Comparison between intra-articular ozone and placebo in the treatment of knee osteoarthritis: A randomized, double-blinded, placebo-controlled study

• Published in: PloS one Vol. 12; no. 7; p. e0179185
• Main Authors: Lopes de Jesus, Carlos César, Dos Santos, Fânia Cristina, de Jesus, Luciana Maria Oliveira Bueno, Monteiro, Iara, Sant'Ana, Maria Sonia Sousa Castro, Trevisani, Virginia Fernandes Moça
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 24.07.2017; Public Library of Science (PLoS)
• Subjects: Aged; Aged, 80 and over; Analysis; Arthritis; Biocompatibility; Biology and Life Sciences; Care and treatment; Clinical trials; Double-Blind Method; Earth Sciences; Ecology and Environmental Sciences; Evidence-based medicine; Female; Generalized linear models; Geriatrics; Gerontology; Humans; Injections, Intra-Articular - methods; Knee; Knee Joint - drug effects; Male; Medicine; Medicine and Health Sciences; Middle Aged; Osteoarthritis; Osteoarthritis, Knee - drug therapy; Oxygen; Ozone; Ozone - administration & dosage; Pain; Pain management; Pain Measurement - methods; Patient outcomes; Patients; pH effects; Physical Sciences; Quality of Life; Rheumatology; Visual perception
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0179185

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. 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). 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. The study confirms the efficacy of ozone concerning pain relief, functional improvement, and quality of life in patients with knee osteoarthritis. International Standard Randomized Controlled Trial Number Register ISRCTNR55861167.