Medical Ozone as a Therapeutic Option in Musculoskeletal Pain Control: A Critical Review of Clinical Trials Considering Safety and Quality Indicators for Procedures and Devices
de Araújo LT, da Silva PC, Masini M. Yale Journal of Biology and Medicine, 2024.
- Study type
- Review
- People studied
- No participants of its own (review)
- Population
- 27 clinical studies (pilot, randomized, and non-randomized trials) of medical ozone for musculoskeletal pain in adults, each with at least five participants
- Published
- 2024, Yale Journal of Biology and Medicine
- Identifiers
- PMID 39351322, DOI 10.59249/HGTG9363
What the authors reported
From 249 records, 27 studies were included, most on low back pain. By the authors' grading, 77.8% of studies had no adverse events, 14.8% mild, 3.7% moderate, and 3.7% serious events, none involving death or disability. Ten studies did not name the ozone generator used. The authors conclude that medical ozone is safe and effective for musculoskeletal pain and call for longer, rigorous trials.
What limits this result
A critical review that grades quality indicators but uses no formal risk-of-bias tool. Case reports, case series, and studies with fewer than five participants were excluded, and only Portuguese, Spanish, and English papers were searched. The abstract gives the no-adverse-event share as "77 (8%)" and the text 77.8%. One author works for an ozone-generator maker that paid for the illustrations.
Harms reported after ozone therapy, and studies of how ozone exposure affects health. One study rarely settles a medical question; our guides weigh each paper against the rest of the evidence.
How the study was done
- Design
- Critical review of clinical trials, described in its methods as a scope review
This study is a scope review of clinical trials using complementary ozone therapy for pain control.
- Setting
- University of the State of Bahia, Salvador, Brazil (first author's affiliation); co-authors at Philozon, an ozone-generator company, and UNICEPLAC, Brasília
- Read from
- Read from the full text of the paper. Read on October 2, 2026.
Study arms
| Group | Participants | What they received |
|---|---|---|
| Included clinical studies | 27 | Medical ozone for musculoskeletal pain, mostly by minimally invasive local injection; two studies used major autohemotherapy or intravenous routes |
Source: Full text on PubMed Central
What it measured
- Search and selection
- 27 studies included from 249 records
- Conditions studied
- Mostly low back pain, including lumbar disc herniation and lumbar degenerative disease
- Ozone doses used
- Concentrations or doses from 20 mcg to 40 mcg, which the authors call a moderate to high dose range
We noticed a wide variability of concentrations/doses ranging from 20 mcg to 40 mcg, which is considered a moderate to high dose range
- Routes
- Minimally invasive local injections, except two studies using major autohemotherapy and intravenous administration
- Adverse events by severity (share of the 27 studies)
- 77.8% none, 14.8% mild, 3.7% moderate, 3.7% serious
Figure 6 shows the adverse events reported in the 27 reviewed studies, where according to intensity and severity, 77.8% had no adverse events; 14.8% were mild adverse events; 3.7% were considered moderate adverse events, and 3.7% serious adverse events.
- Serious adverse events
- None related to death or disability
- Local and systemic adverse events
- Local events in 18.5% of studies, systemic in 3.7%
- Ozone generator reported
- 10 of the included studies did not name the generator used
Safety as reported
Few adverse events in the 27 studies, mostly mild and then moderate; the authors consider the intervention safewe consider this intervention safe, which is confirmed by the report of few adverse events in the 27 clinical studies reviewed, most of which are classified as mild, followed by moderate adverse events.
Source: Full text on PubMed Central
Funding and conflicts
The company where author PCS works (Philozon, an ozone-generator company) paid a computer technology professional to create the illustrations; the authors declared no source of funding
Source: Full text on PubMed Central
Where we cite this study
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