Suarez-Cabezas Sara, Perez-Moneo Begoña, Cabrerizo Ortiz Maria, Hortigüela Aparicio Monica, Gómez Gérez Carmen, Molanes-López Elisa M, Larrainzar-Garijo Ricardo, Vazquez Lopez Paula
Servicio de Pediatría, Hospital Universitario Infanta Leonor, Madrid, Spain.
Departamento de Salud Pública y Materno-Infantil, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
Eur J Pediatr. 2024 Dec 7;184(1):70. doi: 10.1007/s00431-024-05904-w.
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.
踝关节扭伤在儿童群体中是常见的损伤，但目前的文献对于最佳治疗策略尚未达成共识。本研究旨在比较非约束性治疗与包扎对轻度踝关节扭伤儿童的有效性，重点关注功能恢复和疼痛管理。在一家儿科急诊服务机构进行了一项单中心、开放标签、非劣效性随机临床试验。纳入年龄在5至16岁的轻度踝关节扭伤患者。参与者按1:1的比例随机分组，分别接受标准化功能性绷带包扎或仅采取非约束性的一般措施。主要终点为出院后第5天OXAFQ-C评分相差10分以及疼痛强度相差2分。共有113名参与者被随机分配接受功能性绷带包扎（n = 51）或非约束性措施（n = 62）。在第5天，非约束组的OXAFQ-C评分为76.59（标准差15.51），约束组为69.71（标准差15.24），平均差值为6.295（90%CI -0.058至12.647）。疼痛强度的平均差值为0.048（90%CI -0.741至0.838）。在第14天和30天，OXAFQ-C评分或疼痛强度均未观察到差异。结论：这项单中心随机临床试验表明，对于轻度踝关节扭伤的儿科患者，在功能恢复和短期至中期疼痛管理方面，非约束性治疗不劣于包扎治疗。该治疗在患者中接受度很高，且未报告不良反应。试验注册：于2024年1月在clinicaltrials.org上进行回顾性注册，标识符为：NCT06189625。已知信息：• 目前的文献对于踝关节扭伤的最佳管理尚未达成共识，没有证据支持非约束性方法。指南建议进行固定，尽管关于不同约束系统的比较数据不足。一些研究似乎表明早期活动可能会带来更好的结果。新发现：• 本研究通过证明在儿科踝关节扭伤中非约束性治疗与包扎相比的非劣效性，提供了新的证据。它突出了无约束早期活动的安全性和有效性，表明标准管理实践可能发生转变。
