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Abstract
BackgroundThe optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast® brace and Bledsoe® boot) in comparison to Tubigrip®, and (2) to compare the cost of each strategy, including subsequent health care costs.Methods/designSix hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions.DiscussionThis paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.
Highlights
The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear
To aid mobilisation the use of mechanical supports has been suggested. These supports vary in the amount of ankle movement they allow, but all encourage ankle flexion/ extension and aim to minimise inversion/eversion that theoretically reduces the risk of further ligament injury
We have described the protocol and conduct of a large scale UK randomised controlled trial of mechanical supports for the management of acute severe ankle sprains
Summary
Avoidance of residual symptoms including recurrent instability, lasting limitation of physical activity, and need for further medical, rehabilitation or surgical treatment. The focus of this trial is Grade II and III sprains (referred to as severe sprains from this point). To aid mobilisation the use of mechanical supports has been suggested These supports vary in the amount of ankle movement they allow, but all encourage ankle flexion/ extension and aim to minimise inversion/eversion that theoretically reduces the risk of further ligament injury. Other hypothesised benefits of mechanical supports are early restoration of functional mobility, rapid return to usual activities, reduction of pain because the joint is stabilised and protected, and improved quality of life. There is a range of lightweight mechanical supports available, and we have selected the Aircast® Brace
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