Elsevier

The Lancet

Volume 373, Issue 9663, 14–20 February 2009, Pages 575-581
The Lancet

Articles
Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial

https://doi.org/10.1016/S0140-6736(09)60206-3Get rights and content

Summary

Background

Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (Aircast brace, Bledsoe boot, or 10-day below-knee cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains.

Methods

We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450.

Results

Patients who received the below-knee cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the cast compared with tubular compression bandage (mean difference 9%; 95% CI 2·4–15·0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between Aircast brace and tubular compression bandage was 8%; 95% CI 1·8–14·2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and deep-vein thrombosis (three cases).

Interpretation

A short period of immobilisation in a below-knee cast or Aircast results in faster recovery than if the patient is only given tubular compression bandage. We recommend below-knee casts because they show the widest range of benefit.

Funding

National Co-ordinating Centre for Health Technology Assessment.

Section snippets

Background

Acute ankle sprain accounts for between 3% and 5% of all UK emergency department attendances: around 1–1·5 million a year.1, 2 Most sprains are of the lateral ligament complex.2 The severity of injury is graded from I to III.3 Grade I injuries are self-limiting, with only stretching of the ligament. Grade II and III injuries are either a tear or complete rupture of the ligament complex, and are typified by inability to bear weight on the leg, and by substantial amounts of swelling.3 Incapacity,

Participants and setting

We did a multicentre randomised trial, with blinded assessment of outcome, and a 9-month follow-up period. This was a pragmatic trial, testing the provision of mechanical supports within the constraints of normal UK National Health Service (NHS) practice.

Participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across England. Patients had to be over 16 years of age (to ensure skeletal maturity, and avoid inclusion of epiphyseal

Results

The study design is shown in figure 1. 680 people were potentially eligible—ie, had severe sprains. 79 people declined to participate. The most frequent reason for refusal to participate was unwillingness to accept a below-knee cast (46), Bledsoe boot (9), tubular compression bandage (4), or Aircast brace (2), or unwillingness to participate in the research after a full explanation had been given. 584 participants were randomised. Postal questionnaires were received from 83% of randomised

Discussion

Contrary to popular clinical opinion,5 a period of immobilisation was the most effective strategy for promoting rapid recovery. This was achieved best by the application of a below-knee cast. The Aircast brace was a suitable alternative to below-knee casts. Results for the Bledsoe boot were disappointing, especially in view of the substantial additional cost of this device. Tubular compression bandage, which is currently the most commonly used of all the supports investigated,6 was,

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