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

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.