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JOSEPHINE G PATERSON
ANALGESIA FOR PEOPLE
WITH ACUTE ANKLE SPRAIN
David Carter and Jeshni Amblum-Almer discuss the results
of a literature review on using non-steroidal anti-inflammatory
drugs in the management of a common injury
Correspondence
[email protected]
David Carter is an urgent
care centre emergency care
practitioner at West Middlesex
University Hospital NHS Trust
Jeshni Amblum-Almer is
a senior lecturer-practitioner
in primary care at Kingston and
St George’s University, London
Date of submission
February 2 2015
Date of acceptance
March 16 2015
Peer review
This article has been subject
to double-blind review and
has been checked using
antiplagiarism software
Author guidelines
journals.rcni.com/r/
en-author-guidelines
Abstract
Around 302,000 people with soft-tissue ankle
injuries present to UK emergency departments every
year (Ferran and Maffulli 2006). These patients are
generally treated conservatively with analgesia, ice,
compression and elevation, and rest. There is some
discussion in the literature about whether or not
people with these injuries should be treated with
non-steroidal anti-inflammatory drugs (NSAIDs),
with some authors claiming that the inflammatory
response following injury is part of the healing
process and should not be halted. This article
examines the literature on the efficacy of
administering NSAIDs as the first-line drug
management for ankle sprain. It also considers cost
of treatment, prescribing practice and
contraindications of NSAIDs.
Keywords
Analgesia, ankle injuries, non-steroidal
anti-inflammatory drugs, NSAIDs, pain management
PEOPLE WITH ankle sprains commonly present to
general practice and urgent care settings (Slimmon
and Brukner 2010), and an estimated 302,000 are
seen in UK emergency departments (EDs) every year.
These ankle sprains occur predominately on sports
grounds in people aged under 25 and at home in
patients aged over 50 (Ferran and Maffulli 2006).
Boyce (2004) concludes that the highest incidence of
ankle injuries are in people aged between 16 and 20.
Waterman et al (2010) found an incidence rate of
5,840 per 100,000 people a year at the United States
24 April 2015 | Volume 23 | Number 1
Military Academy and that physical activity is a
major contributory factor in ankle sprain.
In a clinical knowledge summary (CKS) on the
management of sprains and strains, the National
Institute for Health and Care Excellence (NICE)
(2012) advocates the use of paracetamol or topical
non-steroidal anti-inflammatory drugs (NSAIDs) with
protection, rest, ice, compression and elevation as
first-line treatment for ankle sprain.
The CKS suggests that NSAIDs should not be
used in the first 48 hours post-injury because they
can delay the healing process. In the experience of
the principal author (DC), however, practitioners in
urgent care settings often prescribe NSAIDs as initial
treatment for soft-tissue injuries (NICE 2012).
NSAIDs can be administered as analgesics,
anti-pyretics and anti-inflammatories. Those licensed
for use in the UK include ibuprofen, diclofenac
and naproxen (NHS Choices 2014).
Pathophysiology
The ankle joint comprises the tibia, fibula,
calcaneum and talus, as well as the cuboid, navicular
and cuneiform bones, all of which are connected by
ligaments (Purcell 2010). These ligaments are made
up of elastin and collagen, and sudden tension that
takes a ligament beyond its stretching capacity
results in a sprain. There are three grades of sprain
(Weintraub 2003):
1. Where the ligament returns to resting length but
there is micro-failure in some fibres.
2. Where the ligament does not recover to resting
length, some ankle instability exists and fibres
sustain a larger amount of rupture.
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Art & science | anti-inflammatory drugs
3. Where there is gross fibre failure and severe ankle
instability.
Ligaments have a poor blood supply so it is vital that
the appropriate treatment is given in a timely manner
to minimise chronic stiffness and calcification
(Purcell 2010).
Soft-tissue injuries go through three phases of
healing: inflammation, proliferation and maturation.
