2002; Hurwitz 2002; Koes 1992; Skillgate 2007; UK
BEAM trial 2004). In total, three studies, all with a high RoB,
were identified with a fatal flaw and excluded from the meta-analyses: Two studies (Chown 2008; Muller 2005) had more than
50% drop-out at the first follow-up measurement and one study
(Goldby 2006) was found to have clinically-relevant baseline differences between the interventions for one or more primary out-
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
14
comes suggesting that randomisation was not properly conducted.
Figure 2. Risk of bias summary: Summary of authors’ judgement on risk of bias items within each included
study.
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
15
The following professions were represented in those studies with a
low RoB: bone-setters (Hemmila 2002), chiropractors (Brønfort
1996; Hondras 2009; Hsieh 2002; Hurwitz 2002), manual/physical therapists (Koes 1992; Ferreira 2007), naprapaths (Skillgate
2007) and combination of various professionals (i.e. chiropractors, physiotherapists and osteopaths) (UK BEAM trial 2004).
sequent follow-up measurements, although not all of these conducted long-term follow-up (Evans 1978; Ferreira 2007; Ghroubi
2007; Gibson 1985; Goldby 2006; Hemmila 2002; Hsieh 2002;
Hurwitz 2002; Koes 1992; Pope 1994; Skillgate 2007; Wilkey
2008; Zaproudina 2009). In another study, there was a difference
in the drop-out rate between groups (Goldby 2006).
Allocation
Slightly less than half of the studies used both an adequate
sequence generation and allocation procedure (Brønfort 1996;
Ferreira 2007; Gudavalli 2006; Hemmila 2002; Hondras 2009;
Hurwitz 2002; Koes 1992; Skillgate 2007; UK BEAM trial 2004;
Wilkey 2008; Zaproudina 2009). In seven studies, both randomisation and allocation was unclear (Evans 1978; Gibson 1985;
Mohseni-Bandpei 2006; Postacchini 1988; Rasmussen 2008;
Waagen 1986).
Blinding
In total, three studies attempted to blind patients to the assigned
intervention by providing a sham treatment (Ghroubi 2007;
Licciardone 2003; Waagen 1986). Of these, only one evaluated
the success of blinding post-treatment (Waagen 1986). In that
study, 40% (N = 6/15) of the sham-SMT subjects thought they
had received the real treatment (consisting of a high-velocity lowamplitude technique), while 7% (N = 1/15) who had received the
real treatment, thought he/she had received a sham treatment, suggesting that participants were largely able to determine whether
they had received the real treatment or not.
Incomplete outcome data
Half of the studies provided an adequate overview of withdrawals
or drop-outs and were able to keep these to a minimum for the sub-
Selective reporting
Published or registered protocols were available for relatively few
studies (Ferreira 2007; Hondras 2009; Skillgate 2007; UK BEAM
trial 2004; Zaproudina 2009), despite an extensive and comprehensive search, which included searching for registered clinical trials in www.clinicaltrials.gov, ISRCTN and other trial registries. In
the absence of these, it was difficult for us to determine whether
outcomes were measured, but not reported because they were
found to be insignificant or unfavourable. Therefore, studies reporting all three primary outcomes (i.e. pain, back-pain specific
functional status, and perceived recovery) were considered to have
fulfilled this criterion. Only one study was identified with no published protocol or registered in one of the main trial registries, but
reported all three primary outcomes (Hurwitz 2002).
Other potential sources of bias
Publication bias. An examination of publication bias was possible
for only one comparison, SMT versus any other intervention, due
to the paucity of data for the other comparisons. Funnel plots were
constructed for the outcomes, pain and functional status Figure 3;
Figure 4 respectively. For the outcome pain, it might appear that
small studies favouring SMT are missing. This may indicate publication bias because some studies may have used SMT as a control
group in a trial evaluating the effects of another intervention.
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16
Figure 3. Funnel plot of comparison: 3. SMT vs. any other intervention, outcome: 3.1 Pain.
Negative values favour SMT; positive values favour the control intervention.
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17
Figure 4. Funnel plot of comparison: 3. SMT vs. any other intervention, outcome: 3.2 Functional status.
Negative values favour SMT; positive values favour the control intervention.
Effects of interventions
See: Summary of findings for the main comparison Spinal
manipulative therapy compared to inert interventions for chronic
low-back pain; Summary of findings 2 spinal manipulative
therapy (SMT) compared to sham SMT for chronic LBP;
Summary of findings 3 Spinal manipulative therapy compared
to all other interventions for chronic low-back pain; Summary
of findings 4 spinal manipulative therapy plus any intervention
compared to the intervention alone for chronic LBP
Primary analyses
Summary effect estimates are presented when there was no substantial heterogeneity. Summary of Findings tables are presented
in Summary of findings for the main comparison (SMT versus
inert interventions), Summary of findings 2 (SMT versus sham
SMT), Summary of findings 3 (SMT versus all other interventions), Summary of findings 4 (SMT plus an intervention versus
the intervention alone).
Effect of SMT versus inert interventions
In total, four studies (Gibson 1985; Koes 1992; Pope 1994;
Postacchini 1988) were identified, one of which had a low RoB
(Koes 1992). Based upon one study (Gibson 1985) (72 participants), there is very low quality evidence (high RoB, inconsistency,
imprecision) that there is no significant difference between SMT
and inert interventions (i.e. detuned short-wave diathermy and detuned ultrasound) for pain relief at one and three months (MD: 6.00, 95% CI: -15.82 to 3.82; MD: 7.00, 95% CI: -3.58 to 17.58,
respectively) (Analysis 1.1). For recovery, one study (Gibson 1985)
(72 participants) with a high RoB, was identified. There is very
low quality evidence (high RoB, inconsistency, imprecision) that
there is no significant difference between SMT and inert interventions at one and three months (RR: 1.03, 95% CI: 0.49 to 2.19;
RR: 0.96, 95% CI: 0.56 to 1.65, respectively) (Analysis 1.2). For
return-to-work, one study (Gibson 1985), with a high RoB, was
identified. There is also very low quality evidence (high RoB, inconsistency, imprecision) that there is no significant difference at
one or three months (RR: 1.29, 95% CI: 1.00 to 1.65; RR: 1.17,
95% CI:0.97 to 1.40, respectively) (Analysis 1.3). No data were
available for functional status or health-related quality of life.
Three studies (Koes 1992; Pope 1994; Postacchini 1988) were
identified for which data for the meta-analyses could not be ex-
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18
tracted. One study (Koes 1992, N = 76) demonstrated a significant
difference in improvement (P < 0.05) between SMT and detuned
physiotherapy modalities at six weeks, but not three months. Another study (Pope 1994, N = 127) demonstrated no statistically
significant difference in pain (P < 0.05) between SMT and use of a
corset or transcutaneous muscle stimulation. Due to poor reporting, it is unclear from the study from Postacchini 1988 (N = 95)
whether there was a statistically significant difference in improvement between SMT and a placebo group (i.e. anti-oedema gel) at
three weeks or six months.
Effect of SMT versus sham SMT
In total, three studies (Ghroubi 2007; Licciardone 2003; Waagen
1986) were identified, all with a high RoB. There was substantial heterogeneity for pain at one month, thus the results are described here. Two studies (Ghroubi 2007; Waagen 1986) demonstrated a non-significant effect in favour of SMT, while another
study (Licciardone 2003) demonstrated a non-significant effect
in favour of sham SMT. All examined different forms of SMT,
that is, unspecified SMT, osteopathic SMT and chiropractic SMT,
respectively, and all were relatively small studies. For pain relief,
based upon one study (Licciardone 2003) (55 participants), there
is very low quality evidence (high RoB, inconsistency, indirectness, imprecision) that there is no significant difference between
SMT and sham SMT at three and six months (MD: 2.50, 95%
CI: -9.64 to 14.64; MD: 7.10, 95% CI: -5.16 to 19.36, respectively) (Analysis 2.1). For functional status, based upon the aforementioned study (Licciardone 2003), there is also very low quality evidence (high RoB, inconsistency, indirectness, imprecision)
that there is no significant difference at one, three or six months
(SMD: -0.45, 95% CI: -0.97 to 0.06; SMD: 0.00, 95% CI: -0.56
to 0.56; SMD: 0.04, 95% CI: -0.52 to 0.61) (Analysis 2.2). No
data were available from any study on recovery, return-to-work,
or health-related quality of life.
Effect of SMT versus all other interventions
In total, 15 studies (Brønfort 1996; Ferreira 2007; Gibson
1985; Gudavalli 2006; Hemmila 2002; Hondras 2009; Hsieh
2002; Hurwitz 2002; Mohseni-Bandpei 2006; Paatelma 2008;
Rasmussen-Barr 2003; Skillgate 2007; UK BEAM trial 2004;
Wilkey 2008; Zaproudina 2009) were examined in the meta-analyses, eight with a low RoB. Data from three studies were not included because these data could not be extracted (Koes 1992; Pope
1994; Postacchini 1988), and data from Koes 1992 (low RoB) are
described below, where relevant.
For pain and to a lesser extent, functional status, there was substantial heterogeneity for the short-term and intermediate followups Analysis 3.1 and Analysis 3.2); therefore, results are reported
separately for these outcomes for only studies with a low RoB. This
step was taken because heterogeneity across studies was much less
when accounting for risk of bias and far more studies were available for this comparison than any of the other comparisons. Furthermore, there was, at most, a two-point difference in pain (100point scale, range: 0.13 to 2.01) and at most a 0.13-point difference for functional status (standardized mean difference (SMD),
range: 0 to 0.13) for any of the particular time measurements between studies with a low RoB only and all studies; therefore, we
feel confident in presenting these stratified results here. In general, the effect was not systematically greater when including all
studies as compared to only including studies with a low RoB. In
total, eight studies (Brønfort 1996; Ferreira 2007;Hemmila 2002;
Hondras 2009; Hsieh 2002; Hurwitz 2002; Skillgate 2007; UK
BEAM trial 2004) with a low RoB were examined (Analyses 7.1
to 7.5).
For pain, there is high quality evidence that SMT provides statistically significantly better pain relief than other interventions at
one and six months (MD: -2.76, 95% CI: -5.19 to -0.32; MD:
-3.07, 95% CI: -5.42 to -0.71, respectively) Figure 5; however,
there is also high quality evidence from three studies (Ferreira
2007; Hurwitz 2002; UK BEAM trial 2004) (1,285 participants)
that SMT is not statistically more effective for pain relief at 12
months (MD: -0.76, 95% CI: -3.19 to 1.66). At three months,
despite substantial heterogeneity from five studies (Brønfort 1996;
Ferreira 2007; Hemmila 2002; Skillgate 2007; UK BEAM trial
2004) (1,047 participants), SMT provides significantly better pain
relief than the control interventions (MD: -4.55, 95% CI: -8.68
to -0.43; I²=61%). It is noteworthy that only one of the effect
estimates (Hemmila 2002, N = 56) favours the control group in
this particular comparison.
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19
Figure 5. Forest plot of comparison: 7. SMT vs. any other intervention - for studies with a low RoB only,
outcome: 7.1 Pain.
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20
For functional status, there is high quality evidence that SMT provides statistically significantly better functional improvement at
one month compared to other interventions (SMD: -0.17, 95%
CI: -0.29 to -0.06). There is moderate quality evidence (inconsistency) of no statistically significant effect at three months (SMD:
-0.18, 95% CI: -0.37 to 0.01) and high quality evidence of no
statistically significant effect at six and 12 months (SMD: -0.12,
95% CI: -0.23 to 0.00; SMD: -0.06, 95% CI: -0.16 to 0.05, respectively) Figure 6.
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Figure 6. Forest plot of comparison: 7. SMT vs. any other intervention - for studies with a low RoB only,
outcome: 7.2 Functional status.
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22
Four studies examined perceived recovery (Gibson 1985;
Gudavalli 2006; Hemmila 2002; Zaproudina 2009), one with a
low RoB (Hemmila 2002). There is moderate quality evidence
(high RoB) from three studies at one month (Gibson 1985;
Gudavalli 2006; Hemmila 2002) (370 participants) and low quality evidence (high RoB, imprecision) from two studies (Gibson
1985; Zaproudina 2009) (182 participants) at three months that
SMT provides a significantly better chance of recovery than the
contrast interventions (RR: 1.20, 95% CI: 1.04 to 1.37; RR: 1.70,
95% CI: 1.20 to 2.40, respectively) (Analysis 3.3). There is also
low quality evidence (inconsistency, imprecision) from one study
(Hemmila 2002) demonstrating no statistically significant difference in effect on recovery at six or 12 months (RR: 1.05, 95% CI:
0.81 to 1.38; RR: 1.17, 95% CI: 0.87 to 1.55, respectively). The
study by Koes 1992 reported significantly (P < 0.05) greater improvement for SMT versus standard medical care, but not physiotherapy at six weeks, and no significant difference between either
at three months.
Four studies (Brønfort 1996; Gibson 1985; Gudavalli 2006;
Hemmila 2002) (596 participants), two of which had a low
RoB (Brønfort 1996; Hemmila 2002), examined return-to-work.
There is low quality evidence (high RoB, imprecision) that there
is no statistically significant effect of SMT on return-to-work at
any short or long-term interval (Analysis 3.4). Four studies examined health-related quality of life (Brønfort 1996; Gudavalli 2006;
Rasmussen-Barr 2003; Zaproudina 2009) (478 participants), one
of which had a low RoB. Based upon these three studies, there
is moderate quality evidence (high RoB) at one month demonstrating no statistically significant difference in effect on healthrelated quality of life (RR: -0.08, 95% CI: -0.29 to 0.13) and very
low quality evidence (high RoB, inconsistency, imprecision) of no
significant difference in effect at three months (RR: 0.21, 95%
CI: -0.27 to 0.70) (Analysis 3.5).
Effect of SMT plus another intervention versus the
intervention alone
In total, five studies (Evans 1978; Hsieh 2002; Licciardone 2003;
Rasmussen 2008; UK BEAM trial 2004) were identified, two of
which had a low RoB (Hsieh 2002; UK BEAM trial 2004). There
is low quality evidence (high RoB, imprecision) from three studies
(Hsieh 2002; Licciardone 2003; Rasmussen 2008) (228 participants) that SMT has a statistically significant effect on pain relief
at one month (MD: -5.88, 95% CI: -10.85 to -0.90) and high
quality evidence from two studies (Licciardone 2003; UK BEAM
trial 2004) (1,016 participants) that SMT has a statistically significant effect on pain relief at three months (MD: -7.23, 95%
CI: -11.72 to -2.74) (Analysis 6.1). There is also high quality evidence from two studies (Rasmussen 2008; UK BEAM trial 2004)
(1,000 participants) that SMT has a statistically significant effect
on pain relief at 12 months (MD: -3.31, 95% CI: -6.60 to -0.02).
However, there is low quality evidence (high RoB, imprecision),
which demonstrates no statistically significant difference in effect
on pain relief at six months (MD: -6.77, 95% CI: -14.07 to 0.53).
Three studies (Hsieh 2002; Licciardone 2003; UK BEAM trial
2004) examined functional status, two of which had a low RoB.
There is low quality evidence (high RoB, imprecision) from two
studies (156 participants) that SMT has a statistically significant effect on functional status at one month (SMD: -0.40, 95%
CI: -0.73 to -0.07) and high quality evidence from two studies
(Licciardone 2003; UK BEAM trial 2004) at three months (1,078
participants) that SMT has a statistically significant effect on functional status (SMD: -0.22, 95% CI: -0.38 to -0.06) and a statistically significant effect at 12 months (SMD: -0.21, 95% CI: 0.34 to -0.09). However, there is low quality evidence (high RoB,
imprecision) that SMT has no statistically significant effect at six
months (SMD: -0.30, 95% CI -0.64 to 0.03) (Analysis 6.2).
One study with a high RoB examined perceived recovery (Evans
1978). There is very low quality evidence (high RoB, inconsistency, imprecision) that SMT demonstrates significantly greater
recovery at one month than the comparison group (RR: 3.40,
95% CI: 1.12 to 10.28) (Analysis 6.3). No data were available on
return-to-work or health-related quality of life.
Sensitivity analyses
Sensitivity analyses were conducted for the comparison SMT versus
all other interventions only. Only two outcomes were examined,
pain and functional status. The sparseness of data for the other
comparisons rendered further sub-analyses meaningless. These
analyses were conducted in order to determine the robustness of
our original analyses and determine whether other factors might
have influenced the overall pooled effect.
On the basis of these sensitivity analyses, results appear more
prominently for those studies with a low RoB because heterogeneity across studies was much less than when all studies were
pooled; however, the overall pooled effect between all studies and
those with a low RoB were only marginally different for pain and
functional status at all time measurements (Figure 7; Figure 8).
It is noteworthy that a small difference in effect was observed for
SMT versus interventions thought to be ineffective as opposed to
SMT versus interventions thought to be effective; however, this
amounted to a difference of at most, five points on a 100-point
scale (Figure 7, Summary Forest plot - pain at 1 month) or 0.3
points in SMD (Figure 8, Summary Forest Plot - functional status
at 1 month). However, none of these analyses suggested a clinically-relevant effect on pain or functional status at any time interval not observed in the primary analyses. Furthermore, with the
exception of two studies (Wilkey 2008; Evans 1978), both with a
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23
high RoB, no other study demonstrated a clinically-relevant effect
for any comparison or time interval for the primary outcomes,
pain, functional status or perceived recovery. The sensitivity analyses were less remarkable at the remaining time intervals and are
available upon request from the contact author.
Figure 7. Summary forest plot as part of the sensitivity analyses. Comparison: SMT vs. all other
interventions. Outcome: Pain at one month.
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24
Figure 8. Summary forest plot as part of the sensitivity analyses. Comparison: SMT vs. all other
interventions. Outcome: Functional status at one month.
We wanted to examine the effect of SMT in subjects with radiating pain; however, most studies included subjects with or without
radiating pain and did not present separate analyses, so this sensitivity analysis was not performed. Finally, while it was not part of
the original sensitivity analysis, lowering the threshold value for
I² to 40% would not have had any bearing on the presentation of
these results.
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25
Spinal manipulative therapy for chronic low-back pain (Review)
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A D D I T I O N A L S U M M A R Y O F F I N D I N G S [Explanation]
spinal manipulative therapy (SMT) compared to sham SMT for chronic LBP
Patient or population: patients with chronic LBP
Settings: Rather diverse
Intervention: spinal manipulative therapy (SMT)
Comparison: sham SMT
Outcomes
Pain
VAS. Scale from: 0-100
(worse pain). Follow-up 1
month
Illustrative comparative risks* (95% CI)
Assumed risk
Corresponding risk
sham SMT
spinal
manipulative
therapy (SMT)
The mean pain ranged The mean Pain in the inacross control groups tervention groups was
from
3.24 lower
31 to 58 points
(13.62 lower to 7.15
higher)
Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
148
(3 studies)
⊕
very low1,2,3,4,5
Pain
The mean pain in the conVAS. Scale from: 0-100 trol groups was
(worse pain). Follow-up: 28.5 points
3 months
The mean Pain in the intervention groups was
2.50 higher
(9.64 lower to 14.64
higher)
55
(1 study)
⊕
very low1,3,4,5
Pain
The mean pain in the conVAS. Scale from: 0-100 trol groups was
(worse pain). Follow-up: 24.5 points
6 months
The mean Pain in the intervention groups was
7.10 higher
(5.16 lower to 19.36
higher)
51
(1 study)
⊕
very low1,3,4,5
Comments
26
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Functional status
Roland Morris Disability
Questionnaire. Scale from
0 to 24 (worse function).
Follow-up: 1 month
The mean functional status in the control groups
was
7.7
The mean Functional status in the intervention
groups was
2.16 lower
(4.65 lower to 0.29
higher)
65
(1 study)
⊕
very low1,3,4,6
Based on SMD: -0.45 (0.97 to 0.06). Strength of
the effect is small.
Functional status
Roland Morris Disability Questionnaire. Scale
from: 0 to 24 (worse
function). Follow-up: 3
months
The mean functional status in the control groups
was
6.1
The mean Functional status in the intervention
groups was
0.00 higher
(2.3 lower to 2.3 higher)
55
(1 study)
⊕
very low1,3,4,6
Based on SMD: 0.00 (0.56 to 0.56). No effect.
Functional status
Roland Morris Disability Questionnaire. Scale
from: 0 to 24 (worse
function). Follow-up: 6
months
The mean functional status in the control groups
was
5
The mean Functional status in the intervention
groups was
0.18 higher
(2.34 lower to 2.75
higher)
51
(1 study)
⊕
very low1,3,4,6
Based on SMD: 0.04 (0.52 to 0.61). Strength of
the effect is small.
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the
assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1
2
3
4
5
6
>25% of participants from studies with a high risk of bias
I-squared=53%
Licciardone et al. included relatively inexperienced osteopathic manipulative physicians.
Less than 400 subjects, total.
Effect includes the possibility of better or worse pain relief with SMT.
Effect includes the possibility of better or worse function with SMT.
27
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Spinal manipulative therapy compared to all other interventions for chronic low-back pain
Patient or population: patients with chronic low-back pain
Settings: Rather diverse
Intervention: spinal manipulative therapy
Comparison: all other interventions
Outcomes
Illustrative comparative risks* (95% CI)
Assumed risk
Corresponding risk
all other interventions
spinal
therapy
Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
manipulative
28
Pain
VAS. Scale from: 0-100
(worse pain). Follow-up:
1 month
The mean pain ranged The mean Pain in the inacross control groups tervention groups was
from
2.76 lower
21.3 to 44 points
(5.19 to 0.32 lower)
1405
(6 studies1 )
⊕⊕⊕⊕
high
Pain
VAS. Scale from: 0-100
(worse pain). Follow-up:
3 months
The mean pain ranged
across control groups
from
27.5 to 44.7 points
The mean Pain in the intervention groups was
4.55 lower
(8.68 to 0.43 lower)
1074
(5 studies1 )
⊕⊕⊕
moderate2
Pain
VAS. Scale from: 0-100
(worse pain). Follow-up:
12 months
The mean pain ranged The mean Pain in the inacross control groups tervention groups was
from
0.76 lower
28 to 50.6 points
(3.19 lower to 1.66
higher)
1285
(3 studies1 )
⊕⊕⊕⊕
high3
Functional status
Roland Morris Disability Questionnaire. Scale
from: 0 to 24 (worse
function). Follow-up: 1
month
The mean functional status ranged across control
groups from
4 to 20.8
1402
(6 studies1 )
⊕⊕⊕⊕
high
The mean Functional status in the intervention
groups was
0.9 lower
(1.6 to 0.3 lower)
Based on SMD: -0.17 (0.29 to -0.06). Strength
of the effect is small.
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Functional status
Roland Morris Disability Questionnaire. Scale
from: 0 to 24 (worse
function). Follow-up: 3
months
The mean functional status ranged across control
groups from
6 to 20.9
The mean Functional status in the intervention
groups was
0.74 lower
(1.5 lower to 0.04 higher)
1323
(6 studies1 )
⊕⊕⊕
moderate4
Based on SMD: -0.18 (0.37 to 0.01). Strength of
the effect is small.
Functional status
Roland Morris Disability
Questionnaire. Scale from
0 to 24 (worse function).
Follow-up: 12 months.
The mean functional status ranged across control
groups from
5.7 to 9.2
The mean Functional status in the intervention
groups was
0.32 lower
(0.86 lower to 0.27
higher)
1418
(4 studies1 )
⊕⊕⊕⊕
high5
Based on SMD: -0.06 (0.16 to 0.05). Strength of
the effect is small.
Recovery at 1 month
Study population
370
(3 studies)
⊕⊕⊕
moderate6
598 per 1000
RR 1.20
(1.04 to 1.37)
718 per 1000
(622 to 819)
Medium risk population
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the
assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1
2
3
4
29
5
Results based upon studies with a low risk of bias.
I-squared=61%
Effect includes the possibility of better or worse pain relief with SMT.
I-squared=52% and widely varying effect estimates in favor of either SMT or the intervention.
Effect includes the possibility of better or worse function with SMT.
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6
>25% of participants from studies with a high risk of bias
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
30
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spinal manipulative therapy plus any intervention compared to the intervention alone for chronic LBP
Patient or population: patients with chronic LBP
Settings: Rather diverse
Intervention: spinal manipulative therapy plus any intervention
Comparison: the intervention alone
Outcomes
Illustrative comparative risks* (95% CI)
Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
31
Assumed risk
Corresponding risk
the intervention alone
spinal
manipulative therapy plus any
intervention
Pain
VAS. Scale from: 0-100
(worse pain). Follow-up:
1 month
The mean pain ranged
across control groups
from
27.8 to 46.5 points
The mean Pain in the intervention groups was
5.88 lower
(10.85 to 0.9 lower)
228
(3 studies)
⊕⊕
low1,2
Pain
VAS. Scale from: 0-100
(worse pain). Follow-up:
3 months
The mean pain ranged
across control groups
from
45.2 to 49.6 points
The mean Pain in the intervention groups was
7.23 lower
(11.72 to 2.74 lower)
1016
(2 studies)
⊕⊕⊕⊕
high
Pain
VAS. Scale from: 0-100
(worse pain). Follow-up:
12 months
The mean pain ranged The mean Pain in the inacross control groups tervention groups was
from
3.31 lower
20 to 47.6 points
(6.6 to 0.02 lower)
1000
(2 studies)
⊕⊕⊕⊕
high
Functional status
Roland Morris Disability Questionnaire. Scale
from: 0 to 24 (worse
function). Follow-up: 1
month
The mean functional status ranged across control
groups from
5.8 to 6.9
156
(2 studies)
⊕⊕
low1,2
The mean Functional status in the intervention
groups was
2.05 lower
(3.73 to 0.36 lower)
Comments
Based on SMD: -0.40 (0.73 to -0.07). Strength
of the effect is small.
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Functional status
Roland Morris Disability Questionnaire. Scale
from: 0 to 24 (worse
function) . Follow-up: 3
months
The mean functional status ranged across control
groups from
5.5 to 6.7
The mean Functional status in the intervention
groups was
1.06 lower
(1.82 to 0.29 lower)
1078
(2 studies)
⊕⊕⊕⊕
high
Based on SMD: -0.22 (0.38 to -0.06). Strength
of the effect is small.
Functional status
Roland Morris Disability Questionnaire. Scale
from: 0 to 24 (worse
function). Follow-up: 12
months
The mean functional status ranged across control
groups from
5.7 to 6.2
The mean Functional status in the intervention
groups was
0.97 lower
(1.56 to 0.41 lower)
994
(1 study)
⊕⊕⊕⊕
high
Based on SMD -0.21 (0.34 to -0.09). Strength
of the effect is small.
Recovery at one month
Study population
32
(1 study)
⊕
very low1,3
176 per 1000
RR 3.40
(1.12 to 10.28)
598 per 1000
(197 to 1000)
Medium risk population
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the
assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1
2
3
>25% of participants from studies with a high risk of bias
Less than 400 subjects, total.
Less than 300 subjects, total.
32
DISCUSSION
Summary of main results
In general, there is high quality evidence that SMT has a statistically significant short-term effect on pain relief and functional
status compared to other interventions as well as varying quality
of the evidence that SMT has a statistically significant short-term
effect on pain relief and functional status when SMT is added to
another intervention. However, the size of the effects were small
and not apparently clinically relevant. In addition, there is very
low quality evidence that SMT is no more effective than inert interventions or sham SMT for short-term pain relief or functional
status. Seemingly these results are conflicting. This might be explained by the fact that relatively few, small studies, quite typically
with a high RoB, evaluated the latter comparisons, thus, these
studies have a high likelihood of a type II error stemming from
the low power of the study to detect a statistically significant and
clinically relevant effect. However, studies with a high RoB typically overestimate the effect compared to studies with a low RoB
(van Tulder 2009), so it is unclear to what extent, if any, various
forms of bias have on those results. Furthermore, it is questionable to what extent studies investigating sham SMT were able to
successfully blind their subjects, as only one study evaluated this
post-treatment, suggesting that the investigators were not entirely
successful; so it is debatable whether these data can be considered
representative for this comparison. Nevertheless, improper blinding is likely to have lead to an overestimation of the effect, not
underestimation, thus, it is also difficult to interpret the essence
of these findings in relation to our more robust comparison, SMT
versus other interventions. Data were particularly sparse for recovery, return-to-work and quality of life, in addition to costs of
care; therefore, no firm conclusions can be drawn regarding these
outcomes.
Recently, there has been much discussion regarding the clinical
importance of small effects identified in continuous outcomes,
such as those examined in this review. Formerly, it was thought
that the effect of a treatment was trivial if the mean difference between the treatment and a control group was appreciably less than
the smallest change thought to be clinically important. This might
not necessarily be so (Guyatt 1998). The addition of the number needed to treat (NNT) may aid interpretation of trials with
continuous outcomes (Froud 2009), especially when expressed as
a standardized mean difference. For example, the largest benefit
demonstrated from any of the treatments in the UK BEAM (2004)
trial was 1.87 points on the Roland-Morris disability questionnaire, which translates to a between-group difference that is not
clinically important (Tveito 2005). A recent re-analysis of these
data suggests that despite the small mean differences between interventions, numbers needed to treat were small, on average, four
to five for manipulation plus exercise or manipulation alone, respectively as compared to ”best care“ at three months follow-up
(Froud 2009). This means that referring four to five patients for
manipulation, would, on average, yield one additional case of im-
provement. Even a conservative estimate with these data suggests
a potentially attractive NNT ratio. However, it should be noted
that this represents a post-hoc analysis and there are some general
limitations to the use of NNT analyses (Wu 2001). Furthermore,
calculation of a NNT is based upon determination of a threshold
value of improvement, which is also open for discussion. Finally,
statistical power is lost when converting scales to binary outcomes;
therefore, this technique might only be attractive when sample
sizes are sufficiently large (Guyatt 1998).
Despite the methodological rigor maintained in this review, there
are likely to be objections. One objection typically raised by clinicians is the lack of respect to the type of manipulative therapy
delivered (e.g. high-velocity low-amplitude manipulation versus
mobilization) or profession of the therapist (e.g. chiropractor versus manual therapist or physiotherapist). Sensitivity analyses were
conducted in order to distinguish whether this resulted in a different effect; however, those results suggest that neither the technique
nor profession of the therapist had a profound influence on the
overall pooled effect.
Another objection might lie with the lack of examining a more
homogenous group of subjects with low-back pain. Non-specific
low-back pain, even when examined by duration, can probably be
viewed as a rather heterogenous group. Even within this review, a
number of studies included subjects with and without radiating
pain; therefore, defining a homogenous population and identifying subgroups seems important. Recent work suggests that clinically important effects are observed when treatment is matched
to the patient’s signs and symptoms rather than provided to all
patients with low-back pain (Brennan 2006). Furthermore, recent
recommendations from a UK consensus, which included senior
researchers experienced in clinical trials for musculoskeletal conditions, include examining subgroups (Foster 2009).
None of the included studies which examined adverse events
reported serious complications. Serious complications following
SMT for low-back pain are extremely rare and have been documented in case reports only, which include cauda equina syndrome
(CES), paraplegia and death (Cherkin 2003). Risk estimates vary
widely for CES, ranging from less than one case per million treatments (Assendelft 1996) to one case per 100 million manipulations (Shekelle 1992). Given the extremely low incidence of serious complications, a review of RCTs provides limited information;
however, estimates based upon case reports are likely to underestimate risk, while large prospective cohorts are lacking. To our
knowledge, only one systematic review has examined the safety of
SMT to the low-back based upon case reports and surveys, which
concluded that the risk of SMTcausing a clinically worsened disc
herniation or CES in a patient presenting with lumbar disc herniation to be estimated at one in 3.7 million treatments (Oliphant
2004).
Limitations and strengths
There are a number of limitations to this review. The primary
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
33
limitation, which is common to many systematic reviews, is the
lack of studies with a low RoB. Despite the fact that the majority
of the studies included in this review were published in the last
decade, methodologically well conducted studies remain scarce.
A second limitation is the possibility of publication bias, which
we attempted to minimize through an extensive database search.
We did not actively seek unpublished studies; however, it could be
argued that this is unlikely to have had an important impact on the
overall results. Suprisingly, many of the studies published in the last
decade did not have a published protocol and to our knowledge,
had not registered their study in one of the many trial registries,
indicating that many trials conducted in the 21st century still do
not conform to international procedure. In the absence of 100%
conformity, it remains difficult to ascertain to what extent studies
do not publish their findings because the results prove less than
favourable. In addition, we uncovered a couple of irregularities,
for example, a study that began recruitment ten years ago, but has
not yet been published (ISRCTN61808774) or another study that
was terminated without further explanation (NCT00269503).
Finally, we would have liked to have conducted a meta-regression
for the purpose of exploring heterogeneity between studies; however, there were too few studies per outcome to allow for a meaningful analysis and the distribution of data for the outcomes, pain
and functional status, appeared to be clustered, that is, the data
did not follow a normal distribution. Furthermore, results from
the sensitivity analyses did not suggest any important directions
of effect for the confounders and effect modifiers examined.
Strengths of this review include the methodological rigor applied,
including a published protocol and the meta-analyses, which allowed us to conduct meaningful sensitivity analyses.
Agreements and disagreements with other
studies or reviews
Ostensibly, these results are consistent with the previous review,
which concluded that there is evidence that SMT is neither superior nor inferior to other effective treatments for patients with
chronic low-back pain. In comparison to the previous review
(Assendelft 2003; Assendelft 2004), approximately two-thirds of
the studies included are new and many more studies have been
included with a low RoB; therefore, our findings are thought to
be much more robust. These results are also consistent with other
recent systematic reviews, which conducted principally narrative
analyses (Brønfort 2008; Chou 2007; Lawrence 2008); however,
the findings from our review are more optimistic than another
review (Ferreira 2002), which conducted meta-analyses. Another
systematic review was identified which pooled data from six tri-
als of osteopathic manipulative therapy (OMT) and concluded
that OMT significantly reduces low-back pain (Licciardone 2005);
however, that review did not limit the results to trials of chronic
low-back pain. A recent review of systematic reviews, including
the earlier version of this review, concluded that SMT produces
small clinical benefits that are equivalent to those of other commonly used therapies (Cherkin 2003).
AUTHORS’ CONCLUSIONS
Implications for practice
High quality evidence suggests that there is no clinically relevant
difference between SMT and other interventions for reducing pain
and improving function in patients with chronic low-back pain.
Therefore, the decision to refer for SMT should be based upon
costs, preferences of the patient and providers and relative safety
of the treatment options.
Implications for research
Future studies should:
1. Evaluate the effects of SMT as an additional or adjunct therapy, for example, in the case of SMT in multi-modal treatment
packages.
2. There is a dire need for cost-effectiveness studies. If SMT is
equal to other presumed effective interventions for chronic lowback pain, SMT may be more cost-effective because the therapy
is typically provided in a limited number of treatment sessions (as
compared to, for example, exercise therapy or behavioural treatment).
ACKNOWLEDGEMENTS
The review authors would like to thank the members of the Editorial Board of the Cochrane Back Review Group for their constructive comments on the protocol and draft version of this review and
Ms Rachel Couban for her assistance with the development of the
search strategies. They also thank Dr. Sally Morton, Mrs. Emily
Yu, Ms. Marika Suttorp, and Dr. Paul Shekelle for their work on
the original review, which laid the ground work for this update. In
addition, they thank Veronica Morton, Nina Zaproudina, Cynthia Long, John Licciardone and Peter McCarthy for providing
additional data not found in their original publications.
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
34
REFERENCES
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Cherkin 1998 {published data only}
Cherkin DC, Deyo RA, Battie M, Street J, Barlow W. A
comparison of physical therapy, chiropractic manipulation, and
provision of an educational booklet for the treatment of patients
with low back pain. N Engl J Med 1998;339:1021–9.
Cote 1994 {published data only}
Cote P, Mior SA, Vernon H. The short-term effect of a spinal
manipulation on pain/pressure threshold in patients with chronic
mechanical low back pain. J Manipulative Physiol Ther 1994;17:
364–8.
Coxhead 1981 {published data only}
Coxhead CE, Inskip H, Meade TW, North WRS, Troup JDG.
Multicentre trial of physiotherapy in the management of sciatic
symptoms. Lancet 1981;1:1065–8.
Coyer 1955 {published data only}
Coyer AB, Curwin I. Low back pain treated by manipulation. Br
Med J 1955;1:705–7.
Doran 1975 {published data only}
Doran DML, Newell DJ. Manipulation in treatment of low back
pain: A multicentre study. BMJ 1975;2:161–4..
Ellestad 1988 {published data only}
Ellestad SM, Nagle RV, Boesler DR, Kilmore MA.
Electromyographic and skin resistance to osteopathic manipulative
treatment for low-back pain. J Am Osteopath Assoc 1988;88:991–7.
Ellestad SM, Nagle RV, Boesler DR, Kilmore MA.
Elektromyographische und Hautwiderstandsreaktionen auf die
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
37
osteopathische manipulative Behandlung des Kreuzschmerzes.
Manuelle Medizin 1990;28:7–12.
Geisser 2005 {published data only}
Geisser ME, Wiggert EA, Haig AJ, Colwell MO. A randomized,
controlled trial of manual therapy and specific adjuvant exercise for
chronic low back pain. Clin J Pain 2005;21(6):463–70.
Gibson 1993 {published data only}
Gibson H, Ross J, Allen J, Latimer J, Maher C. The effect of
mobilization on forward bending range. J Manual Manipulative
Therapy 1993;1:142–7.
Gilbert 1985 {published data only}
Gilbert JR, Taylor DW, Hildebrand A, Evans C. Clinical trial of
common treatments for low back pain in family practice. BMJ
1985;291:791–4.
Glover 1974 {published data only}
Glover JR, Morris JG, Khosla T. Back pain: a randomized clinical
trial of rotational manipulation of the trunk. Br J Ind Med 1974;
31:59–64.
Haas 1995 {published data only}
Haas M, Panzer D, Peterson D, Raphael R. Short-term
responsiveness of manual thoracic end-play assessment to spinal
manipulation: a randomized controlled trial of construct validity. J
Manipulative Physiol Ther 1995;18:582–9.
Haas 2004 {published data only}
Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic
care of chronic low back pain. Spine J 2004;4(5):574–83.
Hawk 2006 {published data only}
Hawk C, Rupert R, Colonvega M, Boyd J, Hall S. Comparison of
bioenergetic synchronization and customary chiropractic care for
older adults with chronic musculoskeletal pain. J Manipulative
Physiol Ther 2006;29:540–9.
Helliwell 1987 {published data only}
Helliwell PS, Cunliffe G. Manipulation in low back pain. The
Physician 1987;April:187–8.
Herzog 1991 {published data only}
Herzog W, Conway PJW, Wilcox BJ. Effects of different treatment
modalities on gait symmetry and clinical measures for sacroiliac
joint patients. J Manipulative Physiol Ther 1991;14:104–9.
Hoehler 1981 {published data only}
Hoehler FK, Tobis JS, Buerger AA. Spinal manipulation for low
back pain. JAMA 1981;245:1835–8.
Hough 2007 {published data only}
Hough E, Stephenson R, Swift L. A comparison of manual therapy
and active rehabilitation in the treatment of non specific low back
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psychological screening score: a pilot study. BMC Musculoskeletal
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outcomes of low back pain: comparison of four treatment groups in
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15(0161-4754 (Print), 1):4–9.
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when left untampered. A randomized clinical trial. Spine 1995;20:
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Khalil 1992 {published data only}
Khalil TM, Asfour SS, Martinez LM, Waly SM, Rosomoff RS,
Rosomoff HL. Stretch ing in the rehabilitation of low-back pain
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manual therapy versus physiotherapy methods used in treatment of
patients with low back pain syndromes. J Manual Medicine 1989;4:
44–6.
Kokjohn 1992 {published data only}
Kokjohn K, Schmid DM, Triano JJ, Brennan PC. The effect of
spinal manipulation on pain and prostaglandin levels in women
with primary dysmenorrhea. J Manipulative Physiol Ther 1992;15:
279–85.
Lewis 2005 {published data only}
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randomized clinical trial comparing two physiotherapy
interventions for chronic low back pain. Spine 2005;30(7):711–21.
