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半月板撕裂和膝关节骨关节炎患者的物理治疗与糖皮质激素注射:一项多中心、随机、对照试验

Physical therapy vs. glucocorticoid injection in patients with meniscal tears and knee osteoarthritis: a multi-center, randomized, controlled trial.

作者信息

Lee Mingzhu, Jing Chao, Lee Kainan

机构信息

Sichuan Taikang Hospital, No. 881 Xianghe 1 Street, Huayang Community, Tianfu New Area, Chengdu, Sichuan, People's Republic of China.

The Sports Science Research Institute of Hebei Province, Shijiazhuang, China.

出版信息

BMC Med. 2025 May 9;23(1):277. doi: 10.1186/s12916-025-04113-y.

DOI:10.1186/s12916-025-04113-y
PMID:40346599
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12065295/
Abstract

BACKGROUND

Physical therapy is commonly recommended for treating meniscus tears and knee osteoarthritis (KOA). However, data from randomized trials that compare the effectiveness of this treatment with that of glucocorticoid injections are lacking.

METHODS

This randomized, single-blind, multicenter trial included 273 patients with KOA who were divided into either the physical therapy group (n = 133) or the glucocorticoid injection group (n = 140). The physical therapy included kinesiology tape, exercise protocols, and exercise training programs to increase core stability and periprosthetic muscle strength. The primary endpoint was the overall Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 1 year. Additionally, proprioception and safety were assessed. All analyses were performed with the use of the intention-to-treat approach. The data are reported as percentages (%) (n), and the threshold for statistical significance was p < 0.05.

RESULTS

There was no significant difference in the baseline characteristics between the two groups (p > 0.05). The average (± SD) WOMAC score at 1-year was 76.85 ± 2.50 in the physiotherapy group. And 99.55 ± 2.09 in the glucocorticoid injection group (mean difference = - 22.70; 95% confidence interval [95% CI] - 23.43 to - 21.96; p < 0.001). Compared with the glucocorticoid injection group, the physical therapy group exhibited superior performance in terms of proprioception, especially in the eyes-closed in situ stepping test (14.27 ± 0.75 versus 5.98 ± 0.74; mean difference = 8.29; 95% CI 8.09-8.50; p < 0.001). The incidence of serious adverse events at the 1-year follow-up was comparable between the two groups. Most of these events were determined to be complications arising from physical therapy and glucocorticoid injection.

CONCLUSIONS

The results revealed that pain, quality of life, and balance were greater in the physiotherapy group than in the glucocorticoid injection group within the 1-year study period. However, the long-term effects beyond this timeframe remain unknown, and future studies with extended follow-up times are needed to confirm the sustainability of these benefits.

TRIAL REGISTRATION

The protocol was approved by the local ethics committee of the ethical commission of the Hebei Sports Science Research Institute (SEC20200213019) and Ethics Committee of Sichuan Taikang Hospital (SCTK-IRB-032). The study was registered at the Chinese Clinical Trial Registry (ChiCTR2000032508).

摘要

背景

物理治疗通常被推荐用于治疗半月板撕裂和膝关节骨关节炎(KOA)。然而,缺乏将这种治疗方法与糖皮质激素注射的有效性进行比较的随机试验数据。

方法

这项随机、单盲、多中心试验纳入了273例KOA患者,他们被分为物理治疗组(n = 133)或糖皮质激素注射组(n = 140)。物理治疗包括肌内效贴布、运动方案以及旨在增强核心稳定性和假体周围肌肉力量的运动训练计划。主要终点是1年时的总体西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分。此外,还评估了本体感觉和安全性。所有分析均采用意向性分析方法。数据以百分比(%)(n)形式报告,统计学显著性阈值为p < 0.05。

结果

两组之间的基线特征无显著差异(p > 0.05)。物理治疗组1年时的平均(±标准差)WOMAC评分为76.85 ± 2.50。糖皮质激素注射组为99.55 ± 2.09(平均差值 = -22.70;95%置信区间[95%CI] -23.43至-21.96;p < 0.001)。与糖皮质激素注射组相比,物理治疗组在本体感觉方面表现更优,尤其是在闭眼原地踏步试验中(14.27 ± 0.75对5.98 ± 0.74;平均差值 = 8.29;95%CI 8.09 - 8.50;p < 0.001)。两组在1年随访时严重不良事件的发生率相当。这些事件大多被确定为物理治疗和糖皮质激素注射引起的并发症。

结论

结果显示,在1年的研究期内,物理治疗组的疼痛、生活质量和平衡状况优于糖皮质激素注射组。然而,超出这个时间范围的长期影响尚不清楚,需要进一步延长随访时间的研究来证实这些益处的可持续性。

试验注册

该方案已获得河北省体育科学研究所伦理委员会地方伦理委员会(SEC20200213019)和四川泰康医院伦理委员会(SCTK - IRB - 032)的批准。该研究已在中国临床试验注册中心注册(ChiCTR2000032508)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9caf/12065295/6edd8542aa63/12916_2025_4113_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9caf/12065295/fe343eb23b94/12916_2025_4113_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9caf/12065295/fe343eb23b94/12916_2025_4113_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9caf/12065295/378e93d8daa9/12916_2025_4113_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9caf/12065295/6a9849fc6a56/12916_2025_4113_Fig3_HTML.jpg
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本文引用的文献

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