During the initial inflammatory phase, patients
experience erythema, swelling and pain (Tortora
and Derrickson 2011), which prevent activity. To help
patients return to their normal activities quickly, the
pain is often reduced and the swelling inhibited by
NSAIDs. However, Bowie (2011), citing ‘controversial
evidence’ of side effects associated with NSAIDs
advises paracetamol and rest, ice, compression and
elevation (RICE) instead.
In ankle sprains, the inflammatory phase typically
lasts between two and seven days (Purcell 2010).
Prostaglandin is responsible for localised swelling
during this phase (Joint Formulary Committee
(JFC) 2014) and NSAIDs work by inhibiting the
action of cyclo-oxygenase-1 (COX‑1) and cyclooxygenase-2 (COX-2), which reduce prostaglandin
production.
The inflammatory phase is followed by the
proliferative phase, when macrophages remove
haematomas, fibroblasts produce collagen, and the
capillary networks begin to rebuild. During the final
maturation phase, which usually begins several weeks
after injury and can last more than a year, collagen
organisation increases and capillary networks return
to normal levels.
Healed ligaments often have reduced tensile
strength, often between 50% and 70% that of
uninjured tissue. However, joint function remains
unchanged due to increased tissue volume (Schepsis
and Busconi 2006).
Literature review
In 2014, the principal author undertook a literature
review to assess the efficacy of NSAIDs as the
first-line drug management for ankle sprain. Initially,
the author searched for articles about randomised
control trials of NSAID use in the treatment of acute
ankle sprain, but later expanded the search to include
musculoskeletal injuries in general.
Using combinations of the search terms ‘NSAIDs’,
‘non-steroidal anti-inflammatory drugs’, ‘sprain’,
‘ankle sprain’, ‘analgesia’, ‘randomised control trial’
and ‘anti-inflammatory’, he searched the Emergency
Nurse, Hunter, PubMed, Science Direct and Springer
databases. Initial inclusion criteria were articles in
English published between 1995 and 2015. A total
of 100 articles were identified.
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Articles were included in the review if they
compared NSAIDs and paracetamol and/or placebo
for musculoskeletal injury, and considered one of
the following outcomes: pain, ankle instability, return
to activity time or reduction in swelling. Those that
focused on chronic conditions, such as osteoarthritis
and back pain, were excluded, leaving a total of
12 relevant articles (Table 1).
Guidelines The NICE (2012) guidelines do not
advocate the early administration of NSAIDs for ankle
sprains due to concerns about delays in healing.
The CKS on the management of sprains and strains
states: ‘Use of oral NSAIDs should be delayed until
48 hours after the initial injury. Early use of NSAIDs
coincides with muscle repair, regeneration, and
growth. Inflammation is a necessary part of the
healing process, therefore decreasing inflammation
may impair the healing process’ (NICE 2012).
On the other hand, a recent review by van den
Bekerom et al (2014) states that the benefits of
using NSAIDs outweigh their adverse effects, such
as gastrointestinal discomfort, and suggests using
them in the initial management of patients with acute
ankle sprains.
Oral NSAIDs In a single-centre trial conducted in
Australia, Slatyer et al (1997) treated 364 army
recruits with acute ankle sprain with either
piroxicam, an NSAID, or placebo. Those treated
with piroxicam experienced less pain and lost fewer
training days, although some had concerns about
ankle instability and reduced range of movement.
In reference to Slatyer et al’s (1997) study,
Bellomo et al (2009) state that ‘changing practice
or issuing strong recommendations on the basis of
single-centre trials seem premature and ill advised’.
However, it should be noted that piroxicam
is not licensed in the UK due to an increased
risk of gastrointestinal side effects (JFC 2014) so
application of Slatyer et al’s (1997) findings to UK
practice would be difficult.
Lyrtzis et al (2011) conducted a small (n=90)
study of the effects of diclofenac and paracetamol
on pain and range of movement in patients with
ankle sprain. The patients had been treated
with either diclofenac sodium 75mg twice daily
or paracetamol 500mg three times a day. It is
unclear why patients did not receive the standard
paracetamol dose of 1g and it seems likely this
sub‑therapeutic dose would have been insufficient
in adult patients.
All patients had been blinded to treatment
and advised RICE for ten days (NICE 2012).
