Struijs AnkleSprain ClincialEvidence 2010

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Ankle sprain
Article in Clinical Evidence · May 2010
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Peter Struijs Gino Kerkhoffs

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Musculoskeletal disorders
..................................................
Ankle sprain
Search date November 2009
Peter Struijs and Gino Kerkhoffs
ABSTRACT
INTRODUCTION: Injury of the lateral ligament complex of the ankle joint occurs in about one in 10,000 people a day, accounting for a
quarter of all sports injuries. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical
question: What are the effects of treatment strategies for acute ankle ligament ruptures? We searched: Medline, Embase, The Cochrane
Library, and other important databases up to November 2009 (Clinical Evidence reviews are updated periodically, please check our website
for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Admin-
istration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 38 systematic reviews,
RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: cold
treatment, diathermy, functional treatment, homeopathic ointment, immobilisation, physiotherapy, surgery, and ultrasound.
QUESTIONS
What are the effects of treatment strategies for acute ankle ligament ruptures?. . . . . . . . . . . . . . . . . . . . . . . . . 3
INTERVENTIONS
TREATING ANKLE SPRAIN Unknown effectiveness
Beneficial Cold treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Functional treatment (early mobilisation with use of an Diathermy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
external support) . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Homeopathic ointment . . . . . . . . . . . . . . . . . . . . . . 12
Physiotherapy (physical therapy) . . . . . . . . . . . . . . 12
Likely to be beneficial
Immobilisation (cast immobilisation may be effective for Unlikely to be beneficial
the first 7–10 days, but a longer period is likely to be
less effective compared with functional treatment) . . Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3
To be covered in future updates
Trade off between benefits and harms Non-steroidal anti-inflammatory drugs
Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Prevention of ankle sprain
Key points
• Injury of the lateral ligament complex of the ankle joint occurs in about one in 10,000 people a day, accounting for
a quarter of all sports injuries.
Pain may be localised to the lateral side of the ankle.
Residual complaints include joint instability, stiffness, and intermittent swelling, and are more likely to occur after
more extensive cartilage damage.
Recurrent sprains can add new damage and increase the risk of long-term degeneration of the joint.
• Despite consensus views that immobilisation is more effective than no treatment, studies have shown that immo-
bilisation for more than 4 weeks worsens function and symptoms in both the short and long term compared with
functional treatment. Immobilisation for up to 10 days may be beneficial for the patient by facilitating decrease in
pain and swelling.
Surgery and immobilisation may have similar outcomes in terms of pain, swelling, and recurrence, but surgery
may lead to increased joint stability.
• Functional treatment, consisting of early mobilisation and an external support, improves function and stability of
the ankle compared with minimal treatment or immobilisation.
We don't know which is the most effective functional treatment, or how functional treatments compare with surgery.
• Ultrasound has not been shown to improve symptoms or function compared with sham ultrasound.
Cold treatment may reduce oedema compared with heat or a contrast bath, but it has not been shown to improve
symptoms compared with placebo.
We don't know whether diathermy, homeopathic ointment, or physiotherapy (physical therapy) improve function
compared with placebo, as we found few studies.
© BMJ Publishing Group Ltd 2010. All rights reserved. .................... 1 .................... Clinical Evidence 2010;05:1115
Ankle sprain
DEFINITION Ankle sprain is an injury of the lateral ligament complex of the ankle joint. The injury is graded on
[1] [2] [3] [4] [5]
the basis of severity. Grade I is a mild stretching of the ligament complex without
joint instability; grade II is a partial rupture of the ligament complex with mild instability of the joint
(such as isolated rupture of the anterior talofibular ligament); and grade III involves complete rupture
of the ligament complex with instability of the joint.This gradation has limited practical consequences
since both grade II and III injuries are treated similarly, and grade I injuries need no specific treatment
[6]
after diagnosis. Unless otherwise stated, studies included in this review did not specify the
grades of injury included, or included both grade II and II.
INCIDENCE/ Ankle sprain is a common problem in acute medical care, occurring at a rate of about one injury
[7]
PREVALENCE per 10,000 people a day. Injuries of the lateral ligament complex of the ankle form a quarter of
[7]
all sports injuries.
AETIOLOGY/ The usual mechanism of injury is inversion and adduction (usually referred to as supination) of the
RISK FACTORS plantar flexed foot. Predisposing factors are a history of ankle sprains, ligament hyperlaxity syn-
drome, and specific malalignment, such as crus varum and pes cavo-varus.
PROGNOSIS Some sports (e.g., basketball, football/soccer, volleyball) are associated with a particularly high
incidence of ankle injuries. Pain and intermittent swelling are the most frequent residual problems,
[4]
often localised on the lateral side of the ankle. Other residual complaints include mechanical
instability and stiffness. People with more extensive cartilage damage have a higher incidence of
[4]
residual complaints. In the long term, the initial traumatic cartilage damage can lead to degener-
ative changes, especially if there is persistent or recurrent instability. Every further sprain has the
potential to add new damage.
AIMS OF To reduce swelling and pain; to restore the stability of the ankle joint; to regain full functional status.
INTERVENTION
OUTCOMES Symptom improvement: ability to walk/bear weight, ankle mobility/range of movement, pain,
swelling, patient perception of improvement/satisfaction, quality of life; Joint stability: subjective
instability; objective instability; Return to normal activities: return to pre-injury level of sports;
return to pre-injury level of work; Recurrence; Adverse effects of treatment, including post-inter-
vention complications.
METHODS Clinical Evidence search and appraisal November 2009. The following databases were used to
identify studies for this systematic review: Medline 1966 to November 2009, Embase 1980 to
November 2009, and The Cochrane Database of Systematic Reviews 2009, Issue 4 (1966 to date
of issue). An additional search within The Cochrane Library was carried out for the Database of
Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). We also
searched for retractions of studies included in the review. Abstracts of the studies retrieved from
the initial search were assessed by an information specialist. Selected studies were then sent to
the contributor for additional assessment, using pre-determined criteria to identify relevant studies.
Study design criteria for inclusion in this review were: published systematic reviews of RCTs and
RCTs in any language. All RCTs were sent for consideration, so there was no minimum blinding,
number of participants, or percentage of participants followed-up. There was no minimum length
of follow-up required to evaluate studies. We included systematic reviews of RCTs and RCTs where
harms of an included intervention were studied applying the same study design criteria for inclusion
as we did for benefits. In addition, we use a regular surveillance protocol to capture harms alerts
from organisations such as the US Food and Drug Administration (FDA) and the UK Medicines
and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required.
To aid readability of the numerical data in our reviews, we round many percentages to the nearest
whole number. Readers should be aware of this when relating percentages to summary statistics
such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of
the quality of evidence for interventions included in this review (see table, p 16 ). The categorisation
of the quality of the evidence (into high, moderate, low, or very low) reflects the quality of evidence
available for our chosen outcomes in our defined populations of interest. These categorisations
are not necessarily a reflection of the overall methodological quality of any individual study, because
the Clinical Evidence population and outcome of choice may represent only a small subset of the
total outcomes reported, and population included, in any individual trial. For further details of how
we perform the GRADE evaluation and the scoring system we use, please see our website
(www.clinicalevidence.com).
© BMJ Publishing Group Ltd 2010. All rights reserved. ........................................................... 2