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MacDonald RS, Bell CJM. An open controlled assessment of
osteopathic manipulation in non-specific low-back pain. Spine
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Mathew JA, Mills SB, Jenkins VM, Grimes SM, Morkel MJ,
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Meade TW, Dyer S, Browne W, Frank AO. Randomised
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Niemisto L, Lahtinen-Suopanki T, Rissanen P, Lindgren KA, Sarna
S, Hurri H. A randomized trial of combined manipulation,
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Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
38
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Skargren EI, Carlsson PG, Oberg BE. One-year follow-up
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Skargren EI, Oberg BE, Carlsson PG, Gade M. Cost and
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Terrett ACJ, Vernon H. Manipulation and pain tolerance. Am J
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Timm 1994 {published data only}
Timm KE. A randomized-control study of active and passive
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References to studies awaiting assessment
Cleland 2006 {published data only}
References to ongoing studies
ISRCTN47636118 {published data only}
Efficacy of conventional physiotherapy and manipulative
physiotherapy in the treatment of low-back pain: A randomised
controlled trial. Ongoing study January 2000; patient recruitment
completed as of June 2008.
ISRCTN61808774 {published data only}
A randomised controlled trial of the effect on chronic low-back pain
of a naturopathic osteopathy intervention. Ongoing study April
2000; recruitment completed; information last updated Nov. 2005.
NCT00269321 {published data only}
randomised clinical trial of chiropractic manual therapy plus home
exercise, supervised exercise plus home exercise and home exercises
alone for individuals 65 and over with chronic mechanical low-back
painPrimary aims: to determine the relative clinical effectiveness
the following treatments for LBP patients 65 years and older in
both the short-term (after 12 weeks) and long-term (after 52
weeks), using LBP as the main outcome measure.Secondary
outcomes: to estimate the short- and long-term relative
effectiveness of the three interventions using:Patient-rated
outcomes: low-back disability, general health status, patient
satisfaction, improvement, and medication use measured by selfreport questionnairesObjective functional performance outcomes:
spinal motion, trunk strength and endurance, and functional ability
measured by examiners masked to treatment group assignmentCost
measures: direct and indirect costs of treatment measured by
questionnaires, phone interviews, and medical records.To describe
elderly LBP patients’ perceptions of treatment and the issues they
consider when determining their satisfaction with care using
qualitative methods nested within the RCT.. Ongoing study
October 2003; recruitment completed as of June 2008..
NCT00269347 {published data only}
Title: Manipulation, exercise and self-care for non-acute low-back
painBuilding upon the principal investigators’ previous
collaborative research, this randomised observer-blinded clinical
trial will compare the following treatment for patients with nonacute low-back pain:chiropractic spinal manipulationrehabilitative
exerciseself care education Theprimary aim is to examine the
relative efficacy of the three interventions in terms of patient rated
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
39
outcomes in the short-term (after 12 weeks) and the long-term
(after 52 weeks) for non-acute low-back pain.Secondary aims
include:To examine the short and long-term relative cost
effectiveness and cost utility of the three treatments.To assess if
there are clinically important differences between pre-specified
subgroups of low-back pain patients. Subgroups are based on
duration and current episode and radiating leg pain.To evaluate if
there treatment group differences in objective lumbar spine
function (range of motion, strength and endurance) after 12 weeks
of treatment and if changes in lumbar function are associated with
changes in patient rated short and long-term outcomes.To identify
if baseline demographic or clinical variables can predict short or
long-term outcome.To describe patients’ interpretations and
perceptions of outcome measures used in clinical trials. Ongoing
study January 2001; recruitment completed as of June 2008;
currently in the review process..
NCT00269503 {published data only}
Official title: A Pilot Study of Chiropractic Prone Distraction for
Subacute Back Pain With Sciatica. Ongoing study Starting date of
trial not provided. Contact author for more information.
NCT00315120 {published data only}
A randomised controlled trial of osteopathic manipulative
treatment and ultrasound physical therapy for chronic low-back
pain. Ongoing study August 2006; estimated study completion
date: June 2010.
NCT00376350 {published data only}
Dose-response/Efficacy of manipulation for chronic low-back pain.
Ongoing study March 2007; estimated completion date March
2011.
NCT00410397 {published data only}
The use of manual therapy to treat low-back and hip pain.
Ongoing study December 2006.
NCT00567333 {published data only}
Individualized chiropractic and integrative care for low-back pain.
Ongoing study June 2007; recruitment completed, currently in the
follow–up phase. Estimated completion: October 2010..
NCT00632060 {published data only}
The efficacy of manual and manipulative therapy for low-back pain
in military active duty personnel: A feasibility study. Ongoing
study February 2008.
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∗
Indicates the major publication for the study
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
42
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Brønfort 1996
Methods
RCT; Adequate allocation procedure; randomisation ratio = 3:2:2
Participants
174 patients randomly allocated to 3 treatment groups; study setting: chiropractic outpatient clinic; patients recruited from local advertisements in newspaper; study conducted
in Minneapolis/St. Paul, Minnesota, USA; recruitment September 1991- May 1993.
Age (mean (SD): Overall: 41.0 (9.7); grp.1- 41.3 (10.5); grp.2 - 40.3 (8.9); grp.3 - 41.4
(9.3)
Gender (% F): Overall: 47%; grp.1 - 54%; grp.2 - 44%; grp.3 -39%
Inclusion criteria: subjects between 20 to 60 years of age with non-specific LBP of at
least 6 weeks duration with or without radiating pain to one or both legs to the level of
the knee.
Duration of the current episode: range 2 to 3 years (median) for all 3 groups.
Exclusion criteria: subjects with LBP caused by specific identifiable pathology in the spine
and lower extremities: organic diseases with referred pain to the lumbar spine; severe
osteopenia; previous back surgery; severe arterial hypertension or existing cardiovascular
diseases requiring medical treatment; poor general health; obesity; history of duodenal
or stomach ulcers; previous hypersensitivity to NSAIDs; pregnancy; pending litigation;
and difficulties with the English language.
Interventions
1) SMT + strengthening exercises (N = 71); 2) NSAIDs + strengthening exercises (N =
52); 3) SMT + stretching exercises (N = 51)
SMT: Treatments provided by 5 licensed chiropractors whose practice experience varied
from 5 to 25 years. A total of 10 tx. sessions were provided, all during the first 5 wks.
of the trial, each lasting 5 to 10 min. The choice of tx. technique was at the discretion
of the chiropractor. No adjunctive physiotherapy was allowed. The thrusting technique
was a high-velocity, low-amplitude thrust, most commonly by a short-lever technique.
Pharmaceutical therapy: Naproxen (500 mg.), twice daily; no other prescription NSAIDs
or analgesics were allowed.
Exercise protocol: Research assistants specifically trained and certified by the principal
investigator supervised all 20 exercise sessions. During the first 5 weeks of tx., 10 exercise
sessions were done in combination w/ either SMT or the NSAID intervention. For the
subsequent 6 wks., patients came solely for the 10 supervised sessions. The dynamic trunk
strengthening protocol consisted of trunk and leg extensions as described by Manniche
(ref.21). At the completion of the study, all patients were encouraged to continue with
their exercises.
The 11-week treatment protocol for all 3 groups consisted of 5 weeks of combination
therapy followed by 6 weeks of exercise therapy alone, totaling 20 1-hour sessions.
Outcomes
Primary outcomes (as defined by the authors): Pain: NRS (11-point ordinal scale);
Back pain-specific functional status: Roland-Morris; Generic functional status: COOPWONCA; Secondary outcomes: Depression: Community Epidemiologic Scale Depression (developed by the National Institutes of Health); Trunk performance tests (trunk
muscle strength, endurance, and range of motion as measured by a computerized digital myograph, Schober’s test, straight leg raise test, and time the subjects were able to
maintain their upper body horizontally unsupported).
Spinal manipulative therapy for chronic low-back pain (Review)
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43
Brønfort 1996
(Continued)
Not reported as a primary or secondary outcome in the methods, but results are presented
for the following: percentage of patients achieving a given percentage reduction in pain;
return-to-work; adverse events.
adverse events: 2 subjects developed severe nausea & vomiting but not gastrointestinal
bleeding due to the NSAID use and subsequently discontinued the study; 8 subjects
developed substantial nausea & dyspepsia and 1 subject severe tinnitus following NSAID
use; 1 subject discontinued exercise because she did not tolerate it well and 7 subjects
developed muscle soreness & stiffness, including neck pain following exercise - these
symptoms gradually abated and did not prevent them from completing the study; 1
subject developed symptoms of a myocardial infarction unrelated to exercise.
Follow-up: 5 & 11 weeks, 1 year
Notes
Authors results and conclusions: Individual group comparisons after 5 & 11 wks. of
intervention on all 3 main outcome measures did not reveal any clear clinically important
or statistically significant differences. Continuance of exercise during the follow-up year,
regardless of type, was associated with a better outcome. For the management of chronic
LBP, trunk exercise in combination with SMT or NSAID therapy seemed to be beneficial
and worthwhile.
Funded by Foundation for Chiropractic Education and Research
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Random group assignments drawn from
sealed opaque envelopes.
Allocation concealment?
Low risk
The allocation process was verified by an independent, professional agent. Comment:
No other information was provided.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind
the patients to other interventions or their
perceptions of potential effectiveness of the
different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to
blind the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item
was scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
”All primary outcome measures were patient-rated and the trunk performance and
range of motion data were obtained by
study-certified clinicians blind to group allocation.“
Spinal manipulative therapy for chronic low-back pain (Review)
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Brønfort 1996
(Continued)
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
At 5 wks (% retained): grp.1 - 87% (62/
71); grp.2 - 85% (44/52); grp.3 - 82% (42/
51)
At 11 wks: grp.1 - 79% (56/71); grp.2 77% (40/52); grp.3 - 71% (36/51)
At 1 year: overall: 72% (not presented for
the individual grps.)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
Free of selective reporting?
High risk
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Low risk
Two patients sought non-study treatment
for LBP during the study period.
Compliance acceptable?
Low risk
Except for the drop-outs, all patients had a
better than 85% compliance rate with medication, SMT sessions and exercise sessions
during the 3 months of the study.
Timing outcome assessments similar?
Low risk
No published protocol was available; recovery not reported. The following were not
reported as a primary or secondary outcome, but reported in the results: percentage of patients achieving a given percentage reduction in pain; return-to-work; side
effects.
Chown 2008
Methods
RCT; unclear allocation treatment assignment
Participants
239 patients randomly allocated to 3 treatment groups; setting: physiotherapy department at one hospital in the United Kingdom; patients referred by the GP or hospital
consultant; recruitment period not stated.
Age (mean (SD)): grp.1 - 44.3 (12.3); grp.2 - 43.5 (12.3); grp.3 - 42.5 (11.9)
Gender (% F): grp.1 - 62%; grp.2 - 57%; grp.3 - 55%
Inclusion criteria: > 3 months of ”simple“ LBP of musculoskeletal origin, without sciatic
symptoms, 18 to 65 years of age.
Duration current episode LBP: not stated, but > 3 months for the population.
Exclusion criteria: > 65 years, serious spinal disorders (e.g. malignancy, osteoporosis,
ankylosing spondylitis), main complaint of pain below the hip, previous spinal surgery,
additional over-riding musculoskeletal disorder, attendance or referral to a specialised
management clinic, medical condition (e.g. cardiovascular disease), anticoagulant treatment, steroid medication, unable to get up from or down to the floor unaided, physical
Spinal manipulative therapy for chronic low-back pain (Review)
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45
Chown 2008
(Continued)
therapy (including. acupuncture) in the previous 3 months.
Interventions
1) Physiotherapy (N = 80): consisting of education/advice; joint mobilization; soft-tissue
mobilisation; McKenzie therapy; neural tension; manual traction; muscle imbalance;
postural correction; isometric stabilisation exercises; global exercise for mobility (+ electrotherapy)
2) Osteopathy (N = 79): consisting of soft-tissue massage; soft-tissue inhibition; softtissue stretch muscle energy; articulation; high velocity thrust manipulation; functional
corrections; exercise advice; education; discussion of psychosocial issues; nutrition/dietary advice.
3) Group exercise with a physiotherapist (N = 80): consisting of problem identification;
basic pathophysiology, anatomy, mechanics; home stretching exercise programme; basic
postural setting use of transversus/multifidus; question and answer session; re-assessment
of subjective and objective markers.
Patients in each group were required to attend 5 tx. sessions within a 3-month period.
Each session was approximately. 30 min. in duration and the format of care was standardized as far as possible.
Outcomes
Pain: not reported; Back-pain specific functional status: Oswestry; Quality of Life: EuroQol EQ-5D; shuttle walk test; satisfaction with the intervention received, satisfaction
with life; recovery - not reported; adverse events - not reported; comment: Outcomes
not defined by the authors as primary or secondary.
Follow-up: 6 weeks after discharge and 12 months.
Notes
Therapists were allowed to choose from the modalities listed above (identified in Table 1
of the article); Group therapy had the worst attendance - with only 40% of the patients
completing all therapy sessions, as compared to 74% for the physiotherapy group and
80% for the osteopathy group; major limitations include problems with recruitment and
retention of the sample.
Authors results and conclusions: All 3 treatments indicated comparable reductions in
mean functional status (Oswestry). Attendance rates were significantly lower among
the group exercise patients. One-on-one therapies provide evidence of greater patient
satisfaction. The study supports the use of a variety of approaches for treatment of chronic
low-back pain, but particular attention needs to be given to problems associated with
attracting enough participants for group sessions.
Funded by St. Albans and Hemel Hempstead NHS Trust Research and Development
Consortium.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Patients were assigned at random to one of
the three therapy regimes by an independent administrator, using block randomisation methods to ensure approximately
equal allocation of patients to each treatment. Random number sequences were
generated from random number tables.
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Chown 2008
(Continued)
Allocation concealment?
Unclear risk
Eligible patients were allocated at random
to one of three therapy regimes: group exercise; physiotherapy; or osteopathy. Note:
No other details were offered as to how this
was performed or by who.
Blinding?
All outcomes - patients?
High risk
It is not clear if attempts were made to
blind patients to the other interventions or
their perceptions of potential effectiveness
of those different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to
blind the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item
was scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
”Where feasible, individuals involved in
the conduct and analysis of the study were
blind to either group membership and/or
baseline assessments. All follow-up assessments were undertaken by an independent
assessor who was blind to baseline measurements and group allocation.“ (Comment:
Attempted blinding would have been limited to assessment and not actual delivery
of care.)
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
The numbers and percentages completing
the therapy regime by group are stated in
Table 3. Group therapy had the worst attendance, with only 40% of patients completing all therapy sessions, compared with
74% within physiotherapy and 80% within
osteopathy.
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
No mention of an ITT analysis; however,
the authors might have chosen not to conduct this given the large percentage of dropouts at the first follow-up measurement (6
weeks).
Free of selective reporting?
High risk
Functional status was the only primary outcome reported.
Similarity of baseline characteristics?
Low risk
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47
Chown 2008
(Continued)
Co-interventions avoided or similar?
Unclear risk
Not stated.
Compliance acceptable?
High risk
In addition to the above item: Investigation
of the reasons for non-completion (Table
4 in article) reveals that the high dropout
rate of patients allocated to group exercise is largely attributable to problems with
waiting and appointment times. Individuals who did not attend a session and did
not subsequently contact the department
were discharged, as local policy dictates.
The 16 ‘other reasons’ included six patients
where further problems were identified, six
patients who were unable to complete the
course, two patients who received more
than six treatment sessions, and one patient
who was expecting surgery.
Timing outcome assessments similar?
Low risk
Evans 1978
Methods
RCT; treatment allocation unclear; Crossover design - consisting of 2 three-week periods.
Participants
36 participants randomly allocated to 2 treatment groups; setting: outpatient department?; participants referred from rheumatological and orthopaedic colleagues; conducted in the UK; period or time of recruitment not presented.
Age: Overall: 25 to 63 years (median - 44.5 years)
Gender (% F): Overall: 53% (17/32)
Inclusion criteria: back pain > 3 weeks, arising from the inferior angles of the scapulae
to the lower sacrum; subjects with femoral or sciatic radiation were allowed. Use of
physiotherapy, surgical corsets, NSAIDs or similar interventions were allowed up to the
screening examination (1 week prior to beginning the study), but the use of various
analgesics (excluding NSAIDs?) was allowed up to entry into the trial (day 1).
Duration of the back pain ranged from 0.2 to 31 years (median 4 years), and the current
attack had been present for 1 1/2 months to 156 months (median 9 months).
Exclusion criteria: subjects with femoral or sciatic nerve root compression signs; use of
NSAIDs in the previous 2 months; spondylitis, inflammatory polyarthritis and any overt
chronic diseases or psychiatric conditions.
Interventions
1) Manipulation (N = 15): delivered by an experienced medically qualified manipulator
using rotational thrust with distraction to both sides; 3 times on weekly interval. No
other information was provided.
2) ”No treatment“ (N = 17): consisting of analgesics.
First tx. phase consisted of SMT + analgesic (codeine phosphate (2 caps of 16 mg.))
versus codeine phosphate alone. After the three week phase, the treatment groups were
reversed. Standardized co-intervention: codeine phosphate.
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48
Evans 1978
(Continued)
Outcomes
Pain (4-point scale: none, mild, moderate, severe); lumbar spine flexion (according to
the method of Macrae and Wright); analgesic consumption (number of codeine capsules
consumed); patient’s assessment of efficacy at the end of the 3-wk. period (4-point
scale: ineffective, equivocal, effective, highly effective); patient’s preference at the end of
the trial; global assessment (4-point scale: deteriorated, no change, slight improvement,
marked improvement); adverse events - reported; comment: Outcomes not defined by
the authors as primary or secondary.
adverse events: There were no side-effects in the control or manipulative treatment
periods except one patient who complained of constipation after having consumed 24
codeine phosphate capsules in the first 4 days.
Follow-up: up to 6 weeks
Notes
Authors results and conclusions: Pain scores were reduced to a significant degree within 4
wks. of starting treatment in the grp. undergoing manipulation during the first treatment
period.
Funded by: Unclear.
The authors worked in various departments. in the UK (Dept. of rheumatology; Dept.
of diagnostic radiology)
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Unclear risk
Patients were allocated according to a random list into two groups. (A & B).
Allocation concealment?
Unclear risk
Note: No other information was provided
on the randomisation procedure or allocation.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind
the patients to other interventions or their
perceptions of potential effectiveness of the
different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to
blind the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item
was scored as ”no“. No mention of trying
to blind any outcome assessors involved in
the study.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
36 Patients entered the trial but four were
lost to follow-up for various reasons, leaving 32. Of these, three defaulted in the final
week, but their results up to that time have
been included.
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Evans 1978
(Continued)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
Not stated.
Free of selective reporting?
High risk
No published protocol; back-pain specific
functional status not reported.
Similarity of baseline characteristics?
Low risk
Baseline gender distribution, age range,
duration of back pain, patient’s height,
weight, site of pain, character of the pain
and the effects of movement, coughing, and
sneezing of the pain were compared (most
of these data were not presented). According to the authors: The distribution of all
these parameters were similar in the two TX
groups and in no instance did the groups
differ from one another significantly.
Co-interventions avoided or similar?
Low risk
Standardized
co-intervention: codeine phosphate 2 caps of 16 mg
when necessary. Pain scores correlated significantly with the number of codeine capsules consumed each week; therefore, number of capsules consumed per group. over
the 3-wk. period were not analysed separately.
Compliance acceptable?
Unclear risk
Not stated.
Timing outcome assessments similar?
Low risk
Ferreira 2007
Methods
RCT; allocation adequately conducted
Participants
240 patients randomly allocated to 3 treatment groups; setting: physical therapy departments at 3 teaching hospitals in Sydney, Australia; recruitment period - May 2002 to
November 2003.
Age: grp.1- 54.8 (15.3); grp.2 - 51.9 (15.3); grp.3 - 54.0 (14.4)
Gender (% F): grp.1- 70.0%; grp.2 - 66.3%; grp.3 - 70.0%
Inclusion criteria: non-specific LBP > 3 months, 18 to 80 years of age. Patients with
osteoarthritis or disc lesions (prolapse, protrusion, or herniation without neurological
compromise) were also eligible.
Duration of LBP: majority of patients across all grps. had > 3 yrs. of LBP.
Exclusion criteria: neurological signs, specific spinal pathology (e.g. malignancy, or inflammatory joint or bone disease) or previous back surgery.
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Ferreira 2007
(Continued)
Interventions
1) General exercise (N = 80). Aim was to improve physical functioning and confidence
in using the spine, and to teach participants to cope with their back problems; exercises
were performed under the supervision of a physical therapist in classes of up to 8 people
with each class lasting approximately 1 hour. The intensity of the exercises was progressed
over the 12 treatments; the class was modelled on the ”Back to fitness“ program described
by Klabber-Moffet and Frost.
2) Motor control exercise (N = 80). Aim was to improve function of specific trunk
muscles thought to control movement of the spine; Each participant was trained by a
physical therapist to recruit the deep muscles of the spine and reduce activity of other
muscles. Initially participants were taught how to contract the transversus abdominis
and multifidus muscles in isolation from the more superficial trunk muscles, but in
conjunction with the pelvic floor muscles. Ultrasonography was used to provide feedback
about muscle recruitment.
Both exercise groups also received cognitive-behavioural therapy. This was designed to
encourage skill acquisition by modelling, the use of pacing, setting progressive goals,
self monitoring of progress, and positive reinforcement of progress. Self-reliance was
fostered by encouraging participants to engage in problem-solving to deal with difficulties
rather than seeking reassurance and advice, by encouraging relevant activity goals, and
by encouraging self-reinforcement.
3) SMT (N = 80). Maitland joint mobilization or manipulation techniques applied by
physical therapists; dose and techniques were at the discretion of the therapist; participants were not given exercises or a home exercise program and were advised to avoid
pain-aggravating activities.
As noted by the authors: Although all physical therapists were qualified to apply all three
interventions, additional training was provided on administration of general exercise,
motor control exercise and spinal manipulative therapy.
All participants were requested to attend up to 12 treatment sessions over an 8 week
period, except for the SMT group, who were allowed to discontinue if their were recovered.
Outcomes
Primary outcome measures (as determined by the authors): Perceived recovery: Global
perceived effect (GPE, presented as a continuous variable, measured on a 11-point scale)
; Patient-specific functional scale (PSFS); Secondary outcome measures: Pain (11-point
VAS); Back-pain specific functional status: Roland-Morris; adverse events - not reported.
Follow-up: 8 weeks, 6 and 12 months
Notes
Authors results and conclusions: The motor control exercise group had slightly better
outcomes than the general exercise group at 8 weeks as did the SMT group. All groups
had similar outcomes at 6 & 12 months. Motor control exercise and SMT produce
slightly better short-term function and perceptions of effect than general exercise, but
not better medium or long-term effects.
Funded by Arthritis Foundation of New South Wales, the Motor Accidents Authority
of New South Wales, and the University of Sydney.
Principal author is a physiotherapist and all authors cited work in physiotherapy departments.
Risk of bias
Bias
Authors’ judgement
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Support for judgement
51
Ferreira 2007
(Continued)
Adequate sequence generation?
Low risk
Randomization was by a random sequence of
randomly permuted blocks of sizes 6, 9 and
15; consecutively numbered, sealed, opaque
envelopes used.
Allocation concealment?
Low risk
The randomisation schedule was known only
to one investigator who was not involved in
recruiting participants, and it was concealed
from patients and the other investigators using
consecutively numbered, sealed, opaque envelopes.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the
patients to other interventions or their perceptions of potential effectiveness of the different
interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item
was scored as ”no“. Below includes the authors
attempt at blinding the ”outcomes assessor“.
Participants reported their outcomes to a trial
physical therapist who was blinded to allocation. The statistician was given grouped data,
but data were coded so that the statistician was
blinded to which group.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
At 8 weeks follow-up (% retained): group 1
- 93% (74/80); grp.2 - 91% (73/80); grp.3 96% (77/80)
At 6 months: grp.1 - 89% (71/80); grp. 2 85% (68/80); grp.3 - 90% (72/80)
At 12 months: grp.1 - 91% (73/80); grp.2 81% (65/80); grp.3 - 91% (73/80)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
Analysis was by intention-to-treat in the sense
that data were analysed for all randomised subjects for whom follow-up data were available.
No attempt was made to impute values for
missing data. Consequently cases with missing
data at a particular follow-up (8 weeks, 6 or 12
months) were dropped from analyses at that
follow-up.
Free of selective reporting?
Low risk
Study
protocol available (ACTRN012605000053628;
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52
Ferreira 2007
(Continued)
see http://www.anzctr.org.au/trial˙view.aspx?
ID=83). All 3 primary outcomes were reported; however, recovery was presented as a
continuous measure.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
Participants in all groups were asked not to
seek other treatments and where possible not
to change current medications for the 8 week
trial period; however, they were permitted to
seek alternate care after the 8 week intervention period.
Compliance acceptable?
Low risk
There was a high degree of adherence to all
three interventions. Of the possible 12 sessions, participants in the general exercise group
attended 9.1 ± 3.9 (mean ± SD) sessions, participants in the motor control exercise group
attended 9.2 ± 3.4 sessions, and participants
in the spinal manipulative therapy group attended 9.8 ± 2.7 sessions.
Timing outcome assessments similar?
Low risk
Ghroubi 2007
Methods
RCT; allocation procedure unclear. 1:1 Randomization scheme.
Participants
64 participants randomly allocated to 2 treatment groups; setting: university hospital
(physical medicine rehabilitation department); study conducted in Tunesia. No statement on period of recruitment.
Age (mean (SD)) overall: 38.2 (9.4) years
Gender (%F): overall - 80%F; 13M
Inclusion criteria: 18-55 years of age; first episode of chronic low-back pain; presenting
at time of palpatory examination with contracture of paravertebral muscles and/or minor
intervertebral derangement. Nature of radiating pain: without sciatica
Duration LBP: range: 16 to 19 months.
Exclusion criteria: if patient had tumour or inflammatory pathology; trauma in the 6
weeks preceding the study; fracture, osteoporosis, lumbosacral radiculopathy or pain radiation into the buttocks, spondylolisthesis, scoliosis, previous spinal surgery, pregnancy,
severe psychiatric illness.
Interventions
1) Spinal manipulation (N = 32): according to the text: the type of manipulation chosen
was dictated by the nature of the initial clinical presentation. Comment: no further description of the training, experience of the manipulator(s?) (physical or manual therapist?
) is given nor the specific technique used.
2) Sham spinal manipulation (N = 32): consisting of putting tension on the spine without
receiving a manipulative impulse or thrust.
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Ghroubi 2007
(Continued)
Both groups underwent 4 treatments (in total), weekly for 4 weeks by the same manipulator. Comment: Probably just one manipulator and delivered the treatment for both
groups (but this is unclear).
Outcomes
Pain: VAS, 10-cm; Back-pain specific functional status: Oswestry; Patient satisfaction
(0 to 100-point scale, ranging from not satisfied to completely satisfied); Schober’s test;
palpatory tenderness with skin rolling; palpatory tenderness of the spinal processes;
contracture of the paravertebral muscles; recovery - not reported; adverse events - not
reported; comment: Outcome measures not defined as primary or secondary by the
authors).
Follow-up: 1 and 2 months
Notes
Authors results and conclusions: Patients receiving true SMT showed significant improvement in pain relief and functional status, which persisted into the second month.
Our study confirms the efficiency of short-term vertebral manipulation for treating
chronic LBP.
Funded by: not stated.
Principal author is medical doctor (physical medicine and functional rehabilitation); one
co-authors is a rheumatologist, and further is unclear.
Study published in French.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Patients randomised by drawing lots. Comment: No further text was provided as to
the actual sequence generation or randomisation procedure nor who was involved and
whether this was performed by an independent researcher.
Allocation concealment?
Unclear risk
Not stated.
Blinding?
All outcomes - patients?
Unclear risk
According to the text, patients were blinded
to treatment, but it is unclear if this was
successfully performed as this was not evaluated at the end of the study.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to
blind the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
Unclear risk
Patient unclear blinding. Outcomes assessed by a blinded outcomes assessor
within the clinic for both follow-up measurements; however, no mention of the success of the blinding by the patients.
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Ghroubi 2007
(Continued)
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
As determined from Table 5 (reporting of
the outcome measures). No drop-outs in
either grp. at the last follow-up interval (2
months).
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
Not reported.
Free of selective reporting?
High risk
No published protocol; recovery not reported.
Similarity of baseline characteristics?
Low risk
Baseline characteristics presented for age,
gender, Schober’s test, Oswestry, duration
LBP, level of pain, profession (no, sedentary or heavy labor), activity levels (sport),
currently receiving other treatments (pain
medication and/or anti-inflammatory 84% for the SMT grp. and 75% for the
sham SMT group.), presence/absence of
derangement or contracture of the paravertebral muscles.
Co-interventions avoided or similar?
Unclear risk
No mention of co-intervention use for either group.
Compliance acceptable?
Low risk
No drop-outs throughout the course of the
study; thus, presumably all patients would
have attended the prescribed number of visits/treatments.
Timing outcome assessments similar?
Low risk
At 1 and 2 months post-baseline.
Gibson 1985
Methods
RCT; method of allocation assignment unclear.
Participants
109 patients randomly allocated to 3 treatment groups; setting: hospital outpatient
department in London, UK; no statement on period of recruitment.
Age (mean(SD)): grp.1 - 34 (14); grp.2 - 35 (16); grp.3 - 40 (16)
Gender (% F): grp.1 -51%; grp.2 - 47%; grp.3 - 32%
Inclusion criteria: LBP greater than 2 months, but less than 12 months.
Duration of the present LBP: Range: 16 to 18 wks. Radiation pattern of pain: unclear.
Exclusion criteria: h/o numbness, paraesthesias, pain worsened by coughing, spondylolysis or -listhesis, treatment elsewhere (excluding use of analgesics), demonstrable neurological deficit, or specific spinal disease (inflammatory, metabolic, or neoplastic).
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55
Gibson 1985
(Continued)
Interventions
1) Osteopathic manipulation and mobilization (N = 41); 2) Short-wave diathermy
(SWD) (N = 34); 3) Placebo (detuned diathermy) (N = 34)
Diathermy: Both active and detuned diathermy were given by one physiotherapist and
consisted of in total 12 treatments per intervention (3 per week for 4 weeks). The detuned
SWD machine was switched on so that the electrical noise and display light gave the
impression that the instrument was in use. The physiotherapist was equally attentive to
patients receiving real and simulated SWD.
The osteopath was a qualified, non-medical practitioner whose attachment to Guy’s
Hospital department of rheumatology for the study was without precedent. He treated
patients once weekly for 4 weeks (thus 4 treatments in total). The osteopathic regimen
included examination, soft-tissue manipulation, passive articulation of stiff spinal segments, and manipulation of the vertebral facet or sacroiliac joints using minimal rotation.
Outcomes
Pain (100-mm VAS - daytime and nocturnal scores); Back-pain specific functional status
- not reported; recovery (% patients pain free); analgesic consumption (% patients);
spinal tenderness (4-point scale, dichotomized to % patients with moderate or severe
tenderness versus none or mild tenderness); lumbar spine flexion (using the method of
Macrae and Wright); return-to-work or activities of daily living (% patients unable to
work or carry out household tasks); adverse events - not reported; comment: Outcomes
not defined as primary or secondary by the authors.
Follow-up: 2, 4, 12 wks.
Notes
Funded by Arthritis and Rheumatism Council; author works in the Dept. of Rheumatology, Guy’s Hospital, London
Authors results and conclusions: More than half of the subjects in each of the 3 grps.
benefited immediately from therapy. Significant improvements were observed in the 3
grps. at the end of 2 wks. tx. and these were still apparent at 12 wks. Benefits obtained
from osteopathy and SWD may have been achieved through a placebo effect.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Unclear risk
The patients were randomly allocated to 3
tx. grps., which were stratified for age and
duration of symptoms.
Allocation concealment?
Unclear risk
Note: no other text was provided on sequence generation or allocation.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind
the patients to other interventions or their
perceptions of potential effectiveness of the
different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to
blind the care providers to the other groups.
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Gibson 1985
(Continued)
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item
was scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
Serial assessments of each patient were
made by one doctor who was unaware of
the treatment allocations. During the study
period 3 different doctors had this role. Patient assessments were carried out immediately before and then 2 and 4 weeks after
the start of treatment, and a final assessment was conducted at 12 weeks (presumably in the clinic).
Patients who did not complete their treatment or did not attend for assessment were
sent a postal questionnaire which asked the
reasons for non-attendance and enquired
about the response to treatment.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
At 2 wks (% retained): grp.1 - 95% (39/41)
; grp.2 - 94% (32/34); grp.3 - 100% (34/
34)
At 4 wks: grp.1 - 95% (39/41); grp.2 - 94%
(32/34); grp.3 - 97% (33/34)
At 12 wks: grp.1 - 93% (38/41); grp.2 79% (27/34); grp.3 - 94% (34/34)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
Not explicitly stated. Participants did not
return for assessment at various intervals
because they were pain-free. It is unclear
from the analysis if these data were included
in subsequent measurements, although it
might appear that these values were ”carried
forward“.
Free of selective reporting?
High risk
No published protocol was available; data
for back specific functional status was not
measured/reported.
Similarity of baseline characteristics?
High risk
Number of patients assigned to the placebo
grp. who needed analgesics, who were unable to work or had restricted ADL’s, who
had moderate or severe spinal tenderness,
or less spinal flexion was (much) higher versus osteopathy or SWD grp. On the other
hand, median pain level and duration of
the pain was similar across the grps.
Co-interventions avoided or similar?
Unclear risk
Not stated.
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(Continued)
Compliance acceptable?
Low risk
Timing outcome assessments similar?
Low risk
Not explicitly stated, but based upon % of
the study grp. retained, it would appear that
compliance was adequate.
Goldby 2006
Methods
RCT; unclear allocation procedure.
Participants
323 patients randomly allocated to 3 treatment groups; setting: 2 physical therapy departments in hospital in the UK; recruitment conducted March 1998 to November
1999.
Age: grp.1 - 43.4 (± 10.7); grp.2 - 41.0 (± 11.7); grp.3 - 41.5 (± 13.0)
Gender % F: grp.1 - 68%; grp.2 - 69.9%; grp.3 - 67.5%
Inclusion criteria: LBP > 12 weeks, age 18 to 65 years, understanding of English.
Duration of the LBP (mean (SD) in yrs.): overall 11.7 (9.9). Radiation pattern of pain:
with or without leg pain (beyond the knee).
Exclusion criteria: non-mechanical LBP; specific spinal condition (stenosis, spondylolisthesis grade III or IV, or recent fracture); significant or worsening neurological deficit;
inflammatory joint disease; lower limb pathology; present or past h/o metastatic disease;
medically unsuitable for exercise class; chronic pain syndrome or h/o > 2 previous lowback surgeries; h/o anxiety neurosis; pregnancy.
Interventions
1) Spinal stabilization rehabilitation program (N = 84): aim was to rehabilitate the neural
control and active subsystems of the lumbar spine’s stabilizing system; ten one-hour
classes were given; max. 12 patients per class.
2) Manual therapy (N = 89): any form of exercise or manual therapy procedure within
the remit of musculoskeletal physiotherapy; however, the therapists were not allowed to
prescribe exercises for the abdominal muscles or pelvic floor, nor were they allowed to
use electrophysical methods; patients were discharged at discretion of the therapist or to
a max.10 sessions.
3) Education (control) ”minimal intervention“ (N = 40): educational booklet ”Back in
Action“.
All groups received Back School, which consisted of 1 group specific 3-hour question
and answer session. The class covered anatomy, biomechanics and lifting, pathologies,
and advice on education, exercise, and general fitness.
Outcomes
Pain: 100-point NRS (back pain, leg pain); Back-pain specific functional status: Oswestry, Low-Back Outcome score; Quality of life: Nottingham Health Profile; Impairment: lumbar flexion (mm); timed walking test; recovery - not reported; adverse events
- not reported.
Note: Outcomes were not defined as primary or secondary by the authors. In addition,
medication use is cited as an outcome in the tables (no. of patients, days per week), but
is not cited in the text.
Follow-up at 3, 6, 12, and 24 months
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Notes
Funded by ”professional organizations“.
Authors results and conclusions: Spinal stabilization is more effective than manually
applied therapy or an education booklet in treating chronic LBP. Both manual therapy
and spinal stabilization program were significantly effective in pain reduction as compared
to an active control.
Principal author is not a physiotherapist, but works in dept. for physiotherapy.
Unclear what techniques were actually used in the manual therapy intervention. i.e.
whether this consisted of mobilization, manipulative or muscle energy techniques.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Numbers were generated using a computer package, Clinstat, and blocks of random numbers were
created.
Allocation concealment?
Unclear risk
After signing informed consent, the research assistant collected the data related to the dependent
variables and informed the researcher of the details required to allocate randomly the subject. At
all times, the research assistant remained blind to
the patients’ group allocation. Patients were randomly allocated to one of the groups using a stratification procedure. Unclear what safeguards were
taken to blind randomisation sequence.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
The research assistant collected the dependent
variables and questions covering activity, socioeconomic conditions and medication. At all times,
the research assistant remained blind to the patients’ group allocation. Outcomes consisted of
self-report measures.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
Follow-up at 3 months (% retained): grp.1 - 93%
(78/84); grp.2 - 96% (85/89); grp.3 - 93% (37/
40)
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At 6 months: grp.1 - 87% (73/84); grp.2 - 85%
(76/89); grp.3 - 63% (25/40)
At 12 months: grp.1 - 85% (71/84); grp.2 - 83%
(74/89); grp.3 - 70% (28/40)
At 24 months: grp.1 - 42% (35/84); grp.2 - 42%
(37/89); grp.3 - 48% (19/40)
Note: percentage drop-out for the 2-year followup varies from Table 1 (those in the table are presumably incorrect because the number of subjects
is incorrect).
Incomplete outcome data addressed?
All outcomes - ITT analysis?
High risk
Not stated in the methods; however, the following
was stated: Of the 346 subjects booked for initial assessment, 44 (12% of the entry population)
were excluded between signing informed consent
and commencing treatment. Of the 302 subjects
remaining, a number (see later) failed to attend
any treatment sessions. Furthermore, some subjects withdrew consent during treatment, and the
researcher withdrew (from the data analysis stage)
those subjects from the 2 active groups (A and B)
who failed to attend more than once.
Free of selective reporting?
High risk
Recovery not reported. No published protocol.
Medication use is cited as an outcome in the tables
(no. of patients, days per week), but is not cited
in the text as an outcome.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
Not stated.
Compliance acceptable?
High risk
There were 17 subjects who failed to attend any
treatment sessions, and 18 were withdrawn for
failing to attend more than once (Table1). Three
subjects in the manual therapy group were prescribed (in error) individual spinal stability exercises. They were also withdrawn from the data
analysis. There was a higher dropout rate for the
education group.
Timing outcome assessments similar?
Low risk
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60
Gudavalli 2006
Methods
RCT; adequate allocation procedure.
Participants
235 patients randomly allocated to 2 treatment groups; setting: two chiropractic and two
orthopaedic clinics in Chicago, USA; recruited via radio and newspaper advertisements,
press releases, cable television advertisements, local posters, and local electronic sign
advertisements; period of recruitment not presented.
Age (mean(SD) in years): grp.1 - 42.2 (11.4); grp.2 - 40.9 (12.8)
Gender (% F): grp.1 - 34.2%; grp.2 - 41.1%
Inclusion criteria: age > 18 years, primary complaint of LBP (from L1 to SI joint), duration longer than 3 months, palpatory tenderness over one or more lumbar zygapophyseal
joints; willing to forego narcotic use during the treatment phase of the study as well as
NSAID use and/or muscle relaxants for 24 h. prior to baseline or at time of outcome
assessment.
Duration of LBP: unclear. Radiation pattern of pain: with or without radiculopathy
Excluded if: evidence of central nervous system (CNS) disease; contraindications to
manual therapy (e.g. severe osteoporosis, lumbar fracture, systemic disease, failed fusion
surgery, inability to undergo physiotherapy or flexion-distraction for any other reason);
psychiatric illness; current or known substance abuse; not fluent and/or illiterate in the
English language; morbidly obese; pregnant; currently receiving care elsewhere for LBP;
treated by chiropractor or PT in the past 6 months; not willing to forego care elsewhere
during the treatment phase; limitation or inability to carry out physical activity without
discomfort.