Three patients treated with diclofenac had stopped
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Oral
Table 1
Literature review results
Authors
Study design
Participants
Conclusion
Study limitations
Slatyer et al
(1997)
Single-centre randomised control
trial (RCT) of piroxicam v placebo
in acute ankle sprain
364 army
recruits
Piroxicam is associated with less pain and
quicker return to activity, but also increased
ankle instability and reduced range of
movement (ROM)
Funded by a pharmaceutical company.
Piroxicam is not licensed in UK.
Participants were a specific subset of
the population
Lyrtzis et al
(2011)
RCT of diclofenac v paracetamol in
acute ankle sprain
90 patients
No difference in pain or ROM
Small sample size. The paracetamol
dose is inadequate for UK practice
Dalton and
Schweinle
(2006)
Multi-centre RCT of
acetaminophen v ibuprofen in
acute ankle sprain
260 patients
No difference in pain, negative anterior drawer
tests or patient satisfaction
Funded by a pharmaceutical company
Ekman et al
(2002)
RCT of celecoxib v ibuprofen v
placebo in acute ankle sprain
445 patients
Celecoxib better than placebo,
but not different from ibuprofen,
for pain and return to work time
Celecoxib is not licensed in UK
135 patients
No difference in pain or swelling, but naproxen
twice a day leads to more gastrointestinal
complications
Small study size and large loss of
participants at follow up. No blinding
Hyaluronic acid injection
Topical
Hajimaghsoudi
RCT of naproxen twice a day v
et al (2013) naproxen as needed in ankle sprain
Ridderikhof
et al (2013)
Double-blinded randomised
multi‑centre trial of
paracetamol v diclofenac
v paracetamol and diclofenac
in acute musculoskeletal trauma
547 patients
Unpublished
No reference to ankle stability
Mason et al
(2004)
Meta-analysis of topical
non-steroidal anti-inflammatory
drugs (NSAIDs) in acute pain
36 RCTs
Topical NSAIDs are better than placebo but not
different from oral NSAIDs
Small trials size over long period with
inconsistent outcomes. Conflict of
interest declared by several authors
Massey et al
(2010)
Meta-analysis of topical NSAIDs
in sprain, strain, sport and
overuse injuries
3,455
patients
Diclofenac gel is better than placebo with
fewer adverse events
Small trial size and limited data to
compare topical NSAIDs with each other
and oral counterparts. Conflict of interest
declared by several authors
Predel et al
(2013)
Multi-centre, double-blinded RCT
of diclofenac spray v placebo in
ankle sprain
236 patients
Diclofenac spray reduced swelling significantly
and pain slightly compared with placebo
Funded by a pharmaceutical company
Petrella et al
(2007)
RCT of hyaluronic acid injection v
placebo in acute ankle sprain
158 athletes
Hyaluronic acid injection reduced pain
and led to a more rapid return to activity
compared with placebo
Small study size
Petrella et al
(2009)
24-month follow up to study of
ankle instability, pain and further
injury
158 athletes
The hyaluronic acid group had reduced pain,
a more rapid return to sport, and fewer
recurrent ankle sprains, missed fewer sport
days and had less adverse events
Participants were a specific subset of
the population
Coronel et al
(2014)
RCT of hyaluronic acid injection v
placebo in acute ankle sprain
31 patients
The hyaluronic acid group had reduced pain
and faster return to activity
Small sample size
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Art & science | anti-inflammatory drugs
treatment within three days due to stomach
problems. Active and passive ranges of movement
(ROM) were calculated through computer images,
which removed the possibility of error associated
with subjective measurement, and no difference
between the two groups’ pain scores was found.
Both groups also showed improvement in pain and
there was no difference between the two groups’
pain and movement outcomes.
Although the study’s sample size was small
and participants were given inadequate doses of
paracetamol, it appears that pain experience and
ROM among participants given paracetamol and
those given NSAIDs were similar.