Ankle sprain
QUESTION What are the effects of treatment strategies for acute ankle ligament ruptures?
OPTION IMMOBILISATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symptom improvement
Compared with functional treatment Immobilisation for a short period (up to 10 days) with below-knee cast may be
more effective than tubular bandage at improving some symptom measures (e.g., ankle function and pain scores)
at 1 and 3 months, but we don't know whether it is more effective at 9 months, and we don't know whether immobil-
isation using Aircast brace or Bledsoe boot are more effective than tubular bandage. Immobilisation for 3 weeks or
longer may be less effective than functional treatment at reducing swelling and pain, or increasing patient satisfaction
in the short/medium term (less than 6 weeks or 6–12 weeks), but we don't know how immobilisation and functional
treatment compare in the longer term (greater than 1 year) (very low-quality evidence).
Compared with surgery We don't know how immobilisation compares with surgery at reducing swelling or pain (low-
quality evidence).
Different forms of immobilisation compared with each other We don't know whether semi-rigid casts or rigid casts
are more effective at reducing pain or swelling at short-term follow-up (low-quality evidence).
Compared with ultrasound We don't know how immobilisation and ultrasound compare at improving recovery times
at 7 days, but immobilisation may be less effective than ultrasound at 14 days (very low-quality evidence).
Joint stability
Compared with functional treatment Immobilisation for at least 3 weeks may be less effective at improving joint sta-
bility at 6 to 12 weeks, but we don't know how immobilisation and functional treatment compare in the longer term
(greater than 1 year) (low-quality evidence).
Compared with surgery Immobilisation for at least 4 weeks may be less effective at reducing objective joint instability,
but may be as effective at reducing subjective joint instability (low-quality evidence).
Different forms of immobilisation compared with each other We don't know whether semi-rigid casts or rigid casts
are more effective at short-term follow-up at reducing objective instability (low-quality evidence).
Return to normal activities

Compared with functional treatment Immobilisation for at least 3 weeks may be less effective at reducing the time
taken to return to sports, time taken to return to normal physical training, or the proportion of people not returning to
sports. Immobilisation for at least 4 weeks is less effective at reducing the time taken to return to work, but, at 1 to
2 years' follow-up, there may no longer be differences between immobilisation and functional treatment in the pro-
portion of people who have returned to work (low-quality evidence).
Compared with surgery Immobilisation seems less effective at reducing the proportion of people not returning to
sports or with reduction in sporting activity (moderate-quality evidence).
Different forms of immobilisation compared with each other Semi-rigid casts may be more effective than rigid casts
at reducing the time taken to return to work (low-quality evidence).
Recurrence
Compared with surgery We don't know how immobilisation and surgery compare at reducing recurrence of ankle
sprains (low-quality evidence).
Note
We found no clinically important results from RCTs about immobilisation compared with no treatment in people with
ankle sprain. There is consensus that immobilisation is more effective than no treatment.
For GRADE evaluation of interventions for ankle sprains, see table, p 16 .
Benefits: Immobilisation versus no treatment:

We found no RCTs comparing immobilisation versus no treatment.
Immobilisation versus functional treatment:

[8] [9] [10]
We found one systematic review (search date 2001) and two subsequent RCTs.
The systematic review included any inpatient, outpatient, or home-based intervention programme
[8]
consisting of immobilisation with or without a plaster cast. It included any trials comparing immo-
bilisation versus either another type or duration of immobilisation or a functional treatment for injuries
to the lateral ligament complex of the ankle, and it reported outcomes at short-term, intermediate,
or long-term follow-up (see comment below). The review analysed a variety of different forms of
Ankle sprain
functional treatment, including strapping, bracing, use of an orthosis, tubigrips, bandages, elastic
bandages, and special shoes, for at least 5 weeks. It found that functional treatment significantly
improved seven outcomes measured at different follow-up times compared with immobilisation. At
short-term follow-up, it found that functional treatment significantly reduced the proportion of people
with persistent swelling compared with immobilisation (3 RCTs; 260 people; 44/144 [31%] with
immobilisation v 25/116 [22%] with functional; RR 1.7, 95% CI 1.2 to 2.6) and significantly decreased
the proportion of people not returning to work (2 RCTs; 150 people; 8/74 [11%] with immobilisation
v 1/76 [1%] with functional; RR 5.75, 95% CI 1.01 to 32.71). At intermediate follow-up, it found that
immobilisation significantly increased objective instability, as assessed with stress x-ray, compared
with functional treatment (1 RCT; 106 people; WMD in talar tilt 2.6°, 95% CI 1.2° to 4.0°; absolute
results not reported), but that functional treatment significantly increased patient satisfaction com-
pared with immobilisation (proportion of people not satisfied with treatment 2 RCTs; 123 people;
10/61 [16%] with immobilisation v 2/62 [3%] with functional treatment; RR 4.2, 95% CI 1.1 to 16.1).
At long-term follow-up, it found that functional treatment significantly decreased the proportion of
people not returning to sports compared with immobilisation and the time taken to return to sports
(immobilisation: 5 RCTs; 360 people; 44/175 [25%] with immobilisation v 24/185 [13%] with func-
tional treatment; RR 1.9, 95% CI 1.2 to 2.9; time taken to return to work: 6 RCTs; 604 people; WMD
8.2 days, 95% CI 6.3 days to 10.2 days; absolute results not reported), and the time taken to return
to sports (3 RCTs; 195 people; WMD 4.9 days, 95% CI 1.5 days to 8.3 days; absolute results not
reported). However, it found that, at long-term follow-up, differences between immobilisation and
functional treatment in persistent swelling, objective instability, proportion of people not returning
to work, and patient satisfaction were no longer significant (absolute numbers and statistical anal-
ysis reported in review). A subgroup analysis using only "high quality" RCTs (defined as scoring
[11]
at least 50% on a recognised quality-evaluation tool ) found that functional treatment significantly
reduced the time taken to return to work compared with immobilisation (2 RCTs; 262 people; WMD
[8]
12.9 days, 95% CI 7.1 days to 18.7 days; absolute results not reported).
The first subsequent RCT (121 semi-professional sports people with acute grade III lateral ankle
ligament) compared 3 weeks of functional treatment (strapping plus early controlled mobilisation)
[9]
versus immobilisation in a plaster cast. It found that functional treatment significantly reduced
time taken to return to normal physical training, and reduced the proportion of people with pain,
swelling, and subjective instability at 3 months compared with immobilisation (mean time to return
to normal training: 6.3 weeks with immobilisation v 5.4 weeks with functional treatment; P = 0.02;
pain: 61% with immobilisation v 35% with functional treatment; absolute results not reported;
P = 0.008; swelling: 49% with immobilisation v 16% with functional treatment; absolute results not
reported; P less than 0.01; subjective instability: 54% with immobilisation v 22% with functional
treatment; absolute results not reported; P = 0.001). However, the RCT found no significant differ-
ence at 12 months between treatments in the proportion of people with pain, swelling, or subjective
instability (pain: 7% with immobilisation v 5% with functional; P = 0.6; swelling: 4% with immobilisation
v 5% with functional; P = 0.8; subjective instability: 7% with immobilisation v 9% with functional;
[9]
P = 0.3; absolute results not reported).
The second subsequent RCT (584 people, aged at least 16 years, with acute severe ankle sprain,
no fracture), was a four-armed trial comparing three types of immobilisation (below-knee cast,
Aircast ankle brace, Bledsoe boot) versus functional treatment (tubular bandage), each applied for
[10]
10 days after randomisation. Acute severe ankle sprain was indicated by inability to weight
bear for at least 3 days after injury on presentation to the emergency department and at re-assess-
ment (2–3 days after presentation and following elevation and immobilisation in tubular compression
bandage to allow swelling to resolve). Participants were allowed to use any additional treatments
during the 9 months' follow-up without restriction, but were asked to report these. The RCT found
that, compared with tubular bandage, below-knee cast significantly improved the primary outcome
of quality of ankle function (assessed by the Foot and Ankle Score [FAOS] on a scale of 0–100)
and also secondary outcomes of pain (assessed by FAOS, scale 0–100), and the physical compo-
nent of the SF-12 questionnaire (scale 0–100) at 1-month follow-up; however, these improvements
were small (FAOS quality: difference 5.9, 95% CI 0.1 to 11.8; FAOS pain: difference 5.1, 95% CI
0.4 to 9.8; SF-12 physical score: difference 2.2, 95% CI 0 to 4.4, all adjusted for age, sex, and
baseline scores). It found no significant difference between tubular bandage and below-knee cast
in activities of daily living (assessed by FAOS, scale 0–100), ability to do sports (assessed by
FAOS, scale 0–100), or the mental component of the SF-12 (scale 0–100) at 1 month (FAOS ac-
tivities of daily living score: difference +3, 95% CI –0.3 to +6.3; FAOS sports score: difference +5,
95% CI –1.7 to +11.8; SF-12 mental score: difference –1, 95% CI –3.4 to +2.2). It found that below-
knee cast significantly improved quality of ankle function and also secondary outcomes of pain,
activities of daily living, and ability to do sports compared with tubular bandage at 3 months; but
found no significant difference in SF-12 physical or mental health components (FAOS quality: dif-
ference 8.7, 95% CI 2.4 to 15.0; results of all other outcomes reported in the RCT). It found no
significant difference between groups in quality of ankle function or any secondary outcome at 9
months (FAOS quality: difference +6, 95% CI –0.7 to +13.2, results of all other outcomes reported
Ankle sprain
in the RCT).The RCT found no significant difference between the Aircast brace and tubular bandage
for quality of ankle function or any secondary outcome at 1 month (FAOS quality: difference +5,
95% CI –1 to +10.7; FAOS pain: difference +4, 95% CI –1.2 to +8.2; FAOS activities of daily living
score: difference 0, 95% CI –2.7 to +4.0; FAOS sports score: difference 0, 95% CI –1.0 to +12.9;
SF-12 physical score: difference –1, 95% CI –3.6 to +0.8; SF-12 mental score: difference 0, 95%
CI –2.7 to +3.0). It found that the Aircast brace significantly improved ankle function and the mental
health component of the SF-12 questionnaire at 3 months, but it found no significant difference
between groups for pain, activities of daily living, and ability to do sports or the physical health
component of the SF-12 questionnaire (FAOS quality: difference 8, 95% CI 1.8 to 14.2, results of
all other outcomes reported in the RCT). It found no significant difference between Aircast brace
and tubular bandage in any outcome at 9 months (FAOS quality: difference +6, 95% CI –0.9 to
+13.1, results of all other outcomes reported in the RCT). The RCT found no significant difference
between the Bledsoe boot and tubular bandage for quality of ankle function or any secondary out-
come at 1-month follow-up (FAOS quality: difference +2, 95% CI –3.9 to +7.6; FAOS pain: difference
+1, 95% CI –4.0 to +5.3; FAOS activities of daily living score: difference 0, 95% CI –3.3 to +3.2;
FAOS sports score: difference 0, 95% CI –7.0 to +6.4; SF-12 physical score: difference –1, 95%
CI –3.5 to +0.8; SF-12 mental score: difference +1, 95% CI –1.8 to +3.8). It also found no significant
difference between groups in any outcome at 3 months' or 9 months' follow-up (FAOS quality [3
months]: difference 6, 95% CI 0 to 12.3; [9 months]: difference +4, 95% CI –2.9 to +10.8, results
[10]
of all other outcomes reported in the RCT). The contributors of this Clinical Evidence review
advise caution with interpreting the results of this RCT, owing to a number of weaknesses, which
[12]
they have described in detail in a separate publication. These include uncertainty about inclusion
criteria (the authors of the RCT did not use a delayed physical examination 5–7 days after trauma
to exclude simple distortions), ill-defined treatment protocol after 10 days (all additional treatments
allowed), uncertainty about validity of blinding postal questionnaire-derived outcomes, and high
withdrawal rate (17%) at 1 month.
Immobilisation versus surgery:

