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

PainSci » bibliography » de Jesus et al 2017
updated

Two pages on PainSci cite de Jesus 2017: 1. The Complete Guide to Patellofemoral Pain Syndrome2. Ozone Therapy for Pain


Common issues and characteristics relevant to this paper: ?Scientific papers have many common characteristics, flaws, and limitations, and many of these are rarely or never acknowledged in the paper itself, or even by other reviewers. I have reviewed thousands of papers, and described many of these issues literally hundreds of times. Eventually I got sick of repeating myself, and so now I just refer to a list common characteristics, especially flaws. Not every single one of them applies perfectly to every paper, but if something is listed here, it is relevant in some way. Note that in the case of reviews, the issue may apply to the science being reviewed, and not the review itself.

  1. A high (and possibly unacknowledged) risk of bias and its consequences (p-hacking, etc).
  2. Damned with faint praise — technically positive results (at least partially) that don’t actually impress.
  3. Paper poorly written enough to cast some doubt on the quality of the study.
  4. Declares statistical significance without acknowledging low effect sizes. Major foul.

original abstract Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.

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.

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