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Comparison between intra-articular ozone and placebo in the treatment of knee osteoarthritis: A randomized, double-blinded, placebo-controlled study.
PLoS One 2017; 12(7):e0179185Plos

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.

Authors+Show Affiliations

Department of Evidence-Based Medicine, Paulista School of Medicine, Sao Paulo Federal University, Sao Paulo, Sao Paulo, Brazil.Department of Geriatrics and Gerontology, Paulista School of Medicine, Sao Paulo Federal University, Sao Paulo, Sao Paulo, Brazil."Dante Pazzanese" Institute of Cardiology, Sao Paulo, Sao Paulo, Brazil.Department of Geriatrics and Gerontology, Paulista School of Medicine, Sao Paulo Federal University, Sao Paulo, Sao Paulo, Brazil.Department of Geriatrics and Gerontology, Paulista School of Medicine, Sao Paulo Federal University, Sao Paulo, Sao Paulo, Brazil.Department of Evidence-Based Medicine, Paulista School of Medicine, Sao Paulo Federal University, Sao Paulo, Sao Paulo, Brazil.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28738079

Citation

Lopes de Jesus, Carlos César, et al. "Comparison Between Intra-articular Ozone and Placebo in the Treatment of Knee Osteoarthritis: a Randomized, Double-blinded, Placebo-controlled Study." PloS One, vol. 12, no. 7, 2017, pp. e0179185.
Lopes de Jesus CC, Dos Santos FC, de Jesus LMOB, et al. Comparison between intra-articular ozone and placebo in the treatment of knee osteoarthritis: A randomized, double-blinded, placebo-controlled study. PLoS ONE. 2017;12(7):e0179185.
Lopes de Jesus, C. C., Dos Santos, F. C., de Jesus, L. M. O. B., Monteiro, I., Sant'Ana, M. S. S. C., & Trevisani, V. F. M. (2017). Comparison between intra-articular ozone and placebo in the treatment of knee osteoarthritis: A randomized, double-blinded, placebo-controlled study. PloS One, 12(7), pp. e0179185. doi:10.1371/journal.pone.0179185.
Lopes de Jesus CC, et al. Comparison Between Intra-articular Ozone and Placebo in the Treatment of Knee Osteoarthritis: a Randomized, Double-blinded, Placebo-controlled Study. PLoS ONE. 2017;12(7):e0179185. PubMed PMID: 28738079.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison between intra-articular ozone and placebo in the treatment of knee osteoarthritis: A randomized, double-blinded, placebo-controlled study. AU - Lopes de Jesus,Carlos César, AU - Dos Santos,Fânia Cristina, AU - de Jesus,Luciana Maria Oliveira Bueno, AU - Monteiro,Iara, AU - Sant'Ana,Maria Sonia Sousa Castro, AU - Trevisani,Virginia Fernandes Moça, Y1 - 2017/07/24/ PY - 2016/12/13/received PY - 2017/05/01/accepted PY - 2017/7/25/entrez PY - 2017/7/25/pubmed PY - 2017/9/22/medline SP - e0179185 EP - e0179185 JF - PloS one JO - PLoS ONE VL - 12 IS - 7 N2 - 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. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/28738079/Comparison_between_intra_articular_ozone_and_placebo_in_the_treatment_of_knee_osteoarthritis:_A_randomized_double_blinded_placebo_controlled_study_ L2 - http://dx.plos.org/10.1371/journal.pone.0179185 DB - PRIME DP - Unbound Medicine ER -