We found one systematic review (search date 2006) comparing surgery (anatomic reconstruction)
versus immobilisation alone for acute injuries to the lateral ligament complex of the ankle (see
[6]
comment below). It found that, compared with immobilisation, surgery significantly reduced the
proportion of people who did not return to sports and who had objective instability (people not return
to sports: 3 RCTs; 267 people; 50/139 [36%] with immobilisation v 21/128 [16%] with surgery; RR
[surgery v immobilisation] 0.48, 95% CI 0.31 to 0.76; objective instability: 7 RCTs; 568 people;
54/295 [18%] with immobilisation v 17/273 [6%] with surgery; RR [surgery v immobilisation] 0.35,
95% CI 0.21 to 0.60). It found no significant difference between surgery and immobilisation in re-
currence, pain, subjective instability, or swelling (recurrence: 8 RCTs; 639 people; 66/328 [20%]
with immobilisation v 55/311 [18%] with surgery; RR [surgery v immobilisation] 0.86, 95% CI 0.63
to 1.18; pain: 8 RCTs; 654 people; RR [surgery v immobilisation] 0.64, 95% CI 0.33 to 1.23; sub-
jective instability: 8 RCTs; 608 people; RR [surgery v immobilisation] 0.77, 95% CI 0.43 to 1.37;
swelling: 9 RCTs; 723 people; 75/365 [21%] with immobilisation v 48/358 [13%] with surgery; RR
[surgery v immobilisation] 0.67, 95% CI 0.38 to 1.18).
Immobilisation versus ultrasound:

See benefits of ultrasound, p 10 .
Different forms of immobilisation versus each other:

[8]
We found one systematic review (search date 2001, 2 RCTs). One small open label RCT (64
people, aged 17–47 years, with acute grade III inversion injury to the ankle) identified by the review
found that a semi-rigid cast for 2 weeks significantly reduced the time taken to return to work
compared with a rigid cast (36 people; 6.3 days with rigid cast v 2.5 days with semi-rigid cast; WMD
[8]
3.80 days, 95% CI 1.16 days to 6.44 days). It found no significant difference in pain, swelling,
or objective instability at short-term follow-up (proportion of people with pain: 7/26 [27%] with rigid
cast v 4/31 [13%] with semi-rigid cast; RR 2.10, 95% CI 0.69 to 6.35; proportion of people with
swelling: 12/26 [46%] with rigid cast v 9/31 [29%] with semi-rigid cast; RR 1.59, 95% CI 0.80 to
3.17; proportion of people with objective instability: 2/26 [8%] with rigid cast v 4/31 [13%] with semi-
rigid cast; RR 0.60, 95% CI 0.12 to 3.00).
Harms: Immobilisation versus no treatment:

We found no RCTs.

[8] [9]
The review and the first subsequent RCT did not report on harms. The second subsequent
RCT reported similar rates of adverse effects among groups (no further details reported). It reported
that three people (1 with Aircast, 1 with tubular compression bandage, 1 with below-knee cast) had
a deep venous thrombosis, and two people (1 with tubular compression bandage, 1 with Aircast)
[10]
had a pulmonary embolism, and two people (1 with Aircast, 1 with Bledsoe) had cellulitis.
Ankle sprain
Two RCTs identified by the review found a smaller proportion of cases of deep venous thrombosis
after cast immobilisation than after surgery (deep venous thrombosis: 2/47 [4%] after cast immobil-
isation v 3/34 [9%] after surgery in first RCT; 0/33 [0%] after cast immobilisation v 1/32 [3%] after
[6] [13]
surgery in second RCT). A third RCT identified by the review found a similar risk of deep
venous thrombosis in both groups (1/50 [2%] after cast immobilisation v 1/50 [2%] after surgery).
[6]
Other RCTs did not specifically address harms. Other known harms of immobilisation include
[13]
pain and impairment in activities of daily living.
Immobilisation versus ultrasound:

See harms of ultrasound, p 10 .
Different forms of immobilisation:

[8]
The review did not report on harms.
Comment: Immobilisation versus no treatment:

There is consensus that immobilisation is more effective in the treatment of ankle sprain than no
treatment.

In the review, follow-up periods for outcome measures were categorised as short term (less than
6 weeks of randomisation), intermediate term (6 weeks to 1 year), or long term (1–2 years after
[8]
treatment). The review excluded trials that focused on the treatment of chronic instability or post-
surgical treatment, unless such injuries occurred in less than 10% of the whole study population.
The first subsequent study included only semi-professional sports people, so the results may not
[9]
be applicable to the general population.

