Non-restraint in pediatric ankle sprain: a non-inferiority randomized clinical trial.

Abstract

Ankle sprains are common injuries in pediatric populations, yet current literature lacks consensus on optimal management strategies. This study aimed to compare the effectiveness of non-restraint treatment versus bandaging in children with mild ankle sprains, focusing on functional recovery and pain management.A single-center, open-label, non-inferiority randomized clinical trial was conducted at a pediatric emergency service. Patients aged 5-16 years with mild ankle sprains were included. Participants were randomized in a 1:1 ratio to receive either a standardized functional bandage or only general measures with non-restraint. The primary endpoints were a 10-point difference in the OXAFQ-C and a 2-point difference in pain intensity at day 5 after discharge. A total of 113 participants were randomly assigned to receive a functional bandage (n = 51) or non-restraint measures (n = 62). At day 5, the OXAFQ-C score in the non-restraint group was 76.59 (SD 15.51) and 69.71 (SD 15.24) in the restraint group, with a mean difference of 6.295 (90% CI - 0.058 to 12.647). The mean difference in pain intensity was 0.048 (90% CI - 0.741 to 0.838). No differences were observed in the OXAFQ-C scores or pain intensity at 14 and 30 days. Conclusions: This single-center, randomized clinical trial demonstrates that non-restraint is non-inferior to bandaging for functional recovery and short- to medium-term pain management in pediatric patients with mild ankle sprains. The treatment was very well accepted among patients and no adverse effects were reported.Trial registration: Retrospectively registered in January 2024 on clinicaltrials.org with identifier: NCT06189625. What is Known • Current literature lacks consensus on optimal ankle sprain management, with no evidence supporting non-restraint approaches. Guidelines recommend immobilization despite insufficient comparative data on different restraint systems. Some studies seem to demonstrate that early mobilization may offer better outcomes. What is New • This study contributes novel evidence by demonstrating the non-inferiority of non-restraint treatment compared to bandaging in pediatric ankle sprains. It highlights the safety and efficacy of early mobilization without restraint, suggesting a potential shift in standard management practices.