#0053
Sustained Acoustic Medicine:
Treating Back Pain Related To Herniated Disc On Earth and Preventing
SABP and Disc Herniation In Space
sam
R. M. Taggart1, S. E. Henderson1, M. D. Langer1, T. M. Best2, L. Hernandez3, G. K. Lewis, Jr.1
1ZetrOZ, Inc., Clinical Department (56 Quarry Rd, Trumbull, Connecticut)
2Ohio State University, Department of Sports Medicine (2050 Kenny Rd, Columbus, Ohio)
3GI Associates, MD (10400 75th Street, Suite 208, Kenosha, Wisconsin)
What is SAM?
Background
 50-80 million people in the U.S. suffer from chronic
 1/3 of adults over age 20 show signs of a herniated disc1
 Space adaptation back pain (SABP) is the most
commonly reported issue among astronauts;1 with 86% of
728 astronauts reporting back pain in a 2012 study.2
 Sustained acoustic medicine (SAM) is the application of
long duration low-intensity ultrasound waves to accelerate
biological processes.
pain1
 SAM has potential to counteract SABP and herniated discs
through two mechanisms:
1. Increased fluid circulation to improve diffusion processes,
delivering nutrients to injured cells and removing waste.
2. Application of convection and rarefaction to the disc that will
reduce distortion and herniation
Clinical Evidence for SAM Therapy
SAM is the first device to pioneer a
therapeutic technology known as
sustained acoustic medicine – a unique
adaptation of the well-established medical
modality of therapeutic ultrasound (TUS)
Trapezius Muscle Spasm Clinical Trial 3
SAM differs from traditional TUS because
it is not confined to the clinician’s office.
 A traditional TUS session in a PT office deposits < 2,000 J of
energy, while SAM can be worn for multi-hour sessions with a
single or dual transducer, allowing it to deposit 18,720 J over 4 h
X = -6
 Recent literature reviews have found that greater amounts of
energy deposition ultimately lead to better and faster recovery.4
Wound Healing Animal Trial
Purpose
Sustained Acoustic Medicine (SAM) Technology
Beam Scan of SAM Transducer
I feel relaxed and
sociable when I smoke
Study Design
Duration:
 10 wk double blind placebo-controlled clinical trial
 Participants self-apply SAM to both sides of the herniated
vertebrae (identified by MRI) daily for 4 h over 8 wks
Participants:
 200 patients: 50 astronauts, 150 general population
 50% active, 50% placebo
Outcome Measures:
 Pain - Visual Analogue Scale (VAS) for pain assessment
 Mobility - Awake activity and sleep quality measured using
accelerometry
 Strength and Range-of-Motion - Straight leg raise & Lasègue
tests
 Disability - Modified Oswestry Disability Questionnaire (MODQ)
Normalized Acoustic Pressure (Pa)
 SABP occurs in 0G conditions
when gravitational and loadbearing forces are absent
 The downward pressure normally
exerted on the spine is removed.
 Lack of pressure leads to spinal
disc distortion, breakdown of
diffusion processes, and disc
herniation.
 The present study will evaluate
use of a long duration therapeutic
ultrasound device in treating back
pain on earth and preventing disc
herniation in space.
Fig. 3. (A) Excisional
wound model (rat).
(B) LITUS device
applied to wounds.
(C) Healing time
(*p<0.01).
For additional clinical data on
SAM, see posters: #0124 on
Tendinitis and #0126 on
Osteoarthritis of the Knee.
Anticipated Results
z=-8
y = 11
 This study will elucidate whether daily application of SAM can relieve
back pain associated with herniated disc.
 We anticipate the following improvements in patients assigned the
active device compared to those who receive the placebo device:
Y axis (cm)
X axis (cm)
Fig. 1: The acoustic field measured 3 mm
from the face of the SAM transducer
(3MHz, 0.132 W/cm2 (ISATA))
Fig. 2. Evolution of engineering of the SAM device by
ZetrOZ. (B-F) Earlier prototypes of the SAM device.
(G) The final SAM device.
Bioeffects Elicited by SAM Therapy
z = 19
 Significant pain decrease during each daily treatment & throughout
the course of the 10-wk study
 Significant activity increase at the end of the study compared to
baseline
 Significant improvements in strength, ROM, and disability at the
end of the study compared to baseline
 This medical breakthrough has potential to enhance lives of
astronauts by improving disc health through prevention of herniation &
SABP, while also showing great promise for the general population.
References
1.
2.
3.
4.
Sayson JV & Hargens AR. (2008). Aviat Space Environ Med 79(4), 365-73.
Kerstman EL et al. (2012). Aviat Space Environ Med 83(1), 2-7.
Lewis Jr, G.K., M.D. Langer, C.R. Henderson Jr, and R. Ortiz, Design and evaluation of a
wearable self-applied therapeutic ultrasound device for chronic myofascial pain. Ultrasound in
medicine & biology, 2013. 39(8): p. 1429-1439.
Alexander LD, Gilman DRD, Brown DR, Brown JL, Houghton PE. Exposure to low amounts of
ultrasound energy does not improve soft tissue shoulder pathology: A systematic review. Phys
Ther. 2010;90(1):14-25.
Acknowledgements
This work is supported by the National Space Biomedical Research Institute
(NSBRI) through NASA Cooperative Agreement NCC 9-58 - Space Medical and
Related Technologies Commercialization Assistance Program (SMARTCAP).
Project SMST03901: “Wearable, Sustained Acoustic Medicine for Back Pain”.
Correspondence may be addressed to Dr. George K. Lewis at: [email protected]