Abstract

Background: Ozone therapy has been utilized for over a hundred years for multiple indications, one of which is knee osteoarthritis. The current study compared the effect of ozone injections versus the current standard of care (corticosteroid injections) on knee pain. The study focuses on pain reduction, functionality, and quality of life. Methods: In this temporally stratified, single-blinded, controlled clinical trial, 40 patients with symptomatic knee osteoarthritis (OA) were stratified into two groups receiving intra-articular 30 μg/ml of ozone (OZ) or steroids (GS) for 3 weeks. The efficacy outcomes for knee OA were the Visual Analogue Scale (VAS), SF-12 KOOS. Patients were followed up for up to 6 months. Results: After 6 weeks from first injection, VAS score in the ozone group declined more than in the corticosteroid injection [mean inter group difference (MD) = 1.5±0.6, p < 0.05 (CI 95% 0.2–2.7)]. Maximal difference between the groups was observed at 12 weeks [mean difference (MD) = 3.9, p < 0.01 (CI 95% 2–5.2)]. The OZ group superiority was maintained at 24 weeks as well [mean difference (MD) = 2.8, p < 0.05 (CI 95% 2–4.8)]. KOOS pain subscale followed a similar trend with maximal difference between the groups at 12 weeks [mean difference (MD) = 18, p < 0.01 (CI 95% 8–32)]. SF-12 (PCS) in the OZ group was similar between groups at BL but was significantly higher at 6 to 24 weeks [(maximal mean difference at 12 weeks = 14, p < 0.01 (CI 95% 10-32)], SF-12 (MCS) was similar in both groups at all timepoints [no statistically significant difference]. At 6 months results were similar in both groups. Conclusions: In all criteria, including pain relief, functionality, and quality of life, the efficacy of ozone was confirmed.

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