Interventions
1) Flexion-Distraction (traction and mobilization) (N = 123): performed on specially
constructed table with moveable headpiece, stationary thoraco-lumbar piece, and a moveable lower extremity piece; first component consisted of traction using the flexion ROM
directed at a specific joint level; the second component was a series of mobilization procedures; Patients also received ultrasound and cryotherapy; the intervention was administered by chiropractors with post-graduate certification in this technique.
2) Exercise therapy (administered by licensed physical therapists and consisted of flexion
or extension exercise, weight training, flexibility exercises, and cardiovascular training)
(N = 112). The aim of the program was to strengthen the muscles surrounding the spine
and increase flexibility; methods used for the stabilizing exercises were consistent with
those of O’Sullivan.
Study participants in both treatment grps. were seen 2 to 4 times per week at the discretion
of the treatment provider, for a total of 4 weeks.
Outcomes
Primary outcomes (as defined by the authors): Pain (100-mm VAS); Back-pain specific
functional status (Roland-Morris); Generic general health (SF-36; 8 sub-scales presented
individually as well as overall score). Secondary outcomes: health care utilization, lowback biomechanics, patient satisfaction (3 questions: “Overall, how much were you
helped?”; “In the future, would you return to this type of care?”; “Would you recommend
this type of care to family or friends?”; adverse events - no adverse events or side-effects
were reported by subjects from either intervention. Results presented separately with and
without radiculopathy.
Follow-up: 4 weeks, 3, 6, 12 months
Notes
Authors results and conclusions: Flexion-distraction provided more pain relief than active
exercise; however, these results varied based upon stratification of patients with and
without radiculopathy and with and without recurrent symptoms.
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Funded by Health Resources and Services Administration, National Chiropractic Mutual
Insurance Company.
Principal author works as a researcher at the chiropractic college where the study was
conducted; 3 of the 7 authors are chiropractors, including the principal author.
Significantly more subjects dropped out of the study from the exercise grp.; unclear
how radiculopathy was defined; subjects were not allowed pain medication in the first 4
weeks, but no restriction after that.
Definition of radiculopathy (personal communication with the primary author), although this was not defined in any of their reports: The leg pain category (radiculopathy)
is defined as a patient presentation with symptoms in the lumbar spine and/or leg and
foot region distal to the knee. These patients exhibit hard clinical evidence of neurological involvement such as dermatomal pain or sensory and/or motor deficit usually
involving L4, L5, and S1 nerve roots.“ Nerve root involvement is verified by (1) provocation of symptoms distal to the knee through Valsalva maneuver and the SLR nerve
root tension test (2) reduction in deep tendon reflexes related to the nerve root and (3)
specific muscle weakness related to the nerve root.
In Table 5 of Cambron JA et al J Alternative Compl. Medicine 2006 - Std. errors are
presented instead of the SD (incorrectly stated in the heading of the table).
The authors were also contacted regarding inconsistencies in the follow-up data for the
2 different reports (Gudavalli et al. European Spine J 2006; Cambron et al. J Alt Comp
Medicine 2006). The data reported in Gudavalli (Table 8) is not consistent with the
data reported in Cambron (Table 5). Here, the change scores are presented for the 2
interventions at the various follow-up periods. This cannot be explained by the number
of subjects analysed because they were the same in both reports. No reply was received
regarding further explanation.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Random number tables were used.
Allocation concealment?
Low risk
Sequentially numbered sealed manila envelopes
held each successive randomised treatment
group allocation. At the time of randomisation
the research assistant opened the next numbered
envelope and the subject was allocated accordingly. The allocation sequence was generated by
the clinical co-coordinator. Neither the clinician
who first saw the patient nor the patient who
agreed to participate in the study was involved
in the allocation to intervention group.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the
patients to other interventions or their perceptions of potential effectiveness of the different
interventions.
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Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
The primary outcome measures were self-administered questionnaires distributed by the research assistants. Study participants were given
blank questionnaires at each assessment point
and placed completed forms in an envelope.
Subjects then sealed the envelope and returned
it to the research assistant. Research assistants
remained blinded to outcome data for the entire study period and were counselled by the research investigators and clinical coordinator, regarding the importance of blinding. They were
trained in administration of informed consent
and outcome data retrieval using simulated patients. Meetings between the research co-coordinator, principal investigator and providers responsible for treatment were held on a regular
basis throughout the study to facilitate quality
control. No incidents of unblinding were reported.
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
At 1 month (% retained): grp.1 - 89% (109/
123); grp.2 - 78% (87/112)
At 3 months: grp.1 - 71% (87/123); grp.2 - 68%
(76/112)
At 6 months: grp.1 - 73% (90/123); grp.2 - 70%
(78/112)
At 12 months: grp.1 - 78% (96/123); grp.2 70% (78/112)
A total of 197 subjects (83.4%) completed the
intervention phase. Of the 38 dropouts, 13 were
from FD and 25 from ATEP (exercise grp). Primary reasons for study withdrawal were diminished interest and scheduling difficulties. Table
3 provides these data according to group membership. A difference in proportions test indicated that significantly more subjects dropped
out of the study from ATEP. The majority listed
“no longer interested in participation” as their
reason for withdrawal.
Incomplete outcome data addressed?
All outcomes - ITT analysis?
High risk
ITT analysis was conducted only at the first follow-up measurement (at 4 weeks); subsequent
analyses were ”per-protocol“.
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Free of selective reporting?
High risk
Recovery not reported. No published protocol
was available.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
Not stated.
Compliance acceptable?
Unclear risk
Not stated what was considered acceptable and
how many sessions were attended in the different
groups.
Timing outcome assessments similar?
Low risk
Hemmila 2002
Methods
RCT; adequate allocation.
Participants
132 patients randomly allocated to 3 treatment groups; setting: primary care centre;
recruited by colleagues in a local health center or via articles and announcements in
newspapers; conducted in Finland; period of recruitment February to June 1994.
Age: overall 41.9 years (range 17 to 64)
Gender: 43% F (49/114)
Inclusion criteria: subacute and chronic back pain (> 7 weeks) with and without radiation
below knee; pain between the shoulders and buttocks.
Duration of LBP: mean - 7.5 years; range 60 days to 40 years.
Exclusion criteria: retirement, pregnancy, malignancy, rheumatic diseases, severe osteoarthritis, cauda equina syndrome, back operation, or vertebral fracture in the past
6 months or any condition that would prevent or contraindicate any of the therapies.
None of the study treatments were allowed during the previous month. Patients also had
to have a minimum pain level of 25mm on a 100-mm visual analogue scale (VAS).
Interventions
1) Bone-setting (BS) (N = 45): delivered by 4 folk-healers aged 40 to 70 years with a
practical experience of up to 30 years, but with no formal medical education. The bonesetters were free to choose the methods from their repertoires. The method they most
commonly applied was gentle mobilization of the spine. The patient sits on a stool with
the therapist behind him. The therapist first uses his fingers to find out if the spinous
processes are in line or “dislocated” up or down or on either side. If a vertebra is found
to be “out of alignment,” the patient is asked to bend forward and slowly straighten up
while the therapist holds his thumbs against the transverse processes of the next lower
vertebra, thus presumably mobilizing the upper facet joints. Another common method
is simply to rub the “misaligned” spinous processes gently from all sides to “negotiate”
them into a “correct position.” Massage was applied occasionally. No direct and forceful,
“chiropractic” manipulations were used; mean no. treatments = 8.1 (2.7) The 2002
report states that this therapy is consistent with chiropractic or osteopathy.
2) Physiotherapy (N = 34): combination of manual, thermal, and electrotherapy. The
therapist was free to choose a suitable method within these categories and to use the
facilities at his disposal: hot/cold packs, infrared heat, ultrasound, shortwave diathermy,
and transcutaneous electric nerve stimulation. In addition to massage, he also employed
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Hemmila 2002
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specific mobilizations and manual traction according to the GP’s prescription, but no
manipulations with impulse. Individual auto-stretching exercises were added if indicated;
mean no. treatments = 9.9 (0.7)
3) Home exercises with individual instruction by PT (N = 35); patients were taught a
constant program: to bend their low back rhythmically from side to side and back and
forth as well as to rotate from side to side, ten times in each direction every 1.5 minutes,
whenever sitting, standing, or lying still (e.g., watching TV, driving a car) or at least
before getting up in the morning and after lying down in the evening. The program also
included 10 sit-up, 10 arch-up, and 10 trunk rotation exercises twice a day; mean no.
treatments = 4.5 (2.2)
A maximum 10 1-hour sessions of each therapy was offered; 6-week treatment program.
Outcomes
Pain (100-mm VAS); Back-pain specific functional status (Oswestry); spinal mobility
(Schober); side bending (degrees); extension (degrees); straight leg raising (degrees); pressure pain threshold level (measured by a dolorimeter); pain provocation score (calculated
from the reactions to 13 tests of spinal and lower limb mobility, piriformis provocation
tests, and sacroiliac provocation tests); use of health resources (i.e. visit to health centers,
sick-leave days, percentage of patients sick-listed - from the 2002 publication); recovery
- not reported; adverse events - not reported. (Comments: Outcomes not defined as
primary or secondary by the authors.)
Follow-up: 6 weeks, 3 and 6 months
Notes
Authors results and conclusions: Oswestry disability scores improved most in the bonesetting group. Traditional bone-setting seemed more effective than exercise or physiotherapy for back pain and disability, even one after therapy.
Funded by Finnish Slot Machine Association and conducted in the facilities at the Folk
Medicine Centre of Kaustinen.
The authors recognize that a ”considerable number of patients“ from the exercise and
physiotherapy group switch over to bone-setting after the 6-week treatment period.
2002 publication is the long-term analysis with this data set. In the 1997 report, it
explicitly states that no direct or forceful ”chiropractic“ manipulations were used, while
the 2002 report states that bone setting is consistent with chiropractic or osteopathy. The
physiotherapy grp. was allowed to perform specific mobilizations, but not manipulations
with impulse (cf. bone-setting grp.).
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
drawing sealed lots
Allocation concealment?
Low risk
A study nurse first registered and interviewed the patients,
obtained a written consent, and finally randomised the patients by drawing sealed lots after a general practitioner
had completed the baseline clinical examinations and measurements. The nurse also delivered the questionnaires and
booked the follow-up therapy sessions, keeping the general
practitioner strictly blind to the randomised therapies
Note: this detailed information was found in the follow-up
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study; information on the randomisation procedure were
lacking in the original 1997 study.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to
other interventions or their perceptions of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind the care
providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was scored as
”no“. Below includes the authors attempt at blinding the
”outcomes assessor“.
A single general practitioner, blinded for the therapies, carried out all the physical examinations: before the randomisation and 6 weeks and 6 months later, following the guidelines recommended for occupational health controls.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
At 6 weeks (% retained): grp.1 - 98% (44/45); grp.2 - 100%
(34/34); grp.3 - 100% (35/35)
At 6 months: grp.1 - 98% (44/45); grp.2 - 100% (34/34);
grp.3 - 100% (35/35)
At 1 year: grp.1 - 98% (44/45); grp.2 - 94% (32/34); grp.3
- 91% (32/35)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
ITT analysis conducted, but unclear why data on the acute
low-back pain subjects (N=18) was not included in the
analysis and whether this formed an a priori strategy.
Free of selective reporting?
High risk
No published protocol was available; disability and recovery were not reported.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
High risk
Patients were advised in the beginning not to take any therapy other than that to which they were randomised. One
patient (3%) from the physiotherapy group had consulted
a physiotherapist and 8 (24%) a bonesetter. During followup one patient from the exercise group was operated on for
a herniated disc and one from the bone-setting group was
referred to a rehabilitation center.
From the 1997 publication: 41% of the physiotherapy,
58% of the bone-setting, and 44% of the exercise patients took some form of therapy during the follow-up period (comment: unclear what this therapy consisted of and
whether it was therapy other than to which the patients
were randomised); however, the authors state in the discussion that ”... the exercise and the physiotherapy patients
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Hemmila 2002
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tended to switch over to bone-setting after the 6-week treatment period.“
76% of the physiotherapy patients (N = 26/34), 89% of the
bone-setting patients (N = 40/45), and 57% of the exercise
patients (N = 20/35) did not seek other therapy to which
they were randomised.
Compliance acceptable?
Low risk
Timing outcome assessments similar?
Low risk
Half of the exercise patients reported having done at least
three quarters of the required home exercises during the 6week treatment period. After 3 months 32 exercise patients
(80%), and after 6 months 19 (54%), still reported having
continued the exercises, while 4 (11%) had physiotherapy
and 8 (23%) bone-setting therapy. Twelve bone-setting patients (27%) had continued on bone-setting and 3 (7%)
had received physiotherapy.
Hondras 2009
Methods
RCT; adequate allocation procedure
Participants
240 participants randomly allocated to 3 treatment groups; setting: chiropractic research
clinic; conducted in Iowa, USA; participants recruited via newspaper, radio, television,
community magazines, flyers, direct mail postcards, health fairs, community-based focus
groups, and word of mouth were sources of advertising and promotion. Specialty community publications targeted older adults. Recruitment period: July 2004 - September
2006.
Age (mean (SD)): overall: 63.1(6.7)
Gender (% F): overall: 44%
Inclusion criteria: at least 55 years old, non-specific low-back pain of at least 4 weeks
duration, and met the following diagnostic classification: pain without radiation, radiation to extremity, proximally or radiation to extremity, distally according to the Quebec
Task Force on Spinal Disorders. 85% of the population had LBP without radiation or
LBP w/ radiation to proximal extremity.
Duration LBP episode (mean (range)): 9.6 to 15.1 years.
Exclusion criteria: LBP associated with frank radiculopathy or neurological signs such as
altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle
weakness or motor loss, symptoms of cauda equina compression, or computed tomography or magnetic resonance imaging evidence of anatomical pathology (e.g., abnormal
disc, lateral or central stenosis); comorbid conditions or general poor health that could
significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders,
and clear evidence of narcotic or other drug abuse; major clinical depression defined as
scores greater than 29 on the Beck Depression Inventory-Second Edition; bone or joint
pathology that contraindicated SMT of the lumbar spine and pelvis, including spinal
fractures, tumours, infections, arthropathies, and significant osteoporosis; pacemaker because of safety issues; current or pending litigation related to this LBP episode; receiving
disability for any health-related condition; received SMT for any reason within the past
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month; unwilling to postpone the use of manual therapies for LBP except those provided
during the study; unable to comprehend English.
Interventions
1) High-velocity low-amplitude SMT (N = 96): side-lying diversified lumbar spine
“adjustment” or maneuver. Participants were positioned in a lateral recumbent or sidelying position with the superior or free hip and knee flexed and adducted across the
midline. The intent of the SMT was to isolate one or more vertebral segments. The
impulse load was delivered by a quick, short, controlled movement of the shoulder, arm
and hand combined with a slight body drop.
2) Low-Velocity Variable Amplitude Spinal Mobilization (N = 95): flexion-distraction
technique or Cox technique. Participants were positioned prone on a treatment table
that was designed to allow free but controllable motion to the lower half of the participant’s body. The distal section of the table also allowed the chiropractor to apply
traction to the lumbar spine. During this maneuver, the intent was to stabilize a specific
vertebra by applying anterior to posterior and cephalad pressure to the spinous process.
Simultaneously, the chiropractor moved the lower mobile portion of the table through
the ranges of motion normal to the human spine.
3) Medical care (N = 49): All participants were scheduled to attend visits at week 3 and
6 to be evaluated by the medical provider and complete questionnaires. Additional visits
were scheduled at the discretion of the medical provider. The goal of pain management
was improvement in pain and optimisation of activities of daily living. The first option
was paracetamol (acetaminophen), followed by NSAIDs and muscle relaxants.
Home Exercise Instruction: During week 3, the medical or chiropractic provider delivered
30 minutes of standardized instructions for a home exercise program to all participants
enrolled in the trial. The exercise prescription guidelines were tailored to individual
participant ability and instructed participants to begin an aerobic program as well as
low-back stretching and strengthening exercises. Participants were given a handout with
pictures of 7 low-back exercises, with the number of sets and repetitions tailored and
delineated for each participant.
Participants receiving SMT or mobilisation were allowed to receive a maximum of 12
visits (not to exceed 3 times per week for the first 2 weeks, 2 times per week for the third
and fourth weeks, and once per week during weeks 5 and 6) versus 3 visits of medical
care. Four chiropractors delivered the chiropractic txs versus one medical physician who
delivered this aspect of care.
Outcomes
Primary outcome (as determined by the authors): Back-pain specific functional status
(Roland-Morris); Secondary outcomes: Pain (100-mm VAS); sub-scale of the FABQ;
perceived recovery (11-point, verbal rating scale) - presented as a continuous outcome
measure; SF-36 - physical function sub-scale. Adverse events were also reported but not
listed as a primary or secondary outcome.
Adverse events: A total of 21 side-effects were reported by 20 participants - all resolved
within 6 days and none required referral for outside care, although one participant from
the medical group was referred for slurred speech. Side-effects were similar in the 2 SMT
groups and consisted mostly of LBP soreness and stiffness.
Follow-up at 3, 6, 12, 24 weeks
Notes
Authors results and conclusions: Distinct forms of spinal manipulation did not lead to
different outcomes in older LBP patients and both SMT procedures were associated
with small yet clinically important changes in functional status by the end of treatment.
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Participants who received either form of SMT had improvements on average in functional
status ranging from 1 to 2.2 points over those who received conservative medical care.
Funded by Bureau of Health Professions Health Resources and Services Administration,
Rockville, MD, USA; and the work was conducted in a facility constructed with support
from Research Facilities Improvement Program from the National Center for Research
Resources, National Institutes of Health, Bethesda, MD, USA.
Primary author is a chiropractor and 3 of the 5 team members are chiropractors. All
authors work at a chiropractic institution.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Participants were randomly assigned by study coordinators through a Web interface to the adaptive computer generated randomisation to one
of 3 interventions in a 2:2:1 treatment allocation ratio: HVLA-SMT, mobilization or medical care, respectively. All future assignments
were concealed. Participant characteristics between groups were balanced by minimizing the
baseline characteristics.
Allocation concealment?
Low risk
Comment: allocation was conducted through
computer interface.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
Assessments at baseline and weeks 3 and 6 (end
of active care) were via self-administered questionnaires at the research clinic. Assessments at
12 and 24 weeks were administered via computer-assisted telephone interviews by trained interviewers who were masked to treatment assignment.
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
Disconcordant drop-out in the medical intervention grp.
At 3 wks. Follow-up (% retained): grp.1 - 98%
(94/96); grp.2 - 92% (87/95); grp.3 - 65% (32/
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49)
At 6 wks: grp.1 - 96% (92/96); grp.2 - 90% (85/
95); grp.3 - 59% (29/49)
At 12 wks: grp.1 - 97% (93/96); grp.2 - 90%
(85/95); grp.3 - 76% (37/49)
At 24 wks: grp.1 - 93% (89/96); grp.2 - 91%
(86/95); grp.3 - 67% (33/49)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
Multiple imputation procedure was used for
missing data, subsequently the regression coefficients and P values between the results based on
the original analyses that were performed on all
available data were compared with that based on
the multiple imputations. The results between
the multiple imputation analyses were very similar to the original analyses for all outcomes; therefore, only the results from the original analyses
are reported.
Free of selective reporting?
Low risk
protocol published and available; all 3 primary
outcomes reported.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
Not stated.
Compliance acceptable?
High risk
Not acceptable for the medical grp. Less than
half attended all 3 prescribed visits, while 16%
did not attend any visits; 20% withdrew from
the study at some point during the 6-week active
care period.
Eighty-three (86%) participants in the HVLASM group and 79 (83%) in the LVVA-SM group
completed 12 intervention visits. An additional
10 and 7 completed at least 10 visits in the 2
groups, respectively. Eight (16%) participants in
the MCMC group did not attend any of their
scheduled visits with the medical provider, 17
(35%) had one visit, 32 (65%) had 2 visits, 23
(47%) had 3 visits, and 4 (8%) had one extra
visit. Of those who had at least one visit, 5 did
not receive a prescription for their LBP, 27 were
prescribed Celebrex, 5 Aleve, 3 Bextra, and one
Naproxen.
Timing outcome assessments similar?
Low risk
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Hsieh 2002
Methods
RCT; unclear allocation procedure
Participants
206 subjects randomly allocated to 4 treatment groups; setting: outpatient physical
therapy clinic at the University of California Irvine Medical Center (UCIMC) and the
Center for Research and Spinal Care at the Los Angeles College of Chiropractic (LACC),
California, USA; participants recruited via public announcements and advertisements in
major local newspapers and local radio stations as well as distribution of study brochures
between May 8, 1996 and June 30, 1998.
Age (mean (SD)): grp.1 - 47.9 (13.7); grp.2 - 49.0 (14.8); grp.3 - 47.4 (14.0); overall 48.4 (13.7)
Gender (% F): grp.1 - 40%; grp.2 - 33%; grp.3 - 33%; overall - 33%
Inclusion criteria: 18 years of age or older, LBP duration of more than 3 weeks and less
than 6 months for the current episode or a pain-free period of at least 2 months in the
preceding 8 months for recurrent LBP.
Duration of the current episode (in Table 1 under the heading ”Pain (wk)“): range: 10.7
to 11.8 wks. (Note: this was confirmed by an e-mail to the principal investigators).
Exclusion criteria: pregnancy; serious medical problems (e.g., advanced cancer, heart
failure); definable neurologic abnormalities in the lower extremities (e.g., peripheral neuropathy, multiple sclerosis, hemiplegia, myelopathy); spine disorders with bony lesions
(e.g., osteoporosis, fracture, unstable spondylolisthesis, multiple myeloma), with radiographs were taken as clinically indicated; significant mental disorders (e.g., psychosis,
mania, major depression), as indicated by telephone inquiry and clinical interview; obesity (a Davenport body mass index exceeding 33 kg per meter of height1); leg pain with
positive nerve root tension test results; litigation; automobile injuries; work injuries;
inappropriate illness behavior (positive Wadell’s sign); anticoagulant therapy; history of
lumbar surgery; and use of the study treatments for the current episode.
Interventions
1) Back school (N = 48): Each patient received the intervention once per week for a
total of 3 weeks. During the first treatment visit, the patient watched three videos about
spine anatomy, common causes of LBP, and body mechanics for daily activities.23 Subsequently, the patients received individual instructions and supervised practice of their
home program by experienced licensed physical therapists and trained experienced licensed chiropractors. These programs included recommended sitting and standing neutral postures, body mechanics, and home exercises (lumbar flexion, extension, stretching,
and stabilization).
2) Myofascial therapy (N = 51): Each patient received therapy three times per week
for 3 weeks. Trained clinicians (physical therapists and chiropractors) performed the
myofascial therapy at each facility. The myofascial therapy program included intermittent
Fluori-Methane sprays and 5 to 10 stretches after 3 to 5 seconds of each isometric
contraction at 50 to 70% of their maximal effort, ischemic compressions using a massage
finger, stripping massage along the orientation of the taut bands by the two thumbs for
3 to 5 strokes, and hot packs for 10 minutes at the completion of therapy. The involved
lumbar paraspinal or gluteal muscles, as indicated by the examiner on the Assessment
Recommendation form, were treated. Additional muscles also could be treated if clinically
indicated.
3) Joint manipulation (N = 49) : Each patient received therapy three times per week for 3
weeks. Experienced licensed chiropractors with a 5-year minimum of clinical experience
delivered joint manipulation at both sites. The joint manipulations, consisting of high
velocity and short-amplitude specific thrusting manipulations (the “Diversified” tech-
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Hsieh 2002
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nique), were performed in the lumbar and/or sacroiliac regions (i.e., the tender locations
indicated by the examiner on the Assessment recommendations form or other levels
clinically deemed by chiropractor to need therapy). Side or sitting posture was allowed.
Drop table techniques also were allowed. All treatments were given on Leander Model
900 EZ Tables. No flexion distraction or mobilization was allowed.
4) Combination of treatments 2 & 3; N = 52
Outcomes
Primary outcomes (as defined by the authors): Pain (visual analogue scale); Back-pain
specific functional status (Roland-Morris). Secondary outcomes: General health (36Item Short-Form Health Survey); Minnesota Multiphasic Personality Inventory; confidence score and satisfaction; work or school lost days; adverse events; recovery - not
reported. Results for the secondary outcome measures showed no apparent pattern and
produced scattered statistically significant effects (according to the authors) - These data
were not available in the publications.
adverse events - 23 patients reported adverse effects from the treatments: 7 in the combined group, 6 in the joint manipulation group, 4 in the myofascial therapy group, and
6 in the back school group. These adverse effects were mostly transient exacerbations
of symptoms, except for one case of constant tinnitus in the myofascial therapy group.
Two of the patients claimed that treatment (joint manipulation) had aggravated their
conditions. Both received conservative care at no charge after 3 weeks of therapy and
were released when their pain became stabilized.
Follow-up: 3 weeks and 6 months
Notes
Authors results and conclusions: All groups showed significant improvement in pain and
functional status following 3 weeks of care, but did not show further improvement at
6 months. For subacute low-back pain, combined joint manipulation and myofascial
therapy was as effective as joint manipulation or myofascial therapy alone. Additionally,
back school was as effective as three manual treatments.
Funding: Human Resources and Service Administration, the Public Health Service, the
Dept. of Health and Human Services, the Foundation for Chiropractic Education and
Research, Leander Health Technologies (supplies chiropractic tables), and the Lloyd
Table Company (also supplies chiropractic tables).
Note: the duration of the current LBP is presented in Table 1 under ”Pain (wk)“
Follow-up to a similar study by these authors published in 1992 on subacute low-back
pain.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
After acceptance into the study, patients were randomised into one of four treatment groups using
a computer program designed to balance allocation of patients according to age, gender, duration of LBP, and treatment preference for physical
therapy or chiropractic. Randomization was performed separately at each site.
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Allocation concealment?
Unclear risk
No other information was provided, e.g. whether
the person who performed the allocation was an independent examiner; whether consecutively numbered, sealed opaque envelopes were used during
allocation, etc.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Below includes the authors attempt
at blinding the ”outcomes assessor“.
Blinded independent examiners (physiatry residents at UCIMC and chiropractic residents at
LACC) performed assessments (of the outcome
measures) 1 to 2 days before the treatment started,
1 to 2 days after 3 weeks of care, and 6 months after
the care. Five monthly telephone follow-up evaluations were conducted regarding work or school
days lost, current pain level (0-10), use of health
care services, and the Roland-Morris activity score.
For this study, the primary efficacy variables were
VAS pain and Roland-Morris activity scores.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
92% (184/200) returned after 3 weeks of care and
89% (178/200) returned at 6 months.
At 3 wks (% retained): grp.1 - 88% (42/48); grp.2
- 96% (49/51); grp.3 - 94% (45/48); grp.4 -92%
(48/52)
At 6 months: grp.1 - 88% (42/48); grp.2 - 92%
(47/51); grp.3 - 83% (40/48); grp.4 -94% (49/52)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
Free of selective reporting?
Unclear risk
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Low risk
Spinal manipulative therapy for chronic low-back pain (Review)
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No published protocol available. Recovery not reported.
During the 3-week trial period, only a minor proportion of the patients (10%) reported use of overthe-counter pain medications (e.g., ibuprofen, ac73
Hsieh 2002
(Continued)
etaminophen). Six patients reported eight visits to
health care practitioners. Among these, two visits
were related to LBP. Therefore, treatment contamination was insignificant.
After 3 weeks of therapy, 12 patients reported continuing care for LBP: 5 patients in the combined
therapy group, 1 patient in the joint manipulation group, 3 patients in the myofascial therapy
group, and 3 patients in the back school group.
Altogether, 33 visits were reported: 16 visits in the
combined therapy group, 1 visit in the joint manipulation group, 13 visits in the myofascial therapy group, and 3 visits in the back school group.
During the study, 18 health care practitioners were
consulted: 8 chiropractors, 5 medical doctors, 2
physical therapists, 1 osteopath, 1 acupuncturist,
and 1 foot reflexologist.
Compliance acceptable?
High risk
Disconcordant compliance across the different
therapies.
Full compliance was noted for 90% (47/52)
treated patients in the combined therapy group,
88% (43/49) treated patients in the joint manipulation group, 92% (47/51) treated patients in
the myofascial therapy group, and 69% (33/48)
treated patients in the back school group. The back
school group was the least compliant.
Timing outcome assessments similar?
Low risk
After 3 weeks of treatment and at 6 months followup.
Hurwitz 2002
Methods
RCT; adequate randomisation procedure
Participants
681 patients randomly allocated to 4 treatment groups; setting: health care network;
conducted in California, USA; participants recruited during the period October 1995
to November 1998.
Age (years) (mean (SD)): overall: 51.0 (16.7)
Gender (% F): overall: 52%
Inclusion criteria: eligible if 1) were health maintenance organization (HMO) members
with the medical group chosen as their health care provider; 2) sought care from a health
care provider on staff at one of the three study sites during the intake period; 3) presented
with a complaint of low-back pain (defined as pain in the region of the lumbosacral
spine and its surrounding musculature) with or without leg pain; 4) had not received
treatment for low-back pain within the previous month; and 5) were at least 18 years
old.
Duration LBP (total - for all 4 groups): 58.3% with symptoms longer than 3 months.
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Exclusion criteria: if 1) had low-back pain resulting from fracture, tumour, infection,
spondyloarthropathy, or other non-mechanical cause; 2) had severe coexisting disease;
3) were being treated by electrical devices (e.g., pacemaker); 4) had a blood coagulation
disorder or were using corticosteroids or anticoagulant medications; 5) had progressive,
unilateral lower limb muscle weakness; 6) had current symptoms or signs of cauda equina
syndrome; 7) had plans to move out of the area; 8) were not easily accessible by telephone;
9) lacked the ability to read English; or 10) if their low-back pain involved third-party
liability or workers’ compensation.
Interventions
1) Medical Care Only (N = 170). Consisted of one or more of the following at the
discretion of the medical provider: instruction in proper back care and strengthening and
flexibility exercises; prescriptions for pain killers, muscle relaxants, anti-inflammatory
agents, and other medications used to reduce or eliminate pain or discomfort; and
recommendations regarding bedrest, weight loss, and physical activities.
2) Chiropractic Care Only (N = 169). Consisted of spinal manipulation or another
spinal-adjusting technique (e.g., mobilization), instruction in strengthening and flexibility exercises, and instruction in proper back care. Chiropractic practice at the study
site is consistent with chiropractic philosophy and training throughout the USA. The
chiropractors routinely used the diversified technique, which is the general type of spinal
manipulation taught in most chiropractic schools and is the most frequently used form
of manipulation.
3) Medical Care with Physical Therapy (N = 170). Patients assigned to this group
received medical care as described above, instruction in proper back care from the physical
therapist, plus one or more of the following at the discretion of the physical therapist:
heat therapy, cold therapy, ultrasound, electrical muscle stimulation (EMS), soft-tissue
and joint mobilization, traction, supervised therapeutic exercise, and strengthening and
flexibility exercises. All physical therapy was administered in the medical group’s physical
therapy dept. and supervised by a licensed physical therapist.
4) Chiropractic Care with Physical Modalities (N = 172). Patients assigned to this group
received chiropractic care as described above plus one or more of the following at the
discretion of the chiropractor: heat or cold therapy, ultrasound, and EMS.
The specific therapies received by patients varied within each treatment group, and our
study protocol did not prescribe the type or amount of care that should be received by
participating patients. Frequency of medical and chiropractic visits were at the discretion
of the medical provider or chiropractor assigned to the patient. Frequency of physical
therapy visits was at the discretion of the supervising physical therapist.
Outcomes
Primary outcomes (as defined by the authors): Pain (11-point NRS, avg. and most severe
pain in the past week); Back-pain specific functional status (Roland-Morris); complete
remission (defined as the first observation during follow-up in which the above outcome
variables were zero (i.e. no low-back pain in the past week and no related disability).
Secondary outcome was perceived recovery (4-point scale - ”a lot better“, ”a little better“,
”the same“, and ”worse“); adverse events - not reported.
Reported (but not listed as primary or secondary outcomes): frequency of pain and
disability days, and use of medication across the groups.
Follow-up at 2 & 6 weeks, 6 months
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Notes
Authors results and conclusions: The mean changes in LBP intensity and disability of
participants in the medical and chiropractic care-only groups were similar at each followup assessment. Physical therapy yielded somewhat better 6-month disability outcomes
than did medical care alone. After 6 months of follow-up, chiropractic care and medical
care for LBP were comparable in their effectiveness. Physical therapy may be marginally
more effective than medical care alone for reducing disability in some patients, but the
possible benefit is small.
Funded by Agency for Healthcare Research and Quality (AHRQ) and the Southern California University of Health Sciences (Note: chiropractic college). The principal author
was supported by a grant from the National Center for Complementary and Alternative
Medicine (NCCAM).
Principal author is a chiropractor and 2 of the 6 authors are chiropractors.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
The study statistician ran a computer program to generate randomised assignments
in blocks of 12, stratified by site. The statistician placed each treatment assignment in
a numbered security envelope. A separate
series of sequentially numbered sealed envelopes was provided for each of the three
sites.
Allocation concealment?
Low risk
When each patient consented to be in the
study, the field coordinator opened the sitespecific envelope in sequence and documented the patient for whom the assignment was made and the time of the assignment.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind
the patients to other interventions or their
perceptions of potential effectiveness of the
different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to
blind the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item
was scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
Follow-up questionnaires mailed to the participants at the follow-up times, which addressed the primary and secondary outcomes.
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(Continued)
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
At 2 wks (% retained): grp.1 - 100% (170/
170); grp.2 - 100% (169/169); grp.3 - 99%
(169/170); grp.4 - 99% (171/172)
At 6 wks: grp.1 - 99% (169/170); grp.2 100% (169/169); grp.3 - 99% (168/170);
grp.4 - 98% (169/172)
At 6 months: grp.1 - 97% (165/170); grp.2
- 98% (165/169); grp.3 - 94% (159/170);
grp.4 - 95% (163/172)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
No attempt was made to impute for missing
values.
Free of selective reporting?
Low risk
No published protocol, but all primary outcomes (pain, functional status, and recovery) were reported.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
High risk
Approximately 20% of patients in the chiropractic groups received concurrent medical care, whereas 7% of patients in the medical groups received concurrent chiropractic
care in the first 6 weeks. None of the chiropractic patients assigned to the chiropractic
grp. only also received physical therapy, as
opposed to approximately 3% of the medical patients assigned to receive medical care
only who also received physical therapy.
Compliance acceptable?
High risk
The specific therapies received by patients
varied within each treatment group and the
study protocol did not prescribe the type or
amount of care that should be received by
participating patients. Frequency of medical and chiropractic visits were at the discretion of the medical provider or chiropractor. Frequency of physical therapy visits was
at the discretion of the supervising physical
therapist.
Ninety-nine percent of patients had at least
one visit to their assigned chiropractic or
medical provider; however, about one-third
of patients randomly assigned to medical
care with physical therapy had no physical
therapy visits.
Timing outcome assessments similar?
Low risk
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Koes 1992
Methods
RCT; adequate allocation procedure
Participants
256 participants randomly allocated to 4 treatment groups; setting: private clinics of
treating therapists and clinic of participating general practitioners; conducted in the
Netherlands; participants recruited via an advertisement and those presenting to the GP;
period of recruitment - January 1988 to December 1989.
Age ((mean) years): overall: 43
Gender (% F): overall: 48%
Inclusion criteria: participants with non-specific back and neck pain for at least 6 weeks;
no physiotherapy or manipulative therapy had been received in the past two years for
back and neck complaints; and the complaint could be reproduced by active or passive
physical examination; no radiation below knee.
Duration present episode LBP (median, overall): 1 year
Exclusion criteria: suspicion of underlying pathology (e.g. metastasis, osteoporosis, herniated disc); received physiotherapy or manual therapy for their back or neck complaints
in the 2 yrs. prior; pregnancy; were unable to speak and read Dutch; or the complaints
could not be reproduced by active or passive movements during the physical examination.
Interventions
1) Manipulation and mobilization (according to directives of the Dutch Society for
Manual Therapy = physiotherapists trained in manipulative techniques) (N = 65): 7
manual therapists involved; no. tx: average 5.4, mean duration tx: 8.9 weeks
2) Physiotherapy (N = 66): consisting of exercises, massage, heat and electrotherapy; the
majority of patients received exercise and massage; 8 physiotherapists involved; no. tx:
average 14.7, mean duration tx: 7.8 weeks
3) Placebo (N = 64): consisting of detuned short-wave diathermy and detuned ultrasound; no. tx: average 11.1, mean duration tx: 5.8
4) General practitioner (N = 61): consisting of advice about posture, analgesics, exercises,
participation in sports, bed rest, etc; 40 GP’s involved; no. tx: 1
After 6 wks, the patients returned to the GP with a written report from the MT or PT in
order to discuss the results and to decide whether the tx. should be continued or altered.
All treatments were given for a maximum of 3 months.
Outcomes
According to the authors in the sequence of importance (outcomes were not defined as
primary or secondary): Severity of the complaint (10-point scale, measured by a blinded
research assistant and consisted of scored based upon the anamnese and physical exam)
; global perceived effect (6 point scale, presented as a continuous variable); pain (West
Haven-Yale Multidimensional Pain Inventory, 6 point sub-scale); generic functional status (Sickness Impact Profile); spinal mobility and physical functioning (degrees); adverse
events - not reported.
Follow-up: 3, 6, 12, 26 & 52 weeks
Notes
Authors results and conclusions: Both physiotherapy and manual therapy decreased
the severity of complaints more and had a higher global perceived effect compared to
continued treatment by the GP. Differences in the effectiveness between physiotherapy
and manual therapy could not be shown.
Funded by Dutch Ministry of Welfare, Health and Cultural Affairs
Principal author is epidemiologist.
LBP data was provided from Gert Bronfort.
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Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Randomization per stratum occurred by use of
list of random numbers. Prestratification by location of the complaint and residence was further carried out to prevent unequal distribution.
Within each stratum, the random assignment
was performed in blocks of eight.
Allocation concealment?
Low risk
Randomization was carried out be a second research assistant
Blinding?
All outcomes - patients?
High risk
Patients were blinded to the placebo therapy
only, but not blinded to the other therapies.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
Physical functioning (e.g. range of motion) was
assessed by a research assistant, blinded to treatment allocation and to the previous scores.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
At 3 wks (% retained): grp.1: 98% (64/65); grp.2
- 97% (64/66); grp.3 - 92% (59/64); grp.4 - 93%
(57/61)
At 6 wks: grp.1: 98% (64/65); grp.2 - 94% (62/
66); grp.3 - 91% (58/64); grp.4 - 90% (55/61)
At 12 wks: grp.1: 95% (62/65); grp.2 - 92% (61/
66); grp.3 - 88% (56/64); grp.4 - 89% (54/61)
At 6 mos: grp.1: 89% (58/65); grp.2 - 83% (55/
66); grp.3 - ?; grp.4 - ?
At 12 mos: grp.1: 85% (55/65); grp.2 - 74% (49/
66); grp.3 - ?; grp.4 - ?
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
Free of selective reporting?
High risk
Similarity of baseline characteristics?
Low risk
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
No published protocol available; back-pain specific functional status not examined.
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Co-interventions avoided or similar?
High risk
Contamination and co-interventions mainly occurred among patients in the placebo and general
practitioner grp. Seven patients in the placebo
grp. received physiotherapy before the 3-week
follow-up; one due to an administrative error,
one due to unmasking of the placebo by the patient, and 5 because the therapist decided that
giving the placebo was not appropriate for the
patient in question.
4 patients in the GP grp. received physiotherapy or manual therapy before the 3-week followup; one because the patient did not want treatment by the GP, one because the GP carried out
manual therapy himself, and two because the GP
thought that a referral was more appropriate.
At the 6-week follow-up, these figures appeared
to be slightly higher. Between the 6- and 12-week
follow-up, a considerable number of patients in
the placebo and GP grp. changed from the assigned therapy.