The review noted that all included RCTs had methodological flaws, and there was insufficient evi-
[6]
dence to determine the relative effectiveness of surgical and conservative treatment.
OPTION FUNCTIONAL TREATMENT (EARLY MOBILISATION WITH USE OF AN EXTERNAL SUP-

PORT). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symptom improvement
Compared with minimal treatment We don't know whether functional treatment (early mobilisation using an external
support) is more effective at reducing residual pain, but mortise separation adjustment may be more effective than
detuned ultrasound at reducing pain, increasing range of motion, and improving ankle function at 1 month (low-
quality evidence).
Compared with surgery We don't know how functional treatment and surgery compare at reducing pain or swelling
(low-quality evidence).
Compared with immobilisation Tubular bandage for a short period (up to 10 days) may be less effective than immo-
bilisation with below-knee cast at improving some symptom measures (e.g., ankle function and pain scores) at 1
and 3 months, but we don't know whether these differences are sustained at 9 months, and we don't know how
tubular bandage and immobilisation using Aircast brace or Bledsoe boot compare with each other. Functional treatment
may be more effective than immobilisation for at least 3 weeks at improving swelling, pain, or patient satisfaction in
the short/medium term (less than 6 weeks or 6–12 weeks), but we don't know whether functional treatment is more
effective in the longer term (greater than 1 year) (very low-quality evidence).
Different functional treatments compared with each other We don’t know which functional treatment is the most ef-
fective at relieving symptoms of ankle sprain (very low-quality evidence).
Joint stability
Compared with minimal treatment Functional treatment (early mobilisation using an external support) is more effective
at reducing the risk of the ankle giving way (moderate-quality evidence).
Compared with immobilisation Functional treatment may be more effective at improving joint stability at 6 to 12 weeks,
but we don't know whether functional treatment is more effective in the longer term (greater than 1 year) (low-quality
evidence).
Compared with surgery We don't know how functional treatment and surgery compare at reducing joint instability
Different functional treatments compared with each other Semi-rigid ankle support may be more effective than an
elastic bandage at increasing subjective joint stability in the short term (less than 6 weeks of treatment), but we don't
Ankle sprain
know whether it is more effective in the intermediate term (6 weeks to 1 year), or long term (1–2 years after treatment).
We don't know whether a semi-rigid device is more effective than tape at improving joint stability (assessed by
physical examination, further details not reported) or at reducing the rates of people reporting the sensation of
spraining the ankle after 4 weeks' follow-up (very low-quality evidence).

Compared with immobilisation Functional treatment may be more effective than immobilisation for at least 4 weeks
at reducing the time taken to return to sports, time taken to return to normal physical training, and the proportion of
people not returning to sports. Functional treatment may be more effective than immobilisation for at least 4 weeks
at reducing the time taken to return to work, but we don't know whether it is more effective in reducing the proportion
of people not returning to work (low-quality evidence).
Compared with surgery We don't know how functional treatment and surgery compare at reducing the time taken to
return to sports (low-quality evidence).
Different functional treatments compared with each other Early functional treatment with an elastic wrapping, early
full weightbearing, and proprioceptive training may be more effective than conventional treatment with an elastic
bandage and partial weightbearing until pain subsides at reducing the time taken to return to work and the time taken
to return to sports in people with grade II and grade III ankle injuries. Semi-rigid ankle support may be more effective
than elastic bandage at reducing the time taken to return to work and the time taken to return to sports (very low-
quality evidence).
Recurrence
Compared with surgery We don't know how functional treatment and surgery compare at reducing recurrence of
ankle sprains (low-quality evidence).
Different functional treatments compared with each other Semi-rigid devices may be no more effective than tape in
reducing recurrence of ankle sprains in people with ankle injures; and early functional treatment may be no more
effective than conventional treatment (very low-quality evidence).
Benefits: Functional treatment versus minimal treatment:

[14]
We found one systematic review (search date 1998, 3 RCTs; 214 people) and one subsequent
[15]
RCT. The review compared functional treatment versus a minimal-treatment policy. It found
that functional treatment significantly reduced the risk of the ankle giving way (absolute numbers
[14]
not reported; RR 0.34, 95% CI 0.17 to 0.71). The review found no significant difference between
treatments in the proportion of people with residual pain (absolute numbers not reported; RR 0.53,
[14]
95% CI 0.27 to 1.02).
The subsequent RCT (30 people with sub-acute or chronic ankle sprain without gross mechanical
[15]
instability) compared mortise separation adjustment versus detuned (sham) ultrasound. It found
that mobilisation significantly reduced pain, increased ankle range of motion, and improved ankle
function at 1 month; results presented graphically).
Functional treatment versus immobilisation:

See benefits of immobilisation, p 3 .
Functional treatment versus surgery:

[6]
We found one systematic review (search date 2006) comparing surgery (tenodesis or anatomic
reconstruction) versus functional treatment alone (see comment below). The review found no sig-
nificant difference between functional treatment and surgery in return to sports, recurrence, pain,
subjective instability, objective instability, ans swelling (3 RCTs; proportion of people who did not
return to sport or with reduction in sporting activity: 22/146 [15%] with functional treatment v 14/147
[10%] with surgery; RR [surgery v functional] 0.77, 95% CI 0.43 to 1.39; recurrence: 5 RCTs; 38/213
[18%] with functional treatment v 46/208 [22%] with surgery; RR [surgery v functional] 1.2, 95% CI
0.8 to 1.8; pain: 5 RCTs; 34/207 [16%] with functional treatment v 38/206 [18%] with surgery; RR
[surgery v functional] 1.0, 95% CI 0.7 to 1.6; subjective instability: 6 RCTs; 62/286 [22%] with
functional treatment v 57/278 [21%] with surgery; RR [surgery v functional] 0.9, 95% CI 0.48 to
1.71; objective instability: 4 RCTs; proportion of people with positive talar tilt: 16/117 [14%] with
functional treatment v 8/105 [8%] with surgery; RR [surgery v functional] 0.6, 95% CI 0.3 to 1.2;
swelling: 5 RCTs; 28/242 [12%] with functional treatment v 25/227 [11%] with surgery; RR [surgery
[6]
v functional] 0.9, 95% CI 0.6 to 1.5; see comment below).
Different types of functional treatment versus each other:

