Tan Jade M, Menz Hylton B, Crossley Kay M, Munteanu Shannon E, Hart Harvi F, Middleton Kane J, Smith Anne J, Collins Natalie J
1Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, 3086 Australia.
2La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, 3086 Australia.
Pilot Feasibility Stud. 2019 Jul 11;5:90. doi: 10.1186/s40814-019-0469-7. eCollection 2019.
Foot orthoses have the potential to be an efficacious treatment for patellofemoral osteoarthritis (PFOA) but have not been evaluated in clinical trials in this population. This study aimed to determine the: (i) feasibility of conducting a randomised controlled trial (RCT) investigating the efficacy of foot orthoses in individuals with PFOA; and (ii) effects of foot orthoses versus flat shoe inserts on pain, function, and knee-related quality of life (QOL).
This 6-week, single-blinded pilot RCT randomly allocated participants with PFOA to receive foot orthoses or flat inserts. The primary outcome of feasibility was determined via the following parameters: one participant recruited per week, 20% (35 h/week) adherence to the intervention, 50% log book completion rate, and < 20% drop-out, with results reported using descriptive statistics. Secondary outcomes included average and maximum pain severity (100 mm visual analogue scale), Anterior Knee Pain Scale, and Knee injury and Osteoarthritis Outcome Score, analysed using analysis of covariance.
Twenty-six participants (16 women; mean (SD) age of 60 (8) years) with PFOA were recruited. All feasibility parameters were exceeded, with three participants recruited per week, > 20% (37.2 [9.8] hours/week) adherence to the intervention, 69.2% (18/26) log-book completion, and 3.8% (1/26) drop-outs. The most common adverse events were arch irritation and shoe fit issues, which were more common in the foot orthoses group (67.9% 32.1%). There was a trend for the foot orthoses group to report larger improvements in average and maximum pain than the flat insert group, with the mean difference for maximum knee pain severity (21.9 mm, 95% CI - 2.1 to 46.0) exceeding the minimal clinically important difference (15 mm). The estimated sample size for a full-scale RCT is 160 participants. Suggestions to improve study design include a greater number of face-to-face follow-up appointments, a larger variety of foot orthoses to reduce rates of adverse events, and increasing follow-up time to determine long-term efficacy.
This study supports the feasibility of a full-scale RCT to determine the efficacy of foot orthoses flat inserts in individuals with PFOA.
The trial protocol was retrospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR number: 12616001287426).
足部矫形器有可能成为治疗髌股关节骨关节炎（PFOA）的有效方法，但尚未在该人群中进行临床试验评估。本研究旨在确定：（i）开展一项随机对照试验（RCT）以研究足部矫形器对PFOA患者疗效的可行性；（ii）足部矫形器与平底鞋垫对疼痛、功能及膝关节相关生活质量（QOL）的影响。
这项为期6周的单盲试验性RCT将PFOA患者随机分配，分别接受足部矫形器或平底鞋垫。可行性的主要结果通过以下参数确定：每周招募1名参与者、干预依从性达20%（每周35小时）、日志完成率达50%以及退出率<20%，结果采用描述性统计报告。次要结果包括平均和最大疼痛严重程度（100毫米视觉模拟量表）、膝前疼痛量表以及膝关节损伤和骨关节炎转归评分，采用协方差分析进行分析。
招募了26名PFOA患者（16名女性；平均（标准差）年龄60（8）岁）。所有可行性参数均被超越，每周招募3名参与者、干预依从性>20%（每周37.2[9.8]小时）、日志完成率69.2%（18/26）以及退出率3.8%（1/26）。最常见的不良事件是足弓刺激和鞋子合脚问题，在足部矫形器组更常见（67.9%对32.1%）。足部矫形器组在平均和最大疼痛方面的改善有高于平底鞋垫组的趋势，最大膝关节疼痛严重程度的平均差异（21.9毫米，95%CI -2.1至46.0）超过最小临床重要差异（15毫米）。一项全面RCT的估计样本量为160名参与者。对改进研究设计的建议包括增加面对面随访预约次数、提供更多种类的足部矫形器以降低不良事件发生率以及延长随访时间以确定长期疗效。
本研究支持开展一项全面RCT以确定足部矫形器与平底鞋垫对PFOA患者疗效的可行性。
试验方案已在澳大利亚和新西兰临床试验注册中心进行回顾性注册（ANZCTR编号：12616001287426）。
