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

Abstract

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

Oxygen–Ozone Therapy for the Treatment of Knee Osteoarthritis: A Systematic Review of Randomized Controlled Trials

“…A detailed description of each study has been provided in Table 1. 8,[13][14][15][16][17][18][19][20][21][22] Study Design and Quality All studies were, as per inclusion criteria, RCTs. The study designs were highly variable: patients in the control groups received different injection or treatment, such as HA in 3 studies; corticosteroids in 4 studies; and placebo, hypertonic dextrose, radiofrequency, or celecoxib þ glucosamine in the remaining 4 studies.…”

Short‐Term Therapeutic Effects of Ozone in the Management of Pain in Knee Osteoarthritis: A Meta‐Analysis

“…Ninety‐three eligible articles were identified, after excluding overlapped abstracts between the databases; 53 abstracts were retrieved for detailed evaluation. Fourteen randomized‐controlled trials remained for analysis after removing 39 unsuitable articles. Finally, only eight studies were chosen for having the necessary data to be included in the meta‐analysis (Figure ).…”

“…First, our meta‐analysis indicated that the ozone IA could be an effective option for the management of knee pain in patients with OA, when compared with placebo or other noninvasive treatments. Lopes de Jesus et al performed a randomized, double‐blinded, placebo‐controlled clinical trial in which patients with knee OA were divided into two groups receiving IA ozone or IA infiltrations of air as placebo treatment for 8 weeks. This study confirmed the efficacy of ozone regarding pain relief, functional improvement, and the patients’ quality of life.…”

“…Fourteen randomized-controlled trials 13,18-20,22-31 remained for analysis after removing 39 unsuitable articles. Finally, only eight studies were chosen for having the necessary data to be included in the meta-analysis 13,19,20,24,26,[29][30][31] (Figure 2).…”

El paradigma del ozono en el tratamiento del dolor

“…A nivel articular, y especialmente en la gonalgia por artrosis de rodilla, también se han publicado artículos que consolidan el uso del ozono mostrando su eficacia versus placebo, plasma rico en plaquetas, ácido hialurónico y corticoides (15)(16)(17)(18); asimismo, una revisión sistemática remarca esa eficacia en el metanálisis obtenido (19). En este número de la Revista de la Sociedad Española del Dolor se presenta un interesante e innovador artículo de Fernández-Cuadros ME y cols., sobre la repercusión del tratamiento con ozono en la gonartrosis, no solo sobre parámetros clínicos de eficacia, sino también, y por primera vez en la literatura científica, sobre indicadores bioquímicos y radiológicos.…”