In a US-based multi-centre, double-blinded study,
Dalton and Schweinle (2006) examined the treatments
of 260 patients with ankle sprain who had been given
standard doses of either paracetamol, known in
the US as acetaminophen, or ibuprofen to evaluate
the hypothesis that NSAIDs impair ligament healing
by inhibiting the inflammation process (Braund and
Abbot 2007). Participants undertook the anterior
drawer test (Purcell 2010) of ROM, used a visual
analogue scale to indicate the pain they experienced
and stated how satisfied they were with their
treatments. Although often overlooked, patient
satisfaction is an important outcome because it can
affect compliance with treatment (Neighbour 2005).
Results indicate no difference in pain scores,
anterior drawer test results or patient satisfaction
between participants who had taken paracetamol
and those who had taken ibuprofen (Dalton and
Schweinle 2006).
Bellomo et al (2009) point out that changing
practice requires ‘suitably powered, robust,
independently supervised and monitored
multi‑centre, randomised, controlled trials’, and
Dalton and Schweinle’s (2006) study, which took
place across 42 healthcare centres, meets these
criteria. However, the researchers declare that
funding was provided by a pharmaceutical company.
Ekman et al (2002) compared the use of celecoxib,
ibuprofen and placebo for ten days in 445 patients
with ankle sprains. One of the measurable outcomes
was pain on weight bearing. Celecoxib was shown
to be better than the placebo for pain management
and return to activity, but there was no difference
between celecoxib and ibuprofen. Ibuprofen was
shown to be its equal in efficacy and superior to
the placebo. It should be noted that celecoxib is
not licensed for musculoskeletal pain in the UK
(JFC 2014).
In a follow-up study, Petrella et al (2004)
compared celecoxib with naproxen for acute ankle
sprain and found no difference in pain score,
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although naproxen was associated with increased
adverse events, specifically dyspepsia.
In an Iran-based study, Hajimaghsoudi et al
(2013) compared the efficacy, in terms of the pain
and swelling experienced by patients, and safety
of treatment with naproxen 500mg twice daily and
RICE, and naproxen as required (PRN) and RICE.
The study, which took place over seven days,
involved 135 patients with acute ankle sprain.
Injuries were judged to be acute if they had
been sustained during the previous 48 hours,
which is longer than in most other trials in the
literature review.
Although the study was randomised, its
participants took naproxen regularly or when they
felt they needed it, which meant that they could
not be blinded. Both groups showed similar clinical
outcomes, but those treated with naproxen twice
daily had more minor gastrointestinal complications
than those treated PRN. Although this study shows
positive results for the use of NSAIDs PRN, it is
limited because participants were not blinded and
many were lost to follow up.
Loss of study participants to follow up can
affect results. Miser (2006) states that an attrition
rate of more than 10% in short-term studies can
invalidate results and, in Hajimaghsoudi et al’s
(2013) study, loss to follow up was just over this
figure. Furthermore, the authors did not consider
whether participants had undertaken RICE before
they presented, or how length of time since injury
affected pain and swelling.
Ridderikhof et al (2013) have submitted
a proposal for a Dutch-based multi-centre,
double- blinded, randomised, inferiority study
of pain scores in 547 patients with acute
musculoskeletal trauma who have been administered
paracetamol, diclofenac or both.
An additional measure to assess ankle stability
pre- and post-treatment would add to the evidence
base related to the use of NSAIDs in the management
of ankle sprains. At time of Emergency Nurse going
to press, the results had not been published, but this
study should add considerably to the evidence base
for NSAID use. It also resembles studies of UK urgent
care centres more than other research in non-UK
populations (Slatyer et al 1997, Lyrtzis et al 2010).
Topical NSAIDs NICE (2012) suggests that,
for immediate treatment of ankle sprain,
paracetamol can be substituted by topical NSAIDs.
This suggestion is based partly on Mason et al’s
(2004) meta-analysis of 36 randomised control
trials, although most of these trials were small and
inconsistent. The researchers conclude that pain
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management with topical NSAIDs is no different
from that with oral NSAIDs but is superior to that
with placebo, and that there is a notable reduction in
side effects with topical NSAIDs (Mason et al 2004).
