Ankles back in randomized controlled trial (ABrCt): braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial

BACKGROUND: Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training) against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. METHODS/DESIGN: This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. DISCUSSION: The ABrCt is the first randomized controlled trial to directly compare the secondary preventive effect of the combined use of braces and neuromuscular training, against the use of either braces or neuromuscular training as separate secondary preventive measures. This study expects to identify the most effective and cost-efficient secondary preventive measure for ankle sprains. The study results could lead to changes in the clinical guidelines on the prevention of ankle sprains, and they will become available in 2012. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2157