Importance Individually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear. Objective To assess the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up. Design, Setting, and Participants Randomized clinical trial conducted at a Swiss university hospital. Participants (N = 220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017. The last participant visit occurred on August 15, 2017. Interventions Participants were randomized to biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n = 111) or to control footwear (n = 109) that had visible outsole pods that were not adjustable and did not create a convex walking surface. Main Outcomes and Measures The primary outcome was knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms). The secondary outcomes included WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms) at 24 weeks of follow-up, and serious adverse events. Results Among the 220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up. At 24 weeks of follow-up, the mean standardized WOMAC pain subscore improved from 4.3 to 1.3 in the biomechanical footwear group and from 4.0 to 2.6 in the control footwear group (between-group difference in scores at 24 weeks of follow-up, -1.3 [95% CI, -1.8 to -0.9]; P < .001). The results were consistent for WOMAC physical function subscore (between-group difference, -1.1 [95% CI, -1.5 to -0.7]), WOMAC stiffness subscore (between-group difference, -1.4 [95% CI, -1.9 to -0.9]), and WOMAC global score (between-group difference, -1.2 [95% CI, -1.6 to -0.8]) at 24 weeks of follow-up. Three serious adverse events occurred in the biomechanical footwear group compared with 9 in the control footwear group (2.7% vs 8.3%, respectively); none were related to treatment. Conclusions and Relevance Among participants with knee pain from osteoarthritis, use of biomechanical footwear compared with control footwear resulted in an improvement in pain at 24 weeks of follow-up that was statistically significant but of uncertain clinical importance. Further research would be needed to assess long-term efficacy and safety, as well as replication, before reaching conclusions about the clinical value of this device. Trial Registration ClinicalTrials.gov Identifier: NCT02363712.

中文翻译：

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生物力学鞋对膝骨关节炎患者膝关节疼痛的影响

重要性 单独校准的生物力学鞋类疗法可以改善有症状的膝骨关节炎患者的疼痛和身体功能，但这种疗法的好处尚不清楚。目的 在 24 周的随访中评估生物力学鞋类疗法与对照鞋类疗法的效果。设计、设置和参与者 在瑞士一家大学医院进行的随机临床试验。2015 年 4 月 20 日至 2017 年 1 月 10 日期间招募了有症状且经放射学证实患有膝骨关节炎的参与者 (N = 220)。最后一次参与者访视发生在 2017 年 8 月 15 日。 干预措施 参与者被随机分配到生物力学鞋类，涉及可单独调节的鞋子连接到外底的外部凸形吊舱 (n = 111) 或用于控制鞋类 (n = 109)，这些鞋具有不可调节的可见外底吊舱，并且不会形成凸形行走表面。主要结果和措施 主要结果是随访 24 周时的膝盖疼痛，使用西安大略大学和麦克马斯特大学骨关节炎指数 (WOMAC) 疼痛子评分标准化，范围从 0（无症状）到 10（极端症状）。次要结局包括 WOMAC 身体功能和僵硬分项评分以及 WOMAC 总体评分，随访 24 周时评分范围从 0（无症状）到 10（极端症状），以及严重不良事件。结果 在 220 名随机参与者（平均年龄，65.2 岁 [SD，9.3 岁]；104 名女性 [47.3%]）中，219 名接受了分配的治疗，213 名（96.8%）完成了随访。随访 24 周时，生物力学鞋组的平均标准化 WOMAC 疼痛子评分从 4.3 改善至 1.3，对照鞋组从 4.0 改善至 2.6（随访 24 周时组间评分差异，- 1.3 [95% CI，-1.8 至 -0.9]；P < .001）。WOMAC 身体功能子评分（组间差异，-1.1 [95% CI，-1.5 至 -0.7]）、WOMAC 硬度子评分（组间差异，-1.4 [95% CI，-1.9 至 -]）的结果一致0.9]），以及 24 周随访时的 WOMAC 总体评分（组间差异，-1.2 [95% CI，-1.6 至 -0.8]）。生物力学鞋组发生了 3 起严重不良事件，而对照鞋组发生了 9 起（分别为 2.7% 和 8.3%）；没有一个与治疗有关。结论和相关性 在患有骨关节炎膝盖疼痛的参与者中，与对照鞋相比，使用生物力学鞋在 24 周的随访中改善了疼痛，具有统计学意义，但临床重要性不确定。在得出有关该设备的临床价值的结论之前，需要进一步研究来评估长期疗效和安全性以及复制性。试验注册 ClinicalTrials.gov 标识符：NCT02363712。