Comparison of Two Different Ozone Injection Sites for Knee Osteoarthritis, Tibio-femoral Joint versus Supra-patellar Recess: An Open Randomized Clinical Trial

Abstract

Background: The aim of this study was to compare the efficacy of ozone injection at Tibio-femoral joint with Supra-patellar recess on knee osteoarthritis (OA). Methods: In this randomized, controlled clinical trial, 99 patients with symptomatic knee OA were randomized into two groups. 47 patients selected to receive 7-8 ml ozone (20 µg/ml) through Tibio-femoral joint injection, and 49 patients received 10 ml ozone (20 µg/ml) through supra-patellar recess injection by using in-plane ultrasound-guided. The primary outcome was the change from baseline in the visual analogue scale (VAS) (0-100 mm) pain score during 3 months after injection. Secondary outcome measures included the Western Ontario and McMaster universities OA Index (WOMAC), Lequesne index, time “Up and Go” (TUG) test, single-limb stance (SLS) tests, patient satisfaction, and adverse effects. All of these measurements were evaluated at the base time, 48 hours, 2 weeks, 1 month, 2 months, and 3 months after injection. Results: Both groups had significantly improvement in the primary and secondary outcome measures. VAS pain score except at the 3–month follow-up (16.8±13.3 versus 18.1±16.6, 95% CI, -7.33 to 4.73, p =0.6), WOMAC pain score, WOMAC stiffness score at all evaluated times, and WOMAC total score at 48 hours after injection (95% CI, -19.4 to -4.9) were significantly better among Tibio-femoral ozone injection compare to Supra-patellar recess injection (95% CI, -20.68 to -6.51, p<0.001)). In both groups satisfaction, TUG and SLS times were improved, but no significant difference was seen between groups (p>0.05). At the 3-month follow-up, WOMAC pain and total scores for only Tibio-femoral joint injection group as well as WOMAC function, TUG and SLS times for both groups were gradually coming back to the baseline. Conclusion: Ozone injection in both groups was associated with pain relief, functional improvement, and quality of life in patient with knee OA. Pain and stiffness of joint were improved better in Supra-patellar recess ozone injection.