[16] [17] [18] [19]
We found one systematic review (search date 2001), three additional, and one
[20]
subsequent RCT.
Ankle sprain
The review compared different types of functional treatment (elastic bandage, tape, lace-up ankle
support, and semi-rigid ankle support) in people with an acute injury to the lateral ligament complex
[16]
of the ankle. It reported outcomes at short-term, intermediate, and long-term follow-up (see
comment below). At short-term follow-up, it found that lace-up ankle support significantly reduced
persistent swelling compared with semi-rigid ankle support (1 RCT; 122 people; 3/60 [5%] with
lace-up ankle v 13/62 [21%] with semi-rigid ankle support; RR [semi-rigid ankle support v lace-up
ankle support] 4.2, 95% CI 1.3 to 14.0), elastic bandage (1 RCT; 122 people; 3/60 [5%] with lace-
up ankle v 17/62 [27%] with elastic bandage; RR [elastic bandage v lace-up ankle support] 5.5,
95% CI 1.7 to 17.8), and tape (1 RCT; 119 people; 3/60 [5%] with lace-up ankle v 12/59 [20%] with
tape; RR [tape v lace-up ankle support] 4.1, 95% CI 1.2 to 13.7). It found that a semi-rigid ankle
support reduced the proportion of people with subjective instability, the time taken to return to work,
and the time to return to sports compared with an elastic bandage (subjective instability: 1 RCT;
124 people; 8/62 [13%] with elastic bandage v 1/62 [2%] with semi-rigid ankle support; RR 8.00,
95% CI 1.03 to 62.07; time to return to work: 2 RCTs; 157 people; WMD 4.2 days, 95% CI 2.4 days
to 6.0 days; time to return to sports: 1 RCT; 84 people; WMD 9.6 days, 95% CI 6.3 days to 12.8
[16]
days). It found no other significant differences in outcomes between treatments (see comment
below), and no significant differences between different types of functional treatments at interme-
[16]
diate or long-term follow-up.
The first additional RCT (116 people with all grades of ankle sprain) compared a semi-rigid device
versus tape. It found low rates of people reporting the sensation of spraining the ankle after 4
weeks' follow-up, but it did not assess the significance of the comparison between groups (2/57
[4%] with tape v 0/59 [0%] with semi-rigid device; statistical assessment not reported). It found no
significant difference between groups in the stability of the ankle (assessed by physical examination,
no further details reported) after 4 weeks (reported as significant; absolute results not reported).
[17]
The second additional RCT (119 people not requiring surgery, treated within 24 hours of injury)
compared two types of tape treatment and found no significant differences between treatment
groups in pain, swelling, or range of movement 5 to 7 days after treatment (AR for pain: 5/59 [8%]
with layer bandage v 3/60 [5%] with elastic tape bandage; swelling: 34/59 [58%] with layer bandage
v 29/60 [47%] with elastic tape bandage; limited range of movement: 21/59 [36%] with layer bandage
[18]
v 28/60 [47%] with elastic tape bandage; all reported as not significant).
The third additional RCT (86 people with grade II and III ankle sprains) compared early functional
treatment (elastic wrapping and early full weightbearing and proprioceptive training) versus conven-
[19]
tional treatment (elastic bandage and partial weightbearing until pain subsided). After 1 week,
[19]
further treatment was similar (identical rehabilitation instructions). The RCT found that early
functional treatment significantly reduced time taken to return to work and time to return to sports
(time taken to return to work: 5.6 days with early functional treatment v 10.2 days with conventional
treatment; P less than 0.05; time to return to sports: 9.6 days with early functional treatment v 19.2
days with conventional treatment; P less than 0.05). It found no significant difference between
groups in final functional outcome or in ankle sprain recurrence (reported as not significant; P value
not reported).
The fourth subsequent RCT (93 people with grade II ankle sprains) compared elastic wrap, air-
stirrup ankle brace, air-stirrup ankle brace plus elastic wrap, and cast immobilisation for 10 days.
[20]
Of these, 68/93 (73%) people completed the 6-month follow-up. Other than the difference in
device, functional treatment strategies were identical. It found no significant difference in outcomes
between groups at 6 months' follow-up.
Harms: Functional treatment versus minimal treatment:

[14] [15]
The review and subsequent RCT gave no information on harms.
Functional treatment versus immobilisation:

See harms of immobilisation, p 3 .
Functional treatment versus surgery:

[6]
The review gave no information on harms.

[21]
Allergic reactions and skin problems have been recorded with tape. Two RCTs identified by
the review, which compared different functional treatments, found that tape treatment was associ-
ated with significantly more complications compared with elastic bandage (0/104 [0%] with elastic
[16]
bandage v 8/104 [8%] with tape; RR 0.11, 95% CI 0.01 to 0.86). Most of these complications
were skin problems (absolute numbers with skin problems not reported). The four additional RCTs
[17] [18] [19] [20]
did not assess harms.
Ankle sprain
Comment: Functional treatment versus surgery:
The review noted that all included RCTs had methodological flaws, and there was insufficient evi-
[6]
dence to determine the relative effectiveness of surgical and conservative treatment.

The review reported follow-up periods for outcome measures as short term (less than 6 weeks of
[16]
treatment), intermediate term (6 weeks to 1 year), or long term (1–2 years after treatment). It
noted that definitive conclusions were hampered by the variety of treatments used and the incon-
sistency of reported follow-up times, and no definite conclusions concerning the optimal functional
[16]
treatment strategy could be drawn.
OPTION SURGERY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symptom improvement
Compared with immobilisation We don't know how surgery and immobilisation compare at reducing swelling or pain
Compared with functional treatment We don't know how surgery and functional treatment compare at reducing pain
or swelling (low-quality evidence).
Joint stability
Compared with immobilisation Surgery may be more effective at reducing objective joint instability, but we don't know
whether it is more effective at reducing subjective joint instability (low-quality evidence).
Compared with functional treatment We don't know how surgery and functional treatment compare at reducing joint
instability (low-quality evidence).

Compared with immobilisation Surgery is less effective at decreasing the time taken to return to sports (moderate-
quality evidence).
Compared with functional treatment Surgery may be no more effective at reducing the time taken to return to sports
Recurrence
Compared with immobilisation We don't know how surgery and immobilisation compare at reducing recurrence of
ankle sprains (low-quality evidence).
Compared with functional treatment We don't know how surgery and functional treatment compare at reducing recur-
rence of ankle sprains (low-quality evidence).
Adverse effects
Surgery is associated with neurological injuries, infections, bleeding, osteoarthritis, and death.
Benefits: Surgery versus immobilisation:

See benefits of immobilisation, p 3 .
Surgery versus functional treatment:

See benefits of functional treatment, p 6 .
Harms: Neurological injuries, infections, bleeding, osteoarthritis, and death are known harms of surgery.
[13] [22] [23] [24] [25] [26]
Other RCTs found dysaesthesia in 4% to 12% of people after surgery.
[27] [28] [29] [27]
Wound necrosis after surgery was reported in two RCTs (2/73 [3%] with surgery;
[28]
3/45 [7%] with surgery ). Tenderness of the scar was reported in six RCTs after surgical inter-
[25] [26] [29] [30] [31] [32]
vention, occurring in 2% to 19% of people.
Surgery versus immobilisation:

See harms of immobilisation, p 3 .
Surgery versus functional treatment:

See harms of functional treatment, p 6 .
Comment: None.

Ankle sprain
OPTION ULTRASOUND. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symptom improvement
Compared with placebo Ultrasound may be no more effective at increasing the proportion of people with general
improvement (not further defined) of an ankle sprain or at improving the ability to walk or bear weight at 7 days (low-
quality evidence).
Compared with immobilisation We don't know how ultrasound and immobilisation compare for improving recovery
times at 7 days, but ultrasound may be more effective at 14 days (very low-quality evidence).
Compared with electrotherapy We don't know how ultrasound and electrotherapy compare for improving swelling,
pain, or walking ability at 7 days (low-quality evidence).
Benefits: Ultrasound versus placebo:

We found one systematic review (search date 2004, see comment below) comparing ultrasound
[33]
versus sham ultrasound treatment. It found no significant difference in general improvement
of symptoms between ultrasound and sham ultrasound at 7 days (3 RCTs; 341 people; 121/169
[72%] with ultrasound v 116/172 [68%] with sham ultrasound; RR 1.04, 95% CI 0.92 to 1.17). It
also found no significant difference in functional disability (the ability to walk or bear weight) between
ultrasound and sham ultrasound at 7 days (2 RCTs; 187 people; 69/95 [73%] with ultrasound v
[33]
61/92 [66%] with sham ultrasound; RR 1.09, 95% CI 0.92 to 1.30).
Ultrasound versus immobilisation:

We found one systematic review (search date 2004, see comment below), which identified one
[33]
RCT that compared ultrasound versus immobilisation over 2 weeks' follow-up. It found no sig-
nificant difference in the proportion of people who recovered with ultrasound compared with immo-
bilisation after 7 days (80 people; 46% with ultrasound v 27% with immobilisation; ARR +19%, 95%
CI –2% to +40%; absolute results not reported). However, after 14 days, it found a significant dif-
ference in the proportion of people who recovered with ultrasound compared with immobilisation
(86% with ultrasound v 59% with immobilisation; ARR 27%, 95% CI 8% to 46%; absolute results
[33]
not reported).
Ultrasound versus electrotherapy:

