Efficacy of two doses of intra-articular ozone therapy for pain and functional mobility in knee osteoarthritis: a double-blind randomized trial.

Aim: This double-blind, trial sought to assess the effectiveness of intra-articular ozone therapy at concentrations of 20 µg/mL and 40 µg/mL in managing pain and enhancing functional mobility in patients with knee osteoarthritis (KOA).

Method: This parallel, three-arm randomized controlled trial, conducted between 2022 and 2023, included 59 knee osteoarthritis (KOA) patients randomly allocated to one of three groups: the first group received 40 µg/mL ozone therapy, the second group received 20 µg/mL ozone therapy, and the control group received oxygen. Functional mobility was assessed through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee flexion range of motion (FROM), the Timed Up and Go (TUG) test, and the six-minute walk test (6MWT). Pain intensity was measured using the Visual Analog Scale (VAS) and the pain subscale of the WOMAC. Intra-articular injections were administered weekly for four consecutive weeks, with assessments conducted pre-treatment, and at two weeks, one month, and two months post-intervention. One-way ANOVA was employed for normally distributed quantitative data, while the Kruskal-Wallis test was utilized for non-normally distributed data. Qualitative variables were analyzed using the Chi-squared or Fisher's exact test, as appropriate.

Results: The groups receiving intra-articular ozone therapy exhibited notable reductions in mean VAS scores and improvement in functional mobility variables when compared to the control group (p < 0.05). However, post-hoc analysis indicated no statistically significant differences between the 40 µg/mL and 20 µg/mL ozone therapy groups regarding these parameters (VAS, FROM, TUG, 6MWT, or WOMAC scores) (p > 0.05).

Conclusion: Both 20 µg/mL and 40 µg/mL doses of intra-articular ozone therapy prove to be effective in reducing pain and enhancing functional mobility in patients with knee osteoarthritis (KOA). Nevertheless, there was no significant difference in the efficacy between the two ozone concentrations.

Trial registration: The trial is registered on us ClinicalTrials.gov in 2024-05-01 with the following ID code NCT06088706.