In another meta-analysis involving 3,455 patients
with acute ankle sprain, strain, sport and overuse
injuries, Massey et al (2010) compared pain levels
experienced by patients who had been given
diclofenac gel with those given placebo.
The researchers found the former group
experienced less pain than the latter, and that
‘adverse events were rare’ in the diclofenac group
(Massey et al 2010), which suggests that diclofenac
gel may be preferable to oral NSAIDS due to its
apparent ability to reduce adverse reactions.
Predel et al (2013) conducted a Hungary‑based
multi-centre, double-blinded, randomised study of
whether diclofenac spray gel reduces swelling in
uncomplicated ankle sprains. To ensure consistency,
all patients’ ankles were measured the same way,
namely the figure‑of‑eight method (Tatro-Adams et al
1995), which has been validated by Petersen et al
(1999). Pain scores were also monitored. Of the
236 people included in the trial, only 5% were lost
to follow up.
Results showed that diclofenac spray reduced
swelling when compared to placebo, which
Predel et al (2013) suggest could lead to earlier
recovery of function and return to normal activity.
There was a small reduction in spontaneous pain
when diclofenac spray was used and the treatment
was well tolerated with only one adverse event,
namely skin irritation.
It should be noted, however, that the researchers
were employed and funded by a pharmaceutical
company that produces diclofenac spray gel.
Hyaluronic acid injection Believed to be present in
the early stages of wound healing, hyaluronic acid
promotes inflammation (Aya and Stern 2014).
To test its efficacy in promoting a more rapid
return to activity with less pain, Peterella et al (2007)
undertook a study of 158 competitive athletes
with ankle sprain who had been treated with
hyaluronic acid injection and RICE, or placebo and
RICE. They found that patients who had received
hyaluronic acid reported reduced pain, a more
rapid return to sport, fewer recurrent ankle sprains,
fewer missed sport days and fewer adverse events
than those given placebo.
It is important to note that participants were
a physically fit group of competitive athletes who
are not representative of the general population.
Nevertheless this is the first study in which
participants were followed up after 24 months.
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Another single-centre study was undertaken
in Canada by Coronel et al (2014). This study
involved only 31 participants, but the researchers
found reductions in pain and a more rapid return
to activity in patients treated with hyaluronic acid.
A large multi-centre trial is required to inform
clinical practice further.
Sodium hyaluronate is licensed for pain
relief and recovery from ankle sprain in the UK
(JFC 2014). However, its cost, at about £139 for
the two injections required (Trent Medicines
Information Service 2012) is higher than that for oral
and topical treatments.
Hyaluronic acid injection is not suitable for all
patients suffering acute ankle sprain, but the fact
that it promotes inflammation yet reduces pain
and swelling might challenge traditional beliefs
that patients should be managed with NSAIDs.
Following publication of further research into
hyaluronic acid injections, the treatment could be
offered to patients whose jobs require their speedy
return to pre‑injury function, such as those in the
armed forces or athletes.
Discussion
Prescribing practice Between 2010/11 and
2013/14, the number of times diclofenac was
prescribed in England reduced from 64% to 28%
of incidents (IMS Health 2014). This sharp fall is
likely to be related to a Medicines and Healthcare
products Regulatory Agency (MHRA) alert about
risks associated with the drug in people with
diabetes, high cholesterol and hypertension
(MHRA 2013).
In the meta-analysis that informed the MHRA
alert, Bhala et al (2013) found that diclofenac at
150mg a day and high-dose ibuprofen, at 2,400mg a
day, resulted in three times the incidence of vascular
events compared with placebo, but that naproxen at
1,000mg a day did not increase the incidence.
There has been a subsequent increase in naproxen
and ibuprofen prescribing, with an approximately
250% increase in naproxen prescriptions between
2010 and 2014 (IMS Health 2014).
Cost implications Being a major factor in
prescribing decisions, costs must be considered
when assessing potential benefits and risks (Prosser
and Wally 2005). The costs of treatment of a range
of drugs are shown in Table 2 (page 30).