We found one systematic review (search date 2004, see comment below) comparing ultrasound
[33]
versus other treatment modalities. One RCT identified by the review compared ultrasound
versus electrotherapy or sham ultrasound. The review found no significant difference between ul-
trasound and electrotherapy in the proportion of people with swelling, ability to walk, or who were
free of pain at 7 days (60 people; AR for less than 0.5 cm swelling: 13/20 [65%] with ultrasound v
17/20 [85%] with electrotherapy; ARR –20%, 95% CI –46% to +6%; AR for ability to walk: 9/20
[45%] with ultrasound v 14/20 [70%] with electrotherapy; ARR –25%, 95% CI –55% to +5%; AR
for freedom from pain: 15/20 [75%] with ultrasound v 18/20 [90%] with electrotherapy; ARR –15%,
[33]
95% CI –38% to +8%).
Harms: Ultrasound versus placebo:

The review reported that one RCT found 8/73 people with ultrasound therapy (plus placebo gel)
reported 11 non-serious adverse reactions including gastrointestinal effects and skin reactions. In
one person, treatment was discontinued due to skin reactions and the person withdrawn from the
[33]
trial.
Ultrasound versus immobilisation:

[33]
The review gave no information on adverse effects.
Ultrasound versus electrotherapy:

[34]
One RCT included in the review RCT found no adverse effects with ultrasound.
Comment: In the review, the quality of four of the included RCTs was described as "modest", and one as
[33]
"good". The review reported RCTs in which one or more of pain, swelling, and functional dis-
ability because of an acute ankle sprain was present, and in which at least one group was treated
with active ultrasound treatment. All the RCTs included follow-up of less than 4 weeks.
OPTION COLD TREATMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symptom improvement
Compared with placebo Cold treatment may be no more effective at relieving symptoms of ankle sprain including
pain, range of movement, or swelling, or in increasing ability to weight bear (very low-quality evidence).
© BMJ Publishing Group Ltd 2010. All rights reserved. .......................................................... 10
Ankle sprain
Compared with other treatments Cold treatment may be more effective than heat or a contrast bath at reducing
oedema at 3 to 5 days after an ankle injury (very low-quality evidence).
Benefits: Cold treatment versus placebo:

[35]
We found one systematic review (search date 1994), which identified one RCT comparing
[36]
cryotherapy versus placebo (simulated treatment). The RCT (143 people, aged 16–50 years,
79% male) found no significant difference between treatments in pain relief, range of movement,
ability to bear weight, or swelling (pain relief or range of movement: reported as not significant, no
further details reported; ability to bear weight: proportion of people who improved by 3 or 4 scale
units in the diary linear analogue: 36% with cold therapy v 29% with placebo; P = 0.15; soft-tissue
swelling: proportion of people with improvement at day 7: 46% with cold treatment v 40% with
[36]
placebo; P = 0.07).
Cold treatment versus different treatments:

[35]
We found one systematic review (search date 1994), which identified one RCT comparing three
[37]
treatments: cold pack, heat treatment, or a contrast bath (see comment below). The RCT (30
people, aged 18–22 years) found significantly less oedema with cold pack compared with heat
treatment or a contrast bath at 3 to 5 days after injury (mean change in ankle volume from pre-
treatment: +3.3 mL with cold treatment v +25.3 mL with heat treatment v +26.5 mL with contrast
[37]
bath; P less than 0.05 [cold treatment v heat treatment or contrast bath]).
Harms: Cold treatment versus placebo:

[36]
The RCT gave no information on harms from cold pack placement.
Cold treatment versus different treatments:

[37]
The RCT gave no information on harms from cold pack placement.
[35]
Comment: The systematic review was narrative in character, and no data were meta-analysed. The sys-
tematic review did not report the grades of injuries. In the RCT identified by the systematic review
that compared cold with heat or a contrast bath, the injured ankle in the contrast bath group was
submerged in warm water for 3 minutes, and then in cold water for 1 minute. This was continued
until the ankle had been given five heat and four cold treatments, beginning and ending with heat.
[37]
OPTION DIATHERMY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symptom improvement
Compared with placebo Diathermy may be no more effective at relieving symptoms of ankle sprains such as oedema
and pain, or at improving range of movements. High-frequency electromagnetic pulsing may be more effective at
improving walking ability, but low-frequency pulsing may be no more effective than placebo (very low-quality evidence).
Benefits: Diathermy versus placebo:

[35]
We found one systematic review (search date 1994, 5 RCTs), which included a range of
severity of ankle sprains, but excluded the most severe injuries (avulsion and osteochondral frac-
tures).The systematic review did not meta-analyse the results of the RCTs and the grades of injuries
were not clearly described in the identified RCTs.
The first RCT (300 people with time from injury to treatment of no more than 4 days) identified by
[38]
the review compared two forms of pulsating short-wave treatment versus placebo. The RCT
found that high-frequency electromagnetic pulsing improved walking ability significantly more
quickly than placebo (change in impairment of gait from day 1 to day 3 of treatment [scale of 0–3
where 0 = normal gait, 3 = need of crutches]: 1.0 with high frequency v 0.9 with low frequency v
0.7 with placebo; P less than 0.01 for high frequency electromagnetic pulsing v placebo). It found
that low-frequency pulsing significantly reduced swelling compared with placebo, while there was
no significant difference between the high-frequency group and placebo (reduction in circumference
of ankle: 4.5 mm with high frequency v 5.0 mm with low frequency v 2.6 mm with placebo; P less
than 0.01 for low frequency v placebo).
The second RCT (50 people with acute grade I or II sprain, within 72 hours of injury) found that
pulsating short-wave diathermy significantly reduced oedema compared with placebo (% decrease
[39]
in ankle volume: 4.7% with diathermy v 0.96% with placebo; P less than 0.01).

Ankle sprain
The third RCT (73 people) found no significant difference between treatments for pain, oedema,
or range of motion compared with placebo at 15 days (results presented graphically; pain scores
[40]
P greater than 0.35; oedema P greater than 0.35; range of motion P = 0.35).
The fourth RCT (37 people) found no significant difference between treatments in pain, elevation,
number of analgesics a day, or time to weight bearing compared with placebo (mean daily pain
score [pain scale 0 = no pain to 10 = worst pain]: 2.37 with diathermy v 2.34 with placebo; mean
elevation/day: 1.87 hours with diathermy v 1.77 hours with placebo; mean number of analgesics/day:
0.44 with diathermy v 0.29 with placebo; mean time to weight bearing: 3.78 days with diathermy v
2.88 days with placebo; all comparisons reported as not significant; P values and CIs not reported).
[41]
The fifth RCT (30 people) found no significant differences between treatments for pain, oedema,
or range of motion compared with placebo (pain scale 0 = no pain to 10 = worst pain, change in
pain score: –3.70 with ice plus high-frequency high-voltage pulsed stimulation [HVPS] v –3.65 with
ice plus low-frequency HVPS v –2.50 with ice alone; significance not reported; change in active
ankle dorsiflexion range of movement: 8° with ice plus high-frequency HVPS v 10° with ice plus
low-frequency HVPS v 7° with ice alone; reported as not significant; change in foot and ankle volume
displacement: –35 mm with ice plus high-frequency HVPS v –38 mm with ice plus low-frequency
[42]
HVPS v –32 mm with ice alone; reported as not significant).
Harms: Diathermy versus placebo:

[35]
Comment: None.
OPTION HOMEOPATHIC OINTMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symptom improvement
Compared with placebo Homeopathic ointments may be more effective at achieving a better outcome based on a
"composite criteria of treatment success" (not further defined) (very low-quality evidence).
Benefits: Homeopathic ointment versus placebo:

