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 生物力学鞋可明显改进膝骨关节炎患者的膝关节痛苦

生物力学鞋可明显改进膝骨关节炎患者的膝关节痛苦

2020-05-19

来历:小柯机器人

作者:

加拿大圣迈克尔医院Peter Jüni联合瑞士伯尔尼大学Stephan Reichenbach近期获得新进展。他们探讨了生物力学鞋对膝骨关节炎患者膝关节痛苦的影响。该作用宣布在2020年5月12日出书的《美国医学会杂志》上。

关于有症状的膝关节骨性关节炎患者,独自纠正生物力学鞋类医治可能会改进痛苦和身体机能,但这种医治的好处尚不清楚。

为了点评生物力学鞋医治与对照鞋医治的作用,研讨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、经印象证明的膝骨关节炎患者。将其随机分为两组,其间111例穿生物力学鞋医治,鞋的外底附有可独自调理的外凸垫;109例穿对照鞋,外底不行调理,且不构成凸面。

随访24周时,选用西安大概和麦克马斯特大学骨关节炎指数(WOMAC)中痛苦、身体机能和僵硬度的子中心评分以及全体评分对膝骨关节炎的病况进行点评,0-10分,分数越高病况越严峻。

220名参与者的均匀年龄为65.2岁,女人占47.3%,共有213人(96.8%)完成了终究随访。在24周的随访中,生物力学鞋组的均匀标准化WOMAC痛苦子中心评分从4.3分改进至1.3分,而对照鞋组则从4.0分改进至2.6分,组间差异明显。生物力学鞋组的均匀标准化WOMAC身体机能子中心评分、僵硬度子中心评分和全体评分均明显低于对照鞋组。生物力学鞋组发作3例(2.7%)严峻不良事情,对照鞋组发作9例(8.3%),但均与医治无关。

总归,关于骨关节炎膝关节痛苦的参与者,运用生物力学鞋与对照鞋比较,在24周的随访中可明显改进痛苦,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.


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