Diclofenac topical spray and ibuprofen gel are
included in the table for purposes of comparison,
and to illustrate the growing cost of topical
medications (Massey et al 2010). The table shows
that paracetamol is the most expensive oral
April 2015 | Volume 23 | Number 1 29
Art & science | anti-inflammatory drugs
medication and that there is little difference between
costs of NSAIDs. Thought should also be given to
the cost of prescribing proton pump inhibitors to
prevent gastrointestinal complications in patients
Table 2
Costs of treatment
Drug type
Dosage
Price
4% in 50g spray
£5.38
400mg three times
a day for 14 days
£0.89
5% in 25g tube
£1.95
Naproxen
500mg twice a day
for seven days
£0.86
Paracetamol
1g four times a day
for 14 days
£1.70
Two injections
£139
Diclofenac spray
Ibuprofen
Ibuprofen gel
Sodium hyaluronate
(Trent Medicines Information Service 2013, British National
Formulary 2014, NHS Business Service Authority 2015)
treated with NSAIDs (Longmore and Longmore
2007) and the cost of treatments associated
with adverse events.
Contraindications NSAIDs can cause considerable
complications in various patient groups, including
older people, people with asthma and those taking
warfarin. Older people are more susceptible to the
adverse affects of NSAIDS, such as gastrointestinal
bleeding and heart failure (Stovitz and Johnson
2003, Bhala et al 2013).
Patients taking warfarin should take NSAIDs
only with caution. Choi et al (2010) found that
almost 40% of the people taking warfarin who
were prescribed NSAIDs (n=98) in their study
experienced an international normalised ratio
increase of more than 15%. This suggests that
simple analgesics would be more appropriate
in this patient group to avoid disrupting their
established medication regimens.
About five million people in the UK have asthma
and NSAID-associated asthma attacks occur in
about one in ten of them. NSAID-associated asthma
attacks are less common in children than adults
(Asthma UK 2014), although the exact reason
for this is unknown.
References
Asthma UK (2014) Knowledge Bank:
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Boyce S (2004) Review of sports injuries
presenting to an accident and emergency
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Coronel P, Gimeno M, Petrella R (2014)
Management of ankle sprain with single
periarticular injection of sodium hyaluronate.
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Dalton J Jr, Schweinle J (2006) Randomized
controlled noninferiority trial to compare
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Ekman E, Fiechtner J, Levy S et al (2002)
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the treatment of acute pain: a multicenter,
double‑blind, randomized controlled trial
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of Orthopedics. 31, 8, 445-451.
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Hajimaghsoudi M, Jalili M, Mokhtari M et al
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(2011) The effect of diclofenac sodium and
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People with asthma should therefore be made
aware that they may experience an NSAID-associated
asthma attack. However, NICE (2012) states that
‘unless NSAIDs clearly cause severe exacerbations
of asthma, people with asthma should not be denied
the benefits of NSAIDs’.
NSAIDs should also be used with extreme caution
in pregnant women due to their cardiovascular side
effects and the risks of abortion (NICE 2012).
Conclusion
Over the past five years, research into the use of
analgesia and NSAIDs in the management of ankle
sprains has increased. However, the value of this
research to clinical practice is undermined because
much of it is funded by pharmaceutical companies
(Bekelman et al 2003).
In addition, much of it was undertaken in
countries other than the UK.
Many of these studies show that there is
no or little difference between the pain levels
experienced by patients given paracetamol and
those given NSAIDs, and those that report a
benefit in using NSAIDs are backed by
pharmaceutical companies. However, it is
accepted that COX-1 and COX-2 NSAIDs cause
gastrointestinal and cardiovascular complications
in people with asthma, older people and those
on warfarin.
While a move towards the use of paracetamol
and topical NSAIDs may be costly in the short term,
it could prevent or reduce hospital admissions in
patients with asthma or those suffering adverse
events such as gastric bleeding.
Further research into hyaluronic acid injections
is required to determine whether they can improve
short- and long-term ankle sprain recovery times
in the general population. Given the high cost of the
injections, however, they may be reserved for use in
specific groups, such as armed forces.
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