In the physiotherapy and manual therapy grp.,
these changes occurred considerably less often.
Compliance acceptable?
Unclear risk
All therapists were free to choose from their usual
therapeutic domains and prescribe TX plans.
Unclear how many txs were prescribed.
Timing outcome assessments similar?
Low risk
Licciardone 2003
Methods
RCT; allocation not properly performed.
Participants
91 patients randomly allocated to 3 treatment groups; setting: university-based osteopathic clinic in USA; recruitment - January 2000 to February 2001 using advertising in
local newspapers and referrals from university-based clinics and from other local physicians.
Age (mean in years (SD)): grp. 1 - 49(12); grp. 2 - 52(12); grp. 3 - 49(12)
Gender (%F): grp. 1 - 69; grp. 2 - 57; grp. 3 - 65
Included if: constant or intermittent, non-specific low-back pain for at least 3 months,
between 21-69 years of age; subjects with sciatica were included only if they tested
negative for all of the following: 1) ankle dorsiflexion weakness; 2) great toe extensor
weakness; 3) impaired ankle reflexes; 4) loss of light touch sensation in the medial, dorsal,
and lateral aspects of the foot; 5) ipsilateral straight-leg-raising test (positive result: leg pain
at 60°); 6) crossed straight-leg raising test (positive result: reproduction of contralateral
pain).
Duration LBP: range - 39% to 63% with LBP > 1 yr.
Excluded if: specific causes of LBP (e.g. fracture, herniated disc, cauda equina, spinal
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osteomyelitis); surgery on the low-back within the preceding 3 months; receiving workers’
compensation or involved in litigation related to the low-back; pregnant; former patient
or employee of the trial clinic site; undergone spinal manipulation in the preceding 3
months or on more than three occasions in the preceding year.
Interventions
1) Orthomanual (or osteopathic) therapy (OMT) (N = 48) - sessions lasted 15 to
30 minutes, and the OMT was performed by pre-doctoral osteopathic manipulative
medicine fellows. The techniques included one or a combination of the following: myofascial release, strain-counterstrain, muscle energy, soft tissue, high-velocity-low-amplitude thrusts, and cranial-sacral. The OMT was aimed at somatic dysfunction in the low
back or adjacent areas.
2) Sham manipulation (N = 23) - subjects received treatments according to the same
protocol and timetable as OMT group. Treatment included range of motion (ROM)
activities, light touch, and simulated OMT techniques. This latter consisted of manually
applied forces of diminished magnitude aimed purposely to avoid treatable areas of
somatic dysfunction and to provide minimal likelihood of therapeutic effect.
3) No-intervention control (N = 20) - allowed to receive usual care (Comment: There
was no personal interaction with the no-intervention control group after the baseline
assessment, data collection, and randomisation (personal communication with the primary author)).
Osteopathic and sham manipulation subjects were treated for a total of seven visits over
5 months, including visits at 1 week, 2 weeks, and 1 month after baseline assessment,
and then monthly thereafter.
All subjects regardless of grp. assignment were allowed to receive usual or other lowback care to complement the trial interventions, with the exception of other OMT or
chiropractic manipulation.
Outcomes
Primary outcome measures (as determined by the authors): Pain: VAS (0 to 10cm); Backpain specific functional status: Roland-Morris; Generic health status: SF-36; lost work
or lost school days due to LBP; number of co-treatments; current back-pain specific
medication use; global satisfaction w/ the care; 8 of the sub-scales from the SF-36 were
considered among the primary outcomes (e.g. physical functioning, bodily pain, general
health, vitality, etc); recovery - not reported; adverse events - not reported
Follow-up: 1, 3, 6 months
Notes
Authors results and conclusions: OMT and sham manipulation both appear to provide
some benefits when used in addition to usual care for treatment of chronic nonspecific
LBP. It remains unclear whether the benefits of OMT can be attributed to the treatment
techniques or other aspects of the treatment.
Funded by American Osteopathic Association.
5 of the 6 authors, including the principal author are osteopaths.
Primary author was contacted for data on VAS and RMDQ at the various follow-up
measurements that was not clearly reported in the article - this data was received. Predoctoral fellows may not have had sufficient practical experience to provide OMT w/
the same efficacy as more seasoned practitioners or to provide non-therapeutic sham
manipulation; low baseline RMDQ scores
Risk of bias
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Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Randomization was performed using sequential sealed envelopes prepared by the
clinical research technician before enrolment of the subjects. The subjects were assigned randomly to one of three treatment
groups in an approximate 2:1:1 ratio: OMT,
sham manipulation, or no intervention as a
control condition. The intent of this allocation strategy was to enrol comparable numbers of subjects receiving OMT and not receiving OMT, and subsequently to combine
the sham manipulation and no-intervention
control groups should no statistically significant differences be observed between the
latter groups.
Allocation concealment?
Unclear risk
The treating pre-doctoral osteopathic manipulative medicine fellows subsequently
opened the sealed envelopes and recorded
the allocation of subjects as they entered
the trial. All trial personnel with the exception of the osteopathic fellows were blinded
to treatment group assignments throughout
the trial. Note: Unclear, but appears that
those who determined allocation were also
involved in the actual treatment.
Blinding?
All outcomes - patients?
Unclear risk
Subjects assigned to sham manipulation
were blinded to the therapy; however, no
mention by the authors of post-treatment
evaluation of the success of blinding by the
patients (comment: confirmed via contact
with the principal author). The authors do
mention that they tried to ensure that the
protocol for the real and sham treatment
were carried out as prescribed.
Blinding?
All outcomes - providers?
High risk
Care providers were not blinded.
Blinding?
All outcomes- outcome assessors?
Unclear risk
Unclear blinding of the patient; therefore,
here it is unclear.
All trial personnel, with the exception to the
osteopathic fellows, were blinded to treatment group assignments throughout the
trial. In the no-intervention control group,
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follow-up was via postal questionnaires and
not during a visit to the clinic (as opposed to
the other treatment groups). No post-treatment interview (or questionnaire) was conducted to assess success of blinding by the
patients.
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
At 1 month (% retained): OMT (42/48) =
88%; sham (23/23) = 100%; control (17/
20) = 85%
at 3 months: OMT (36/48) = 75%; sham
(19/23) = 83%; control (16/20) = 80%
at 6 months: OMT (32/48) = 67%; sham
(19/23) = 83%; control (15/20) = 75%
No explanations were offered for individuals
that dropped-out.
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
Not stated and no attempt was made to impute for missing cases.
Free of selective reporting?
High risk
(According to the authors) 14 primary outcomes: Pain (10-cm VAS); Back-pain specific functional status: Roland-Morris; SF36 (8 sub-scales, incl. physical functioning, role limitations - physical & emotional,
bodily pain, general health, vitality, social
functioning, and mental health); number
of co-treatments, current back pain-specific
medication use, lost work or school days related to back pain, and global satisfaction
with back care. Recovery was not reported.
No published protocol was available and the
authors note 14 primary outcomes, thus no
a priori decision was made regarding which
were primary and secondary, leading to potential reporting bias of those outcomes that
were significant.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Low risk
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All the subjects, regardless of group assignment, were allowed to receive usual or other
low-back care to complement the trial interventions, with the exception of other
OMT or chiropractic manipulation. Data
were collected on each subject’s use of cotreatments throughout the trial including
prescription and over-the-counter medications, physical therapy, massage therapy, hy83
Licciardone 2003
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drotherapy, transcutaneous electrical nerve
stimulation, spinal and epidural injections,
acupuncture, herbal therapies, and meditation. However, the OMT subjects used significantly fewer co-treatments than the nointervention control subjects at 6 months.
There were no significant differences among
the treatment groups in back-pain specific
medication use or lost work or school days
over time.
(Comment: Co-intervention use was assessed only at baseline, 1 and 6 months,
asking about such use during the 4 previous weeks. The 1-month assessment probably did not provide sufficient time following
randomisation to make appointments with
clinicians, clinics, hospitals, etc. outside the
trial protocol. Whereas by 6 months, subjects had more time to acquire such co-treatments (personal communication with the
primary author).)
Compliance acceptable?
Unclear risk
Timing outcome assessments similar?
Low risk
Unclear if (or what percentage of ) the subjects assigned to OMT or sham manipulation attended the number or sessions prescribed in the methods.
Mohseni-Bandpei 2006
Methods
RCT; unclear allocation procedure.
Participants
120 patients randomly allocated to 2 treatment groups; setting: outpatient physical
therapy department in Norfolk and Norwich Hospital, United Kingdom; period of
recruitment not stated.
Age: manipulation/exercise grp 34.8 (10.6); ultrasound/exercise grp 37.2 (10.2)
Gender (% F): grp.1 - 61%; grp. 2 - 57%
Included if: between 18 and 55 years with LBP between L1 and L5 and the sacroiliac
joints; LBP >3 months duration, signs and symptoms that were interpreted as referred
from the lumbar spine and not other organs; good self-reported general health; and were
literate in the English language.
Duration of current LBP (mean (SD) in months): grp. 1 - 35.9 (48.3); grp. 2 - 50.8
(62.9)
Radiation pattern of pain: unclear.
Excluded if: underlying disease, such as malignancy; obvious disc herniation, osteoporosis, viscerogenic causes, infection or systemic disease of the musculoskeletal system;
previous SMT or ultrasound treatment; neurologic or sciatic nerve root compression,
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radicular pain, sensory disturbances, loss of strength and reflexes; previous back surgery;
evidence of previous vertebral fractures or major structural abnormalities; tumour of the
spine; pregnancy; devices such as heart pacemakers; or registered disabled or receiving
benefits because of LBP.
Interventions
1) SMT + exercise (N = 60) - Maitland technique; high-velocity low-amplitude thrust
on lumbar spine and SI joint. On average each patient was treated for 4 sessions (range
2 to 7 sessions), once or twice per week
2) ultrasound + exercise (N = 60): 1 MHz; on average each patient was treated for 6
sessions (range 3 to 11 sessions), once or twice per week
Exercise as recommended by Schneiders et al. Patients were given a written set of exercises
generated by PhysioTools computer package, which is available in most physiotherapy
departments in the UK. The physiotherapist chose exercises most appropriate for each
individual patient’s condition.
Outcomes
Pain: 100-mm VAS; Back-pain specific functional status: Oswestry; Lumbar range of
motion (ROM), surface EMG, muscle endurance; recovery - not reported; adverse events
- not reported; (comment: Outcomes not defined as primary or secondary by the authors)
.
Follow-up: post-treatment (6 weeks), 6 months - mean group differences presented only
Notes
Funded by: Islamic Republic of Iran Ministry of Health and Medical Education (Mazandaran University of Medical Sciences).
Principal author: medical doctor
Authors results and conclusions: Although improvements were recorded in both interventions, patients receiving manipulation + exercise showed greater improvement compared with those receiving ultrasound + exercise at both the end of treatment and at six
months follow-up.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Unclear risk
The participants who met the inclusion and exclusion criteria were assigned a number according
to a block-style randomisation scheme.
Allocation concealment?
Unclear risk
Note: no other information was provided on the
sequence generation or allocation.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
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Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
An assessor blinded to treatment allocation conducted an assessment of both subjective (pain,
functional status) and objective outcomes (lumbar range of motion, surface EMG, and muscle
endurance).
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
Follow-up post-treatment (% retained): grp.1 93% (56/60); grp.2 - 93% (56/60)
At 6 months: grp.1 - 67% (40/60); grp.2 - 55%
(33/60)
Note: 8 patients dropped-out during the treatment phase for various reasons, ranging from family problems to psychological problems, moving
residence, loss of contact. No reasons were given
regarding loss to follow-up during the post-treatment phase.
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
Not stated.
Free of selective reporting?
High risk
Recovery not reported; no published protocol was
available.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
The physiotherapist chose exercises most appropriate for each individual patient’s condition;
therefore, it is also unclear to what extent these
were similar between groups. Patients were allowed to continue with their medication (i.e. pain
killers, non-steroidal anti-inflammatory drugs,
muscle relaxants)
Compliance acceptable?
Unclear risk
Not stated.
Timing outcome assessments similar?
Low risk
Muller 2005
Methods
RCT; adequate treatment allocation
Participants
115 patients randomly allocated to 3 treatment groups; setting: multidisciplinary spinal
pain unit of a general hospital in Queensland, Australia; recruited from February 1999
to October 2001.
Age: overall 39 (IQR 29-46); grp. 1- 39 (29-53); grp. 2 - 38 (27-47); grp. 3 - 39 (26-43)
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Gender (% F): overall: 46.8%; grp.1 - 52.2%; grp. 2 - 45%; grp. 3 - 42.1%
Included if: uncomplicated mechanical spinal pain > 13 weeks, > 17 years of age.
Duration of the current LBP (median (IQR)): grp.1 - 4 to 12 months (range: 4 mos. to
45 yrs); grp.2 - 4 to 12 months (range: 4 mos. to 20 yrs); grp.3 - 1 to 5 years (range: 4
mos. to 30 yrs)
Excluded if: nerve root involvement, spinal anomalies other than sacralisation or lumbarisation, pathological conditions other than mild-moderate osteoarthrosis, > grade 1
spondylolisthesis of L5 on S1, previous spinal surgery, or leg length inequality of > 9mm.
Interventions
1) SMT (N = 36): High-velocity low-amplitude spinal manipulative thrust to a joint
10,18 was performed as judged safe and usual treatment by the treating chiropractor for
the spinal level of involvement to mobilize the spinal joints at that level.
2) Acupuncture (N = 36): Acupuncture was performed using sterile HWATO Chinese
Acupuncture Guide Tube Needles (50 mm long; 0.25-mm gauge) for 20-minute appointments. For each patient, 8 to 10 needles were placed in local paraspinal intramuscular maximum pain areas, and approximately 5 needles were placed in distal acupuncture
point meridians (upper limb, lower limb, or scalp). Once patients could satisfactorily
tolerate the needles, needle agitation was performed by turning or ”flicking“ the needles
at approximately 5-minute intervals. Needles were placed in local paraspinal pain areas
and in distal acupuncture point meridians; treatment frequency was the same as defined
above for SMT.
3) Medication (NSAIDs or paracetamol) (N = 43): Celecoxib (Celebrex) (200 to 400
mg/d; 27 patients) unless celecoxib had previously been tried; the next drug of choice was
rofecoxib (Vioxx) (12.5 to 25 mg/d; 11 patients), followed by acetaminophen (paracetamol) (500 mg tablets 2 to 6 per day; 5 patients). Dosage followed pharmaceutical
guidelines.
The frequency and duration of the manipulation and acupuncture were standardized
in order to account for potential placebo effects originating from different lengths of
exposure to the treating clinician, namely two 20-minute office visits per week until
patients became asymptomatic or achieved acceptable pain relief.
Outcomes
Pain: visual analogue scale (VAS; 0 to 10cm); Back-pain specific functional status: Oswestry; generic health status: SF-36; straight-leg raising; active range of motion for the
lumbar and cervical spines; recovery - not reported; adverse events - 6% in the medication grp. had an adverse reaction - presumably none in the manipulation grp., but
this is not clearly stated by the authors; (comment: Outcomes not defined as primary or
secondary outcomes by the authors.).
Follow-up: 4 & 9 weeks, 12 months
Notes
Authors results and conclusions: In patients with chronic spinal pain syndromes, spinal
manipulation may be the only treatment modality of the assessed regimens that provides
both broad and significant long-term benefit.
Funded by Queensland State Government Health Dept., and supported by the
Townsville Hospital.
Unclear what proportion of patients with low-back pain; possibly biased by high and
differential rates of drop-out between the groups and crossover contamination; results
presented in median and IQR; earlier publications Giles 1999, Giles 2003. The neck
was also examined in this study and outcomes relating to this area were also measured.
Four week data reported in Giles 1999.
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Considered to have a fatal flaw due to the differential and large proportion of drop-outs,
especially for the acupuncture group at the short-term and medication group at the longterm measurement.
One of the 2 authors is a chiropractor (Giles).
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
After informed written consent had been obtained, the patients were randomised in a balanced way.
Allocation concealment?
Unclear risk
Each patient drew a sealed envelope from a box
with 150 well-shuffled envelopes containing one
of three possible treatment codes so that an efficacy comparison could be made between three active treatments. Comment: no other text was provided in any of the other publications regarding
the randomisation and allocation procedure. It is
not clear if the person involved in the randomisation procedure was an independent research assistant; thus, unclear what safeguards were in place,
for example.
Blinding?
All outcomes - patients?
High risk
”It was not possible to blind the treating or nontreating clinicians“.
Blinding?
All outcomes - providers?
High risk
”It was not possible to blind the treating or nontreating clinicians“.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Below includes the authors attempt at blinding the ”outcomes assessor“.
All the outcome assessments were performed exclusively by the research assistant providing subjective questionnaires and performing objective
measurements, except for an additional assessment for patients who experienced early recovery or an adverse reaction. Such additional assessment was performed by a non-treating clinician.
The individual endpoint of the study was defined
as either early recovery (symptoms
no longer present at the week 2 or week 5 assessment) or the final assessment at week 9,
whichever occurred earlier.
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Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
At 4 weeks (% retained): grp.1 - 74%; grp.2 48%; grp.3 -80% (Quote: ”The proportion of
drop-outs in the treatment groups differed significantly with respect to the interventions“. Comment: The number of subjects presented in the
results are confusing from the pilot study (Giles
1999). According to this, the drop-outs were
36% for SMT and 48% for medication. The
numbers for acupuncture cannot be correct because it states that 26 subjects dropped out of the
acupuncture grp, but just 20 were randomised to
this group.)
At 9 wks (% retained): grp. 1 - 69% (25/36); grp.
2 - 61% (22/36); grp. 3 - 51% (22/43); overall 60% (69/115)
At 12 mos (% retained): grp. 1 - 64% (23/36)
; grp. 2 - 56% (20/36); grp. 3 - 44% (19/43);
overall - 54% (62/115)
Reasons for drop-outs varied among the groups.
More subjects changed treatment at wk.9 for the
medication grp. versus the SMT grp. (23% vs.
6%)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
High risk
An ITT and per-protocol analysis was conducted;
however, the ITT analysis was conducted on a
very limited data set given the large percentage of
drop-outs, for example 54% (62/115) at 12 mos.
Free of selective reporting?
High risk
No published protocol available; recovery not reported.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
Not stated.
Compliance acceptable?
High risk
Differential and large degree of drop-out from
the study; ”During patient tracking, it was found
that 22 patients received, at some stage after their
study treatment period but within the extended
follow-up period, a different treatment from the
randomised regimen“.
Timing outcome assessments similar?
Low risk
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Paatelma 2008
Methods
RCT; unclear allocation procedure
Participants
134 patients randomly allocated to 3 treatment groups; recruited from 4 occupational
health care centres in Jyvaskyla, Finland; occupational physicians identified the eligible
subjects; period of recruitment not reported.
Age (mean (SD)): grp. 1 - 44 (10); grp. 2 - 44 (9); grp. 3 - 44 (15); no overall age reported
Gender (% F): grp.1 - 42%; grp. 2 - 29%; grp. 3 - 35%
Inclusion criteria: 18 to 65 years of age, employed, with current non-specific LBP with or
without radiating pain to one or both lower legs; no restrictions on duration or recurrence
of the LBP.
Duration of the LBP: Personal communication with the primary author: Slightly more
than 50% were defined as chronic by the authors.
Exclusion criteria: pregnancy, low-back surgery less than 2 months previously, red flag
indicating serious spinal pathology.
Interventions
1) OMT (orthopedic manual therapy) (N = 45): includes spinal manipulation, specific
mobilization, and muscle-stretching techniques; high-velocity, low-force techniques were
used, including prone or side-lying manipulation to L1 to L5 and sacro-iliac manipulation or mobilization. Patients were taught to perform self-mobilisation, stretching and
exercises at home daily.
2) McKenzie (N = 52): subjects were assessed and classified into the various mechanical
syndromes, which was subsequently selected as the treatment strategy; this consisted
of education supported by the book ”Treat your own back“, and an active therapy
component (exercises to be repeated several times per day, every 1 to 2 hours, on a regular
basis).
3) Advice-only (N = 37): 45 to 60 min. counselling from a physiotherapist concerning
the good prognosis of LBP and concerning pain tolerance, medication usage, and returnto-work. Patients were told to avoid bed rest, and advised to continue their routine
as actively as possible, incl. exercise activities. A 2-page educational booklet was also
supplied.
The advice group received just one visit and the number of visits for the OMT and
McKenzie grp. ranged from 3 to 7 (mean: 6 txs per group).
Outcomes
Pain: back and leg pain (VAS, 0 to 100); Back-pain specific functional status: RolandMorris; recovery - not reported; adverse events - not reported; (comment: Outcomes
were not defined as primary or secondary by the authors).
Follow-up: at 3, 6 & 12 months
Notes
Authors results and conclusions: No differences emerged between the orthopaedic manual therapy and McKenzie method grp. for pain or functional status at any follow-up
measurement. OMT and McKenzie seem to be only marginally more effective than one
session of assessment and advice only.
Funded by: not stated.
Primary author is physiotherapist and 4 of the 6 authors were physiotherapists (2 were
medical doctors).
Risk of bias
Bias
Authors’ judgement
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Adequate sequence generation?
Low risk
randomisation was by a stack of sealed envelopes,
numbered in an order prepared from a random
number table. Note: no other text was available.
Allocation concealment?
Unclear risk
Unclear if the sealed envelopes were opaque or
not and whether an independent examiner was involved in the actual allocation procedure.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. No mention of trying to blind the
outcomes assessor.
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
High drop-out rate among the advice-only group.
Follow-up (% retained) at 3 months: OMT (43/
45 = 96%); McKenzie (48/52 = 92%); Adviceonly (29/37 = 78%)
At 6 months: OMT (40/45 = 89%); McKenzie
(47/52 = 90%); Advice-only (27/37 = 73%)
At 12 months: OMT (35/45 = 78%); McKenzie
(45/52 = 87%); Advice-only (26/37 = 70%)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
missing values were replaced with imputed values
generated by the subjects’ previous scores
Free of selective reporting?
High risk
recovery not reported; no published protocol available.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
Co-interventions were not allowed by design, but
unclear whether subjects actually sought other care
(not examined or not reported)
Compliance acceptable?
Unclear risk
not reported
Timing outcome assessments similar?
Low risk
At 3, 6, 12 months
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Pope 1994
Methods
RCT; unclear allocation procedure
Participants
164 subjects allocated to chiropractic treatment/manipulation, massage, corset, and transcutaneous muscle stimulation; recruited via a chiropractic college (Whittier Health
Center at the Los Angeles College of Chiropractic) and via additional advertising (e.g.
radio, newspaper, flyers); period of recruitment unclear.
Age: 32 years (median age - for the entire group), 72% were under 40 years of age, 8%
were ≥ 50 years of age.
Gender: 38% F (entire group) - not listed separately per intervention
Inclusion criteria: 18 to 55 years of age; current LBP between 3 weeks to 6 months
duration and preceded by a period of 3 weeks without LBP; generally good health (selfreported); not pregnant; no sciatica (defined by pain below the knee, a positive straight
leg raising test, and neurologic deficit, including subjects with buttock and upper thigh
pain); no neurological deficits, such as loss of sensation, strength and reflex; no previous
vertebral fracture, tumour, infection or spondyloarthropathy; no previous back surgery;
Davenport weight index not greater than 33 (wt/ht², units kg and m); no previous
manipulative therapy for this episode; no conditions potentially aggravated by electrical
devices (i.e. heart pacemaker); no workmen’s compensation or disability insurance issues;
willing to travel to the facility for treatment and to be randomised.
Duration current episode of LBP: 29% < 6months, 35% between 6 months & 2 years,
36% longer than 2 years.
Exclusion criteria: not explicitly defined.
Interventions
1) spinal manipulation (N = 70): subject was placed in side-lying position with the
side of the manipulable lesion most superior from the table surface. Once the end of
the physiologic range of motion was achieved, a dynamic short-lever high-velocity lowamplitude thrust was applied exerting a force on the lumbar spine and/or sacroiliac joint.
This maneuver was performed unilaterally or bilaterally at each treatment session as
determined by the treating physician. Frequency of treatment sessions was 3 times per
week for 3 weeks. Full-compliance was defined as receiving 3 or more sessions per week,
with partial compliance defined as 1-2 sessions per week, and no compliance defined if
subjects received no sessions. 5 licensed chiropractors delivered the manipulations to the
patients. No statement provided on level of experience.
2) soft-tissue massage (N = 37): effleurage was provided with the patient in the prone
position on a chiropractic table; smooth non-forceful motions were used; the skin of the
back from the buttocks to the shoulders was rubbed in a rhythmic fashion. The time
for treatment did not exceed 15min. and the number of treatment sessions for the 3week period was the same as for spinal manipulation (as listed above). 2 licensed massage
therapists, delivered by chiropractic interns, provided these treatments.
3) transcutaneous muscle stimulation (TMS) (N = 28): patients were fitted with the
Myocare PLUS muscle stimulating unit that was programmed for continuous use. A
biphasic pulse rate was used and the amplitude was set at a maximum of 91mA. Four
TMS electrodes were placed on the back in the area around the pain. Placement of the
electrodes was linear. Patients were instructed to wear the TMS unit for a cumulative
total of at least 8 hrs./day for a minimum of 1 hour at a time. Full compliance was a
minimum of 7 hrs./day on average, partial compliance was a minimum of 4 to 7 hrs./
day and no compliance was < 4 hrs./day.
4) corset (N = 29): patients were measured and fitted for a Freeman Lumbosacral Corset
by a trained clinician. The corset is a canvas corset with metal stays in the back. The
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patient was instructed to wear the corset during waking hours, except when bathing.
Further, the patient was allowed to remove the corset for a maximum of 10 min. at a
time, up to three times per day.
A chiropractor instructed and monitored the use of the corset and TMS units. Compliance was measured by a diary maintained by the subject with the same hourly usage
figures as for TMS.
Outcomes
Pain: 10 cm. VAS (converted to a 0 to 100 numerical scale); Back-pain specific functional status: not reported; Recovery: not reported; adverse events: not reported; additional outcomes: range of motion (Schober’s test), maximum voluntary extension effort,
Sorensen Fatigue Test (via EMG monitoring). (Outcomes were not defined as primary
or secondary.)
Follow-up: weekly for 3 weeks.
Notes
Authors results and conclusions: After three weeks, the manipulation group scored the
greatest improvements in flexion and pain while the massage group had the best extension
effort and fatigue time, and the muscle stimulation group the best extension. Non of the
changes in physical outcome measures (ROM, pain, fatigue, strength) were significantly
different between any of the groups.
Funded by:Foundation for Chiropractic Education and Research
Primary author is a researcher at the Iowa Spine Research Center, University of Iowa; 3
of the 6 research members are chiropractors.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Unclear risk
”....Patients were assigned a number according to
a block-style randomisation scheme.“ No information was provided as to how the numbers were
generated nor whether allocation was concealed.
Allocation concealment?
Unclear risk
Not stated.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Outcomes assessors were blinded
to allocation and collected data on the primary
outcomes (e.g. pain, function, etc).
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Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
88% follow-up at the final assessment (3 weeks)
. The dropout rates were not significantly different between the 4 groups, but were lowest for the
manipulation group (6% vs. 14 to 21%). No description on the reason for dropout was provided.
No sensitivity analysis was conducted comparing
baseline values between subjects who completed
the study and those who did not.
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
Not stated.
Free of selective reporting?
High risk
Back-pain specific functional status and recovery
not reported; no available protocol published.
Similarity of baseline characteristics?
Low risk
Testing of the primary outcome factors at baseline,
as well as certain other background factors (e.g.
number of previous LBP incidents, length of current LBP episode, job status, pain level) indicate
that there were no statistically significant differences among the treatment groups, except in one
case. The mean confidence (0 to 10) that their proposed care would work was significantly higher at
the first visit in the manipulation group (7.7) than
in the TMS (6.4) or corset (6.0) groups, based on
Tukey’s studentized range test for means (P < 0.05)
.
While potentially clinically relevant, this one factor was not thought to appreciably offset the overall judgement of the reviewers’ assessment of this
criterion.
Co-interventions avoided or similar?
Unclear risk
Not stated.
Compliance acceptable?
Low risk
The rates for completing all 4 visits are not significantly different (64% to 79% among the treatment
groups), but are lowest in the TMS group. There
was no statistically significant difference in compliance among the 4 treatments. At the fourth evaluation, the percentages for full compliance were
38% for SMT, 47% for massage, 50% for TMS,
and 65% for corset groups. For the TMS group,
27% of the 22 rated did not comply at all; for
SMT, 21% did not comply; for massage, 10% did
not comply; and for the corset group, 6% did not
comply at all.
Timing outcome assessments similar?
Low risk
For all groups, weekly for 3 weeks.
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Postacchini 1988
Methods
RCT; allocation procedure unclear
Participants
459 patients randomly allocated to 6 treatment groups; setting: 2 low-back pain clinics
(university orthopaedic clinic and a ”Static Center“ of Rome) between January 1985 October 1986; setting: hospital outpatient department; conducted in Italy.
Age (mean (years)): grp.1B - 38.4; grp. 2B - 39.5
Gender (% F): grp.1B - 51% (39/77); grp. 2B - 49% (39/80)
Inclusion criteria: low-back pain, aged 17 to 58 years. Pattern of pain radiation: with
and without radiation below knee; 2 groups - acute (< 4 weeks) and chronic (> 9 weeks)
LBP.
Duration of the current LBP (mean): grp. 1B - 13 months; grp. 2B - 9 months (all other
grps. are not relevant for this report).
Exclusion criteria: Pregnancy or nursing women, serious general diseases, psychiatric
disturbances, medico-legal litigation.
Interventions
Two principal grps: grp.1 - LBP only; grp. 2 - LBP radiating to the buttocks and/or
thighs and no neurological changes.
Subgrps. were defined as: A - LBP <4 wks. duration and no LBP in the preceding 6
months; B - continuous or almost continuous LBP lasting more than 2 months; C chronic LBP with an episode of acute pain at the time of clinical observation.
1) Manipulation by trained chiropractor (at follow-up: N = 87); no. tx chronic patients:
12; at a rate of 2 tx per week
2) Diclofenac ”full dose“ (at follow-up: N = 81); duration tx: 2 weeks
3) Physiotherapy: massage, electrotherapy, infrared, etc. (at follow-up: N = 78); no. tx:
15, daily for 3 weeks
4) Bed rest (at follow-up: N = 29); duration tx: 6 to 8 days
5) Back school (at follow-up: N = 50); no. tx: 4 in 1 week
6) Placebo gel (at follow-up: N = 73); duration 1 or 2 weeks
Outcomes
Pain (4-point scale: ranging from none to most severe pain imaginable); Back-pain specific functional status (4-point scale: extremely, moderately, slightly or not limited);
spinal mobility (forward flexion: fingertip to floor distance); abdominal muscle strength
(assessed by the leg-lowering test, and isometric endurance); recovery - not reported;
adverse events - not reported. Evaluation was based upon a sum score including both
subjective and objective measures. Comment: Outcomes not defined as primary or secondary by the authors.
Follow-up: 3 weeks, 2 & 6 months
Notes
Authors results and conclusions: In subgrp.1B, the best results were obtained with physiotherapy at short-term and low-back school at the long-term. For subgrp.2B, physiotherapy gave the best results at both short- and long-term follow-up.
Funded by: grant from the Centro Studi di Patologia Vertebrale, Rome
Principal author is an orthopedist?
Unequal numbers for the intervention grps. because not all interventions applied to the
various groups (acute - chronic)
Risk of bias
Bias
Authors’ judgement
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Adequate sequence generation?
Unclear risk
Patients in each grp. were randomly assigned to
the following treatments.
Allocation concealment?
Unclear risk
Note: No other information was provided on the
sequence generation or allocation.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. No mention if there were any attempts to blind the outcome assessors to treatment
allocation for the subjective or objective outcome
measures.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Unclear risk
Not stated.
Incomplete outcome data addressed?
All outcomes - ITT analysis?
High risk
13% of those randomised were either lost to follow-up or changed their assigned treatment and
subsequently not included in the analyses.
Free of selective reporting?
High risk
No published protocol available; recovery not reported.
Similarity of baseline characteristics?
Unclear risk
Similar for the 2 grps. with chronic LBP (based
upon age, gender, and duration of symptoms), but
unclear for the baseline scores for functional status.
Co-interventions avoided or similar?
High risk
8% (38/459) of the subjects had interrupted or
changed their assigned treatment.
Compliance acceptable?
Unclear risk
Not stated.
Timing outcome assessments similar?
Low risk
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Rasmussen 2008
Methods
RCT; unclear allocation procedure
Participants
72 patients randomly allocated to 2 treatment groups; setting: dept. of rheumatology
in Frederiksberg Hospital, Denmark; patients were referred from general practitioners;
period of recruitment - ”one year“.
Age (years): grp. A (with SMT): 38 (range: 26 to 57); grp. B (no SMT): 42 (range: 27
to 65); no data were presented for the entire grp.
Gender: grp. A: % F = 49%; grp. B: % F = 57%
Inclusion criteria: patients of 18-60 years of age with LBP in more than 3 months.
Pain duration of LBP (in months (median (quartiles))): grp.A - 17 (6 to 47); grp.B - 8
(4 to 41)
Exclusion criteria: ongoing insurance claim, unsettled social pension claim, LBP caused
by major accident, pain extension below knee, excessive distribution of pain according
to a pain drawing, neurological diseases including known disc herniation, significant
medical diseases including cancer, inflammation, language problems, suspected noncompliance or planned other treatment in the first 4 weeks.
Interventions
1) SMT + exercise (N = 35); 2) exercise alone (no SMT) (N = 37)
SMT: performed with a specific thrust (high velocity, low amplitude) at the level of
reduced movement, called dysfunction (reference to Greenman PE. Principles of Manual
Medicine). The type of manipulator not clear nor is the training. Medical manipulator?
Exercises (extension): All patients were instructed in 2 simple extension exercises (extension-in-lying, and repeated extension-in-standing). The exercises were to be performed
3 to 5 times with a gradual increase of the extension. After a short break the procedure
was to be repeated 4 to 6 times. The patients were instructed to perform these exercises
as often as possible during the day and at least once per hour.
Three office visits were conducted over a period of 4 weeks (baseline, 2 and 4 weeks).
Outcomes
Pain: NRS (0 to 10) for worst pain within the last 48 h for both low-back and leg
pain; Back-pain specific functional status: not measured; recovery - not reported; manual
medical examination: number of segments with reduced movement; adverse events - 4
pts. in the SMT + exercise grp. reported worsening of the LBP vs. 3 pts. in the no SMT
+ exercise grp. - no patient was hospitalised due to LBP or disc herniation; (Comment:
Outcomes were not defined as primary or secondary by the authors).
Follow-up: 2 & 4 weeks, 1 year
Notes
Authors results and conclusions: Pain in both back and legs decreased without differences
between the grps. No additional effect was demonstrated of manipulation when extension
exercises were used as a basic therapy.
Funding by the Oak Foundation
Uncertain what the background is of the primary and co-authors.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Unclear risk
Half of the patients were randomised to a manipulative therapy. The information of whether to receive manipulation or not was given to the ex-
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aminer in an envelope in the medical chart to be
opened by the end of the manual medical examination, when the patient was lying on the side.
The patients were not informed of their therapy
(manipulation or not) before the end of the follow-up, then a letter with a description of the randomisation was sent to their general practitioner
who had referred the patient to the study.
Unclear if these were sequentially numbered,
opaque envelopes.
Allocation concealment?
Unclear risk
Note: no other information was provided regarding randomisation or allocation.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Below includes the authors attempt
at blinding the ”outcomes assessor“.
”Blinding was attempted by placing the manipulation at the end of an extended examination. Our
results did not point towards such bias as the results
in the manipulated group were no better than in
controls.......The blinding of the examiner was furthermore attempted by mixing patients at different stages of the project“ (comment: no statement
as to whether the outcome assessor was blinded to
treatment allocation).
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
56 patients responded to the questionnaires after
three months and one year (= 78%); no data was
presented for the 3 months (note: was this preplanned by the authors?); acceptable drop-out rate
for the 1-year data. Unclear why patients droppedout; this was not described.
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
According to the authors an ITT analysis was performed; however, this represents a complete caseanalysis. No attempt was made to correct for missing data.
Free of selective reporting?
High risk
Functional status and recovery - not reported; no
published protocol available
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Similarity of baseline characteristics?
Low risk
Similar for the most important sociodemographic
measures, including baseline pain; however, manipulation grp. (A) had much longer pain duration than grp. B (17 months: median, IQR: 6 to
47 vs. 8 months: median, IQR: 4 to 41]
Co-interventions avoided or similar?
Unclear risk
Not stated.
Compliance acceptable?
Low risk
Regarding exercise: after 4 weeks 100% reported
daily exercises, and at one-year follow-up 79%
in group A and 75% in group B respectively, reported to be exercising as instructed several times
per week. Baseline values or changes in these were
not related to compliance at one-year follow-up.
Note: according to fig.1 - all patients randomised
to the 2 grps. returned at 2 & 4 weeks; therefore,
would have received their manipulative treatment,
if assigned.
Timing outcome assessments similar?
Low risk
Rasmussen-Barr 2003
Methods
RCT; unclear allocation procedure
Participants
47 patients randomly allocated to 2 treatment groups; setting: physiotherapy clinic in
Stockholm, Sweden; period of recruitment from 1999-2000.
Age (median(SD)): ST - grp.: 39 (12); MT - grp.: 37 (10)
Gender: ST - grp: 71% F; MT - grp: 78% F
Inclusion criteria: Men and women aged 18 to 60 years with LBP (pain > 6 weeks) with
or without radiation to the knee and pain provoked by provocation tests of lower lumbar
segments; with subacute, chronic or recurrent low-back pain.
Duration LBP (> 3 months): 88% - exercise group; 91% - manual therapy group.
Exclusion criteria: Prior segmental stabilizing training, manual treatment in the previous
3 months, prior spinal surgery, radiation to the leg or legs with overt neurological signs,
pregnancy, known lumbar disc hernia, diagnosed inflammatory joint disease, known
severe osteoporosis, or known malignant disease.
Interventions
1) Stabilizing training group (N = 24): The ST-group patients underwent a 6-week
treatment programme, meeting individually with a physiotherapist (MT) once a week
for 45 min. The patients were told how to activate and control their deep abdominal
and lumbar multifidus (MF) muscles. The first phase was cognitive and the patients
were taught how these muscles act as stabilizers for the lumbar spine. The importance
of re-learning motor control of these muscles was underlined. The patients were taught
how to activate the deep abdominal muscles together with relaxed breathing in different
positions (e.g. supine crooked-lying, four-point kneeling, prone, sitting and standing).
The activation of MF together with the deep abdominal muscles was also trained. The
physiotherapist monitored the patient by palpating the lower abdominal quadrant for
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deep tensioning of the abdominal muscles and by palpating the MF at the painful level.
A biopressure unit was used in the learning process. The patients were encouraged to
perform the exercises daily at home.
2) Manual therapy group (N = 23): The MT-group patients underwent a 6-week programme, being treated individually once a week by a physiotherapist (MT) for 45 min.
Manual techniques were used, based on findings from the physical examination. They
could include a combination of muscle stretching, segmental traction, and soft tissue
mobilization and, if needed mobilization of stiff thoracic and upper lumbar segments.
No manipulation was done. The patients were encouraged to go on with their usual activities or exercises (not controlled). None of these exercises included specific stabilizing
exercises. The patients were also taught basic ergonomics.
Outcomes
Pain: VAS (0 to 10 cm); Back-pain specific functional status: Oswestry & Disability
Rating Index (a 12-item back-specific questionnaire); recovery - not reported; general
health status: VAS (0 to 10 cm); satisfaction: VAS (0 to 10 cm); patients were also queried
at 3 & 12 months regarding whether they had sought additional physiotherapy following
the last therapy session; adverse events - not reported (comment: Outcomes not defined
as primary or secondary by the authors.)
Follow-up at 6 weeks (post-treatment), 3 & 12 months
Notes
Authors results and conclusions: Following the tx. period, there was a significant difference between the grps. in assessed function. More individuals in the ST-grp. had
improved than the MT-grp. At 3 months, the ST-grp. performed significantly better in
terms of pain, functional status, and general health. In the long-term, pts. in the MTgrp. reported more recurrent periods.
