Postgraduate Program in Rehabilitation Sciences, Universidade Federal do Rio Grande do Norte, Santa Cruz, Brazil.
Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.
BMJ Open. 2023 Jul 3;13(7):e069872. doi: 10.1136/bmjopen-2022-069872.
Hallux valgus (HV) is one of the most prevalent forefoot deformities, and its frequency increases with age, reaching nearly 23% in adulthood (females are usually more affected). Studies on customised insoles and orthoses for HV showed inconclusive results. There is no consensus in literature regarding the ideal insole or length of use for pain relief or functional improvement in individuals with HV. This study will assess the effects of a customised insole with retrocapital bar associated with an infracapital bar of the first metatarsal on pain and function of individuals with symptomatic HV.
This is the protocol for a blinded, sham-controlled randomised clinical trial. Eighty participants with symptomatic HV will be randomised into two groups (40 per group): customised insole or sham insole. Assessments will be performed at baseline (T0), six (T6) and 12 weeks (T12) of intervention. A follow-up will occur after 4 weeks of intervention (T16). The primary and secondary outcomes will be pain (Numerical Pain Scale) and function (Foot Function Index), respectively.
Analysis of variance with a mixed design or Friedman's test will be considered according to data distribution; post-hoc analyses will be performed using Bonferroni test. Time × group interaction and within-group and between-group differences will also be assessed. The intent-to-treat analysis will be used. A significance level of 5% and 95% s will be adopted for all statistical analyses.
This protocol was approved by the research ethics committee of the Faculty of Health Sciences of Trairi/Federal University of Rio Grande do Norte (UFRN/FACISA; opinion number 5411306). The study results will be disseminated to participants, submitted to a peer-reviewed journal and presented in scientific meetings.
NCT05408156.
拇外翻（HV）是最常见的前足畸形之一，其发病率随着年龄的增长而增加，在成年人中接近 23%（女性通常受影响更大）。针对 HV 的定制鞋垫和矫形器的研究结果尚无定论。对于 HV 患者，缓解疼痛或改善功能的理想鞋垫或使用时间长度，文献中尚无共识。本研究将评估带有跟骨后支的定制鞋垫与第一跖骨下支联合使用对有症状的 HV 患者的疼痛和功能的影响。
这是一项盲法、假对照随机临床试验的方案。将 80 名有症状的 HV 患者随机分为两组（每组 40 名）：定制鞋垫或假鞋垫。将在基线（T0）、干预 6 周（T6）和 12 周（T12）进行评估。干预后 4 周（T16）将进行随访。主要和次要结局将分别是疼痛（数字疼痛量表）和功能（足功能指数）。
根据数据分布，将考虑使用混合设计的方差分析或 Friedman 检验；将使用 Bonferroni 检验进行事后分析。还将评估时间×组交互作用以及组内和组间差异。将使用意向治疗分析。所有统计分析均采用 5%和 95%置信区间。
本方案已获得特雷里大学健康科学学院（UFRN/FACISA；意见号 5411306）的研究伦理委员会批准。研究结果将向参与者传播，提交给同行评议的期刊，并在科学会议上展示。
NCT05408156。
