Munteanu Shannon E, Landorf Karl B, McClelland Jodie A, Roddy Edward, Cicuttini Flavia M, Shiell Alan, Auhl Maria, Allan Jamie J, Buldt Andrew K, Menz Hylton B
Discipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia.
La Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia.
Trials. 2017 Apr 27;18(1):198. doi: 10.1186/s13063-017-1936-1.
This article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoarthritis (OA).
Ninety participants with first MTPJ OA will be randomised to receive full-length shoe-stiffening insert(s) (Carbon Fibre Spring Plate, Paris Orthotics, Vancouver, BC, Canada) plus rehabilitation therapy or sham shoe insert(s) plus rehabilitation therapy. Outcome measures will be obtained at baseline, 4, 12, 24 and 52 weeks; the primary endpoint for assessing effectiveness being 12 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include the function domain of the FHSQ, severity of first MTPJ pain (using a 100-mm Visual Analogue Scale), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 and EuroQol (EQ-5D-5L™) questionnaires), use of rescue medication and co-interventions, self-reported adverse events and physical activity levels (using the Incidental and Planned Activity Questionnaire). Data will be analysed using the intention-to-treat principle. Economic analysis (cost-effectiveness and cost-utility) will also be performed. In addition, the kinematic effects of the interventions will be examined at 1 week using a three-dimensional motion analysis system and multisegment foot model.
This study will determine whether shoe-stiffening inserts are a cost-effective intervention for relieving pain associated with first MTPJ OA. The biomechanical analysis will provide useful insights into the mechanism of action of the shoe-stiffening inserts.
Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000552482 . Registered on 28 April 2016.
本文描述了一项平行组、参与者和评估者双盲的随机对照试验的设计，该试验比较了用于减轻与第一跖趾关节（MTPJ）骨关节炎（OA）相关疼痛的鞋用加固鞋垫与假鞋垫的有效性。
90名患有第一跖趾关节OA的参与者将被随机分组，分别接受全长鞋用加固鞋垫（碳纤维弹簧板，加拿大不列颠哥伦比亚省温哥华市巴黎矫形器公司）加康复治疗，或假鞋垫加康复治疗。在基线、4周、12周、24周和52周时获取结果测量数据；评估有效性的主要终点为12周。主要结果测量指标将是足部健康状况问卷（FHSQ）中的足部疼痛领域。次要结果测量指标将包括FHSQ的功能领域、第一跖趾关节疼痛的严重程度（使用100毫米视觉模拟量表）、症状的总体变化（使用15点李克特量表）、健康状况（使用简短健康调查问卷12®第2.0版和欧洲生活质量量表（EQ - 5D - 5L™）问卷）、急救药物和联合干预措施的使用情况、自我报告的不良事件以及身体活动水平（使用偶然和计划活动问卷）。将采用意向性分析原则对数据进行分析。还将进行经济分析（成本效益和成本效用）。此外，将在1周时使用三维运动分析系统和多节段足部模型检查干预措施的运动学效果。
本研究将确定鞋用加固鞋垫是否是一种减轻与第一跖趾关节OA相关疼痛的具有成本效益的干预措施。生物力学分析将为鞋用加固鞋垫的作用机制提供有用的见解。
澳大利亚新西兰临床试验注册中心，标识符：ACTRN12616000552482。于2016年4月28日注册。