Funding by the Anne-Marie and Ragnar Hemborg Foundation.
All authors were registered physiotherapists.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
The first woman and first man included in the
study were randomised to one of the groups by lot
(25 ST cards and 25 MT cards in a box). The men
and the women were then separately and consistently randomised to either group. At randomisation the patients were assigned a unique code.
Allocation concealment?
Unclear risk
Unclear to what extent the physiotherapist was involved in the treatment allocation; no mention of
an independent research assistant involved in this
aspect; thus, unclear what safeguards were in place
to protect sequence generation.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
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Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. No mention of an attempt to blind
the ”outcomes assessor“.
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
Follow-up post-treatment (% retained): grp.1 - 22/
24 (92%); grp.2 - 19/23 (83%)
At 3 months: grp. 1 - 17/24 (71%); grp. 2 - 16/
23 (70%)
At 12 months: grp. 1 - 17/24 (71%); grp. 2 - 14/
23 (61%)
No reasons were provided from the authors for
drop-outs following the initiation of treatment,
although they state given the high number of dropouts, this study should be considered a pilot study.
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
Not stated; presumably the data analysed is based
upon the case-data available.
Free of selective reporting?
Unclear risk
Recovery was not reported; no published protocol
was available
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
By design, patients were not allowed the intervention in which they were not randomised; patients
were queried at 3 & 12 months regarding whether
they had sought additional physiotherapy following the last therapy session; however, the authors
do not report whether other interventions were
sought during or following the treatment phase.
Compliance acceptable?
Unclear risk
Patients in the stabilizing training grp. were required to keep a diary for exercises to be completed
at home everyday; however, it is not stated whether
these diaries were checked and whether they were
compliant with the therapy.
Timing outcome assessments similar?
Low risk
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Skillgate 2007
Methods
RCT; adequate allocation procedure
Participants
409 patients (primarily women) randomly allocated to 2 treatment groups; setting:
private clinics; recruited by advertising from employees at 2 large public companies
(about 40,000, mainly women in the healthcare sector, schools, and in the postal service)
in Stockholm, Sweden from March to September 2005.
Age (mean (SD) years): grp. 1 - 46(11); grp. 2 - 48(10)
Gender (% F): grp. 1 - 74%; grp. 2 - 68%
Inclusion criteria: presence of back and neck pain of the kind that brought about marked
dysfunction at work or in leisure time, for at least 2 weeks.
Duration LBP: grp. 1 - 78% > 3mos.; grp. 2 - 72% > 3 mos. Radiation pattern of pain: ?
Exclusion criteria: Symptoms too mild as determined by an administrator, pregnancy,
specific diagnoses such as acute slipped disc or spinal stenosis, inability to understand
Swedish, visits to a naprapath in the preceding 2 mo. or another manual therapist in the
preceding month with the exception of massage. An experienced physician further excluded patients based upon the following: too mild symptoms (the physicians’ subjective
opinion based on the estimated pain and disability in the questionnaires filled in before
the examination, and the results of the anamnesis and physical examination), evidencebased advice during the past month, surgery in the painful area, acute prolapsed disc,
spondylolisthesis, stenosis, or “red flags” (older than 55 when the pain debut for the
first time, recent trauma in the area, constant pain or pain getting worse in the night,
cancer in the past or at present, consumption steroids now or recently, drug abuser, HIV,
very bad general health, significant weight loss, very bad disability, intensified pain at
the smallest movement, obvious structural deformity of the spine, saddle anesthesia/
sphincter disturbance, extended muscle weakness, inflammatory or rheumatic diseases,
marked morning stiffness, long-lasting severe disability, or peripheral joints affected).
Interventions
1) Naprapathy (N = 206) - delivered by 1 of 8 experienced Naprapaths; A maximum of 6
treatments were given within 6 weeks in the naprapath’s own clinic and a combination of
naprapathic manual techniques (such as spinal manipulation/mobilization, massage, and
stretching) was given adapted to the patient’s condition. Preventive and rehabilitating
advices on physical activity and ergonomics were often given. Each appointment lasted
for about 45 minutes.
2) Standard care or ”evidence-based“ care (provided by physician) (N = 203) - Evidencebased care defined as support and advice on staying active and on pain coping strategies including locus of control, according to guidelines, and evidence-based reviews.The
evidence-based care was given in direct conjunction with the medical examination (an
additional 15 min). The care involved advice and support according to the best scientific evidence available, aiming to empower the patient with an understanding of the
importance of staying active and living as normal a life as possible, including work and
physical activities. The care also aimed to improve the pain coping strategies. Advice on
exercises was general and adapted to the patient’s condition. A booklet with examples of
exercises and general information on back and neck pain was provided.
Outcomes
Primary outcomes (as defined by the authors): pain and disability as measured by a
modified version of the Chronic Pain Questionnaire by von Korff, which consisted of each
3 items measuring both pain and disability. Neck pain was measured by the Whiplash
Disability Questionnaire. Secondary outcomes: perceived recovery (based upon an 11point scale) and subsequently dichotomized. adverse events - none were serious; limited
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to minor short-term reactions such as muscle soreness, tiredness, and increased pain,
typically following the first 2 treatments.
Follow-up at 3, 7 and 12 weeks.
Notes
Authors results and conclusions: At 7 & 12 weeks, statistically significant differences
were found between the groups for all outcomes favouring naprapathy; separate analyses
for neck and back pain showed similar results. This trial suggests that combined manual
therapy, like naprapathy, might be an alternative to consider for back and neck pain
patients.
Funding: Swedish Research Council, the Stockholm County Council, the Uppsala
County Council, Capio; the Swedish Naprapathic Association and Health Care Science
Post-Graduate School at Karolinska Institute.
Long-term data (1 year) to be available in a 2010 publication (not published at the time
of this review).
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Included patients were assigned to 2 groups by
randomisation and no pre stratification or blocking was used. An assistant not involved in the
project prepared 500 opaque, sequentially numbered sealed envelops with cards numbered 1 or
2 (randomised by a computer), indicating the
2 interventions. Patients were sequentially numbered in the order they came to the study center
and received the assignment envelope with the
corresponding number.
Allocation concealment?
Low risk
The unmasking was performed by the physician
after the medical examination, so that the assistant, the physician, and the patient were all blind
to the group assignment until after all patient
baseline data were collected.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the patients to other interventions or their perceptions
of potential effectiveness of the different interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. No mention of an attempt to
blind the ”outcomes assessor“. All outcomes in
the trial were self-rated by web-based or postal
questionnaire 5 times during the year following
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Skillgate 2007
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inclusion.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
Follow-up (% retained) at 3 weeks: Naprapathy 95% (196/206); Standard care - 92% (186/203)
At 7 weeks: Naprapathy - 94% (194/206); Standard care - 91% (184/203)
At 12 weeks: Naprapathy - 95% (195/206); Standard care - 89% (180/203)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
Free of selective reporting?
Low risk
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
The treatments in both groups were conformed
to the patients’ condition, but standardized as far
as possible concerning, for example, the length
of treatment sessions and how to perform them
in different situations, by several group meetings held in advance with the physicians and the
naprapaths.
Compliance acceptable?
Unclear risk
Not explicitly stated, but there was high retention
in both groups.
Timing outcome assessments similar?
Low risk
Protocol published.
ISRCTN56954776
See
http://isrctn.org/
UK BEAM trial 2004
Methods
RCT; adequate allocation procedure
Participants
1334 patients were randomly allocated to 6 treatment groups; recruited from 181 general
practices (in 14 centres) from the General Practice Research Framework; conducted in
the United Kingdom; period of recruitment not reported.
Age: overall - 43.1 (11.2) years
Gender: overall - 56.1 % F
Inclusion criteria: Patients were eligible if: Their ages were between 18 and 65 years;
were registered for medical care with a participating practice; had consulted with simple
low-back pain-pain of musculoskeletal origin in the area bounded by the lowest palpable
ribs, the gluteal folds, and the posterior axillary lines, including pain referred into the
legs provided it was mainly above the knee; had a score of four or more on the Roland
disability questionnaire at randomisation; had experienced pain every day for the 28 days
before randomisation or for 21 out of the 28 days before randomisation and 21 out of
the 28 days before that; agreed to avoid physical treatments, other than trial treatments,
for three months.
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Duration current episode > 3 months: 58.7% for all groups.
Exclusion criteria: Patients were not eligible if: They were aged 65 or over, because the
spinal manipulation package could be more hazardous in older people with osteoporosis; there was a possibility of serious spinal disorder, including malignancy, osteoporosis,
ankylosing spondylitis, cauda equina compression, and infection; complained mainly
of pain below the knee, as clinical outcome was likely to be different; had previously
had spinal surgery, as clinical outcome was likely to be very different; had another musculoskeletal disorder that was more troublesome than their back pain; had previously
attended, or been referred to, a specialised pain management clinic; had a severe psychiatric or psychological disorder; had another medical condition, such as cardiovascular
disease, that could interfere with therapy; had moderate to severe hypertension (systolic
blood pressure > 180 mm Hg or diastolic blood pressure > 105 mm Hg, on at least two
separate occasions; were taking anticoagulant treatment; were taking long term steroids,
which might lead to osteoporosis; could not walk 100 m when free of back pain, because
exercise would be difficult; could not get up from and down to the floor unaided; had
received physical therapy (including acupuncture) in the previous three months; had a
Roland disability questionnaire score of three or less on the day of randomisation; could
not read and write fluently in English.
Interventions
1) Best care in general practice (N = 338); 2) Best care plus exercise alone (N = 310); 3)
Best care plus private manipulation alone (N = 180); 4) Best care plus NHS manipulation
alone (N = 173); 5) Best care plus private manipulation plus exercise (N = 172); 6) Best
care plus NHS manipulation plus exercise (N = 161)
Best care in general practice = based upon the UK national acute back pain guidelines,
which advise continuing normal activities and avoiding rest. Clinical and support staff
from the participating practices were invited to training sessions on the ”active management“ of back pain. Copies of ”The Back Book“ were provided as well as the corresponding patient booklet.
Exercise programme = developed (“back to fitness”) from previous trials. It comprises initial individual assessment followed by group classes incorporating cognitive behavioural
principles. We trained physiotherapists with at least two years’ experience since qualification to deliver this programme. Classes ran in local community facilities. Up to 10
people took part in each session. We invited participants to attend up to eight 60 minute
sessions over four to eight weeks and a “refresher” class 12 weeks after randomisation.
Manipulation = A multidisciplinary group developed a package of techniques representative of those used by the UK chiropractic, osteopathic, and physiotherapy professions.
The three professional associations agreed to the use of this package in this trial. Similar
numbers of qualified manipulators from each of these professions treated participants.
They all had a minimum of two years’ clinical experience and were skilled in a range
of manipulative techniques, including high velocity thrusts. Participants randomised
to private manipulation received treatment in manipulators’ own consultation rooms.
Those randomised to NHS manipulation saw the same manipulators in NHS premises.
Following initial assessment, manipulators chose from the agreed manual and non-manual treatment options. They agreed to do high velocity thrusts on most patients at least
once.We invited participants to attend up to eight 20 minute sessions, if necessary, over
12 weeks.
Combined treatment = We invited participants to attend eight sessions of manipulation
over six weeks, eight sessions of exercise in the next six weeks, and a refresher class at 12
weeks. Other aspects of treatment were identical to those in the manipulation only or
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UK BEAM trial 2004
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exercise only groups.
Outcomes
”Main outcome measures“ (as defined by the authors) - Pain: not reported separately;
Back-pain specific functional status: Roland-Morris (RMDQ) & Modified von Korff
scale (composite scale of pain and disability); Recovery - not reported; Beliefs: Back
Beliefs Questionnaire (BBQ) & Fear-Avoidance Beliefs Questionnaire (FABQ); General
health: SF-36 & EuroQol; Specific health transition (Beurskens et al.); Troublesomeness
(Deyo et al.); Distress and Risk Assessment Method (DRAM); adverse events (serious
adverse events - defined as an event leading to hospitalisation or death within one week of
treatment) - no serious adverse events were reported. Comment: There were no defined
secondary outcomes.
Cost-effectiveness data available, published under a separate document at: http://
www.bmj.com/content/329/7479/1381
Follow-up at 3 & 12 months
Notes
Authors results and conclusions: All groups improved with time. Relative to ”best care“
in general practice, manipulation followed by exercise achieved a moderate benefit at
three months and a small benefit at 12 months; spinal manipulation achieved a small to
moderate benefit at three months and a small benefit at 12 months; and exercise achieved
a small benefit at three months, but not 12 months.
Funding by Medical Research Council; National Health Service in England, Northern
Ireland, Scotland and Wales.
Note: The differences in change scores for exercise and manipulation, either in combination with one another or alone, were not clinically relevant compared to ”best care“
for the principal outcome measure, functional status; however, an economic evaluation
with this data set suggests (according to the authors) that spinal manipulation is a cost
effective addition to ”best care“ for back pain in general practice. Manipulation alone
probably gives better value for money than manipulation followed by exercise.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
After consenting participants had completed
baseline assessments, nurses contacted the remote randomisation service by telephone in order to obtain the participants random treatment
allocation.
Allocation concealment?
Low risk
Participants were stratified by practice and allocated between the six treatment groups by randomly permuted blocks.
Blinding?
All outcomes - patients?
High risk
”As UK BEAM was a pragmatic trial to estimate
the effectiveness of manipulation and exercise in
routine clinical practice, blinding of participants
and professionals was neither desirable nor possible.“
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UK BEAM trial 2004
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Blinding?
All outcomes - providers?
High risk
”As UK BEAM was a pragmatic trial to estimate
the effectiveness of manipulation and exercise in
routine clinical practice, blinding of participants
and professionals was neither desirable nor possible.“
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. Outcomes were measured via selfreport questionnaires.
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
Follow-up at 3 months (% retained): GP care 76%; exercise only - 73%; SMT groups only 81% & 82%; SMT + exercise groups - 75% &
81%
At 12 months: GP care - 73%; exercise only 69%; SMT groups only - 78% & 77%; SMT +
exercise groups - 77% & 78%
Note: No explanation was provided as to the reason for the drop-outs
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Low risk
No attempt was made to correct for missing cases
through for example, imputation.
Free of selective reporting?
Low risk
Protocol was published separately prior to
publication of the study and was available online http://www.controlled-trials.com/
ISRCTN32683578/32683578; although recovery not examined as an outcome measure and
pain not reported separately.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
stated in the inclusion criteria; however, unclear
whether this was actually checked
Compliance acceptable?
Unclear risk
A maximum number of sessions were determined
for both the exercise and manipulation group,
but it is unclear how many sessions were attended.
Timing outcome assessments similar?
Low risk
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Waagen 1986
Methods
RCT; unclear allocation procedure
Participants
29 subjects randomly allocated to 2 treatment groups; setting: chiropractic college clinic
in Iowa, USA; recruitment over a ”two-month period“.
Age (years) (mean (SD not provided)): grp. 1 - 25.2; grp. 2 - 24.3
Gender (% F): grp. 1 - 46% (5/11); grp. 2 - 61% (11/18)
Inclusion criteria: 18 to 65 years of age; chief complaint of LBP; patient was naive to
chiropractic tx. (note: presumably refers to a new patient who had never undergone
chiropractic care). Radiation pattern of pain: no radiation below knee.
Duration of the current LBP: overall: 2.5 to 2.8 years
Exclusion criteria: Pregnancy, malingering, patient who is not ambulatory or receiving
Worker’s Compensation for a back problem; obesity, radiographic evidence of osseous
fractures, osteoporosis, or spondylolisthesis; LBP due to visceral (e.g. kidney, liver, urinary
bladder) disorder; disc herniation, severe concurrent infectious or other systemic disease
process; neurologic deficits indicated by leg pain, numbness or weakness.
Interventions
1) Manipulation (N = 11): treated exclusively with spinal adjustive therapy; no adjunctive
or concurrent therapy, either chiropractic or medical, was given during the trial period;
therapy consisted of full-spine adjustments in order to correct all chiropractic lesions (i.e.
subluxations); the location of the adjustments were determined by palpation, inspection
and consultation with the patient.
2) Sham manipulation (N = 18): consisted of an adjustment using minimal force for a
generalized manipulation; the lumbar drop-piece on a standard chiropractic adjusting
table was set to minimal tension; an adjustment was simulated by applying gentle pressure
over both posterior superior iliac spines such that the lumbar section fell; soft-tissue
massage was also provided.
All patients were treated 2 to 3 times weekly for 2 weeks (total 4 to 6 txs) by experienced
chiropractors from the college faculty.
Outcomes
Pain: 10-cm. VAS; Back-pain specific functional status and recovery: not reported; spinal
mobility (consisting of active and passive SLR to both sides, lumbar flexion, extension
and lateral bending - in total 8 measures and a ”global index“ is presented which gives an
overall change for these measures); recovery - not reported; adverse events - not reported;
comment: Outcome measures were not defined as primary or secondary by the authors.
Follow-up: 2 weeks
Notes
Authors results and conclusions: Experimental patients had significantly more relief from
pain as well as global change in spinal mobility than the controls. Given the small sample
size, the results reported must be considered preliminary.
Funded by Palmer College of Chiropractic.
Unclear what the background of the authors is.
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Unclear risk
Patients were randomly assigned to one of the two
tx. grps. using a code based upon the patient number issued when the patient was first admitted to
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Waagen 1986
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the clinic.
Allocation concealment?
Unclear risk
Note: no other information was provided on the
sequence generation or allocation.
Blinding?
All outcomes - patients?
Low risk
Patients assigned to either a real or sham treatment. The success of blinding was assessed during a post-trial interview. Eleven (6 sham SMTgrp., 5 SMT grp.) of the 15 pts. thought they had
received ”standard“ (or real) chiropractic adjustments, while 4 patients (3 sham SMT grp., 1 SMT
grp.) thought they had received the sham treatment.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
Low risk
Assessment of treatment effects was conducted by
a grp. of licensed chiropractors who were not involved in treating the patients. Evaluating clinicians were blinded with regard to the type of treatment received by the patients. Post-treatment evaluation of the patients suggests that blinding was
successful.
Incomplete outcome data addressed?
All outcomes - drop-outs?
High risk
At 2 weeks (% retained): grp.1 - 82% (9/11); grp.2
- 56% (10/18)
Overall at 2 weeks: 66% (19/29)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
Not stated, but small study with large and differential degree of drop-out.
Free of selective reporting?
High risk
No published protocol available; back pain specific
function and recovery not reported.
Similarity of baseline characteristics?
Low risk
Age, duration of the symptoms and function of
the lumbar spine (using a untested ”global index“)
were similar, although pre-treatment pain level 1point difference (11-point scale) between the grps.
- no measure of variation is presented; reasonable
difference in % females in the 2 grps. (61% vs.
46%).
Co-interventions avoided or similar?
Unclear risk
Not stated.
Compliance acceptable?
Unclear risk
Not stated.
Timing outcome assessments similar?
Low risk
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Wilkey 2008
Methods
RCT; adequate allocation procedure.
Participants
30 patients randomly allocated to 2 treatment groups; setting: National Health Services
hospital outpatient clinic or chiropractic clinic in the United Kingdom; recruitment
period not reported.
Age (years): grp.1 - 39.8 (range: 26 to 64); grp.2 - 48.5 (range: 31 to 61)
Gender (% F): grp.1 - 64%; grp.2 - 50%
Inclusion criteria: LBP > 12 weeks with or without radiation into the legs; 18 to 65 years
Duration with LBP (mean (range) in years): grp.1 - 4.0 (0.5 to 10); grp.2 - 7.3 (0.5 to
20)
Pattern of pain radiation: with or without radiation into the legs
Exclusion criteria: neurologic disease ; neurological deficit due to prolapsed HNP; spinal
stenosis; acute fracture; h/o spinal surgery; h/o carcinoma; gross anatomical abnormality
or high comorbidity due to other diseases.
Interventions
1) Hospital pain clinic (N = 12): consisted of standard pharmaceutical therapy (NSAIDs,
analgesics, gabapentin), facet joint and soft-tissue injections, and/or TENS. These
modalities could be used in isolation or in combination with any of the other modalities.
2) Chiropractic treatment (N = 18): All techniques that were employed are recognized
within the chiropractic profession as methods used for the treatment of LBP, e.g. sideposture diversified manipulation to the lumbar spine and pelvis; flexion-distraction; trigger point therapy using a large variety of techniques; soft-tissue massage; home exercises
were prescribed and advice was given regarding posture and activities of daily living.
Treatment period was 8 weeks with a maximum of 16 treatment sessions. Both control
and treatment groups underwent their therapy within the hospital.
Outcomes
Pain: 11-point NRS; Back-pain specific functional status: Roland-Morris; recovery not reported; adverse events - not reported; Comment: Outcomes were not defined as
primary or secondary by the authors.
Follow-up: 2, 4, 6 and 8 weeks
Notes
Authors results and conclusions: At 8 weeks, the mean improvement in RMDQ was
5.5 points greater for the chiropractic group (decrease in disability by 5.9) than for the
pain-clinic group (0.36). Reduction in mean pain intensity at week 8 was 1.8 points
greater for the chiropractic group than for the pain-clinic group. This study suggests that
chiropractic management administered in an NHS setting may be effective for reducing
levels of disability and perceived pain during the period of treatment for a subpopulation
with chronic LBP.
Funded by National Health Services.
A pragmatic study (i.e. examined ”chiropractic management“ rather than SMT alone);
data is poorly reported - the figures do not present any measure of variation. Data was
requested from the authors for pain and functional status and was received.
Risk of bias
Bias
Authors’ judgement
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Adequate sequence generation?
Low risk
Patients were randomised into the treatment or
control group by way of sealed envelope (20 envelopes for each group): This consisted of randomly mixed, sealed envelopes being chosen and
opened by one of the hospital secretaries who
then contacted the patient, advising them of
their allocation.
Allocation concealment?
Low risk
The process of allocation was performed independently of the treating clinicians.
Blinding?
All outcomes - patients?
High risk
There is no mention of attempts to blind the
patients to other interventions or their perceptions of potential effectiveness of the different
interventions.
Blinding?
All outcomes - providers?
High risk
No mention if there were any attempts to blind
the care providers to the other groups.
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item was
scored as ”no“. No mention of trying to blind an
”outcomes assessor“. Outcomes were assessed by
self-report measures, presumably at the facilities
where the patients were treated (comment - but
this is not clear).
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
Only 1 in the pain clinic grp. and 2 in the chiropractic tx. grp. did not complete the trial.
Incomplete outcome data addressed?
All outcomes - ITT analysis?
Unclear risk
Not stated; however, small trial and only 3 subjects did not complete the trial. Presumably all
data was included in the analyses?
Free of selective reporting?
Unclear risk
No published protocol; recovery not reported.
Similarity of baseline characteristics?
Low risk
The mean duration of symptoms within the chiropractic group, 7.34 years (0.5 to 20 years), was
almost twice that of those assigned to the pain
clinic, 4.04 years (0.5 to 10 years). The peak
duration was similar: 3 years for the pain clinic
group and 2.5 years for the chiropractic groups,
respectively. The mean age for those within the
chiropractic group was higher than that of the
pain clinic: 48.5 (range 31 to 61) years compared to 39 (range 26 to 64) years. Scores for
the principal outcome measures (pain and functional status) were similar at baseline.
Co-interventions avoided or similar?
Unclear risk
Not stated.
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Wilkey 2008
(Continued)
Compliance acceptable?
High risk
Timing outcome assessments similar?
Low risk
The mean attendance for treatment in the pain
clinic group was 1.9 sessions compared with
11.3 for the chiropractic group. Three patients
within the control group were seen only once
with treatment administered at the initial consultation with the follow-up falling outside of
the 8-week treatment period and only 2 patients
within the same group were seen on three occasions over the 8 weeks.
Zaproudina 2009
Methods
RCT; adequate allocation procedure; randomisation 1:1
Participants
131 patients randomly allocated to 2 treatment groups; setting: private clinics?; conducted in Finland; recruitment via newspaper advertisement from April 2003 to December 2005.
Age (years): grp.1 - 40.7 (5.3); grp.2 - 41.7 (5.8)
Gender (% F): grp.1 - 53%; grp.2 - 49%
Inclusion criteria: chronic LBP, with or without referred leg pain, and with a minimal
VAS of 30 (0 to 100) and/or an ODI of at least 16%. From Ritvanen 2007, the following
is also to be found: between 20 and 60 years old, had LBP that restricted functioning
(referred pain not distal to the knee), and had LBP present on at least half of the days in
a 12-month period in a single episode or in multiple episodes.
Duration LBP: The average duration of LBP was 10.6 years (personal communication
with primary author).
Exclusion criteria: specific pathology (e.g. infection, tumour, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis), radicular syndrome
or cauda equina syndrome) (personal communication).
Interventions
1) Traditional bone setting (TBS) (N = 65): is based on manual whole body treatment.
A bone setter begins the treatment from the toes and feet up to the hands and head and
mobilizes tissues and malocclusions. The aims of TBS treatment are usually to abolish
malpositions, to relax the muscles, and to remove excessive muscle contraction and body
asymmetry. The patients received 5 TBS treatments with 2-week intervals; these were
carried out by experienced bone setters.
2) Physical therapy (PT) (N = 66): included massage, therapeutic stretching, trunk
stabilization exercise, and exercise therapy. The patients treated by PT received an average
of 5 treatments (usually weekly - personal communication) and also got instructions for
home training; PT was performed by a fitness center specialist.
The timetable for tx. was chosen by the treatment provider in agreement with the patient.
Outcomes
Pain (100-mm visual analogue scale); Back-pain specific functional status (Oswestry);
perceived recovery (11-point scale); Health-Related Quality of Life (15D); depression
(Rimon’s Brief Depression Questionnaire); spinal mobility (finger-floor distance, sidebending, passive straight leg raise); adverse events - not reported. Comment: Outcomes
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Zaproudina 2009
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were not defined as primary or secondary by the authors. Note: the earlier publication
focused on EMG activity of the paraspinal muscles at L1-2 and L4-5 levels, and the SD’s
presented for pain and functional status in Ritvanen (T.2) are probably SE’s (compared
with this publication).
Follow-up at 1, 6 & 12 months post-tx., which corresponds approximately to 3, 9, 15
months post-baseline.
Notes
Authors results and conclusions: Pain levels as well as spinal mobility did not differ between the groups; however, functional status, perceived recovery and QoL scores tended
to favour the TBS grp. Long-term results did not differ between the grps.
Funded by Finland’s Slot Machine Association and in collaboration with the Folk Healing
Association.
This publication is the long-term follow-up to the study by Ritvanen 2007, although
short-term outcomes are also reported in this publication. The first part of the study
was conducted in 2003 and continued in 2005 with an additional 60 LBP patients.
The extension was performed with the same protocol; Health-related quality of lifemeasurements were, however, added in 2005, while the focus of the earlier publication
was on electromyographic (EMG) responses to treatment.
The primary author was contacted regarding missing information and the following is
her response. Low-back pain was defined by European guidelines for the management
of chronic non-specific low-back pain as pain and discomfort, localised below the costal
margin and above the inferior gluteal folds, with or without referred leg pain, persisting
for at least 12 weeks; chronic “non-specific” i.e. low-back pain that is not attributable to
a recognisable, known specific pathology (e.g. infection, tumour, osteoporosis, fracture,
structural deformity, inflammatory disorder (e.g. ankylosing spondylitis), radicular syndrome or cauda equina syndrome).
Risk of bias
Bias
Authors’ judgement
Support for judgement
Adequate sequence generation?
Low risk
Patients were randomised by a closed envelope system. The closed envelopes were
set in two boxes (for men and women separately). Upon leaving, the patients drew an
envelope at random. Each envelope contained instructions concerning the examination and treatments and as to which
group a patient was randomised.
Allocation concealment?
Low risk
An independent assessor generated the allocation sequence, enrolled the patients, and
assigned the patients to their groups. Comment: based upon information provided in
Ritvanen 2007.
Blinding?
All outcomes - patients?
High risk
”The researchers were blinded in the selection intervention group, but the treatment
providers and subjects were not blinded.“
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Blinding?
All outcomes - providers?
High risk
”........ the treatment providers and subjects
were not blinded.“
Blinding?
All outcomes- outcome assessors?
High risk
Patient was not blinded; therefore, this item
was scored as ”no“. No mention of trying to
blind an ”outcomes assessor“. Self-reported
outcome measures.
Incomplete outcome data addressed?
All outcomes - drop-outs?
Low risk
Follow-up at 1 month post-treatment (%
retained): grp.1 - 88% (57/65); grp.2 - 91%
(60/66)
At 12 months post-treatment: grp.1 - 77%
(50/65); grp.2 - 80% (53/66)
Incomplete outcome data addressed?
All outcomes - ITT analysis?
High risk
Some subjects were quite clearly excluded
from the analyses for various reasons in
both groups: operated on the back (N = 3)
or discontinued because of worsening (N =
3), thus representing a ”per-protocol“ analysis.
Free of selective reporting?
Low risk
Published protocol (ISRCTN 13338472;
http://www.controlled-trials.com/
ISRCTN13338472) and all 3 primary outcomes were reported.
Similarity of baseline characteristics?
Low risk
Co-interventions avoided or similar?
Unclear risk
Not stated.
Compliance acceptable?
Unclear risk
Not stated.
Timing outcome assessments similar?
High risk
Pre-post treatment analysis. First post-tx.
analysis was performed one month after the
last tx. session. Pt’s informed the researchers
when tx. was completed and the first posttx. was planned one month from the last
session. In FT grp., all patients received 5
tx. sessions and in TBS grp. sessions ranged
on avg. from 3 to 5 (personal communication).
TBS grp. received 5 txs at 2 week intervals;
therefore, post-tx = ~10 weeks; FT grp. received 5 txs. usually weekly; therefore, posttx. = ~at 5 weeks. Thus, difference in timing
would be approximately one month, which
could be important for the short-term follow-up.
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BMI = body-mass index; EMG = electromyograph; FABQ = Fear Avoidance Beliefs Questionnaire; FT or PT = physiotherapist or
physical therapist; GP = general practitioner; GPE = global perceived effect; grp. = group; h/o = history of; HVLA = high-velocity
low-amplitude; IQR = interquartile range; ITT = intention to treat analysis; no. txs = number of treatments; NRS = numerical rating
scale; ODI = Oswestry Disability Index; OMT = osteopathic (or orthomanual) manipulative therapy; post-tx. = post-treatment; pt.
= patient; RCT = randomised controlled trial; ROM = range of motion; SD = standard deviation; SIP = Sickness Impact ProfIle; SI
joint = sacroiliac joint; SLR = straight leg-raise; SMT = spinal manipulative therapy; tx. = treatment; VAS = visual analogue scale;
wks. = weeks; yr. = year.
Number of subjects listed following the definition of the intervention is the number of subjects allocated to the intervention and not
necessarily the number that actually received the intervention or were available for assessment.
Characteristics of excluded studies [ordered by study ID]
Study
Reason for exclusion
Andersson 1999
Proportion with chronic low-back pain longer than 12 weeks unclear
Arkuszewski 1986
Only alternate, no truly randomised allocation
Aure 2003
Contribution of SMT to the treatment effect could not be discerned. The aim of this study was to compare
the effect of manual therapy, including specific exercises and segmental techniques to general exercise therapy
in chronic LBP patients.
The trial was also identified in the literature search conducted for the European Guidelines for the Management of Chronic Low-back pain (European Spine Journal 2006; 15(supplement 2): see p. S241; also available
from http://www.backpaineurope.org/web/files/WG2˙Guidelines.pdf ). However, they excluded it because
”the patients in the manual therapy group also received a substantial amount of exercise therapy, making the
respective effects of the manual therapy and the exercise therapy difficult to ascertain“. This study was also
excluded from the section on exercises for the same reason.
Beyerman 2006
Duration of low-back pain unspecified
Brennan 1994
No relevant outcome measure (pain or disability)
Brønfort 1989
Mean duration low-back pain less than 12 weeks
Brønfort 2004
Evaluates exclusively sciatica; included low-back pain patients with radiating pain into the proximal or distal
part of the lower extremity, with or without neurologic signs.
Burton 2000
Evaluates exclusively sciatica (leg pain worse than back pain); unilateral, unremitting pain; positive straight
leg raising test with positive nerve root tension signs, radiculopathy limited to a single nerve root. In addition,
there was unequivocal evidence of single-level non-sequestrated lumbar disc herniation on either computed
tomography (CT) or magnetic resonance imaging (MRI).
Cherkin 1998
Mean duration low-back pain less than 12 weeks
Cote 1994
No patients; assessment < 1 day; no relevant outcome measure (pain or disability)
Coxhead 1981
Evaluates exclusively sciatica (with or without back pain).
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(Continued)
Coyer 1955
Only alternate, not truly randomised
Doran 1975
Proportion with low-back pain longer than 12 weeks unclear
Ellestad 1988
Not all subjects LBP; no relevant outcome measure
Geisser 2005
Not SMT as defined in this review - ”muscle energy technique“ which did not involve manipulation or
mobilization of the spine.
Gibson 1993
No patients (healthy subjects); no relevant outcome measure; follow-up < 1 day
Gilbert 1985
No manual mobilization / manipulation
Glover 1974
Duration low-back pain unspecified
Haas 1995
No patients; no relevant outcome measure; follow-up < 1 day
Haas 2004
RCT of SMT which evaluated the effects of the number of chiropractic treatment visits for SMT only versus
SMT + physical modalities for chronic low-back pain and disability; all subjects received high-velocity lowamplitude SMT.
Hawk 2006
Did not specifically examine chronic LBP in the analysis of the data.
Helliwell 1987
No relevant outcome measure
Herzog 1991
Proportion with low-back pain longer than 12 weeks unclear
Hoehler 1981
Mean duration low-back pain less than 12 weeks
Hough 2007
Quasi-RCT; participants were alternately included
Hsieh 1992
Proportion with low-back pain longer than 12 weeks unclear
Indahl 1995
No manipulation / mobilization
Khalil 1992
Stretching, no real manipulation
Kinalski 1989
Duration low-back pain unspecified
Kokjohn 1992
No low-back pain patients; follow-up < 1 day
Lewis 2005
Contribution of SMT to the treatment effect could not be discerned.
MacDonald 1990
Proportion with low-back pain longer than 12 weeks unclear
Marshall 2008
Not an RCT involving SMT; participants were randomised to 2 forms of exercise (and not SMT)
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Mathews 1987
Mean duration low-back pain less than 12 weeks
Meade 1990/1995
Proportion with low-back pain longer than 12 weeks unclear
Niemisto 2003/2005
Contribution of SMT to the treatment effect could not be discerned.
Nwuga 1982
Alternate, no truly random allocation
Ongley 1987
Contribution of SMT to the treatment effect could not be discerned; participants in the SMT treatmentarm received only one manipulation treatment, in addition to other treatment modalities.
Petty 1995
No random allocation
Rupert 1985
Proportion with low-back pain longer than 12 weeks unclear
Shearar 2005
Proportion with low-back pain longer than 12 weeks unclear
Siehl 1971
No relevant outcome measure
Sims-Williams 1978
Duration of low-back pain unspecified
Skagren 1997
Mean duration with low-back pain less than 12 weeks
Terrett 1984
No relevant outcome measure
Timm 1994
Post-surgical evaluation of SMT
Triano 1995
Proportion with low-back pain longer than 12 weeks unclear; included subjects >50 days of LBP.
Wreje 1992
Majority with low-back pain less than 12 weeks
Zylbergold 1981
Duration of low-back pain unspecified
Characteristics of studies awaiting assessment [ordered by study ID]
Cleland 2006
Methods
Official title: Comparison of the Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of
Patients With Low-Back Pain Who Satisfy a Clinical Prediction Rule: A Randomised Clinical Trial.
Purpose: The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in
a subgroup of patient with low-back pain that satisfy the clinical prediction rule.
Participants
Inclusion Criteria:
1. Chief complaint of pain and/or numbness in the lumbar spine, buttock, and/or lower extremity
2. Oswestry disability score of at least 25%
3. Age greater than 18 years and less than 60 years
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Cleland 2006
(Continued)
4. At least four out of five of the following criteria:Duration of current episode < 16 days (judged from the
patient’s self-report)No symptoms extending distal to the knee (judged from the pain diagram) FABQ-W score <
19. At least one hip with > 35° internal rotation range of motion (measured in prone). Stiffness in the lumbar spine
(judged from segmental mobility testing)
Exclusion Criteria:
1. Red flags noted in the participant’s general medical screening questionnaire (i.e. tumour, metabolic diseases,
RA, osteoporosis, prolonged history of steroid use, etc.)
2. Signs consistent with nerve root compression, this includes any one of the following:Reproduction of lowback or leg pain with straight leg raise at less than 45°; Muscle weakness involving a major muscle group of the
lower extremity; Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon); Diminished or
absent sensation to pinprick in any lower extremity dermatome
3. Prior surgery to the lumbar spine or buttock
4. Current pregnancy
5. Past medical history of osteoporosis or spinal compression fracture
6. Inability to comply with treatment schedule (weekly sessions for four weeks)
Interventions
Mobilization
Outcomes
Notes
Study completed. Principal investigator: Joshua Cleland, DPT, OCS. Sponsor: Franklin Pierce University. Collaborator: University of Southern California. link:http://clinicaltrials.gov/show/NCT00257998.
To determine if the population has a mean duration > 12 weeks with low-back pain.
Characteristics of ongoing studies [ordered by year of study]
NCT00410397
Trial name or title
The use of manual therapy to treat low-back and hip pain
Methods
RCT
Target sample size: 27
Participants
Inclusion Criteria: Written informed consent; 18 to 65 years of age; lumbopelvic pain; no limits on duration?
Exclusion Criteria: Cardiovascular disease (heart-failure, myocardial infarction, hypertension), diabetes,
rheumatoid arthritis, osteoarthritis, chronic illness, pregnancy, neurodegenerative disease, osteopenia, osteoporosis, cancer
Interventions
osteopathic manipulation. Study focuses on treating pelvic muscle pain as a way of lessening LBP.
Outcomes
Primary Outcome Measures: Reduction in low-back pain on a 1 to 10 scale. ( Time Frame: Immediately
following treatment. )
Secondary Outcome Measures: Reduction in low-back pain on a 0 to 10 scale. ( Time Frame: 6 to 8 hours
after treatment. )
Reduction in low-back pain on a 0 to 10 scale. ( Time Frame: After four weeks of therapy. )
Starting date
December 2006
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NCT00410397
(Continued)
Contact information
Principal Investigator: Correy R Babb, Oklahoma State University of Osteopathic Medicine
Notes
http://clinicaltrials.gov/show/NCT00410397
Oklahoma State University Center for Health Sciences
NCT00632060
Trial name or title
The efficacy of manual and manipulative therapy for low-back pain in military active duty personnel: A
feasibility study
Methods
RCT
Target sample size: 100
Participants
Inclusion Criteria: Active Duty; aged 18 to 35; new episode of low-back pain (LBP) or a recurrence of a past
episode of low-back pain; no limitations on duration of the presenting LBP
Exclusion Criteria: LBP from other somatic tissues as determined by history, examination, and course (i.e.
pain referred from visceral conditions); radicular pain worse than back pain; co-morbid pathology or poor
health conditions that may directly impact spinal pain. Patients who have case histories and physical examination findings indicating other than average health will be excluded from the study; bone and joint
pathology contraindicating patient for M/MT. Patients with spinal fracture, tumours, infections, inflammatory arthropathies and significant osteoporosis will be referred for appropriate care and will be excluded
from the study; other contraindications for M/MT of the lumbar spine and pelvis (i.e. bleeding disorders
or anticoagulant therapy); pregnancy (all potential female participants will undergo pregnancy testing); use
of manipulative care for any reason within the past month; unable to follow course of care for four weeks;
unable to give informed consent for any reason; unable to confirm that they will not be deployed during the
course of the study: ”Will you be deployed, receiving orders for a distant temporary active duty assignment,
attending training at a distant sight, or otherwise absent from Ft. Bliss over the next 6 weeks?“
Interventions
1) No Intervention Standard Care Control Group - Participants randomised to the standard care group will
continue their use of non-prescription or prescription medication and reduced duty loads, as prescribed by
the credentialed medical provider.
