Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.
Department of Podiatry, Monash Health, Melbourne, Victoria, Australia.
J Foot Ankle Res. 2024 Sep;17(3):e70000. doi: 10.1002/jfa2.70000.
Midfoot osteoarthritis (OA) is a painful and disabling condition. Arch contouring foot orthoses have been recommended for midfoot OA, yet there is no high-quality evidence from randomised controlled trials to support their use. This clinical trial aims to evaluate the efficacy of arch contouring foot orthoses for midfoot OA.
This will be a parallel-group randomised controlled superiority trial. One-hundred and forty community-dwelling people with painful midfoot OA will be randomised to receive either arch contouring foot orthoses or flat sham inserts. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks; the primary endpoint for assessing efficacy being 12 weeks. The primary outcome measure will be average midfoot pain whilst walking over the last 7 days on an 11-point numerical rating scale. Secondary outcome measures include function (walking/standing subscale of the Manchester-Oxford Foot Questionnaire), participants' perception of overall treatment effect (self-reported global rating of change on a 15-point Likert scale), physical activity (Incidental and Planned Exercise Questionnaire), general health-related quality of life (Short Form-12 Version® 2.0), use of co-interventions and adverse events.
This trial will evaluate the efficacy of arch contouring foot orthoses for relieving pain and improving function, physical activity and health-related quality of life in people with midfoot OA. The findings will provide high-quality evidence as to whether arch contouring foot orthoses are efficacious and will help to inform clinical guidelines about the use of foot orthoses for midfoot OA.
Australian and New Zealand Clinical Trial Registry (ACTRN12623000953639).
中足骨关节炎（OA）是一种疼痛和致残的疾病。拱形轮廓足部矫形器已被推荐用于中足 OA，但随机对照试验没有高质量的证据支持其使用。本临床试验旨在评估拱形轮廓足部矫形器对中足 OA 的疗效。
这将是一项平行组随机对照优效性试验。将 140 名患有疼痛性中足 OA 的社区居民随机分为接受拱形轮廓足部矫形器或平 sham 插入组。在基线、4、8 和 12 周时进行结果测量；评估疗效的主要终点是 12 周。主要结局测量指标为 11 点数字评分量表上过去 7 天行走时的平均中足疼痛。次要结局指标包括功能（曼彻斯特-牛津足部问卷的行走/站立子量表）、参与者对整体治疗效果的感知（15 点 Likert 量表的自我报告整体变化评分）、身体活动（偶然和计划锻炼问卷）、一般健康相关生活质量（简短形式 12 版本®2.0）、共干预措施的使用和不良事件。
本试验将评估拱形轮廓足部矫形器缓解中足 OA 患者疼痛、改善功能、身体活动和健康相关生活质量的疗效。研究结果将提供高质量的证据，证明拱形轮廓足部矫形器是否有效，并有助于为中足 OA 的足部矫形器使用提供临床指南。
澳大利亚和新西兰临床试验注册中心（ACTRN12623000953639）。
