加拿大圣迈克尔医院Peter Jüni联合瑞士伯尔尼大学Stephan Reichenbach近期取得新进展。他们探讨了生物力学鞋对膝骨关节炎患者膝关节疼痛的影响。该成果发表在2020年5月12日出版的《美国医学会杂志》上。

对于有症状的膝关节骨性关节炎患者，单独矫正生物力学鞋类治疗可能会改善疼痛和身体机能，但这种治疗的益处尚不清楚。

为了评估生物力学鞋治疗与对照鞋治疗的效果，研究组在瑞士的一家大学医院进行了一项随机临床试验。2015年4月20日至2017年1月10日，他们招募了220例有症状的、经影像证实的膝骨关节炎患者。将其随机分为两组，其中111例穿生物力学鞋治疗，鞋的外底附有可单独调节的外凸垫；109例穿对照鞋，外底不可调节，且不形成凸面。

随访24周时，采用西安大略和麦克马斯特大学骨关节炎指数（WOMAC）中疼痛、身体机能和僵硬度的子核心评分以及整体评分对膝骨关节炎的病情进行评估，0-10分，分数越高病情越严重。

220名参与者的平均年龄为65.2岁，女性占47.3%，共有213人（96.8%）完成了最终随访。在24周的随访中，生物力学鞋组的平均标准化WOMAC疼痛子核心评分从4.3分改善至1.3分，而对照鞋组则从4.0分改善至2.6分，组间差异显著。生物力学鞋组的平均标准化WOMAC身体机能子核心评分、僵硬度子核心评分和整体评分均显著低于对照鞋组。生物力学鞋组发生3例（2.7%）严重不良事件，对照鞋组发生9例（8.3%），但均与治疗无关。

总之，对于骨关节炎膝关节疼痛的参与者，使用生物力学鞋与对照鞋相比，在24周的随访中可显著改善疼痛，但临床重要性不确定。

附：英文原文

Title: Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial

Author: Stephan Reichenbach, David T. Felson, Cesar A. Hincapié, Sarah Heldner, Lukas Bütikofer, Armando Lenz, Bruno R. da Costa, Harald M. Bonel, Richard K. Jones, Gillian A. Hawker, Peter Jüni

Issue&Volume: 2020/05/12

Abstract: 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.