2) Experimental Manual / Manipulative Therapy Group: Participants randomised to the M/MT group will
receive a course of M/MT along with standard care. The patient will see the chiropractor twice a week for
the entire course of the study, regardless of manipulation or not.
Outcomes
Primary Outcome Measures: Decreased pain ( Time Frame: Baseline, 2 & 4 weeks )
Secondary Outcome Measures: Increased function ( Time Frame: Baseline, 2 & 4 weeks )
Starting date
February 2008
Contact information
Roxana Delgado, MS; Keith P Meyers, MD
Notes
http://clinicaltrials.gov/show/NCT00632060
Primary sponsor: Samueli Institute for Information Biology. Collaborators: Palmer Center for Chiropractic
Research (PCCR); William Beaumont Army Medical Center; United States Army Fort Bliss
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NCT00567333
Trial name or title
Individualized chiropractic and integrative care for low-back pain
Methods
RCT
The primary aim of this study is to determine the relative clinical efficacy of 1) chiropractic care and 2)
multidisciplinary, integrative care in 200 patients with sub-acute or chronic LBP, in both the short-term (after
12 weeks) and long-term (after 52 weeks).
Chiropractic care will include therapies within the professional scope of practice. Integrative, multidisciplinary care will include chiropractic, massage therapy, traditional Chinese medicine (including acupuncture)
, medication, cognitive behavioral therapy, exercise, and patient education.
Secondary aims are to assess between group differences in frequency of symptoms, disability, fear avoidance
behavior, self efficacy, general health, improvement, patient satisfaction, work loss, medication use, lumbar
dynamic motion, and torso muscle endurance. Patients’ and providers’ perceptions of treatment will be
described using qualitative methods and cost-effectiveness and cost utility will be assessed in the short- and
long-term.
Participants
Inclusion Criteria: Mechanical LBP classified as 1, 2, 3, or 4 using Quebec Task Force (QTF) classification.
(This includes back pain, stiffness or tenderness with or without musculoskeletal and neurological signs); LBP
localized to posterior aspect of body, below the costal margin and above the inferior gluteal folds; pain level
> 3 on 0 to 10 scale; current LBP episode > 6 weeks duration; 18 years of age and older; stable prescription
medication plan (No changes in prescription medications that affect musculoskeletal pain in the previous
month.)
Exclusion Criteria: Ongoing treatment for LBP by other non-study providers; Progressive neurological deficits
or cauda equina syndrome; QTF classifications 5 (spinal instability or fracture) and 11 (other diagnoses
including visceral diseases, compression fractures, metastases). These are serious conditions not amenable
to the conservative treatments proposed: QTF 7 (Spinal stenosis syndrome characterized by pain and/or
paraesthesias in one or both legs aggravated by walking); uncontrolled hypertension or metabolic disease;
blood clotting disorders; severe osteoporosis; inflammatory or destructive tissue changes of the spine; patients
with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery; pregnant or nursing
women
Interventions
Chiropractic care (A combination of professional therapies with the scope of practice, including spinal manipulation therapy, spinal mobilization, stretching and strengthening exercises, and self-care education).
Multidisciplinary, integrative care (A combination of therapies which may include acupuncture/Oriental
medicine, chiropractic, cognitive behavioral therapy, exercise therapy, medicine, self-care information, and
massage therapy).
Outcomes
Primary Outcome Measures: Patient-rated back pain. ( Time Frame: Short term: 12 weeks, Long term: 52
weeks) (Designated as safety issue: No)
Secondary Outcome Measures: Frequency of Symptoms (Time Frame: 12 and 52 weeks) (Designated as safety
issue: No)
Low-Back Disability (Time Frame:12 and 52 weeks) (Designated as safety issue: No)
Fear Avoidance (Time Frame:12 and 52 weeks) (Designated as safety issue: No)
Self-Efficacy (Time Frame: 12 and 52 weeks) (Designated as safety issue: No)
General Health Status (Time Frame:12 and 52 weeks) (Designated as safety issue: No)
Improvement (Time Frame:12 and 52 weeks) (Designated as safety issue: No)
Patient Satisfaction (Time Frame:12 and 52 weeks) (Designated as safety issue: No)
Work Loss (Time Frame:12 and 52 weeks) (Designated as safety issue: No)
Medication Use (Time Frame:12 and 52 weeks) (Designated as safety issue: No)
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NCT00567333
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Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance. (Time
Frame: Short term:12 weeks) (Designated as safety issue: No)
Starting date
June 2007; recruitment completed, currently in the follow-up phase. Estimated completion: October 2010.
Contact information
Principal investigator: Gert Brønfort, DC, PhD
Notes
http://clinicaltrials.gov/show/NCT00567333
Primary sponsor: Northwestern Health Sciences University
NCT00315120
Trial name or title
A randomised controlled trial of osteopathic manipulative treatment and ultrasound physical therapy for
chronic low-back pain
Methods
RCT
Target sample size: 488
Participants
21-69 years of age with chronic LBP
Inclusion Criteria: Must give a positive response to the question: ”Have you had low-back pain constantly or on
most days for the last three months?“; Must identify the low back as the primary site of pain; Must agree to not
receive any of the following outside of the study during the period of participation: osteopathic manipulative
treatment, chiropractic adjustment (including ”mobilization“ or ”manipulation“), physical therapy; Women
must not be pregnant or plan to become pregnant during the period of study participation (a negative
pregnancy test and willingness to maintain an acceptable method of contraception will be required)
Exclusion Criteria: History of any of the following conditions which may be underlying causes of low-back
symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina
syndrome; History of surgery involving the low back within the past year or planned low-back surgery in
the future; History of receiving Workers’ Compensation benefits within the past three months; Involvement
in current litigation relating to back problems; Current pregnancy or plan to become pregnant during the
course of participation in the study; Any of the following that may limit a provider’s choice of osteopathic
manipulative treatment techniques or hamper compliance with the study protocol: angina or congestive
heart failure symptoms that occur at rest or with minimal activity, history of a stroke or transient ischemic
attack within the past year; Any of the following that may represent potential contraindications to receiving
ultrasound physical therapy: implantation of a cardiac pacemaker, implantation of artificial joints or other
biomedical devices, active bleeding or infection in the low back, pregnancy; Use of intravenous, intramuscular,
or oral corticosteroids within the past month; History of osteopathic manipulative treatment, chiropractic
adjustment, or physical therapy within the past three months or on more than three occasions during the
past year; Practitioner or student of any of the following: osteopathic medicine (D.O.) allopathic medicine
(M.D.), chiropractic (D.C.), physical therapy
Interventions
1) Active osteopathic manipulation and active ultrasound physical therapy
2) Sham osteopathic manipulation and active ultrasound physical therapy
3) Active osteopathic manipulation and sham ultrasound physical therapy
4) Sham osteopathic manipulation and sham ultrasound physical therapy
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NCT00315120
(Continued)
Outcomes
Primary Outcome Measures: Visual analogue scale score for pain (Time Frame: 1, 2, 4, 8 & 12 weeks)
Secondary Outcome Measures: Roland Morris Disability Questionnaire; Medical Outcomes Study SF-36
Health Survey; Work disability; Satisfaction with back care (Time Frame: 4, 8 & 12 weeks)
Starting date
August 2006; estimated study completion date: June 2010
Contact information
Principal investigator: John Licciardone, DO, MS, MBA
Notes
http://clinicaltrials.gov/show/NCT00315120
Principal sponsor: University of Horth Texas Health Science Center
ISRCTN47636118
Trial name or title
Efficacy of conventional physiotherapy and manipulative physiotherapy in the treatment of low-back pain:
A randomised controlled trial
Methods
RCT; Target sample size: 440
Participants
Inclusion criteria: Patients are medically referred; patients presented no contraindication to Conventional
physiotherapy (CPT) and Manipulative (MPT) physiotherapy; aged 18 to 65 years; low-back pain (LBP)
not treated by physiotherapist in the previous month; duration of LBP at least 2 weeks before attending
physiotherapy; patient’s consent to participate in the randomised controlled trial; patient’s agreement to be
followed up to 12 months post-commencement of treatment
Exclusion criteria: Does not meet inclusion criteria
Interventions
The objective of this trial was to compare the relative effectiveness of two common forms of physiotherapy:
1. Conventional Physiotherapy (CPT): consists of the use of electrical current, heat, cold, exercise and massage,
and
2. Manipulative Physiotherapy (MPT): primarily consists of passive joint mobilisation and manipulative
techniques, in the short and long term.
Outcomes
The main outcome measures were disability, health and pain. These parameters were assessed by the:
1. Aberdeen Low-Back Pain Disability Scale
2. Current Perceived Health 42 (CPH42) Profile
3. Numerical Pain Scale (NRS). The NRS measures pain intensity from no pain to intolerable pain along an
11-point scale.
The research assistants, who were blind to the treatment routine administered the questionnaires at baseline,
then at 3, 6, and 12 weeks (short term) followed by 6, 9, 12 months (long term) after physiotherapy commenced.
Starting date
January 2000; patient recruitment completed as of June 2008
Contact information
Dr ASL Leung; Department of Rehabilitation Sciences; The Hong Kong Polytechnic University
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ISRCTN47636118
Notes
(Continued)
http://isrctn.org/ISRCTN47636118; status of this study is unknown and attempts to contact the primary
investigator were unsuccessful.
Sponsored by: Hong Kong Health Services Research Fund (China)
NCT00376350
Trial name or title
Dose-response/Efficacy of manipulation for chronic low-back pain
Methods
RCT
Target sample size: 400
Participants
Inclusion Criteria: 18 years and older with chronic LBP; current episode of low-back pain of mechanical
origin; threshold low-back pain level
Exclusion Criteria: Contraindications to spinal manipulation or massage; complicating conditions that could
confound clinical outcome; prophylactic use of prescription medication; health-related litigation, claims, or
disability compensation
Interventions
This study will determine the number of visits to a chiropractor for spinal manipulation, light massage,
and ultrasound necessary for optimal relief of chronic low-back pain. The study will also determine the
effectiveness of spinal manipulation.
Outcomes
Primary Outcome Measures: Modified Von Korff Pain Scale for low-back pain; Modified Von Korff Disability
Scale (Time Frame: baseline, 2, 6, 12, 18, 24, 39, 52 weeks)
Secondary Outcome Measures: Pain days; Disability days;Low-back pain unpleasantness; Fear avoidance
beliefs;
General health status/QoL; Healthcare utilization; Bias monitoring (Time Frame: baseline Baseline, 2; 6, 12,
18, 24, 39, 52 weeks); Patient satisfaction (Time Frame: 12 wk); Objective measures
Starting date
March 2007; estimated completion date March 2011
Contact information
Principal investigator, Mitchell Haas, DC
Notes
http://clinicaltrials.gov/show/NCT00376350
Primary sponsor: National Center for Complementary and Alternative Medicine (NCCAM)
ISRCTN61808774
Trial name or title
A randomised controlled trial of the effect on chronic low-back pain of a naturopathic osteopathy intervention
Methods
Random allocation to an intervention arm and usual care.
Target sample size: 240
Participants
240 clients aged between 20 and 65 presenting at ten general practices in Brent in the summer of 2000 with
low-back pain of over three months duration.
Exclusion criteria: not provided
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ISRCTN61808774
(Continued)
Interventions
Questionnaire inquiry of disability, pain and sense of well being administered at recruitment, 3, 6, 12 months,
and at 5 years. Half will be randomised to an intervention arm that comprises treatment at the British College
of Naturopathy and Osteopathy (BCNO) by third/fourth year students under the supervision of experienced
trainer practitioners. This intervention will be naturopathic osteopathy and include patient diaries. Up to
seven treatments will be given, expecting an average of five weekly treatments.
Outcomes
Assessment of:
1. Disability using the Roland Morris Score
2. Self competence using the Perceived Pain Management Competence Scale
3. Beliefs using the Back Beliefs Questionnaire
4. Pain using the Von Korff questionnaire
5. Well-being using the SF12.
All of these are self-administered questionnaires.
Starting date
April 2000; recruitment completed; information last updated Nov. 2005
Contact information
Dr. Paul Thomas
Notes
http://isrctn.org/ISRCTN61808774. Sponsored by the Dept. of Health in the UK. Status unknown. Several
attempts were made to contact the primary investigator.
NCT00269321
Trial name or title
randomised clinical trial of chiropractic manual therapy plus home exercise, supervised exercise plus home
exercise and home exercises alone for individuals 65 and over with chronic mechanical low-back pain
Primary aims: to determine the relative clinical effectiveness the following treatments for LBP patients 65
years and older in both the short-term (after 12 weeks) and long-term (after 52 weeks), using LBP as the main
outcome measure.
Secondary outcomes: to estimate the short- and long-term relative effectiveness of the three interventions
using:
1. Patient-rated outcomes: low-back disability, general health status, patient satisfaction, improvement,
and medication use measured by self-report questionnaires
2. Objective functional performance outcomes: spinal motion, trunk strength and endurance, and
functional ability measured by examiners masked to treatment group assignment
3. Cost measures: direct and indirect costs of treatment measured by questionnaires, phone interviews,
and medical records.
4. To describe elderly LBP patients’ perceptions of treatment and the issues they consider when
determining their satisfaction with care using qualitative methods nested within the RCT.
Methods
RCT
Target sample size: 240
Participants
Inclusion Criteria: Sub-Acute and chronic low-back pain (Defined as current episode more than 6 weeks
duration.); Quebec Task Force classifications 1, 2, 3 and 4. (This includes patients with back pain, stiffness
or tenderness, with or without musculoskeletal signs and neurological signs.); 65 years of age and older;
Independent ambulation; community dwelling (residency outside nursing home); score of 20 or more on
Folstein Mini-Mental State Examination; stable prescription medication plan (no changes in prescription
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NCT00269321
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medications that affect musculoskeletal pain in previous month).
Exclusion Criteria: Referred low-back pain from local joint lesions of the lower extremities or from visceral
diseases; significant infectious disease determined by history or by referral to supplementary diagnostic tests;
ongoing treatment for low-back pain by other health care providers; mean baseline low-back pain score of 20
percentage points or less; contraindications to exercise determined by history or by referral to supplementary
diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable
angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease,
poorly controlled blood pressure, uncontrolled metabolic disease)’; contraindications to spinal manipulation
(i.e. progressive neurological deficits blood clotting disorders; infectious and non-infectious inflammatory or
destructive tissue changes of the spine; severe osteoporosis)
Interventions
1) Chiropractic Manual treatment + home exercise (procedure+behavior)
2) Supervised rehabilitative exercise+home exercise
3) Home exercise
Outcomes
Primary Outcome Measures: Patient-rated pain (0 to 11 box scale) (Time Frame: short term = 12 weeks; long
term = 52 weeks)
Secondary Outcome Measures: General Health; Disability; Improvement; Satisfaction; Medication use (Time
Frame: short term = 12 weeks; long term = 52 weeks)
Biomechanical test: Lumbar spinal motion Trunk strength & endurance; Functional Ability Observed Pain
Behavior (Time Frame: short term = 12 weeks)
Starting date
October 2003; recruitment completed as of June 2008.
Contact information
Principal investigator: Gert Brønfort, DC, PhD
Notes
http://clinicaltrials.gov/show/NCT00269321
Sponsored by: Northwestern Health Sciences University
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NCT00269347
Trial name or title
Title: Manipulation, exercise and self-care for non-acute low-back pain
Building upon the principal investigators’ previous collaborative research, this randomised observer-blinded
clinical trial will compare the following treatment for patients with non-acute low-back pain:
1. chiropractic spinal manipulation
2. rehabilitative exercise
3. self care education Theprimary aim is to examine the relative efficacy of the three interventions in
terms of patient rated outcomes in the short-term (after 12 weeks) and the long-term (after 52 weeks) for
non-acute low-back pain.
Secondary aims include:
1. To examine the short and long-term relative cost effectiveness and cost utility of the three treatments.
2. To assess if there are clinically important differences between pre-specified subgroups of low-back pain
patients. Subgroups are based on duration and current episode and radiating leg pain.
3. To evaluate if there treatment group differences in objective lumbar spine function (range of motion,
strength and endurance) after 12 weeks of treatment and if changes in lumbar function are associated with
changes in patient rated short and long-term outcomes.
4. To identify if baseline demographic or clinical variables can predict short or long-term outcome.
5. To describe patients’ interpretations and perceptions of outcome measures used in clinical trials
Methods
RCT; Target sample size: 300
Participants
Inclusion criteria: patients are 18-65 years of age; Québec task force classification 1,2,3 and 4 (this includes
patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs)
; primary complaint of back pain, with current episode greater than or equal to six weeks duration.
Exclusion criteria: previous lumbar spine surgery; back pain referred from local joint lesions of the lower
extremities or from visceral diseases; progressive neurological deficits due to nerve root or spinal cord compression; aortic and peripheral vascular disease; existing cardiac disease requiring medical treatment; blood
clotting disorders; diffuse idiopathic hyperostosis; infectious and noninfectious inflammatory or destructive
tissue changes of the lumbar spine; presence of significant infectious disease, or other severe debilitating
health problems; substance abuse; ongoing treatment for back pain by other health care providers; pregnant
or nursing women; pain score of less than 30 percentage points; pending our current litigation
Interventions
1)Chiropractic Spinal Manipulation
2) Procedure: Exercise
3) Behavioral: Self-care
Outcomes
Primary Outcome Measures: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
Secondary Outcome Measures: Disability (Modified Roland Scale); General Health (SF-36); Improvement
(7 point scale); Disability (NHIS); Bothersomeness (7 point scale); Frequency (7 point scale); Satisfaction
(5 point scale); Depression (CES-D); Medication use; Fear-avoidance (FABQ); Lumbar range of motion;
Lumbar strength and endurance; Health care costs and utilization at baseline, weeks 4,12,26,52
Starting date
January 2001; recruitment completed as of June 2008; currently in the review process.
Contact information
Principal investigator: Gert Brønfort, DC, PhD
Notes
http://clinicaltrials.gov/show/NCT00269347
Sponsored by: Northwestern Health Sciences University
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NCT00269503
Trial name or title
Official title: A Pilot Study of Chiropractic Prone Distraction for Subacute Back Pain With Sciatica
Methods
RCT; Target sample size: 60
Participants
Inclusion Criteria: active duty military personnel; aged 18-45 (age is limited to 45 years due to the natural
aging and degeneration of the discs; the less hydration the disc maintain, the less likely manipulation will
be successful); Have subacute low-back pain (more than three months duration but less than six months
duration), with radicular component (sciatica) rated at a minimum level of 4 on the Numerical Rating Scale
(NRS) of the Brief Pain Inventory; Have a confirmed herniated disc, as noted on MRI, which correlates with
the clinical findings (sciatica)
In this study, a ”herniated disc“ refers to any localized displacement of disc material, including nucleus,
cartilage, fragmented apophyseal bone, or fragmented anular tissue, which results in back and leg pain.
”Herniated Disc“ also will include disc extrusions and disc bulges (protrusions) only when with associated
annular tears.
In this study, ”sciatica“ refers to pain in the lower extremity(ies) that follows the course of the sciatic nerve
Exclusion Criteria: patients who are not able to give informed consent; pregnant or nursing women; patients
who have a primary bone disease, cancer, infection, spondylolysis or spondylolisthesis; patients who have had
prior spine surgery, including rhizotomy; participation in another conflicting research study; patients who
cannot commit to a trial lasting up to eight weeks or cannot come for bi-weekly treatments; patients who
are going through a course of physical therapy or chiropractic treatment or at the time of planned enrolment
or are being currently being managed and/or treated for any pain condition; patients who have an unstable
medical or psychiatric condition; patients who are planning or have been advised to have spine surgery; any
contraindications to either prone distraction or side posture manipulation will disqualify potential subjects
from any participation in this study; patients with a pacemaker.
Interventions
Conditions to be treated: Herniated Disc, lower back pain, sciatica.
Procedures to be examined: prone distraction, side-posture manipulation, side-posture manipulation and
prone distraction and usual care (control group).
Outcomes
Primary Outcome Measures:
-Change in overall leg pain intensity, as assessed by the change, if any, of leg pain documented on the Numerical
Rating Scale (NRS) in the Brief Pain Inventory (BPI) from baseline to 8 weeks
-Time to pain relief, defined as NRS less than 4 after 2 consecutive visits
Secondary Outcome Measures:
-Change in overall back pain intensity, as assessed by the change, if any, of back pain documented on the BPI
from baseline to 8 weeks
-Change in overall pain intensity, as assessed by the change, if any, of the sum of back and leg pain documented
on the BPI at measured intervals
-Change in overall pain intensity, as assessed by the change, if any, of the sum of back and leg pain documented
on the BPI from baseline to 8 weeks
-Patient satisfaction with treatment, as assessed by The Client Satisfaction Questionnaire
-Medication use, as assessed by the Medication Log
-Functional disability, as assessed by The Roland-Morris Low-Back Pain and Disability Questionnaire
-Lost/decreased workdays
-Change, if any, in percent of disc herniation, as determined by the study neuroradiologist
-Descriptive changes in disc morphology, as assessed by the study neuroradiologist
-Variability of treatment, as assessed by the number or prescriptions written, the number of visits to the
Primary Care Clinic, as well as the number of referrals to additional treatments outside of the chiropractic
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
127
NCT00269503
(Continued)
clinic
Starting date
Contact information
Notes
Study terminated. No explanation offered. link: http://clinicaltrials.gov/show/nct00269503
Spinal manipulative therapy for chronic low-back pain (Review)
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128
DATA AND ANALYSES
Comparison 1. SMT vs. inert interventions
Outcome or subgroup title
1 Pain
1.1 Pain at 1 month
1.2 Pain at 3 months
2 Perceived recovery
2.1 Recovery at 1 month
2.2 Recovery at 3 months
3 Return to work
3.1 Return to work at 1
month
3.2 Return to work at 3
months
No. of
studies
1
1
1
1
1
1
1
1
1
No. of
participants
Statistical method
Effect size
72
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Subtotals only
-6.0 [-15.82, 3.82]
7.0 [-3.58, 17.58]
Subtotals only
1.03 [0.49, 2.19]
0.96 [0.56, 1.65]
Subtotals only
1.29 [1.00, 1.65]
70
Risk Ratio (M-H, Random, 95% CI)
1.17 [0.97, 1.40]
72
70
72
70
Comparison 2. SMT vs. sham SMT
Outcome or subgroup title
1 Pain
1.1 Pain at 1 month
1.2 Pain at 3 months
1.3 Pain at 6 months
2 Functional status
2.1 Functional status at 1
month
2.2 Functional status at 3
months
2.3 Functional status at 6
months
No. of
studies
No. of
participants
Statistical method
Effect size
65
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Subtotals only
-3.24 [-13.62, 7.15]
2.5 [-9.64, 14.64]
7.10 [-5.16, 19.36]
Subtotals only
-0.45 [-0.97, 0.06]
1
55
Std. Mean Difference (IV, Random, 95% CI)
Not estimable
1
51
Std. Mean Difference (IV, Random, 95% CI)
0.04 [-0.52, 0.61]
3
3
1
1
1
1
148
55
51
Spinal manipulative therapy for chronic low-back pain (Review)
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129
Comparison 3. SMT vs. any other intervention
Outcome or subgroup title
1 Pain
1.1 Pain at 1 month
1.2 Pain at 3 months
1.3 Pain at 6 months
1.4 Pain at 12 months
2 Functional status
2.1 Functional status at 1
month
2.2 Functional status at 3
months
2.3 Functional status at 6
months
2.4 Functional status at 12
months
3 Perceived recovery
3.1 Recovery at 1 month
3.2 Recovery at 3 months
3.3 Recovery at 6 months
3.4 Recovery at 12 months
4 Return to work
4.1 Return to work at 1
month
4.2 Return to work at 3
months
4.3 Return to work at 12
months
5 Health-related Quality of Life
5.1 Health-related quality of
life at 1 month
5.2 Health-related quality of
life at 3 months
5.3 Health-related quality of
life at 12 months
No. of
studies
No. of
participants
Statistical method
Effect size
1820
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Subtotals only
-4.16 [-6.97, -1.36]
-2.54 [-6.13, 1.06]
-3.76 [-6.58, -0.95]
-0.89 [-2.92, 1.14]
Subtotals only
-0.22 [-0.36, -0.07]
10
1770
Std. Mean Difference (IV, Random, 95% CI)
-0.05 [-0.23, 0.13]
9
1806
Std. Mean Difference (IV, Random, 95% CI)
-0.12 [-0.22, -0.02]
8
1860
Std. Mean Difference (IV, Random, 95% CI)
-0.09 [-0.18, 0.00]
71
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Subtotals only
1.20 [1.04, 1.37]
1.70 [1.20, 2.40]
1.05 [0.81, 1.38]
1.17 [0.87, 1.55]
Subtotals only
1.10 [0.91, 1.35]
2
188
Risk Ratio (M-H, Random, 95% CI)
1.03 [0.93, 1.14]
3
389
Risk Ratio (M-H, Random, 95% CI)
1.09 [0.98, 1.21]
4
3
361
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Subtotals only
-0.08 [-0.29, 0.13]
3
246
Std. Mean Difference (IV, Random, 95% CI)
0.21 [-0.27, 0.70]
1
31
Std. Mean Difference (IV, Random, 95% CI)
1.00 [-1.75, -0.24]
15
11
10
8
7
14
10
4
3
2
1
1
4
1
1894
1587
1594
1728
370
182
112
109
Comparison 4. Subset of comparison 3. SMT vs. ineffective interventions
Outcome or subgroup title
1 Pain
1.1 Pain at 1 month
1.2 Pain at 3 months
1.3 Pain at 6 months
No. of
studies
No. of
participants
4
3
2
3
277
147
242
Statistical method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Effect size
Subtotals only
-8.02 [-16.14, 0.10]
-4.59 [-17.20, 8.03]
-8.92 [-13.43, -4.41]
130
1.4 Pain at 12 months
2 Functional status
2.1 Functional status at 1
month
2.2 Functional status at 3
months
2.3 Functional status at 6
months
2.4 Functional status at 12
months
3 Perceived recovery
3.1 Recovery at 1 month
3.2 Recovery at 3 months
4 Return to work
4.1 Return to work at 1
month
4.2 Return to work at 3
months
1
3
2
206
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
-5.0 [-12.46, 2.46]
Subtotals only
-0.47 [-0.85, -0.09]
1
82
Std. Mean Difference (IV, Random, 95% CI)
0.64 [0.19, 1.08]
3
243
Std. Mean Difference (IV, Random, 95% CI)
-0.28 [-0.56, 0.01]
1
82
Std. Mean Difference (IV, Random, 95% CI)
Not estimable
71
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Subtotals only
1.00 [0.48, 2.12]
1.42 [0.71, 2.83]
Subtotals only
1.10 [0.91, 1.35]
65
Risk Ratio (M-H, Random, 95% CI)
1.02 [0.90, 1.17]
1
1
1
1
1
1
82
71
65
Comparison 5. Subset of comparison 3. SMT vs. effective interventions
Outcome or subgroup title
1 Pain
1.1 Pain at 1 month
1.2 Pain at 3 months
1.3 Pain at 6 months
1.4 Pain at 12 months
2 Functional status
2.1 Functional status at 1
month
2.2 Functional status at 3
months
2.3 Functional status at 6
months
2.4 Functional status at 12
months
3 Perceived recovery
3.1 Recovery at 1 month
3.2 Recovery at 3 months
3.3 Recovery at 6 months
3.4 Recovery at 12 months
4 Return to work
4.1 Return to work at 3
months
4.2 Return to work at 12
months
5 Health-related Quality of Life
No. of
studies
No. of
participants
Statistical method
Effect size
1660
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Subtotals only
-3.04 [-5.98, -0.10]
-2.09 [-6.29, 2.11]
-2.24 [-5.25, 0.78]
-0.52 [-2.57, 1.53]
Subtotals only
-0.17 [-0.31, -0.03]
10
1732
Std. Mean Difference (IV, Random, 95% CI)
