Comparison Between Intra-Articular Ozone and Placebo in the Treatment of Knee Osteoarthritis: A Randomized, Double-Blinded, Placebo-Controlled Study

PLoS One. 2017 Jul 24;12(7):e0179185. doi: 10.1371/journal.pone.0179185. eCollection 2017.

Abstract

Objective: The aim of the trial was to determine the effectiveness of oxygen-ozone injections on knee osteoarthritis concerning pain reduction, joint functional improvement, and quality of life.

Methods: In this randomized, double-blinded, placebo controlled clinical trial, 98 patients with symptomatic knee osteoarthritis (OA) were randomized into two groups receiving intra-articular 20 μg/ml of ozone (OZ) or placebo (PBO) for 8 weeks. The efficacy outcomes for knee OA were the Visual Analogue Scale (VAS), Lequesne Index, Timed Up and Go Test (TUG Test), SF-36, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Geriatric Pain Measure (GPM).

Results: After 8 weeks of treatment, ozone was more effective than the placebo: VAS [mean difference (MD) = 2.16, p < 0.003 (CI 95% 0.42-3.89)], GPM [MD = 18.94, p < 0.004 (CI 95% 3.43-34.44)], LEQ [MD = 4.05, p < 0.001 (CI 95% 1.10-7.00)], WOMAC (P) [median of diff = 9.999, p = 0.019 (CI 95% 0.000-15.000)], WOMAC (JS) [median of diff = 12.499, p < 0.001 (CI 95% 0.000-12.500)], WOMAC (PF) = [median of diff = 11.760, p = 0.003 (CI 95% 4.409-19.119)], TUG (no statistical difference) and SF-36 (FC) [(MD = -25.82, p < 0.001 (CI 95% 33.65-17.99)], SF-36 (PH) [MD = -40.82, p < 0.001 (CI 95% -54.48-27.17)], SF-36 (GSH) [MD = -3.38, p < 0.001 (CI 95% -4.83-1.93)], SF-36 (SA) [MD = 2.17, p < 0.001 (CI 95% -19.67-8.24), SF-36 (EA) [MD = -35.37, p < 0.001 (CI 95% -48.86-21.89)]. Adverse events occurred in 3 patients (2 in the placebo group and 1 in the ozone group) and included only puncture accidents.

Conclusions: The study confirms the efficacy of ozone concerning pain relief, functional improvement, and quality of life in patients with knee osteoarthritis.

Trial registration: International Standard Randomized Controlled Trial Number Register ISRCTNR55861167.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Female
  • Humans
  • Injections, Intra-Articular / methods
  • Knee Joint / drug effects*
  • Male
  • Middle Aged
  • Osteoarthritis, Knee / drug therapy*
  • Ozone / administration & dosage*
  • Pain Measurement / methods
  • Quality of Life

Substances

  • Ozone

Grant support

The authors received no especific funding for this work.