超声引导下臭氧治疗与皮质类固醇治疗膝骨关节炎患者的疗效：一项多中心随机对照试验。

The efficacy of ultrasonography-guided oxygen-ozone therapy versus corticosteroids in patients with knee osteoarthritis: A multicenter randomized controlled trial.

机构信息

Ankara Gaziler Phsycial Therapy and Rehabilitation Education and Research Hospital, University of Health Sciences, Ankara, Turkey.

Department of Medical and Surgical Sciences, University of Catanzaro "Magna Graecia", Catanzaro, Italy.

出版信息

J Back Musculoskelet Rehabil. 2024;37(6):1455-1466. doi: 10.3233/BMR-240023.

DOI:10.3233/BMR-240023

PMID:39240624

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11612948/

Abstract

BACKGROUND

Osteoarthritis (OA) is a widely-known disease distinguished by the breakdown of joint cartilage, leading to pain and morning stiffness. In this context, the role of corticosteroids is well known, but there is still a gap of knowledge on the duty of oxygen-ozone therapy (O2-O3).

OBJECTIVE

To evaluate for effectiveness of ultrasound-guided O2-O3 injections compared with corticosteroid injections among patients diagnosed with knee OA.

METHODS

This randomized controlled clinical trial was conducted on participants with knee OA who were randomly sorted into two groups: group A, undergoing corticosteroid group (n= 47) and group B, undergoing O2-O3 (n= 49) were injected within the knee joint under ultrasound guidance. The primary outcome measure was the change in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score between baseline and 12-weeks post-injection. Secondary outcome measures included visual analog scale scores, joint effusion and a knee flexion ROM. Assessments were recorded at baseline and 4-weeks and 12-weeks post-injection. For the examination of intra- and inter-group variations at various time points, a repeated-measure analysis of variance (two-way ANOVA) was employed.

RESULTS

Ninety-six participants completed this study. Based on repeated measurement analysis of variance, a significant effect of time was found for all outcome measures in both groups. Both groups showed clinically significant improvements in knee pain, quality of life and, function. Baseline, 4-week post-injection and 12-week post-injection WOMAC scores (mean ± standard deviation) were 72.54 ± 18.89, 45,95 ± 13.30 and 37.10 ± 19.87 (p= 0.00, p= 0.00, p= 0.00; respectively) in the corticosteroid group, respectively and 68.23 ± 20.18, 42.99 ± 18.67, and 33.43 ± 18.24 (p= 0.00, p= 0.00, p= 0.00; respectively) in the ozone group, respectively. However, no significant group × time interaction was determined regarding all outcome measures.

CONCLUSION

The study demonstrates the efficacy of O2-O3 compared to steroid injections regarding functioning and pain relief among patients with diagnosed knee OA.

摘要

背景

骨关节炎（OA）是一种广为人知的疾病，其特征是关节软骨的破裂，导致疼痛和晨僵。在这种情况下，皮质类固醇的作用是众所周知的，但关于臭氧治疗（O2-O3）的作用仍存在知识空白。

目的

评估超声引导下 O2-O3 注射与皮质类固醇注射治疗膝骨关节炎患者的疗效。

方法

这是一项随机对照临床试验，纳入了被诊断为膝骨关节炎的患者，并将他们随机分为两组：A 组，接受皮质类固醇注射（n=47），B 组，接受超声引导下膝关节内 O2-O3 注射（n=49）。主要结局指标为注射后 12 周时 Western Ontario 和 McMaster 大学骨关节炎（WOMAC）评分的变化。次要结局指标包括视觉模拟评分、关节积液和膝关节屈曲 ROM。在基线和注射后 4 周和 12 周时进行评估。为了检查不同时间点的组内和组间变化，采用重复测量方差分析（双向 ANOVA）。

结果

96 名参与者完成了这项研究。基于重复测量方差分析，两组所有结局指标在时间上均有显著影响。两组患者的膝关节疼痛、生活质量和功能均有显著改善。皮质类固醇组的 WOMAC 评分在基线、注射后 4 周和 12 周时分别为 72.54±18.89、45.95±13.30 和 37.10±19.87（p=0.00、p=0.00、p=0.00；分别），臭氧组的 WOMAC 评分分别为 68.23±20.18、42.99±18.67 和 33.43±18.24（p=0.00、p=0.00、p=0.00；分别）。然而，在所有结局指标方面，均未确定组间×时间的交互作用。