-0.10 [-0.27, 0.06]
8
1647
Std. Mean Difference (IV, Random, 95% CI)
-0.09 [-0.19, 0.02]
8
1822
Std. Mean Difference (IV, Random, 95% CI)
-0.11 [-0.22, 0.00]
123
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Subtotals only
1.20 [1.05, 1.38]
1.80 [1.21, 2.69]
1.05 [0.81, 1.38]
1.17 [0.87, 1.55]
Subtotals only
1.04 [0.89, 1.21]
389
Risk Ratio (M-H, Random, 95% CI)
1.09 [0.98, 1.21]
Std. Mean Difference (IV, Random, 95% CI)
Subtotals only
13
9
9
7
7
13
9
3
2
1
1
1
3
1
3
4
1663
1484
1436
1690
299
117
112
109
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131
5.1 Health-related quality of
life at 1 month
5.2 Health-related quality of
life at 3 months
5.3 Health-related quality of
life at 12 months
3
361
Std. Mean Difference (IV, Random, 95% CI)
-0.08 [-0.29, 0.13]
3
246
Std. Mean Difference (IV, Random, 95% CI)
0.21 [-0.27, 0.70]
1
31
Std. Mean Difference (IV, Random, 95% CI)
1.00 [-1.75, -0.24]
Comparison 6. SMT + intervention vs. intervention alone
Outcome or subgroup title
1 Pain
1.1 Pain at 1 month
1.2 Pain at 3 months
1.3 Pain at 6 months
1.4 Pain at 12 months
2 Functional status
2.1 Functional status at 1
month
2.2 Functional status at 3
months
2.3 Functional status at 6
months
2.4 Functional status at 12
months
3 Perceived recovery
3.1 Recovery at 1 month
No. of
studies
No. of
participants
Statistical method
Effect size
156
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Subtotals only
-5.88 [-10.85, -0.90]
-7.23 [-11.72, -2.74]
-6.77 [-14.07, 0.53]
-3.31 [-6.60, -0.02]
Subtotals only
-0.40 [-0.73, -0.07]
2
1078
Std. Mean Difference (IV, Random, 95% CI)
-0.22 [-0.38, -0.06]
2
142
Std. Mean Difference (IV, Random, 95% CI)
-0.30 [-0.64, 0.03]
1
994
Std. Mean Difference (IV, Random, 95% CI)
-0.21 [-0.34, -0.09]
1
1
32
32
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
3.4 [1.12, 10.28]
3.4 [1.12, 10.28]
4
3
2
2
2
3
2
228
1016
143
1000
Comparison 7. Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only
Outcome or subgroup title
1 Pain
1.1 Pain at 1 month
1.2 Pain at 3 months
1.3 Pain at 6 months
1.4 Pain at 12 months
2 Functional status
2.1 Functional status at 1
month
2.2 Functional status at 3
months
2.3 Functional status at 6
months
No. of
studies
No. of
participants
Statistical method
Effect size
1402
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Subtotals only
-2.76 [-5.19, -0.32]
-4.55 [-8.68, -0.43]
-3.07 [-5.42, -0.71]
-0.76 [-3.19, 1.66]
Subtotals only
-0.17 [-0.29, -0.06]
6
1323
Std. Mean Difference (IV, Random, 95% CI)
-0.18 [-0.37, 0.01]
5
1313
Std. Mean Difference (IV, Random, 95% CI)
-0.12 [-0.23, -0.00]
8
6
5
4
3
8
6
1405
1074
1105
1285
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132
2.4 Functional status at 12
months
3 Perceived recovery
3.1 Recovery at 1 month
3.2 Recovery at 6 months
3.3 Recovery at 12 months
4 Return to work
4.1 Return to work at 3
months
4.2 Return to work at 12
months
5 Health-related Quality of Life
5.1 Health-related quality of
life at 1 month
5.2 Health-related quality of
life at 3 months
4
Std. Mean Difference (IV, Random, 95% CI)
-0.06 [-0.16, 0.05]
123
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Subtotals only
1.18 [0.93, 1.50]
1.05 [0.81, 1.38]
1.17 [0.87, 1.55]
Subtotals only
1.04 [0.89, 1.21]
2
198
Risk Ratio (M-H, Random, 95% CI)
1.06 [0.86, 1.31]
1
1
105
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Subtotals only
-0.17 [-0.55, 0.22]
1
96
Std. Mean Difference (IV, Random, 95% CI)
-0.02 [-0.42, 0.39]
1
1
1
1
2
1
1418
113
112
109
Comparison 8. Subset of comparisons 1, 2 & 3. SMT vs. ineffective/sham/inert interventions
Outcome or subgroup title
1 Pain
1.1 Pain at 1 month
1.2 Pain at 3 months
1.3 Pain at 6 months
1.4 Pain at 12 months
2 Functional status
2.1 Functional status at 1
month
2.2 Functional status at 3
months
2.3 Functional status at 6
months
2.4 Functional status at 12
months
No. of
studies
No. of
participants
Statistical method
Effect size
271
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Subtotals only
-6.07 [-11.52, -0.62]
0.14 [-6.16, 6.44]
-6.04 [-12.94, 0.85]
-5.0 [-12.46, 2.46]
Subtotals only
-0.47 [-0.72, -0.23]
2
137
Std. Mean Difference (IV, Random, 95% CI)
0.34 [-0.28, 0.96]
4
294
Std. Mean Difference (IV, Random, 95% CI)
-0.22 [-0.47, 0.03]
1
82
Std. Mean Difference (IV, Random, 95% CI)
Not estimable
7
6
3
4
1
4
3
459
234
293
82
Spinal manipulative therapy for chronic low-back pain (Review)
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133
Analysis 1.1. Comparison 1 SMT vs. inert interventions, Outcome 1 Pain.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 1 SMT vs. inert interventions
Outcome: 1 Pain
Study or subgroup
SMT
Inert interventions
Mean Difference
N
Mean(SD)
N
Mean(SD)
39
21 (22.5)
33
27 (20)
Weight
IV,Random,95% CI
Mean Difference
IV,Random,95% CI
1 Pain at 1 month
Gibson 1985
Subtotal (95% CI)
39
100.0 %
33
-6.00 [ -15.82, 3.82 ]
100.0 % -6.00 [ -15.82, 3.82 ]
Heterogeneity: not applicable
Test for overall effect: Z = 1.20 (P = 0.23)
2 Pain at 3 months
Gibson 1985
Subtotal (95% CI)
38
13 (22.5)
38
32
6 (22.5)
32
100.0 %
7.00 [ -3.58, 17.58 ]
100.0 %
7.00 [ -3.58, 17.58 ]
Heterogeneity: not applicable
Test for overall effect: Z = 1.30 (P = 0.19)
-20
-10
Favours SMT
Spinal manipulative therapy for chronic low-back pain (Review)
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0
10
20
Favours inert tx
134
Analysis 1.2. Comparison 1 SMT vs. inert interventions, Outcome 2 Perceived recovery.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 1 SMT vs. inert interventions
Outcome: 2 Perceived recovery
Study or subgroup
SMT
Inert interventions
n/N
n/N
Risk Ratio
Weight
11/39
9/33
100.0 %
1.03 [ 0.49, 2.19 ]
39
33
100.0 %
1.03 [ 0.49, 2.19 ]
16/38
14/32
100.0 %
0.96 [ 0.56, 1.65 ]
38
32
100.0 %
0.96 [ 0.56, 1.65 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Recovery at 1 month
Gibson 1985
Subtotal (95% CI)
Total events: 11 (SMT), 9 (Inert interventions)
Heterogeneity: not applicable
Test for overall effect: Z = 0.09 (P = 0.93)
2 Recovery at 3 months
Gibson 1985
Subtotal (95% CI)
Total events: 16 (SMT), 14 (Inert interventions)
Heterogeneity: not applicable
Test for overall effect: Z = 0.14 (P = 0.89)
0.01
0.1
Favors inert tx
1
10
100
Favors SMT
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135
Analysis 1.3. Comparison 1 SMT vs. inert interventions, Outcome 3 Return to work.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 1 SMT vs. inert interventions
Outcome: 3 Return to work
Study or subgroup
SMT
Inert interventions
n/N
n/N
Risk Ratio
Weight
35/39
23/33
100.0 %
1.29 [ 1.00, 1.65 ]
39
33
100.0 %
1.29 [ 1.00, 1.65 ]
36/38
26/32
100.0 %
1.17 [ 0.97, 1.40 ]
38
32
100.0 %
1.17 [ 0.97, 1.40 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Return to work at 1 month
Gibson 1985
Subtotal (95% CI)
Total events: 35 (SMT), 23 (Inert interventions)
Heterogeneity: not applicable
Test for overall effect: Z = 1.99 (P = 0.046)
2 Return to work at 3 months
Gibson 1985
Subtotal (95% CI)
Total events: 36 (SMT), 26 (Inert interventions)
Heterogeneity: not applicable
Test for overall effect: Z = 1.65 (P = 0.099)
0.5
0.7
Favors inert tx
1
1.5
2
Favors SMT
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136
Analysis 2.1. Comparison 2 SMT vs. sham SMT, Outcome 1 Pain.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 2 SMT vs. sham SMT
Outcome: 1 Pain
Study or subgroup
SMT
Sham SMT
Mean Difference
Weight
IV,Random,95% CI
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
Ghroubi 2007
32
49.37 (16.78)
32
58.43 (28.8)
35.3 %
-9.06 [ -20.61, 2.49 ]
Licciardone 2003
42
37.7 (26.2)
23
30.7 (21.9)
34.3 %
7.00 [ -4.95, 18.95 ]
9
23 (15)
10
31 (15)
30.4 %
-8.00 [ -21.51, 5.51 ]
100.0 %
-3.24 [ -13.62, 7.15 ]
100.0 %
2.50 [ -9.64, 14.64 ]
100.0 %
2.50 [ -9.64, 14.64 ]
100.0 %
7.10 [ -5.16, 19.36 ]
100.0 %
7.10 [ -5.16, 19.36 ]
1 Pain at 1 month
Waagen 1986
Subtotal (95% CI)
83
65
Heterogeneity: Tau2 = 44.76; Chi2 = 4.27, df = 2 (P = 0.12); I2 =53%
Test for overall effect: Z = 0.61 (P = 0.54)
2 Pain at 3 months
Licciardone 2003
Subtotal (95% CI)
36
31 (24.5)
36
19
28.5 (20.3)
19
Heterogeneity: not applicable
Test for overall effect: Z = 0.40 (P = 0.69)
3 Pain at 6 months
Licciardone 2003
Subtotal (95% CI)
32
31.6 (22.4)
32
19
24.5 (21.1)
19
Heterogeneity: not applicable
Test for overall effect: Z = 1.14 (P = 0.26)
-20
-10
Favours SMT
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10
20
Favours sham SMT
137
Analysis 2.2. Comparison 2 SMT vs. sham SMT, Outcome 2 Functional status.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 2 SMT vs. sham SMT
Outcome: 2 Functional status
Study or subgroup
SMT
Sham SMT
Std. Mean Difference
N
Mean(SD)
N
Mean(SD)
42
5.7 (4.1)
23
7.7 (4.8)
Weight
IV,Random,95% CI
Std. Mean Difference
IV,Random,95% CI
1 Functional status at 1 month
Licciardone 2003
Subtotal (95% CI)
42
23
100.0 %
-0.45 [ -0.97, 0.06 ]
100.0 %
-0.45 [ -0.97, 0.06 ]
100.0 %
0.0 [ -0.56, 0.56 ]
100.0 %
0.0 [ -0.56, 0.56 ]
100.0 %
0.04 [ -0.52, 0.61 ]
100.0 %
0.04 [ -0.52, 0.61 ]
Heterogeneity: not applicable
Test for overall effect: Z = 1.73 (P = 0.084)
2 Functional status at 3 months
Licciardone 2003
Subtotal (95% CI)
36
6.1 (4.5)
36
19
6.1 (4.1)
19
Heterogeneity: not applicable
Test for overall effect: Z = 0.0 (P = 1.0)
3 Functional status at 6 months
Licciardone 2003
Subtotal (95% CI)
32
32
5.2 (4.5)
19
5 (4.5)
19
Heterogeneity: not applicable
Test for overall effect: Z = 0.15 (P = 0.88)
-2
-1
Favours SMT
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1
2
Favours sham SMT
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Analysis 3.1. Comparison 3 SMT vs. any other intervention, Outcome 1 Pain.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 3 SMT vs. any other intervention
Outcome: 1 Pain
Study or subgroup
SMT
Other intervention
Mean Difference
Weight
IV,Random,95% CI
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
Brnfort 1996
62
34 (19)
43
36 (22)
6.5 %
-2.00 [ -10.10, 6.10 ]
Gibson 1985
39
21 (22.5)
32
28 (24)
4.5 %
-7.00 [ -17.91, 3.91 ]
Gudavalli 2006
123
17.4 (22.3)
112
23.4 (20.7)
9.2 %
-6.00 [ -11.50, -0.50 ]
Hemmila 2002
22
30.5 (15)
34
27 (15)
6.6 %
3.50 [ -4.54, 11.54 ]
Hemmila 2002
22
30.5 (15)
35
30 (15)
6.6 %
0.50 [ -7.50, 8.50 ]
Hondras 2009
90 29.49 (19.29)
16 33.47 (19.49)
4.9 %
-3.98 [ -14.33, 6.37 ]
Hondras 2009
83 27.63 (19.31)
16 33.47 (19.49)
4.8 %
-5.84 [ -16.25, 4.57 ]
Hsieh 2002
22
25.8 (19.3)
42
21.3 (12.8)
5.8 %
4.50 [ -4.45, 13.45 ]
Hsieh 2002
22
25.8 (19.3)
49
27.8 (18.2)
5.4 %
-2.00 [ -11.54, 7.54 ]
Hurwitz 2002
169
34 (19)
169
36 (19)
11.0 %
-2.00 [ -6.05, 2.05 ]
Hurwitz 2002
169
31 (18)
168
35 (20)
11.0 %
-4.00 [ -8.06, 0.06 ]
Mohseni-Bandpei 2006
56
23.4 (19)
56
37.9 (19)
7.5 %
-14.50 [ -21.54, -7.46 ]
Rasmussen-Barr 2003
19
24 (26.7)
22
20 (17.8)
3.1 %
4.00 [ -10.12, 18.12 ]
Skillgate 2007
92
36 (14.4)
80
44 (13.4)
10.9 %
-8.00 [ -12.16, -3.84 ]
Wilkey 2008
18
42.8 (22.5)
12
70 (24.1)
2.3 %
-27.20 [ -44.35, -10.05 ]
1 Pain at 1 month
Subtotal (95% CI)
1008
886
100.0 % -4.16 [ -6.97, -1.36 ]
Heterogeneity: Tau2 = 14.40; Chi2 = 30.48, df = 14 (P = 0.01); I2 =54%
Test for overall effect: Z = 2.91 (P = 0.0037)
2 Pain at 3 months
Brnfort 1996
56
27 (20)
40
35 (22)
7.6 %
-8.00 [ -16.60, 0.60 ]
Ferreira 2007
77
41 (26)
147
44 (24.5)
8.8 %
-3.00 [ -10.03, 4.03 ]
Gibson 1985
38
13 (22.5)
27
25 (22.5)
5.9 %
-12.00 [ -23.10, -0.90 ]
Gudavalli 2006
87
21.5 (22.3)
76
23.7 (20.7)
9.2 %
-2.20 [ -8.80, 4.40 ]
Hemmila 2002
22
30 (15)
35
31 (15)
8.0 %
-1.00 [ -9.00, 7.00 ]
Hemmila 2002
22
30 (15)
34
27.5 (15)
8.0 %
2.50 [ -5.54, 10.54 ]
Paatelma 2008
23
18 (12.6)
52
10 (14.8)
9.3 %
8.00 [ 1.47, 14.53 ]
-20
-10
Favors SMT
0
10
20
Favors Other intervention
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Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Study or subgroup
SMT
Other intervention
Mean Difference
Weight
N
Mean(SD)
N
Mean(SD)
Paatelma 2008
23
18 (12.6)
37
17 (13.3)
9.1 %
1.00 [ -5.70, 7.70 ]
Rasmussen-Barr 2003
16
22 (28.1)
17
14 (14.1)
3.9 %
8.00 [ -7.31, 23.31 ]
Skillgate 2007
89
26 (14.4)
73
37 (13.4)
11.2 %
-11.00 [ -15.29, -6.71 ]
275
40.9 (24.87)
204 44.73 (24.42)
11.1 %
-3.83 [ -8.29, 0.63 ]
57
23.4 (23.9)
7.9 %
-4.60 [ -12.75, 3.55 ]
100.0 %
-2.54 [ -6.13, 1.06 ]
UK BEAM trial 2004
Zaproudina 2009
Subtotal (95% CI)
785
60
IV,Random,95% CI
(. . . Continued)
Mean Difference
IV,Random,95% CI
28 (20.9)
802
Heterogeneity: Tau2 = 25.18; Chi2 = 33.61, df = 11 (P = 0.00042); I2 =67%
Test for overall effect: Z = 1.38 (P = 0.17)
3 Pain at 6 months
Ferreira 2007
72
43 (26)
139
45.6 (26)
8.0 %
-2.60 [ -10.00, 4.80 ]
Gudavalli 2006
90
19.7 (22.3)
74
26.8 (20.7)
9.0 %
-7.10 [ -13.69, -0.51 ]
Hemmila 2002
22
25 (15)
35
30 (15)
7.3 %
-5.00 [ -13.00, 3.00 ]
Hemmila 2002
22
25 (15)
34
26 (15)
7.2 %
-1.00 [ -9.04, 7.04 ]
Hsieh 2002
20
24 (24.1)
42
22.9 (19.8)
4.1 %
1.10 [ -11.04, 13.24 ]
Hsieh 2002
20
24 (24.1)
47
29.9 (22.8)
4.0 %
-5.90 [ -18.31, 6.51 ]
Hurwitz 2002
163
18 (18)
159
22 (20)
12.7 %
-4.00 [ -8.16, 0.16 ]
Hurwitz 2002
165
26 (19)
165
28.5 (19)
12.8 %
-2.50 [ -6.60, 1.60 ]
Mohseni-Bandpei 2006
40
27.1 (19)
33
40.2 (19)
6.5 %
-13.10 [ -21.86, -4.34 ]
Paatelma 2008
23
14 (8.1)
37
22 (17.8)
8.9 %
-8.00 [ -14.62, -1.38 ]
Paatelma 2008
23
14 (8.1)
52
10 (7.4)
13.2 %
4.00 [ 0.13, 7.87 ]
Zaproudina 2009
57
24.5 (24.6)
60
31.3 (25.6)
6.2 %
-6.80 [ -15.90, 2.30 ]
Subtotal (95% CI)
717
100.0 % -3.76 [ -6.58, -0.95 ]
877
Heterogeneity: Tau2 = 11.71; Chi2 = 23.36, df = 11 (P = 0.02); I2 =53%
Test for overall effect: Z = 2.62 (P = 0.0089)
4 Pain at 12 months
Ferreira 2007
73
49 (27)
138
50.6 (28.5)
6.7 %
-1.60 [ -9.41, 6.21 ]
Gudavalli 2006
96
20.9 (22.3)
78
23.3 (20.7)
10.0 %
-2.40 [ -8.80, 4.00 ]
Hurwitz 2002
156
27.5 (18)
148
28 (20)
22.4 %
-0.50 [ -4.78, 3.78 ]
Hurwitz 2002
153
32.5 (19)
153
34 (19)
22.7 %
-1.50 [ -5.76, 2.76 ]
Paatelma 2008
23
11 (14.1)
37
16 (19.3)
5.7 %
-5.00 [ -13.48, 3.48 ]
Paatelma 2008
23
11 (14.1)
52
8 (17)
7.5 %
3.00 [ -4.39, 10.39 ]
Rasmussen-Barr 2003
14
18 (21.5)
17
13 (13.3)
2.5 %
5.00 [ -7.92, 17.92 ]
200 41.54 (26.02)
18.2 %
0.14 [ -4.61, 4.89 ]
4.4 %
-4.10 [ -13.80, 5.60 ]
UK BEAM trial 2004
Zaproudina 2009
264 41.68 (25.67)
50
26.6 (26.2)
53
30.7 (23.9)
-20
-10
Favors SMT
0
10
20
Favors Other intervention
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Study or subgroup
SMT
Subtotal (95% CI)
852
N
Other intervention
Mean(SD)
N
Mean Difference
Mean(SD)
Weight
IV,Random,95% CI
(. . . Continued)
Mean Difference
IV,Random,95% CI
876
100.0 %
-0.89 [ -2.92, 1.14 ]
Heterogeneity: Tau2 = 0.0; Chi2 = 3.72, df = 8 (P = 0.88); I2 =0.0%
Test for overall effect: Z = 0.86 (P = 0.39)
-20
-10
0
Favors SMT
10
20
Favors Other intervention
Analysis 3.2. Comparison 3 SMT vs. any other intervention, Outcome 2 Functional status.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 3 SMT vs. any other intervention
Outcome: 2 Functional status
Study or subgroup
SMT
Other intervention
Std. Mean Difference
Weight
IV,Random,95% CI
Std. Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
62
19.1 (19.3)
43
20.8 (17.8)
7.7 %
-0.09 [ -0.48, 0.30 ]
Gudavalli 2006
123
3.8 (4.7)
112
4.5 (4.4)
11.3 %
-0.15 [ -0.41, 0.10 ]
Hemmila 2002
20
16.7 (11.6)
33
16.1 (7.7)
4.9 %
0.06 [ -0.49, 0.62 ]
Hemmila 2002
20
16.7 (11.6)
29
16.2 (9.5)
4.7 %
0.05 [ -0.52, 0.62 ]
Hondras 2009
87
4.35 (2.9)
16
6.42 (2.91)
5.0 %
-0.71 [ -1.25, -0.17 ]
Hondras 2009
94
4.62 (2.91)
16
6.42 (2.91)
5.1 %
-0.61 [ -1.15, -0.08 ]
Hsieh 2002
22
4.42 (4.92)
49
5.8 (5.12)
5.6 %
-0.27 [ -0.77, 0.24 ]
Hsieh 2002
22
4.42 (4.92)
42
4.26 (3.52)
5.4 %
0.04 [ -0.48, 0.55 ]
Hurwitz 2002
169
6.5 (5)
168
7.5 (5.4)
12.7 %
-0.19 [ -0.41, 0.02 ]
Hurwitz 2002
169
6.8 (5.6)
169
7.3 (5.6)
12.7 %
-0.09 [ -0.30, 0.12 ]
Mohseni-Bandpei 2006
56
12.9 (12.7)
56
22.1 (14.9)
7.9 %
-0.66 [ -1.04, -0.28 ]
Rasmussen-Barr 2003
19
12 (4.4)
22
9 (7.4)
4.1 %
0.47 [ -0.15, 1.10 ]
Skillgate 2007
92
1.9 (2.45)
80
2.4 (2.28)
10.0 %
-0.21 [ -0.51, 0.09 ]
Wilkey 2008
18
8.16 (6.27)
12
14.36 (5.03)
2.8 %
-1.04 [ -1.82, -0.25 ]
100.0 %
-0.22 [ -0.36, -0.07 ]
1 Functional status at 1 month
Brnfort 1996
Subtotal (95% CI)
973
847
-1
-0.5
Favors SMT
0
0.5
1
Favors Other intervention
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Study or subgroup
SMT
N
Other intervention
Mean(SD)
N
Std. Mean Difference
Mean(SD)
Weight
IV,Random,95% CI
(. . . Continued)
Std. Mean Difference
IV,Random,95% CI
Heterogeneity: Tau2 = 0.03; Chi2 = 24.14, df = 13 (P = 0.03); I2 =46%
Test for overall effect: Z = 2.97 (P = 0.0030)
2 Functional status at 3 months
Brnfort 1996
56
15.1 (17.4)
40
20.9 (17)
7.9 %
-0.33 [ -0.74, 0.07 ]
Ferreira 2007
77
7.9 (6)
147
8.8 (6)
10.2 %
-0.15 [ -0.43, 0.13 ]
Gudavalli 2006
86
3.1 (4.7)
76
3.1 (4.4)
9.6 %
0.0 [ -0.31, 0.31 ]
Hemmila 2002
22
18.6 (11.6)
33
14.1 (7.7)
6.0 %
0.47 [ -0.08, 1.02 ]
Hemmila 2002
22
18.6 (11.6)
35
16.5 (9.5)
6.1 %
0.20 [ -0.33, 0.73 ]
Hondras 2009
85
3.45 (4.03)
19
5.62 (4.05)
6.5 %
-0.53 [ -1.04, -0.03 ]
Hondras 2009
93
4.11 (4.05)
19
5.62 (4.05)
6.6 %
-0.37 [ -0.87, 0.13 ]
Paatelma 2008
23
2 (3.7)
37
0 (2.2)
6.1 %
0.69 [ 0.15, 1.23 ]
Paatelma 2008
23
2 (3.7)
52
1 (4.4)
6.7 %
0.24 [ -0.26, 0.73 ]
Rasmussen-Barr 2003
16
13 (12.6)
17
6 (4.4)
4.3 %
0.73 [ 0.02, 1.44 ]
Skillgate 2007
90
1.3 (2.45)
73
2.4 (2.28)
9.5 %
-0.46 [ -0.77, -0.15 ]
287
5.09 (4.74)
225
5.47 (4.35)
11.9 %
-0.08 [ -0.26, 0.09 ]
57
12.2 (10.9)
60
15.9 (10.1)
8.6 %
-0.35 [ -0.72, 0.02 ]
100.0 %
-0.05 [ -0.23, 0.13 ]
UK BEAM trial 2004
Zaproudina 2009
Subtotal (95% CI)
937
833
Heterogeneity: Tau2 = 0.06; Chi2 = 33.55, df = 12 (P = 0.00079); I2 =64%
Test for overall effect: Z = 0.60 (P = 0.55)
3 Functional status at 6 months
Ferreira 2007
72
7.7 (6.2)
139
9.3 (6.7)
11.5 %
-0.24 [ -0.53, 0.04 ]
Gudavalli 2006
90
2.8 (4.7)
78
3.4 (4.4)
10.1 %
-0.13 [ -0.43, 0.17 ]
Hemmila 2002
22
14.3 (11.6)
33
15.9 (9.5)
3.2 %
-0.15 [ -0.69, 0.39 ]
Hemmila 2002
22
14.3 (11.6)
33
13.4 (7.7)
3.2 %
0.09 [ -0.45, 0.63 ]
Hondras 2009
89
4.06 (4.36)
17
5.34 (4.27)
3.5 %
-0.29 [ -0.81, 0.23 ]
Hondras 2009
86
3.44 (4.39)
17
5.34 (4.27)
3.4 %
-0.43 [ -0.96, 0.09 ]
Hsieh 2002
21
3.29 (4.73)
47
5.06 (4.78)
3.5 %
-0.37 [ -0.89, 0.15 ]
Hsieh 2002
21
3.29 (4.73)
42
3.48 (3.86)
3.4 %
-0.05 [ -0.57, 0.48 ]
Hurwitz 2002
165
4.1 (5.6)
165
4.8 (5.6)
20.0 %
-0.12 [ -0.34, 0.09 ]
Hurwitz 2002
163
3.8 (5)
159
3.5 (5.4)
19.6 %
0.06 [ -0.16, 0.28 ]
Mohseni-Bandpei 2006
40
14.1 (12.7)
33
20.7 (14.9)
4.3 %
-0.48 [ -0.94, -0.01 ]
Paatelma 2008
23
1 (3)
37
1 (5.2)
3.5 %
0.0 [ -0.52, 0.52 ]
Paatelma 2008
23
1 (3)
52
0 (3)
3.8 %
0.33 [ -0.16, 0.82 ]
Zaproudina 2009
57
12.2 (12.1)
60
14.5 (8.9)
7.1 %
-0.22 [ -0.58, 0.15 ]
-1
-0.5
Favors SMT
0
0.5
1
Favors Other intervention
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142
Study or subgroup
SMT
Subtotal (95% CI)
894
N
Other intervention
Mean(SD)
N
Std. Mean Difference
Mean(SD)
Weight
IV,Random,95% CI
(. . . Continued)
Std. Mean Difference
IV,Random,95% CI
912
100.0 %
-0.12 [ -0.22, -0.02 ]
Heterogeneity: Tau2 = 0.0; Chi2 = 12.50, df = 13 (P = 0.49); I2 =0.0%
Test for overall effect: Z = 2.41 (P = 0.016)
4 Functional status at 12 months
Ferreira 2007
73
9.2 (6.6)
138
9.2 (6.7)
10.6 %
0.0 [ -0.28, 0.28 ]
Gudavalli 2006
95
2.7 (4.7)
78
3.1 (4.4)
9.5 %
-0.09 [ -0.39, 0.21 ]
Hemmila 2002
22
15.3 (11.6)
32
13.7 (7.7)
2.9 %
0.17 [ -0.38, 0.71 ]
Hemmila 2002
22
15.3 (11.6)
32
17.2 (9.5)
2.9 %
-0.18 [ -0.72, 0.36 ]
Hurwitz 2002
153
6.6 (5.6)
153
7.1 (5.6)
16.9 %
-0.09 [ -0.31, 0.14 ]
Hurwitz 2002
156
6.2 (5)
148
6 (5.4)
16.8 %
0.04 [ -0.19, 0.26 ]
Paatelma 2008
23
0 (1.5)
37
0 (2.2)
3.1 %
0.0 [ -0.52, 0.52 ]
Paatelma 2008
23
0 (1.5)
52
1 (1.5)
3.4 %
-0.66 [ -1.16, -0.16 ]
Rasmussen-Barr 2003
14
8 (9.6)
17
8 (5.9)
1.7 %
0.0 [ -0.71, 0.71 ]
UK BEAM trial 2004
273
5.15 (4.79)
216
5.74 (4.56)
26.6 %
-0.13 [ -0.30, 0.05 ]
50
12.5 (11)
53
16 (10.7)
5.6 %
-0.32 [ -0.71, 0.07 ]
100.0 %
-0.09 [ -0.18, 0.00 ]
Zaproudina 2009
Subtotal (95% CI)
904
956
Heterogeneity: Tau2 = 0.0; Chi2 = 9.21, df = 10 (P = 0.51); I2 =0.0%
Test for overall effect: Z = 1.93 (P = 0.053)
-1
-0.5
Favors SMT
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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0.5
1
Favors Other intervention
143
Analysis 3.3. Comparison 3 SMT vs. any other intervention, Outcome 3 Perceived recovery.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 3 SMT vs. any other intervention
Outcome: 3 Perceived recovery
Study or subgroup
SMT
Other intervention
n/N
n/N
Risk Ratio
Weight
11/39
9/32
3.4 %
1.00 [ 0.48, 2.12 ]
Gudavalli 2006
82/103
54/83
54.4 %
1.22 [ 1.02, 1.47 ]
Hemmila 2002
18/22
26/34
25.5 %
1.07 [ 0.82, 1.40 ]
Hemmila 2002
18/22
21/35
16.7 %
1.36 [ 0.98, 1.91 ]
186
184
100.0 %
1.20 [ 1.04, 1.37 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Recovery at 1 month
Gibson 1985
Subtotal (95% CI)
Total events: 129 (SMT), 110 (Other intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 1.51, df = 3 (P = 0.68); I2 =0.0%
Test for overall effect: Z = 2.56 (P = 0.010)
2 Recovery at 3 months
Gibson 1985
16/38
8/27
24.9 %
1.42 [ 0.71, 2.83 ]
Zaproudina 2009
36/57
21/60
75.1 %
1.80 [ 1.21, 2.69 ]
95
87
100.0 %
1.70 [ 1.20, 2.40 ]
Subtotal (95% CI)
Total events: 52 (SMT), 29 (Other intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 0.35, df = 1 (P = 0.56); I2 =0.0%
Test for overall effect: Z = 3.02 (P = 0.0025)
3 Recovery at 6 months
Hemmila 2002
15/22
22/34
50.0 %
1.05 [ 0.72, 1.54 ]
Hemmila 2002
15/22
22/34
50.0 %
1.05 [ 0.72, 1.54 ]
44
68
100.0 %
1.05 [ 0.81, 1.38 ]
Subtotal (95% CI)
Total events: 30 (SMT), 44 (Other intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 0.0, df = 1 (P = 1.00); I2 =0.0%
Test for overall effect: Z = 0.38 (P = 0.70)
4 Recovery at 12 months
Hemmila 2002
15/22
18/32
47.3 %
1.21 [ 0.80, 1.84 ]
Hemmila 2002
15/22
20/33
52.7 %
1.13 [ 0.76, 1.67 ]
44
65
100.0 %
1.17 [ 0.87, 1.55 ]
Subtotal (95% CI)
Total events: 30 (SMT), 38 (Other intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 0.06, df = 1 (P = 0.80); I2 =0.0%
Test for overall effect: Z = 1.04 (P = 0.30)
0.5
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Analysis 3.4. Comparison 3 SMT vs. any other intervention, Outcome 4 Return to work.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 3 SMT vs. any other intervention
Outcome: 4 Return to work
Study or subgroup
SMT
Other intervention
n/N
n/N
Risk Ratio
Weight
35/39
26/32
100.0 %
1.10 [ 0.91, 1.35 ]
39
32
100.0 %
1.10 [ 0.91, 1.35 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Return to work at 1 month
Gibson 1985
Subtotal (95% CI)
Total events: 35 (SMT), 26 (Other intervention)
Heterogeneity: not applicable
Test for overall effect: Z = 0.99 (P = 0.32)
2 Return to work at 3 months
Brnfort 1996
61/71
43/52
41.1 %
1.04 [ 0.89, 1.21 ]
Gibson 1985
36/38
25/27
58.9 %
1.02 [ 0.90, 1.17 ]
109
79
100.0 %
1.03 [ 0.93, 1.14 ]
Subtotal (95% CI)
Total events: 97 (SMT), 68 (Other intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 0.03, df = 1 (P = 0.87); I2 =0.0%
Test for overall effect: Z = 0.57 (P = 0.57)
3 Return to work at 12 months
Brnfort 1996
47/52
30/38
33.0 %
1.14 [ 0.95, 1.38 ]
Gudavalli 2006
90/107
65/84
57.0 %
1.09 [ 0.94, 1.25 ]
Hemmila 2002
12/22
22/32
5.7 %
0.79 [ 0.51, 1.24 ]
Hemmila 2002
12/22
16/32
4.3 %
1.09 [ 0.65, 1.83 ]
203
186
100.0 %
1.09 [ 0.98, 1.21 ]
Subtotal (95% CI)
Total events: 161 (SMT), 133 (Other intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 2.34, df = 3 (P = 0.50); I2 =0.0%
Test for overall effect: Z = 1.51 (P = 0.13)
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Analysis 3.5. Comparison 3 SMT vs. any other intervention, Outcome 5 Health-related Quality of Life.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 3 SMT vs. any other intervention
Outcome: 5 Health-related Quality of Life
Study or subgroup
SMT
N
Other intervention
Mean(SD)
Std. Mean Difference
N
Mean(SD)
Weight
IV,Random,95% CI
Std. Mean Difference
IV,Random,95% CI
1 Health-related quality of life at 1 month
Brnfort 1996
Gudavalli 2006
62
71.9 (14.3)
43
74.3 (14.6)
28.4 %
-0.17 [ -0.55, 0.22 ]
104
74.4 (18.7)
111
74.2 (19.4)
60.3 %
0.01 [ -0.26, 0.28 ]
19
72 (23.7)
22
79 (12.6)
11.2 %
-0.37 [ -0.99, 0.25 ]
100.0 %
-0.08 [ -0.29, 0.13 ]
Rasmussen-Barr 2003
Subtotal (95% CI) 185
176
Heterogeneity: Tau2 = 0.0; Chi2 = 1.46, df = 2 (P = 0.48); I2 =0.0%
Test for overall effect: Z = 0.78 (P = 0.44)
2 Health-related quality of life at 3 months
Brnfort 1996
56
75.4 (12)
40
75.6 (11.1)
36.8 %
-0.02 [ -0.42, 0.39 ]
Rasmussen-Barr 2003
16
79 (14.1)
17
80 (11.1)
24.9 %
-0.08 [ -0.76, 0.61 ]
Zaproudina 2009
57
0.94 (0.04)
60
0.9 (0.08)
38.4 %
0.62 [ 0.25, 0.99 ]
100.0 %
0.21 [ -0.27, 0.70 ]
100.0 %
-1.00 [ -1.75, -0.24 ]
100.0 %
-1.00 [ -1.75, -0.24 ]
Subtotal (95% CI) 129
117
Heterogeneity: Tau2 = 0.12; Chi2 = 6.39, df = 2 (P = 0.04); I2 =69%
Test for overall effect: Z = 0.87 (P = 0.38)
3 Health-related quality of life at 12 months
Rasmussen-Barr 2003
14
Subtotal (95% CI)
14
68 (15.6)
17
82 (11.9)
17
Heterogeneity: not applicable
Test for overall effect: Z = 2.59 (P = 0.0097)
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Analysis 4.1. Comparison 4 Subset of comparison 3. SMT vs. ineffective interventions, Outcome 1 Pain.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 4 Subset of comparison 3. SMT vs. ineffective interventions
Outcome: 1 Pain
Study or subgroup
SMT
Passive/ineff intervent.
Mean Difference
Weight
IV,Random,95% CI
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
Gibson 1985
39
21 (22.5)
32
28 (24)
26.8 %
-7.00 [ -17.91, 3.91 ]
Hsieh 2002
45
25.8 (19.3)
49
27.8 (18.2)
35.7 %
-2.00 [ -9.60, 5.60 ]
Mohseni-Bandpei 2006
56
23.4 (19)
56
37.9 (19)
37.4 %
-14.50 [ -21.54, -7.46 ]
1 Pain at 1 month
Subtotal (95% CI)
140
137
100.0 % -8.02 [ -16.14, 0.10 ]
Heterogeneity: Tau2 = 33.02; Chi2 = 5.67, df = 2 (P = 0.06); I2 =65%
Test for overall effect: Z = 1.93 (P = 0.053)
2 Pain at 3 months
Gibson 1985
38
13 (22.5)
27
25 (22.5)
43.0 %
-12.00 [ -23.10, -0.90 ]
Paatelma 2008
45
18 (12.6)
37
17 (13.3)
57.0 %
1.00 [ -4.65, 6.65 ]
Subtotal (95% CI)
83
64
100.0 % -4.59 [ -17.20, 8.03 ]
Heterogeneity: Tau2 = 64.31; Chi2 = 4.19, df = 1 (P = 0.04); I2 =76%
Test for overall effect: Z = 0.71 (P = 0.48)
3 Pain at 6 months
Hsieh 2002
40
24 (24.1)
47
29.9 (22.8)
20.7 %
-5.90 [ -15.81, 4.01 ]
Mohseni-Bandpei 2006
40
27.1 (19)
33
40.2 (19)
26.5 %
-13.10 [ -21.86, -4.34 ]
Paatelma 2008
45
14 (8.1)
37
22 (17.8)
52.8 %
-8.00 [ -14.20, -1.80 ]
Subtotal (95% CI)
125
117
100.0 % -8.92 [ -13.43, -4.41 ]
Heterogeneity: Tau2 = 0.0; Chi2 = 1.32, df = 2 (P = 0.52); I2 =0.0%
Test for overall effect: Z = 3.88 (P = 0.00011)
4 Pain at 12 months
Paatelma 2008
Subtotal (95% CI)
45
11 (14.1)
45
37
100.0 %
16 (19.3)
37
-5.00 [ -12.46, 2.46 ]
100.0 % -5.00 [ -12.46, 2.46 ]
Heterogeneity: not applicable
Test for overall effect: Z = 1.31 (P = 0.19)
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Analysis 4.2. Comparison 4 Subset of comparison 3. SMT vs. ineffective interventions, Outcome 2
Functional status.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 4 Subset of comparison 3. SMT vs. ineffective interventions
Outcome: 2 Functional status
Study or subgroup
SMT
Passive/ineff intervent.
Std. Mean Difference
Weight
IV,Random,95% CI
Std. Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
Hsieh 2002
45
4.42 (4.92)
49
5.8 (5.12)
48.2 %
-0.27 [ -0.68, 0.13 ]
Mohseni-Bandpei 2006
56
12.9 (12.7)
56
22.1 (14.9)
51.8 %
-0.66 [ -1.04, -0.28 ]
100.0 %
-0.47 [ -0.85, -0.09 ]
100.0 %
0.64 [ 0.19, 1.08 ]
100.0 %
0.64 [ 0.19, 1.08 ]
1 Functional status at 1 month
Subtotal (95% CI)
101
105
Heterogeneity: Tau2 = 0.03; Chi2 = 1.86, df = 1 (P = 0.17); I2 =46%
Test for overall effect: Z = 2.44 (P = 0.015)
2 Functional status at 3 months
Paatelma 2008
45
Subtotal (95% CI)
2 (3.7)
37
45
0 (2.2)
37
Heterogeneity: not applicable
Test for overall effect: Z = 2.79 (P = 0.0052)
3 Functional status at 6 months
Hsieh 2002
41
3.29 (4.73)
47
5.06 (4.78)
35.7 %
-0.37 [ -0.79, 0.05 ]
Mohseni-Bandpei 2006
40
14.1 (12.7)
33
20.7 (14.9)
30.2 %
-0.48 [ -0.94, -0.01 ]
Paatelma 2008
45
1 (3)
37
1 (5.2)
34.1 %
0.0 [ -0.43, 0.43 ]
100.0 %
-0.28 [ -0.56, 0.01 ]
100.0 %
0.0 [ -0.43, 0.43 ]
100.0 %
0.0 [ -0.43, 0.43 ]
Subtotal (95% CI)
126
117
Heterogeneity: Tau2 = 0.01; Chi2 = 2.43, df = 2 (P = 0.30); I2 =18%
Test for overall effect: Z = 1.92 (P = 0.054)
4 Functional status at 12 months
Paatelma 2008
Subtotal (95% CI)
45
45
0 (1.5)
37
0 (2.2)
37
Heterogeneity: not applicable
Test for overall effect: Z = 0.0 (P = 1.0)
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Analysis 4.3. Comparison 4 Subset of comparison 3. SMT vs. ineffective interventions, Outcome 3
Perceived recovery.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 4 Subset of comparison 3. SMT vs. ineffective interventions
Outcome: 3 Perceived recovery
Study or subgroup
SMT
Passive/ineff intervent.
n/N
n/N
Risk Ratio
Weight
11/39
9/32
100.0 %
1.00 [ 0.48, 2.12 ]
39
32
100.0 %
1.00 [ 0.48, 2.12 ]
16/38
8/27
100.0 %
1.42 [ 0.71, 2.83 ]
38
27
100.0 %
1.42 [ 0.71, 2.83 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Recovery at 1 month
Gibson 1985
Subtotal (95% CI)
Total events: 11 (SMT), 9 (Passive/ineff intervent.)
Heterogeneity: not applicable
Test for overall effect: Z = 0.01 (P = 0.99)
2 Recovery at 3 months
Gibson 1985
Subtotal (95% CI)
Total events: 16 (SMT), 8 (Passive/ineff intervent.)
Heterogeneity: not applicable
Test for overall effect: Z = 1.00 (P = 0.32)
0.5
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Analysis 4.4. Comparison 4 Subset of comparison 3. SMT vs. ineffective interventions, Outcome 4 Return
to work.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 4 Subset of comparison 3. SMT vs. ineffective interventions
Outcome: 4 Return to work
Study or subgroup
SMT
Passive/ineff intervent.
n/N
n/N
Risk Ratio
Weight
35/39
26/32
100.0 %
1.10 [ 0.91, 1.35 ]
39
32
100.0 %
1.10 [ 0.91, 1.35 ]
36/38
25/27
100.0 %
1.02 [ 0.90, 1.17 ]
38
27
100.0 %
1.02 [ 0.90, 1.17 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Return to work at 1 month
Gibson 1985
Subtotal (95% CI)
Total events: 35 (SMT), 26 (Passive/ineff intervent.)
Heterogeneity: not applicable
Test for overall effect: Z = 0.99 (P = 0.32)
2 Return to work at 3 months
Gibson 1985
Subtotal (95% CI)
Total events: 36 (SMT), 25 (Passive/ineff intervent.)
