Paterson Kade L, Bennell Kim L, Metcalf Ben R, Campbell Penny K, Kasza Jessica, Wrigley Tim V, Hinman Rana S
Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia.
School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
BMC Musculoskelet Disord. 2020 Apr 15;21(1):247. doi: 10.1186/s12891-020-03275-5.
Structural features of lateral tibiofemoral (TF) joint osteoarthritis (OA) occur in up to half of all people with knee OA, and co-existing lateral TF OA is associated with worse knee pain in people with mixed compartmental knee OA. Clinical guidelines for management of knee OA advocate advice about appropriate footwear, yet there is no research evaluating which types of footwear are best for managing pain associated with lateral TF OA. Biomechanical evidence suggests that "motion-control" footwear, which possess midsoles that are stiffer medially compared to laterally, may shift load away from the lateral compartment of the knee and thus may reduce knee pain associated with lateral TF OA. The primary aim of this study is to compare the effects of motion-control shoes to neutral shoes on knee pain in people with predominantly lateral TF OA.
This will be an assessor- and participant-blinded, two-arm, comparative effectiveness randomized controlled trial (RCT) conducted in Melbourne, Australia. We will recruit a minimum of 92 people with painful lateral TF OA from the community. Participants will be randomly allocated to receive either motion-control shoes or neutral shoes and will be instructed to wear their allocated shoes for a minimum of 6 h per day for 6 months. The primary outcome is change in self-reported knee pain on walking, measured using a numerical rating scale, assessed at baseline and 6 months. Secondary outcomes include other measures of knee pain, physical function, quality of life, participant-perceived change in pain and function, and physical activity levels.
This study will compare the efficacy of motion-control shoes to neutral shoes for people with painful lateral TF OA. Findings will be the first to provide evidence of the effects of footwear on knee pain in this important subgroup of people with knee OA and allow clinicians to provide accurate advice about the most appropriate footwear for managing pain associated with lateral TF OA.
This trial has been prospectively registered by the Australian New Zealand Clinical Trials Registry on 15/11/2018 (reference: ACTRN12618001864213).
在所有膝关节骨关节炎（OA）患者中，高达一半的人存在胫股（TF）外侧关节骨关节炎的结构特征，并且并存的TF外侧骨关节炎与混合性膝关节间室OA患者更严重的膝关节疼痛相关。膝关节OA管理的临床指南提倡就合适的鞋类提供建议，但尚无研究评估哪种类型的鞋类最适合管理与TF外侧OA相关的疼痛。生物力学证据表明，“运动控制”鞋类的中底内侧比外侧更硬，可能会将负荷从膝关节外侧间室转移开，从而可能减轻与TF外侧OA相关的膝关节疼痛。本研究的主要目的是比较运动控制鞋与中性鞋对以TF外侧OA为主的患者膝关节疼痛的影响。
这将是一项在澳大利亚墨尔本进行的、评估者和参与者双盲、双臂、比较有效性随机对照试验（RCT）。我们将从社区招募至少92名患有疼痛性TF外侧OA的患者。参与者将被随机分配接受运动控制鞋或中性鞋，并被指示每天至少穿6小时分配的鞋子，持续6个月。主要结局是使用数字评分量表测量的步行时自我报告的膝关节疼痛变化，在基线和6个月时进行评估。次要结局包括膝关节疼痛的其他测量指标、身体功能、生活质量、参与者感知的疼痛和功能变化以及身体活动水平。
本研究将比较运动控制鞋与中性鞋对患有疼痛性TF外侧OA患者的疗效。研究结果将首次提供鞋类对这一重要膝关节OA亚组患者膝关节疼痛影响的证据，并使临床医生能够就管理与TF外侧OA相关疼痛的最合适鞋类提供准确建议。
本试验已由澳大利亚新西兰临床试验注册中心于2018年11月15日进行前瞻性注册（注册号：ACTRN12618001864213）。