[43] [44]
We found one systematic review (search date 1998), which included one RCT. The review
found that people treated with a homeopathic ointment had a significantly better outcome based
on a "composite criteria of treatment success" compared with people treated with placebo (69
[43]
people with acute ankle sprains; P = 0.028; no further data reported). The number of people
initially randomised in the RCT and losses to follow-up were not reported.
Harms: Homeopathic ointment versus placebo:

[43]
Comment: None.
OPTION PHYSIOTHERAPY (PHYSICAL THERAPY). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symptom improvement
Physiotherapy plus proprioceptive training compared with physiotherapy alone Physiotherapy plus proprioceptive
training (star excursion balance training) may be more effective at improving single-leg stance times at 4 weeks (low-
quality evidence).
Recurrence
Physiotherapy plus proprioceptive training compared with physiotherapy alone We don't know whether adding
physiotherapy to proprioceptive training (star excursion balance training) is more effective than physiotherapy alone
at reducing recurrence of ankle strain at 3 months (low-quality evidence).
Benefits: Physiotherapy (physical therapy) plus proprioceptive training versus physiotherapy alone:
We found one small RCT (40 males with acute grade II ankle sprains; 32/40 [80%] completed the
programme) comparing star excursion balance training plus standard physiotherapy versus standard
[45]
physiotherapy alone. Standard physiotherapy included superficial heat, ultrasound, range-of-
[45]
motion exercise, and strengthening and stretching exercises. The star excursion balance test
is composed of closed kinetic controlled motion, and the ability to balance on one leg; this was
modified in the RCT into a proprioceptive and balance training programme. People balanced on
Ankle sprain
the sprained ankle while using the other foot to reach as far as it could in eight other directions
under direct supervision. The RCT found that star excursion balance training plus physiotherapy
significantly improved mean single-leg stance times compared with physiotherapy alone at 4 weeks
(eyes closed: 39.9 seconds with balance training plus physiotherapy v 18 seconds with standard
physiotherapy alone; P = 0.002). After 3 months' follow-up, it found no significant difference in re-
current sprains between groups (1/15 [7%] with training v 2/17 [12%] with control; reported as no
[45]
significant difference; P value not reported). The RCT did not report on other outcomes.
Harms: Physiotherapy (physical therapy) plus proprioceptive training versus physiotherapy alone:
[45]
The RCT gave no information on harms.
Comment: The method of randomisation in the RCT was not specifically defined; it noted that "simple random
[45]
sampling" was used. We have included RCTs on general physiotherapy in this option; we have
not included other specific joint manipulations (e.g., chiropractic) in this option.
GLOSSARY
Anatomic reconstruction Surgical reconstruction of lateral ankle ligament complex through suturing of the ligaments.
Crus varum Varus of the lower leg (O-leg).
Diathermy Warming body tissues using electromagnetic radiation, electric current, or ultrasonic waves for the reduction
of inflammatory response, oedema, and pain.
Dysaesthesia Decreased sensitivity of the skin for stimuli.
Functional treatment Involves dorsal and plantar flexion exercises of the ankle joint. The main differences between
functional treatment strategies are the types of external device applied for treatment. The supports can be divided
according to rigidity into elastic bandage, tape, lace-up ankle support, and semirigid ankle support. Functional
treatment may involve strapping, bracing, use of an orthosis, tubigrips, bandages, elastic bandages, and the use of
special shoes. Propriocepsis training (to enhance joint stability) may also be involved in this regimen.
Immobilisation Limiting the mobility of a joint complex to zero degrees with the use of a plaster cast or soft cast,
thus fully immobilising the ankle joint.
Pes cavo-varus Severe high arched, varus foot.
Tenodesis Surgical reconstruction of lateral ankle ligament complex using tendon graft.
Low-quality evidence 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.
Moderate-quality evidence Further research is likely to have an important impact on our confidence in the estimate
of effect and may change the estimate.
Mortise separation adjustment An adjustment technique involving special manual manipulation of the foot and
ankle.
Very low-quality evidence Any estimate of effect is very uncertain.
SUBSTANTIVE CHANGES
Functional treatment (early mobilisation with use of an external support) One RCT added, comparing three
[10]
different types of immobilisation versus functional treatment for 10 days, at 1, 3, and 9 months' follow-up. It found
that below-knee cast improved ankle function, pain, and the physical component of the SF-12 questionnaire at 1-
month follow-up, and improved ankle function, pain, activities of daily living, and ability to do sports at 3 months' follow-
up compared with functional treatment. It found that an ankle brace improved ankle function and the mental health
component of the SF-12 questionnaire at 3 months' follow-up compared with functional treatment. However, it found
no significant difference between any type of immobilisation and functional treatment for any other outcome at 1, 3,
[6]
or 9 months' follow-up. One systematic review comparing functional treatment versus surgery updated. It now
includes one RCT, previously reported separately in this Clinical Evidence review. Categorisation unchanged (Ben-
eficial).
Immobilisation One RCT added, comparing three different types of immobilisation versus functional treatment for
[10]
10 days, at 1, 3 and 9 months' follow-up. It found that below-knee cast improved ankle function, pain, and the
physical component of the SF-12 questionnaire at 1-month follow-up, and improved ankle function, pain, activities
of daily living, and ability to do sports at 3 months' follow-up compared with functional treatment. It found that an
ankle brace improved ankle function and the mental health component of the SF-12 questionnaire at 3 months' follow-
up compared with functional treatment. However, it found no significant difference between any type of immobilisation
and functional treatment for any other outcome at 1, 3, or 9 months' follow-up. One systematic review comparing
[6]
surgery versus immobilisation updated, search date update, no new evidence added. Categorisation unchanged
(Likely to be beneficial).

Ankle sprain
Surgery One systematic review comparing surgery versus functional treatment or versus immobilisation updated.
[6]
The review now includes one RCT comparing surgery versus functional treatment, previously reported separately
in this Clinical Evidence review. Categorisation unchanged (Trade-off between benefits and harms).
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Peter AA Struijs
Academic Medical Center
Amsterdam
The Netherlands
Gino MMJ Kerkhoffs

Academic Medical Center
Amsterdam
The Netherlands
Competing interests: PS and GK declare that they are the authors of some studies referenced in this review.