Heterogeneity: not applicable
Test for overall effect: Z = 0.34 (P = 0.73)
0.5
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Analysis 5.1. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 1 Pain.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 5 Subset of comparison 3. SMT vs. effective interventions
Outcome: 1 Pain
Study or subgroup
SMT
Active/Eff. intervention
Mean Difference
Weight
IV,Random,95% CI
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
62
34 (19)
43
36 (22)
7.6 %
-2.00 [ -10.10, 6.10 ]
Gudavalli 2006
123
17.4 (22.3)
112
23.4 (20.7)
11.0 %
-6.00 [ -11.50, -0.50 ]
Hemmila 2002
22
30.5 (15)
34
27 (15)
7.6 %
3.50 [ -4.54, 11.54 ]
Hemmila 2002
22
30.5 (15)
35
30 (15)
7.7 %
0.50 [ -7.50, 8.50 ]
Hondras 2009
90 29.49 (19.29)
16 33.47 (19.49)
5.6 %
-3.98 [ -14.33, 6.37 ]
Hondras 2009
83 27.63 (19.31)
16 33.47 (19.49)
5.5 %
-5.84 [ -16.25, 4.57 ]
Hsieh 2002
45
25.8 (19.3)
42
21.3 (12.8)
9.1 %
4.50 [ -2.34, 11.34 ]
Hurwitz 2002
169
34 (19)
169
36 (19)
13.4 %
-2.00 [ -6.05, 2.05 ]
Hurwitz 2002
169
31 (18)
168
35 (20)
13.3 %
-4.00 [ -8.06, 0.06 ]
Rasmussen-Barr 2003
19
24 (26.7)
22
20 (17.8)
3.5 %
4.00 [ -10.12, 18.12 ]
Skillgate 2007
92
36 (14.4)
80
44 (13.4)
13.2 %
-8.00 [ -12.16, -3.84 ]
Wilkey 2008
18
42.8 (22.5)
12
70 (24.1)
2.5 %
-27.20 [ -44.35, -10.05 ]
1 Pain at 1 month
Brnfort 1996
Subtotal (95% CI) 914
100.0 % -3.04 [ -5.98, -0.10 ]
749
Heterogeneity: Tau2 = 12.58; Chi2 = 23.76, df = 11 (P = 0.01); I2 =54%
Test for overall effect: Z = 2.03 (P = 0.043)
2 Pain at 3 months
Brnfort 1996
56
27 (20)
40
35 (22)
9.0 %
-8.00 [ -16.60, 0.60 ]
Ferreira 2007
77
41 (26)
147
44 (24.5)
10.3 %
-3.00 [ -10.03, 4.03 ]
Gudavalli 2006
87
21.5 (22.3)
76
23.7 (20.7)
10.7 %
-2.20 [ -8.80, 4.40 ]
Hemmila 2002
22
30 (15)
35
31 (15)
9.5 %
-1.00 [ -9.00, 7.00 ]
Hemmila 2002
22
30 (15)
34
27.5 (15)
9.5 %
2.50 [ -5.54, 10.54 ]
Paatelma 2008
45
18 (12.6)
52
10 (14.8)
11.7 %
8.00 [ 2.55, 13.45 ]
Rasmussen-Barr 2003
16
22 (28.1)
17
14 (14.1)
5.0 %
8.00 [ -7.31, 23.31 ]
Skillgate 2007
89
26 (14.4)
73
37 (13.4)
12.6 %
-11.00 [ -15.29, -6.71 ]
275
40.9 (24.87)
204 44.73 (24.42)
12.5 %
-3.83 [ -8.29, 0.63 ]
57
23.4 (23.9)
9.4 %
-4.60 [ -12.75, 3.55 ]
UK BEAM trial 2004
Zaproudina 2009
60
28 (20.9)
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Study or subgroup
SMT
N
Active/Eff. intervention
Mean(SD)
Subtotal (95% CI) 746
N
Mean Difference
Mean(SD)
Weight
IV,Random,95% CI
(. . . Continued)
Mean Difference
IV,Random,95% CI
738
100.0 %
-2.09 [ -6.29, 2.11 ]
Heterogeneity: Tau2 = 31.65; Chi2 = 34.65, df = 9 (P = 0.00007); I2 =74%
Test for overall effect: Z = 0.98 (P = 0.33)
3 Pain at 6 months
Ferreira 2007
72
43 (26)
139
45.6 (26)
9.4 %
-2.60 [ -10.00, 4.80 ]
Gudavalli 2006
90
19.7 (22.3)
74
26.8 (20.7)
10.7 %
-7.10 [ -13.69, -0.51 ]
Hemmila 2002
22
25 (15)
34
26 (15)
8.5 %
-1.00 [ -9.04, 7.04 ]
Hemmila 2002
22
25 (15)
35
30 (15)
8.6 %
-5.00 [ -13.00, 3.00 ]
Hsieh 2002
40
24 (24.1)
42
22.9 (19.8)
6.8 %
1.10 [ -8.47, 10.67 ]
Hurwitz 2002
163
18 (18)
159
22 (20)
15.4 %
-4.00 [ -8.16, 0.16 ]
Hurwitz 2002
165
26 (19)
165
28.5 (19)
15.5 %
-2.50 [ -6.60, 1.60 ]
Paatelma 2008
45
14 (8.1)
52
10 (7.4)
17.7 %
4.00 [ 0.89, 7.11 ]
Zaproudina 2009
57
24.5 (24.6)
60
31.3 (25.6)
7.3 %
-6.80 [ -15.90, 2.30 ]
100.0 %
-2.24 [ -5.25, 0.78 ]
Subtotal (95% CI) 676
760
Heterogeneity: Tau2 = 10.84; Chi2 = 18.64, df = 8 (P = 0.02); I2 =57%
Test for overall effect: Z = 1.45 (P = 0.15)
4 Pain at 12 months
Ferreira 2007
73
49 (27)
138
50.6 (28.5)
6.9 %
-1.60 [ -9.41, 6.21 ]
Gudavalli 2006
96
20.9 (22.3)
78
23.3 (20.7)
10.3 %
-2.40 [ -8.80, 4.00 ]
Hurwitz 2002
153
32.5 (19)
153
34 (19)
23.2 %
-1.50 [ -5.76, 2.76 ]
Hurwitz 2002
156
27.5 (18)
148
28 (20)
22.9 %
-0.50 [ -4.78, 3.78 ]
Paatelma 2008
45
11 (14.1)
52
8 (17)
11.0 %
3.00 [ -3.19, 9.19 ]
Rasmussen-Barr 2003
14
18 (21.5)
17
13 (13.3)
2.5 %
5.00 [ -7.92, 17.92 ]
200 41.54 (26.02)
18.6 %
0.14 [ -4.61, 4.89 ]
4.5 %
-4.10 [ -13.80, 5.60 ]
100.0 %
-0.52 [ -2.57, 1.53 ]
UK BEAM trial 2004
Zaproudina 2009
264 41.68 (25.67)
50
26.6 (26.2)
Subtotal (95% CI) 851
53
30.7 (23.9)
839
Heterogeneity: Tau2 = 0.0; Chi2 = 3.15, df = 7 (P = 0.87); I2 =0.0%
Test for overall effect: Z = 0.50 (P = 0.62)
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Analysis 5.2. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 2 Functional
status.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 5 Subset of comparison 3. SMT vs. effective interventions
Outcome: 2 Functional status
Study or subgroup
SMT
N
Active/Eff. intervention
Std. Mean Difference
Weight
IV,Random,95% CI
Std. Mean Difference
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
62
19.1 (19.3)
43
20.8 (17.8)
8.5 %
-0.09 [ -0.48, 0.30 ]
Gudavalli 2006
123
3.8 (4.7)
112
4.5 (4.4)
13.4 %
-0.15 [ -0.41, 0.10 ]
Hemmila 2002
20
16.7 (11.6)
29
16.2 (9.5)
4.9 %
0.05 [ -0.52, 0.62 ]
Hemmila 2002
20
16.7 (11.6)
33
16.1 (7.7)
5.1 %
0.06 [ -0.49, 0.62 ]
Hondras 2009
94
4.62 (2.91)
16
6.42 (2.91)
5.4 %
-0.61 [ -1.15, -0.08 ]
Hondras 2009
87
4.35 (2.9)
16
6.42 (2.91)
5.3 %
-0.71 [ -1.25, -0.17 ]
Hsieh 2002
45
4.42 (4.92)
42
4.26 (3.52)
7.7 %
0.04 [ -0.38, 0.46 ]
Hurwitz 2002
169
6.5 (5)
168
7.5 (5.4)
15.5 %
-0.19 [ -0.41, 0.02 ]
Hurwitz 2002
169
6.8 (5.6)
169
7.3 (5.6)
15.5 %
-0.09 [ -0.30, 0.12 ]
Rasmussen-Barr 2003
19
12 (4.4)
22
9 (7.4)
4.3 %
0.47 [ -0.15, 1.10 ]
Skillgate 2007
92
1.9 (2.45)
80
2.4 (2.28)
11.5 %
-0.21 [ -0.51, 0.09 ]
Wilkey 2008
18
8.16 (6.27)
12
14.36 (5.03)
2.9 %
-1.04 [ -1.82, -0.25 ]
100.0 %
-0.17 [ -0.31, -0.03 ]
1 Functional status at 1 month
Brnfort 1996
Subtotal (95% CI) 918
742
Heterogeneity: Tau2 = 0.02; Chi2 = 18.20, df = 11 (P = 0.08); I2 =40%
Test for overall effect: Z = 2.32 (P = 0.020)
2 Functional status at 3 months
Brnfort 1996
56
15.1 (17.4)
40
20.9 (17)
8.2 %
-0.33 [ -0.74, 0.07 ]
Ferreira 2007
77
7.9 (6)
147
8.8 (6)
11.1 %
-0.15 [ -0.43, 0.13 ]
Gudavalli 2006
86
3.1 (4.7)
76
3.1 (4.4)
10.3 %
0.0 [ -0.31, 0.31 ]
Hemmila 2002
22
18.6 (11.6)
33
14.1 (7.7)
5.9 %
0.47 [ -0.08, 1.02 ]
Hemmila 2002
22
18.6 (11.6)
35
16.5 (9.5)
6.0 %
0.20 [ -0.33, 0.73 ]
Hondras 2009
93
4.11 (4.05)
19
5.62 (4.05)
6.6 %
-0.37 [ -0.87, 0.13 ]
Hondras 2009
85
3.45 (4.03)
19
5.62 (4.05)
6.5 %
-0.53 [ -1.04, -0.03 ]
Paatelma 2008
45
2 (3.7)
52
1 (4.4)
8.3 %
0.24 [ -0.16, 0.64 ]
Rasmussen-Barr 2003
16
13 (12.6)
17
6 (4.4)
4.1 %
0.73 [ 0.02, 1.44 ]
-1
-0.5
Favors SMT
0
0.5
1
Favors Active/Eff. intervention
(Continued . . . )
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
153
Study or subgroup
Skillgate 2007
UK BEAM trial 2004
Zaproudina 2009
SMT
Active/Eff. intervention
Std. Mean Difference
Weight
(. . . Continued)
Std. Mean Difference
N
Mean(SD)
N
Mean(SD)
90
1.3 (2.45)
73
2.4 (2.28)
10.2 %
-0.46 [ -0.77, -0.15 ]
287
5.09 (4.74)
225
5.47 (4.35)
13.6 %
-0.08 [ -0.26, 0.09 ]
57
12.2 (10.9)
60
15.9 (10.1)
9.0 %
-0.35 [ -0.72, 0.02 ]
100.0 %
-0.10 [ -0.27, 0.06 ]
Subtotal (95% CI) 936
IV,Random,95% CI
IV,Random,95% CI
796
Heterogeneity: Tau2 = 0.05; Chi2 = 26.08, df = 11 (P = 0.01); I2 =58%
Test for overall effect: Z = 1.22 (P = 0.22)
3 Functional status at 6 months
Ferreira 2007
72
7.7 (6.2)
139
9.3 (6.7)
12.5 %
-0.24 [ -0.53, 0.04 ]
Gudavalli 2006
90
2.8 (4.7)
78
3.4 (4.4)
11.1 %
-0.13 [ -0.43, 0.17 ]
Hemmila 2002
22
14.3 (11.6)
33
13.4 (7.7)
3.7 %
0.09 [ -0.45, 0.63 ]
Hemmila 2002
22
14.3 (11.6)
33
15.9 (9.5)
3.6 %
-0.15 [ -0.69, 0.39 ]
Hondras 2009
89
4.06 (4.36)
17
5.34 (4.27)
3.9 %
-0.29 [ -0.81, 0.23 ]
Hondras 2009
86
3.44 (4.39)
17
5.34 (4.27)
3.9 %
-0.43 [ -0.96, 0.09 ]
Hsieh 2002
41
3.29 (4.73)
42
3.48 (3.86)
5.7 %
-0.04 [ -0.47, 0.39 ]
Hurwitz 2002
165
4.1 (5.6)
165
4.8 (5.6)
20.8 %
-0.12 [ -0.34, 0.09 ]
Hurwitz 2002
163
3.8 (5)
159
3.5 (5.4)
20.4 %
0.06 [ -0.16, 0.28 ]
Paatelma 2008
45
1 (3)
52
0 (3)
6.5 %
0.33 [ -0.07, 0.73 ]
Zaproudina 2009
57
12.2 (12.1)
60
14.5 (8.9)
7.9 %
-0.22 [ -0.58, 0.15 ]
100.0 %
-0.09 [ -0.19, 0.02 ]
Subtotal (95% CI) 852
795
Heterogeneity: Tau2 = 0.00; Chi2 = 10.46, df = 10 (P = 0.40); I2 =4%
Test for overall effect: Z = 1.65 (P = 0.099)
4 Functional status at 12 months
Ferreira 2007
73
9.2 (6.6)
138
9.2 (6.7)
11.7 %
0.0 [ -0.28, 0.28 ]
Gudavalli 2006
95
2.7 (4.7)
78
3.1 (4.4)
10.7 %
-0.09 [ -0.39, 0.21 ]
Hemmila 2002
22
15.3 (11.6)
32
13.7 (7.7)
3.9 %
0.17 [ -0.38, 0.71 ]
Hemmila 2002
22
15.3 (11.6)
32
17.2 (9.5)
3.9 %
-0.18 [ -0.72, 0.36 ]
Hurwitz 2002
156
6.2 (5)
148
6 (5.4)
16.2 %
0.04 [ -0.19, 0.26 ]
Hurwitz 2002
153
6.6 (5.6)
153
7.1 (5.6)
16.3 %
-0.09 [ -0.31, 0.14 ]
Paatelma 2008
45
0 (1.5)
52
1 (1.5)
6.4 %
-0.66 [ -1.07, -0.25 ]
Rasmussen-Barr 2003
14
8 (9.6)
17
8 (5.9)
2.4 %
0.0 [ -0.71, 0.71 ]
UK BEAM trial 2004
273
5.15 (4.79)
216
5.74 (4.56)
21.5 %
-0.13 [ -0.30, 0.05 ]
50
12.5 (11)
53
16 (10.7)
7.0 %
-0.32 [ -0.71, 0.07 ]
100.0 %
-0.11 [ -0.22, 0.00 ]
Zaproudina 2009
Subtotal (95% CI) 903
919
Heterogeneity: Tau2 = 0.01; Chi2 = 11.53, df = 9 (P = 0.24); I2 =22%
-1
-0.5
Favors SMT
0
0.5
1
Favors Active/Eff. intervention
(Continued . . . )
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
154
Study or subgroup
SMT
Active/Eff. intervention
N
Mean(SD)
N
Std. Mean Difference
Mean(SD)
Weight
IV,Random,95% CI
(. . . Continued)
Std. Mean Difference
IV,Random,95% CI
Test for overall effect: Z = 1.93 (P = 0.053)
-1
-0.5
0
Favors SMT
0.5
1
Favors Active/Eff. intervention
Analysis 5.3. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 3 Perceived
recovery.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 5 Subset of comparison 3. SMT vs. effective interventions
Outcome: 3 Perceived recovery
Study or subgroup
SMT
Active/Eff. intervention
n/N
n/N
Risk Ratio
Weight
Gudavalli 2006
82/103
54/83
56.3 %
1.22 [ 1.02, 1.47 ]
Hemmila 2002
18/22
21/35
17.3 %
1.36 [ 0.98, 1.91 ]
Hemmila 2002
18/22
26/34
26.3 %
1.07 [ 0.82, 1.40 ]
147
152
100.0 %
1.20 [ 1.05, 1.38 ]
36/57
21/60
100.0 %
1.80 [ 1.21, 2.69 ]
57
60
100.0 %
1.80 [ 1.21, 2.69 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Recovery at 1 month
Subtotal (95% CI)
Total events: 118 (SMT), 101 (Active/Eff. intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 1.31, df = 2 (P = 0.52); I2 =0.0%
Test for overall effect: Z = 2.61 (P = 0.0091)
2 Recovery at 3 months
Zaproudina 2009
Subtotal (95% CI)
Total events: 36 (SMT), 21 (Active/Eff. intervention)
Heterogeneity: not applicable
Test for overall effect: Z = 2.91 (P = 0.0036)
3 Recovery at 6 months
Hemmila 2002
15/22
22/34
50.0 %
1.05 [ 0.72, 1.54 ]
Hemmila 2002
15/22
22/34
50.0 %
1.05 [ 0.72, 1.54 ]
44
68
100.0 %
1.05 [ 0.81, 1.38 ]
Subtotal (95% CI)
Total events: 30 (SMT), 44 (Active/Eff. intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 0.0, df = 1 (P = 1.00); I2 =0.0%
0.5
0.7
1
Favors Active/Eff. intervention
1.5
2
Favors SMT
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155
(. . .
Study or subgroup
SMT
Active/Eff. intervention
n/N
n/N
Risk Ratio
Weight
M-H,Random,95% CI
Continued)
Risk Ratio
M-H,Random,95% CI
Test for overall effect: Z = 0.38 (P = 0.70)
4 Recovery at 12 months
Hemmila 2002
15/22
18/32
47.3 %
1.21 [ 0.80, 1.84 ]
Hemmila 2002
15/22
20/33
52.7 %
1.13 [ 0.76, 1.67 ]
44
65
100.0 %
1.17 [ 0.87, 1.55 ]
Subtotal (95% CI)
Total events: 30 (SMT), 38 (Active/Eff. intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 0.06, df = 1 (P = 0.80); I2 =0.0%
Test for overall effect: Z = 1.04 (P = 0.30)
0.5
0.7
1
Favors Active/Eff. intervention
1.5
2
Favors SMT
Analysis 5.4. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 4 Return to
work.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 5 Subset of comparison 3. SMT vs. effective interventions
Outcome: 4 Return to work
Study or subgroup
SMT
Active/Eff. intervention
n/N
n/N
Risk Ratio
Weight
61/71
43/52
100.0 %
1.04 [ 0.89, 1.21 ]
71
52
100.0 %
1.04 [ 0.89, 1.21 ]
47/52
30/38
33.0 %
1.14 [ 0.95, 1.38 ]
Gudavalli 2006
90/107
65/84
57.0 %
1.09 [ 0.94, 1.25 ]
Hemmila 2002
12/22
22/32
5.7 %
0.79 [ 0.51, 1.24 ]
Hemmila 2002
12/22
16/32
4.3 %
1.09 [ 0.65, 1.83 ]
203
186
100.0 %
1.09 [ 0.98, 1.21 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Return to work at 3 months
Brnfort 1996
Subtotal (95% CI)
Total events: 61 (SMT), 43 (Active/Eff. intervention)
Heterogeneity: not applicable
Test for overall effect: Z = 0.48 (P = 0.63)
2 Return to work at 12 months
Brnfort 1996
Subtotal (95% CI)
Total events: 161 (SMT), 133 (Active/Eff. intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 2.34, df = 3 (P = 0.50); I2 =0.0%
Test for overall effect: Z = 1.51 (P = 0.13)
0.5
0.7
1
Favors Active/Eff. intervention
Spinal manipulative therapy for chronic low-back pain (Review)
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1.5
2
Favors SMT
156
Analysis 5.5. Comparison 5 Subset of comparison 3. SMT vs. effective interventions, Outcome 5 Healthrelated Quality of Life.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 5 Subset of comparison 3. SMT vs. effective interventions
Outcome: 5 Health-related Quality of Life
Study or subgroup
SMT
N
Active/Eff. intervention
Mean(SD)
Std. Mean Difference
N
Mean(SD)
Weight
IV,Random,95% CI
Std. Mean Difference
IV,Random,95% CI
1 Health-related quality of life at 1 month
Brnfort 1996
Gudavalli 2006
62
71.9 (14.3)
43
74.3 (14.6)
28.4 %
-0.17 [ -0.55, 0.22 ]
104
74.4 (18.7)
111
74.2 (19.4)
60.3 %
0.01 [ -0.26, 0.28 ]
19
72 (23.7)
22
79 (12.6)
11.2 %
-0.37 [ -0.99, 0.25 ]
100.0 %
-0.08 [ -0.29, 0.13 ]
Rasmussen-Barr 2003
Subtotal (95% CI) 185
176
Heterogeneity: Tau2 = 0.0; Chi2 = 1.46, df = 2 (P = 0.48); I2 =0.0%
Test for overall effect: Z = 0.78 (P = 0.44)
2 Health-related quality of life at 3 months
Brnfort 1996
56
75.4 (12)
40
75.6 (11.1)
36.8 %
-0.02 [ -0.42, 0.39 ]
Rasmussen-Barr 2003
16
79 (14.1)
17
80 (11.1)
24.9 %
-0.08 [ -0.76, 0.61 ]
Zaproudina 2009
57
0.94 (0.04)
60
0.9 (0.08)
38.4 %
0.62 [ 0.25, 0.99 ]
100.0 %
0.21 [ -0.27, 0.70 ]
100.0 %
-1.00 [ -1.75, -0.24 ]
100.0 %
-1.00 [ -1.75, -0.24 ]
Subtotal (95% CI) 129
117
Heterogeneity: Tau2 = 0.12; Chi2 = 6.39, df = 2 (P = 0.04); I2 =69%
Test for overall effect: Z = 0.87 (P = 0.38)
3 Health-related quality of life at 12 months
Rasmussen-Barr 2003
14
Subtotal (95% CI)
14
68 (15.6)
17
82 (11.9)
17
Heterogeneity: not applicable
Test for overall effect: Z = 2.59 (P = 0.0097)
-1
-0.5
Favors Active/Eff. intervention
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0
0.5
1
Favours SMT
157
Analysis 6.1. Comparison 6 SMT + intervention vs. intervention alone, Outcome 1 Pain.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 6 SMT + intervention vs. intervention alone
Outcome: 1 Pain
Study or subgroup
SMT+ another intervention
Intervention alone
Mean Difference
Weight
IV,Random,95% CI
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
Hsieh 2002
48
20.4 (13.5)
49
27.8 (18.2)
61.0 %
-7.40 [ -13.77, -1.03 ]
Licciardone 2003
42
37.7 (26.2)
17
46.5 (20.7)
15.5 %
-8.80 [ -21.43, 3.83 ]
Rasmussen 2008
35
30 (22.2)
37
30 (22.2)
23.5 %
0.0 [ -10.26, 10.26 ]
1 Pain at 1 month
Subtotal (95% CI)
125
103
100.0 % -5.88 [ -10.85, -0.90 ]
Heterogeneity: Tau2 = 0.0; Chi2 = 1.69, df = 2 (P = 0.43); I2 =0.0%
Test for overall effect: Z = 2.32 (P = 0.021)
2 Pain at 3 months
Licciardone 2003
36
31 (24.5)
16
45.2 (20.1)
10.8 %
-14.20 [ -26.89, -1.51 ]
UK BEAM trial 2004
246 40.76 (24.94)
204 44.73 (24.42)
43.5 %
-3.97 [ -8.55, 0.61 ]
UK BEAM trial 2004
275
239 49.59 (25.04)
45.7 %
-8.69 [ -13.02, -4.36 ]
Subtotal (95% CI)
40.9 (24.87)
557
100.0 % -7.23 [ -11.72, -2.74 ]
459
Heterogeneity: Tau2 = 6.61; Chi2 = 3.50, df = 2 (P = 0.17); I2 =43%
Test for overall effect: Z = 3.16 (P = 0.0016)
3 Pain at 6 months
Hsieh 2002
49
22.4 (20.1)
47
29.9 (22.8)
71.9 %
-7.50 [ -16.11, 1.11 ]
Licciardone 2003
32
31.6 (22.4)
15
36.5 (22.5)
28.1 %
-4.90 [ -18.68, 8.88 ]
Subtotal (95% CI)
81
62
100.0 % -6.77 [ -14.07, 0.53 ]
Heterogeneity: Tau2 = 0.0; Chi2 = 0.10, df = 1 (P = 0.75); I2 =0.0%
Test for overall effect: Z = 1.82 (P = 0.069)
4 Pain at 12 months
Rasmussen 2008
28
20 (14.8)
28
20 (14.8)
16.9 %
0.0 [ -7.75, 7.75 ]
UK BEAM trial 2004
245 39.68 (25.83)
200 41.54 (26.02)
39.3 %
-1.86 [ -6.70, 2.98 ]
UK BEAM trial 2004
264 41.68 (25.67)
235 47.56 (25.91)
43.9 %
-5.88 [ -10.41, -1.35 ]
Subtotal (95% CI)
537
463
100.0 % -3.31 [ -6.60, -0.02 ]
Heterogeneity: Tau2 = 1.08; Chi2 = 2.28, df = 2 (P = 0.32); I2 =12%
Test for overall effect: Z = 1.97 (P = 0.049)
-20
-10
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0
10
20
Favours interv. alone
158
Analysis 6.2. Comparison 6 SMT + intervention vs. intervention alone, Outcome 2 Functional status.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 6 SMT + intervention vs. intervention alone
Outcome: 2 Functional status
Study or subgroup
SMT+ another intervention
Intervention alone
Std. Mean Difference
Weight
IV,Random,95% CI
Std. Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
Hsieh 2002
48
3.73 (3.76)
49
5.8 (5.12)
66.3 %
-0.46 [ -0.86, -0.05 ]
Licciardone 2003
42
5.67 (4.12)
17
6.94 (4.97)
33.7 %
-0.29 [ -0.85, 0.28 ]
1 Functional status at 1 month
Subtotal (95% CI)
90
100.0 % -0.40 [ -0.73, -0.07 ]
66
Heterogeneity: Tau2 = 0.0; Chi2 = 0.23, df = 1 (P = 0.63); I2 =0.0%
Test for overall effect: Z = 2.38 (P = 0.017)
2 Functional status at 3 months
36
6.11 (4.46)
16
5.94 (6.29)
7.1 %
0.03 [ -0.56, 0.62 ]
UK BEAM trial 2004
287
5.09 (4.74)
256
6.66 (4.8)
47.8 %
-0.33 [ -0.50, -0.16 ]
UK BEAM trial 2004
258
4.84 (4.5)
225
5.47 (4.35)
45.1 %
-0.14 [ -0.32, 0.04 ]
Licciardone 2003
Subtotal (95% CI)
581
497
100.0 % -0.22 [ -0.38, -0.06 ]
Heterogeneity: Tau2 = 0.01; Chi2 = 3.00, df = 2 (P = 0.22); I2 =33%
Test for overall effect: Z = 2.63 (P = 0.0086)
3 Functional status at 6 months
Hsieh 2002
48
3.56 (3.46)
47
5.06 (4.78)
69.7 %
-0.36 [ -0.76, 0.05 ]
Licciardone 2003
32
5.22 (4.48)
15
6.2 (6.6)
30.3 %
-0.18 [ -0.80, 0.43 ]
100.0 %
-0.30 [ -0.64, 0.03 ]
Subtotal (95% CI)
80
62
Heterogeneity: Tau2 = 0.0; Chi2 = 0.21, df = 1 (P = 0.65); I2 =0.0%
Test for overall effect: Z = 1.76 (P = 0.078)
4 Functional status at 12 months
UK BEAM trial 2004
257
4.72 (4.65)
216
5.74 (4.56)
47.4 %
-0.22 [ -0.40, -0.04 ]
UK BEAM trial 2004
273
5.15 (4.79)
248
6.16 (4.88)
52.6 %
-0.21 [ -0.38, -0.04 ]
Subtotal (95% CI)
530
464
100.0 % -0.21 [ -0.34, -0.09 ]
Heterogeneity: Tau2 = 0.0; Chi2 = 0.01, df = 1 (P = 0.92); I2 =0.0%
Test for overall effect: Z = 3.36 (P = 0.00077)
-2
-1
Favours SMT+ intervention
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0
1
2
Favours interv. alone
159
Analysis 6.3. Comparison 6 SMT + intervention vs. intervention alone, Outcome 3 Perceived recovery.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 6 SMT + intervention vs. intervention alone
Outcome: 3 Perceived recovery
Study or subgroup
SMT+ another intervention
Intervention alone
n/N
n/N
Risk Ratio
Weight
9/15
3/17
100.0 %
3.40 [ 1.12, 10.28 ]
15
17
100.0 %
3.40 [ 1.12, 10.28 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Recovery at 1 month
Evans 1978
Total (95% CI)
Total events: 9 (SMT+ another intervention), 3 (Intervention alone)
Heterogeneity: not applicable
Test for overall effect: Z = 2.17 (P = 0.030)
0.01
0.1
1
10
Favors SMT + interv.
100
Favors intervention alon
Analysis 7.1. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB
only, Outcome 1 Pain.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only
Outcome: 1 Pain
Study or subgroup
SMT
Other intervention
Mean Difference
Weight
IV,Random,95% CI
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
Brnfort 1996
62
34 (19)
43
36 (22)
7.4 %
-2.00 [ -10.10, 6.10 ]
Hemmila 2002
22
30.5 (15)
34
27 (15)
7.5 %
3.50 [ -4.54, 11.54 ]
Hemmila 2002
22
30.5 (15)
35
30 (15)
7.5 %
0.50 [ -7.50, 8.50 ]
Hondras 2009
90
29.49 (19.29)
16
33.47 (19.49)
4.9 %
-3.98 [ -14.33, 6.37 ]
Hondras 2009
83
27.63 (19.31)
16
33.47 (19.49)
4.8 %
-5.84 [ -16.25, 4.57 ]
Hsieh 2002
22
25.8 (19.3)
49
27.8 (18.2)
5.6 %
-2.00 [ -11.54, 7.54 ]
Hsieh 2002
22
25.8 (19.3)
42
21.3 (12.8)
6.3 %
4.50 [ -4.45, 13.45 ]
169
31 (18)
168
35 (20)
18.8 %
-4.00 [ -8.06, 0.06 ]
1 Pain at 1 month
Hurwitz 2002
-20
-10
Favors SMT
0
10
20
Favors Other intervention
(Continued . . . )
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
160
Study or subgroup
SMT
Other intervention
Mean Difference
Weight
N
Mean(SD)
N
Mean(SD)
Hurwitz 2002
169
34 (19)
169
36 (19)
18.9 %
-2.00 [ -6.05, 2.05 ]
Skillgate 2007
92
36 (14.4)
80
44 (13.4)
18.4 %
-8.00 [ -12.16, -3.84 ]
Subtotal (95% CI) 753
IV,Random,95% CI
(. . . Continued)
Mean Difference
IV,Random,95% CI
100.0 % -2.76 [ -5.19, -0.32 ]
652
Heterogeneity: Tau2 = 3.91; Chi2 = 12.35, df = 9 (P = 0.19); I2 =27%
Test for overall effect: Z = 2.22 (P = 0.027)
2 Pain at 3 months
Brnfort 1996
56
27 (20)
40
35 (22)
12.8 %
-8.00 [ -16.60, 0.60 ]
Ferreira 2007
77
41 (26)
147
44 (24.5)
15.7 %
-3.00 [ -10.03, 4.03 ]
Hemmila 2002
22
30 (15)
35
31 (15)
13.9 %
-1.00 [ -9.00, 7.00 ]
Hemmila 2002
22
30 (15)
34
27.5 (15)
13.8 %
2.50 [ -5.54, 10.54 ]
Skillgate 2007
89
26 (14.4)
73
37 (13.4)
22.1 %
-11.00 [ -15.29, -6.71 ]
275
40.9 (24.87)
204
44.73 (24.42)
21.7 %
-3.83 [ -8.29, 0.63 ]
UK BEAM trial 2004
Subtotal (95% CI) 541
533
100.0 % -4.55 [ -8.68, -0.43 ]
Heterogeneity: Tau2 = 15.28; Chi2 = 12.68, df = 5 (P = 0.03); I2 =61%
Test for overall effect: Z = 2.16 (P = 0.031)
3 Pain at 6 months
Ferreira 2007
72
43 (26)
139
45.6 (26)
10.2 %
-2.60 [ -10.00, 4.80 ]
Hemmila 2002
22
25 (15)
34
26 (15)
8.6 %
-1.00 [ -9.04, 7.04 ]
Hemmila 2002
22
25 (15)
35
30 (15)
8.7 %
-5.00 [ -13.00, 3.00 ]
Hsieh 2002
20
24 (24.1)
42
22.9 (19.8)
3.8 %
1.10 [ -11.04, 13.24 ]
Hsieh 2002
20
24 (24.1)
47
29.9 (22.8)
3.6 %
-5.90 [ -18.31, 6.51 ]
Hurwitz 2002
163
18 (18)
159
22 (20)
32.1 %
-4.00 [ -8.16, 0.16 ]
Hurwitz 2002
165
26 (19)
165
28.5 (19)
33.1 %
-2.50 [ -6.60, 1.60 ]
Subtotal (95% CI) 484
621
100.0 % -3.07 [ -5.42, -0.71 ]
Heterogeneity: Tau2 = 0.0; Chi2 = 1.41, df = 6 (P = 0.97); I2 =0.0%
Test for overall effect: Z = 2.55 (P = 0.011)
4 Pain at 12 months
Ferreira 2007
73
49 (27)
138
50.6 (28.5)
9.6 %
-1.60 [ -9.41, 6.21 ]
Hurwitz 2002
156
27.5 (18)
148
28 (20)
32.0 %
-0.50 [ -4.78, 3.78 ]
Hurwitz 2002
153
32.5 (19)
153
34 (19)
32.4 %
-1.50 [ -5.76, 2.76 ]
UK BEAM trial 2004
264
41.68 (25.67)
200
41.54 (26.02)
26.0 %
0.14 [ -4.61, 4.89 ]
100.0 %
-0.76 [ -3.19, 1.66 ]
Subtotal (95% CI) 646
639
Heterogeneity: Tau2 = 0.0; Chi2 = 0.31, df = 3 (P = 0.96); I2 =0.0%
Test for overall effect: Z = 0.62 (P = 0.54)
-20
-10
Favors SMT
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Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
0
10
20
Favors Other intervention
161
Analysis 7.2. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB
only, Outcome 2 Functional status.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only
Outcome: 2 Functional status
Study or subgroup
SMT
Other intervention
Std. Mean Difference
Weight
IV,Random,95% CI
Std. Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
Brnfort 1996
62
19.1 (19.3)
43
20.8 (17.8)
8.2 %
-0.09 [ -0.48, 0.30 ]
Hemmila 2002
20
16.7 (11.6)
33
16.1 (7.7)
4.1 %
0.06 [ -0.49, 0.62 ]
Hemmila 2002
20
16.7 (11.6)
29
16.2 (9.5)
3.9 %
0.05 [ -0.52, 0.62 ]
Hondras 2009
87
4.35 (2.9)
16
6.42 (2.91)
4.3 %
-0.71 [ -1.25, -0.17 ]
Hondras 2009
94
4.62 (2.91)
16
6.42 (2.91)
4.4 %
-0.61 [ -1.15, -0.08 ]
Hsieh 2002
22
4.42 (4.92)
42
4.26 (3.52)
4.7 %
0.04 [ -0.48, 0.55 ]
Hsieh 2002
22
4.42 (4.92)
49
5.8 (5.12)
4.9 %
-0.27 [ -0.77, 0.24 ]
Hurwitz 2002
169
6.5 (5)
168
7.5 (5.4)
25.8 %
-0.19 [ -0.41, 0.02 ]
Hurwitz 2002
169
6.8 (5.6)
169
7.3 (5.6)
26.0 %
-0.09 [ -0.30, 0.12 ]
Skillgate 2007
92
1.9 (2.45)
80
2.4 (2.28)
13.6 %
-0.21 [ -0.51, 0.09 ]
100.0 %
-0.17 [ -0.29, -0.06 ]
1 Functional status at 1 month
Subtotal (95% CI) 757
645
Heterogeneity: Tau2 = 0.00; Chi2 = 9.25, df = 9 (P = 0.41); I2 =3%
Test for overall effect: Z = 3.00 (P = 0.0027)
2 Functional status at 3 months
Brnfort 1996
56
15.1 (17.4)
40
20.9 (17)
11.7 %
-0.33 [ -0.74, 0.07 ]
Ferreira 2007
77
7.9 (6)
147
8.8 (6)
16.8 %
-0.15 [ -0.43, 0.13 ]
Hemmila 2002
22
18.6 (11.6)
33
14.1 (7.7)
8.1 %
0.47 [ -0.08, 1.02 ]
Hemmila 2002
22
18.6 (11.6)
35
16.5 (9.5)
8.4 %
0.20 [ -0.33, 0.73 ]
Hondras 2009
93
4.11 (4.05)
19
5.62 (4.05)
9.2 %
-0.37 [ -0.87, 0.13 ]
Hondras 2009
85
3.45 (4.03)
19
5.62 (4.05)
9.1 %
-0.53 [ -1.04, -0.03 ]
Skillgate 2007
90
1.3 (2.45)
73
2.4 (2.28)
15.2 %
-0.46 [ -0.77, -0.15 ]
287
5.09 (4.74)
225
5.47 (4.35)
21.5 %
-0.08 [ -0.26, 0.09 ]
100.0 %
-0.18 [ -0.37, 0.01 ]
UK BEAM trial 2004
Subtotal (95% CI) 732
591
Heterogeneity: Tau2 = 0.03; Chi2 = 14.64, df = 7 (P = 0.04); I2 =52%
Test for overall effect: Z = 1.89 (P = 0.059)
3 Functional status at 6 months
-1
-0.5
Favors SMT
0
0.5
1
Favors Other intervention
(Continued . . . )
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
162
Study or subgroup
SMT
Other intervention
Std. Mean Difference
Weight
(. . . Continued)
Std. Mean Difference
N
Mean(SD)
N
Mean(SD)
Ferreira 2007
72
7.7 (6.2)
139
9.3 (6.7)
16.1 %
-0.24 [ -0.53, 0.04 ]
Hemmila 2002
22
14.3 (11.6)
33
13.4 (7.7)
4.5 %
0.09 [ -0.45, 0.63 ]
Hemmila 2002
22
14.3 (11.6)
33
15.9 (9.5)
4.5 %
-0.15 [ -0.69, 0.39 ]
Hondras 2009
89
4.06 (4.36)
17
5.34 (4.27)
4.8 %
-0.29 [ -0.81, 0.23 ]
Hondras 2009
86
3.44 (4.39)
17
5.34 (4.27)
4.8 %
-0.43 [ -0.96, 0.09 ]
Hsieh 2002
21
3.29 (4.73)
47
5.06 (4.78)
4.9 %
-0.37 [ -0.89, 0.15 ]
Hsieh 2002
21
3.29 (4.73)
42
3.48 (3.86)
4.8 %
-0.05 [ -0.57, 0.48 ]
Hurwitz 2002
165
4.1 (5.6)
165
4.8 (5.6)
28.1 %
-0.12 [ -0.34, 0.09 ]
Hurwitz 2002
163
3.8 (5)
159
3.5 (5.4)
27.5 %
0.06 [ -0.16, 0.28 ]
100.0 %
-0.12 [ -0.23, 0.00 ]
Subtotal (95% CI) 661
IV,Random,95% CI
IV,Random,95% CI
652
Heterogeneity: Tau2 = 0.0; Chi2 = 6.61, df = 8 (P = 0.58); I2 =0.0%
Test for overall effect: Z = 1.99 (P = 0.047)
4 Functional status at 12 months
Ferreira 2007
73
9.2 (6.6)
138
9.2 (6.7)
13.8 %
0.0 [ -0.28, 0.28 ]
Hemmila 2002
22
15.3 (11.6)
32
17.2 (9.5)
3.7 %
-0.18 [ -0.72, 0.36 ]
Hemmila 2002
22
15.3 (11.6)
32
13.7 (7.7)
3.7 %
0.17 [ -0.38, 0.71 ]
Hurwitz 2002
153
6.6 (5.6)
153
7.1 (5.6)
22.1 %
-0.09 [ -0.31, 0.14 ]
Hurwitz 2002
156
6.2 (5)
148
6 (5.4)
21.9 %
0.04 [ -0.19, 0.26 ]
UK BEAM trial 2004
273
5.15 (4.79)
216
5.74 (4.56)
34.7 %
-0.13 [ -0.30, 0.05 ]
100.0 %
-0.06 [ -0.16, 0.05 ]
Subtotal (95% CI) 699
719
Heterogeneity: Tau2 = 0.0; Chi2 = 2.34, df = 5 (P = 0.80); I2 =0.0%
Test for overall effect: Z = 1.03 (P = 0.30)
-1
-0.5
Favors SMT
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
0
0.5
1
Favors Other intervention
163
Analysis 7.3. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB
only, Outcome 3 Perceived recovery.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only
Outcome: 3 Perceived recovery
Study or subgroup
SMT
Other intervention
n/N
n/N
Risk Ratio
Weight
Hemmila 2002
18/22
26/34
58.3 %
1.07 [ 0.82, 1.40 ]
Hemmila 2002
18/22
21/35
41.7 %
1.36 [ 0.98, 1.91 ]
44
69
100.0 %
1.18 [ 0.93, 1.50 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Recovery at 1 month
Subtotal (95% CI)
Total events: 36 (SMT), 47 (Other intervention)
Heterogeneity: Tau2 = 0.01; Chi2 = 1.25, df = 1 (P = 0.26); I2 =20%
Test for overall effect: Z = 1.39 (P = 0.16)
2 Recovery at 6 months
Hemmila 2002
15/22
22/34
50.0 %
1.05 [ 0.72, 1.54 ]
Hemmila 2002
15/22
22/34
50.0 %
1.05 [ 0.72, 1.54 ]
44
68
100.0 %
1.05 [ 0.81, 1.38 ]
Subtotal (95% CI)
Total events: 30 (SMT), 44 (Other intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 0.0, df = 1 (P = 1.00); I2 =0.0%
Test for overall effect: Z = 0.38 (P = 0.70)
3 Recovery at 12 months
Hemmila 2002
15/22
18/32
47.3 %
1.21 [ 0.80, 1.84 ]
Hemmila 2002
15/22
20/33
52.7 %
1.13 [ 0.76, 1.67 ]
44
65
100.0 %
1.17 [ 0.87, 1.55 ]
Subtotal (95% CI)
Total events: 30 (SMT), 38 (Other intervention)
Heterogeneity: Tau2 = 0.0; Chi2 = 0.06, df = 1 (P = 0.80); I2 =0.0%
Test for overall effect: Z = 1.04 (P = 0.30)
0.5
0.7
Favors other intervention
1
1.5
2
Favors SMT
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
164
Analysis 7.4. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB
only, Outcome 4 Return to work.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only
Outcome: 4 Return to work
Study or subgroup
SMT
Other intervention
n/N
n/N
Risk Ratio
Weight
61/71
43/52
100.0 %
1.04 [ 0.89, 1.21 ]
71
52
100.0 %
1.04 [ 0.89, 1.21 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Return to work at 3 months
Brnfort 1996
Subtotal (95% CI)
Total events: 61 (SMT), 43 (Other intervention)
Heterogeneity: not applicable
Test for overall effect: Z = 0.48 (P = 0.63)
2 Return to work at 12 months
Brnfort 1996
47/52
30/38
65.8 %
1.14 [ 0.95, 1.38 ]
Hemmila 2002
12/22
22/32
19.2 %
0.79 [ 0.51, 1.24 ]
Hemmila 2002
12/22
16/32
15.0 %
1.09 [ 0.65, 1.83 ]
96
102
100.0 %
1.06 [ 0.86, 1.31 ]
Subtotal (95% CI)
Total events: 71 (SMT), 68 (Other intervention)
Heterogeneity: Tau2 = 0.01; Chi2 = 2.48, df = 2 (P = 0.29); I2 =19%
Test for overall effect: Z = 0.53 (P = 0.59)
0.5
0.7
Favors other intervention
1
1.5
2
Favors SMT
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
165
Analysis 7.5. Comparison 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB
only, Outcome 5 Health-related Quality of Life.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 7 Subset of comparison 3. SMT vs. any other intervention - studies w/ low RoB only
Outcome: 5 Health-related Quality of Life
Study or subgroup
SMT
N
Other intervention
Mean(SD)
Std. Mean Difference
N
Mean(SD)
43
74.3 (14.6)
Weight
IV,Random,95% CI
Std. Mean Difference
IV,Random,95% CI
1 Health-related quality of life at 1 month
Brnfort 1996
Subtotal (95% CI)
62
71.9 (14.3)
62
43
100.0 %
-0.17 [ -0.55, 0.22 ]
100.0 %
-0.17 [ -0.55, 0.22 ]
100.0 %
-0.02 [ -0.42, 0.39 ]
100.0 %
-0.02 [ -0.42, 0.39 ]
Heterogeneity: not applicable
Test for overall effect: Z = 0.83 (P = 0.41)
2 Health-related quality of life at 3 months
Brnfort 1996
Subtotal (95% CI)
56
75.4 (12)
56
40
75.6 (11.1)
40
Heterogeneity: not applicable
Test for overall effect: Z = 0.08 (P = 0.93)
-1
-0.5
Favors other intervention
Spinal manipulative therapy for chronic low-back pain (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
0
0.5
1
Favours SMT
166
Analysis 8.1. Comparison 8 Subset of comparisons 1, 2 & 3. SMT vs. ineffective/sham/inert interventions,
Outcome 1 Pain.
Review:
Spinal manipulative therapy for chronic low-back pain
Comparison: 8 Subset of comparisons 1, 2 % 3. SMT vs. ineffective/sham/inert interventions
Outcome: 1 Pain
Study or subgroup
SMT
N
Ineffective/sham/inert
Mean Difference
Weight
IV,Random,95% CI
Mean Difference
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
Ghroubi 2007
32 49.37 (16.78)
32
58.43 (28.8)
13.0 %
-9.06 [ -20.61, 2.49 ]
Gibson 1985
20
21 (22.5)
33
27 (20)
12.4 %
-6.00 [ -17.99, 5.99 ]
Gibson 1985
20
21 (22.5)
32
28 (24)
11.4 %
-7.00 [ -19.90, 5.90 ]
Hsieh 2002
45
25.8 (19.3)
49
27.8 (18.2)
19.4 %
-2.00 [ -9.60, 5.60 ]
Licciardone 2003
42
37.7 (26.2)
23
30.7 (21.9)
12.5 %
7.00 [ -4.95, 18.95 ]
Mohseni-Bandpei 2006
56
23.4 (19)
56
37.9 (19)
20.6 %
-14.50 [ -21.54, -7.46 ]
9
23 (15)
10
31 (15)
10.7 %
-8.00 [ -21.51, 5.51 ]
1 Pain at 1 month
Waagen 1986
Subtotal (95% CI)
224
100.0 % -6.07 [ -11.52, -0.62 ]
235
Heterogeneity: Tau2 = 24.74; Chi2 = 11.44, df = 6 (P = 0.08); I2 =48%
Test for overall effect: Z = 2.18 (P = 0.029)
2 Pain at 3 months
Gibson 1985
19
13 (22.5)
32
6 (22.5)
18.1 %
7.00 [ -5.77, 19.77 ]
Gibson 1985
19
13 (22.5)
27
25 (22.5)
17.2 %
-12.00 [ -25.21, 1.21 ]
Licciardone 2003
36
31 (24.5)
19
28.5 (20.3)
19.5 %
2.50 [ -9.64, 14.64 ]
Paatelma 2008
45
18 (12.6)
37
17 (13.3)
45.1 %
1.00 [ -4.65, 6.65 ]
100.0 %
0.14 [ -6.16, 6.44 ]
Subtotal (95% CI)
119
115
Heterogeneity: Tau2 = 14.60; Chi2 = 4.57, df =