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

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.