Ankle sprain
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a
judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and
harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices.
Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research
we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the
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Ankle sprain
TABLE GRADE evaluation of interventions for ankle sprains
Important out-
comes Symptom improvement (pain, swelling, range of motion, walking ability), Joint stability, Return to normal activities (work or sport), Recurrence, Quality of life, Adverse effects
Type
Number of studies of evi- Consis- Direct- Effect
(participants) Outcome Comparison dence Quality tency ness size GRADE Comment
at least 5 (at least Symptom improvement Immobilisation v functional 4 –2 –1 –2 0 Very low Quality points deducted for methodological flaws in one RCT
[8] [9] [10]
965) treatment (uncertainty about blinding and poor follow-up). Consistency
point deducted for different results at different end points. Di-
rectness points deducted for restricted population in one study
and uncertainty about inclusion criteria (possible inclusion of
simple distortions) in another RCT.
at least 2 (at least Joint stability Immobilisation v functional 4 0 –1 –1 0 Low Consistency point deducted for different results at different
[8] [9]
227) treatment end points. Directness point deducted for restricted population
in one study
at least 9 (at least Return to normal activi- Immobilisation v functional 4 0 –1 –1 0 Low Consistency point deducted for different results at different
[8] [9]
875) ties treatment end points. Directness point deducted for restricted population
in one study
[6]
17 (1377) Symptom improvement Immobilisation v surgery 4 –2 0 0 0 Low Quality points deducted for methodological flaws and insuffi-
cient evidence to compare effects of treatments
[6]
14 (1065) Joint stability Immobilisation v surgery 4 –2 0 0 0 Low Quality points deducted for methodological flaws and insuffi-
[6]
3 (267) Return to normal activi- Immobilisation v surgery 4 –2 0 0 +1 Moderate Quality points deducted for methodological flaws and insuffi-
ties cient evidence to compare effects of treatments. Effect-size
point added for RR less than 0.5
[6]
8 (639) Recurrence Immobilisation v surgery 4 –2 0 0 0 Low Quality points deducted for methodological flaws and insuffi-
[8]
1 (57) Symptom improvement Different forms of immobilisa- 4 –2 0 0 0 Low Quality points deducted for methodological flaws and sparse
tion v each other data
[8]
1 (57) Joint stability Different forms of immobilisa- 4 –2 0 0 0 Low Quality points deducted for methodological flaws and sparse
tion v each other data
[8]
1 (36) Return to normal activi- Different forms of immobilisa- 4 –2 0 0 0 Low Quality point deducted for methodological flaws and sparse
ties tion v each other data
[14] [15]
4 (244) Symptom improvement Functional treatment v minimal 4 –1 –1 0 0 Low Quality point deducted for incomplete reporting of results.
treatment Consistency point deducted for conflicting results
[14]
3 (214) Joint stability Functional treatment v minimal 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results
treatment
at least 5 (at least Symptom improvement Functional treatment v surgery 4 –2 0 0 0 Low Quality points deducted for methodological flaws and uncer-
[6]
469) tainty about treatment effects
at least 6 (at least Joint stability Functional treatment v surgery 4 –2 0 0 0 Low Quality points deducted for methodological flaws and uncer-
[6]
564) tainty about treatment effects
[6]
3 (293) Return to normal activi- Functional treatment v surgery 4 –2 0 0 0 Low Quality points deducted for methodological flaws and uncer-
ties tainty about treatment effects
© BMJ Publishing Group Ltd 2010. All rights reserved. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Ankle sprain
Important out-
Type
[6]
5 (421) Recurrence Functional treatment v surgery 4 –2 0 0 0 Low Quality points deducted for methodological flaws and uncer-
tainty about treatment effects
[16] [17] [18]
3 (360) Symptom improvement Different functional treatments 4 –1 –1 –1 0 Very low Quality point deducted for inconsistent follow-up times. Con-
v each other sistency point deducted for different results at different end
points. Directness point deducted for multiple interventions
in comparison
[16] [17]
2 (240) Joint stability Different functional treatments 4 –2 –1 –1 0 Very low Quality points deducted for inconsistent follow-up times and
v each other incomplete reporting. Consistency point deducted for different
results at different end points. Directness points deducted for
multiple interventions in comparison
[16] [20]
3 (243) Return to normal activi- Different functional treatments 4 –3 –1 –2 0 Very low Quality points deducted for sparse data, incomplete reporting
ties v each other of results, and inconsistent follow-up times. Consistency point
deducted for different results at different end points. Directness
points deducted for multiple interventions in comparison and
differences in grades of injuries
[20]
1 (86) Recurrence Different functional treatments 4 –2 0 –1 0 Very low Quality points deducted for sparse data and incomplete report-
v each other ing of results. Directness point deducted for multiple interven-
tions in comparison
[33]
3 (341) Symptom improvement Ultrasound v placebo 4 –1 0 –1 0 Low Quality point deducted for short follow-up. Directness point
deducted for broad outcome
[33]
1 (80) Symptom improvement Ultrasound v immobilisation 4 –3 –1 0 0 Very low Quality points deducted for sparse data, short follow-up, and
incomplete reporting of results. Consistency point deducted
for different results at different end points
[33]
1 (60) Symptom improvement Ultrasound v electrotherapy 4 –2 0 0 0 Low Quality points deducted for sparse data and short follow-up
[36]
1 (143) Symptom improvement Cold treatment v placebo 4 –2 0 –1 0 Very low Quality points deducted for sparse data and incomplete report-
ing of results. Directness point deducted for uncertainty of
grade of injuries
[37]
1 (30) Symptom improvement Cold treatment v other treat- 4 –2 0 –1 0 Very low Quality points deducted for sparse data and incomplete report-
ments ing of results. Directness point deducted for uncertainty of
grade of injuries
[38] [39] [40]
5 (490) Symptom improvement Diathermy v placebo 4 –1 –1 –2 0 Very low Quality points deducted for incomplete reporting of results.
[41] [42]
Consistency point deducted for conflicting results. Directness
point deducted for uncertainty of grade of injury and inclusion
of multiple interventions and outcomes
[43]
1 (69) Symptom improvement Homoeopathic ointment v 4 –3 0 –1 0 Very low Quality points deducted for incomplete reporting of results,
placebo sparse data, uncertainties about follow-up, and randomisation.
Directness point deducted for composite outcome
[45]
1 (32) Symptom improvement Physiotherapy plus propriocep- 4 –2 0 0 0 Low Quality points deducted for sparse data and uncertainty about
tive training v physiotherapy randomisation
© BMJ Publishing Group Ltd 2010. All rights reserved. ............................................................................................................ 17

Ankle sprain
Important out-
Type
[45]
1 (32) Recurrence Physiotherapy plus propriocep- 4 –2 0 0 0 Low Quality points deducted for sparse data and uncertainty about
tive training v physiotherapy randomisation
Type of evidence: 4 = RCT; 2 = Observational
Consistency: similarity of results across studies
Directness: generalisability of population or outcomes
Effect size: based on relative risk or odds ratio
© BMJ Publishing Group Ltd 2010. All rights reserved. ............................................................................................................ 18
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Article in Clinical Evidence · May 2010

Peter Struijs Gino Kerkhoffs

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International Consensus Meeting on Cartilage Repair of the Ankle View project

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Return to normal activities

For GRADE evaluation of interventions for ankle sprains, see table, p 16 .

Benefits: Immobilisation versus no treatment:

Immobilisation versus functional treatment:

Immobilisation versus surgery:

Immobilisation versus ultrasound:

Different forms of immobilisation versus each other:

Harms: Immobilisation versus no treatment:

Immobilisation versus functional treatment:

Immobilisation versus ultrasound:

Different forms of immobilisation:

Comment: Immobilisation versus no treatment:

Immobilisation versus functional treatment:

Immobilisation versus surgery:

OPTION FUNCTIONAL TREATMENT (EARLY MOBILISATION WITH USE OF AN EXTERNAL SUP-

Return to normal activities

For GRADE evaluation of interventions for ankle sprains, see table, p 16 .

Benefits: Functional treatment versus minimal treatment:

Functional treatment versus immobilisation:

Functional treatment versus surgery:

Different types of functional treatment versus each other:

Harms: Functional treatment versus minimal treatment:

Functional treatment versus immobilisation:

Functional treatment versus surgery:

Different types of functional treatment versus each other:

Different types of functional treatment versus each other:

Return to normal activities

For GRADE evaluation of interventions for ankle sprains, see table, p 16 .

Benefits: Surgery versus immobilisation:

Surgery versus functional treatment:

Surgery versus immobilisation:

Surgery versus functional treatment:

© BMJ Publishing Group Ltd 2010. All rights reserved. ........................................................... 9

For GRADE evaluation of interventions for ankle sprains, see table, p 16 .

Benefits: Ultrasound versus placebo:

Ultrasound versus immobilisation:

Ultrasound versus electrotherapy:

Harms: Ultrasound versus placebo:

Ultrasound versus immobilisation:

Ultrasound versus electrotherapy:

OPTION COLD TREATMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

For GRADE evaluation of interventions for ankle sprains, see table, p 16 .

Benefits: Cold treatment versus placebo:

Cold treatment versus different treatments:

Harms: Cold treatment versus placebo:

Cold treatment versus different treatments:

For GRADE evaluation of interventions for ankle sprains, see table, p 16 .

Benefits: Diathermy versus placebo:

© BMJ Publishing Group Ltd 2010. All rights reserved. .......................................................... 11

Harms: Diathermy versus placebo:

OPTION HOMEOPATHIC OINTMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

For GRADE evaluation of interventions for ankle sprains, see table, p 16 .

Benefits: Homeopathic ointment versus placebo: