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

研究概要

One hundred thirteen children with mild ankle sprains were randomized to receive either non-restraint management (n=62) or a standardized functional ankle bandage applied for 5 days plus the same general measures (n=51). The primary outcomes of interest were ankle function measured by the Oxford Ankle Foot Questionnaire for Children (OXAFQ-C) and pain intensity on a 0–10 scale at 5 days, with non-inferiority margins of −10 OXAFQ-C points and −2 pain points. Secondary outcomes included presence and severity of pain at 5, 14, and 30 days, days of ibuprofen use, crutch use and days on crutches, recurrence of symptoms, adverse effects of the bandage, and satisfaction with care, treatment, and recovery. Outcomes were assessed via structured follow-up at 5, 14, and 30 days after injury. Overall, the results of the study revealed that non-restraint was non-inferior to bandaging for ankle function and pain at all time points, with similar OXAFQ-C scores and pain scores by 14 and 30 days, but with fewer patients requiring crutches (23.9% vs 51.2%, p=0.0084) and substantially fewer bandage-related adverse effects in the non-restraint group. These findings suggest that routine bandaging may be unnecessary for mild pediatric ankle sprains, as simple non-restraint management achieves comparable recovery with fewer device-related problems and similar satisfaction.