Critical comments on ultrasound-guided paravertebral oxygen-ozone injections

The randomized controlled trial by Forogh and Kazemi compared ultrasound-guided "paravertebral" ozone-oxygen injections with pure oxygen in patients with chronic discogenic low back pain. While the study addresses an important clinical question, its methodological limitations constrain the reliability of its conclusions. The sample size of only 30 participants provides insufficient statistical power, and the justification for effect size and minimal clinically important difference is inadequate. Blinding was not verified, raising concerns that sensory cues from ozone injections may have compromised masking. The use of pure oxygen as a control, though novel, is problematic since oxygen is not biologically inert, and the absence of a true placebo arm prevents disentangling ozone-specific effects from contextual or procedural influences. Outcomes were limited to subjective measures (VAS and ODI) without objective functional or imaging endpoints. Overall, enthusiasm for ozone therapy is premature, and larger, rigorously designed trials are essential before clinical adoption.

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Publication Details

Journal
Journal of Back and Musculoskeletal Rehabilitation
Published
2026-03-17
DOI
https://doi.org/10.1177/10538127261432690
Primary Topic
Medical and Biological Ozone Research
Type
article
Field-Weighted Citation Impact
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article

Critical comments on ultrasound-guided paravertebral oxygen-ozone injections

Francesco Vaiano, Luigi Valdenassi, Salvatore Chirumbolo, Umberto Tirelli et al.
Journal of Back and Musculoskeletal Rehabilitation
Medical and Biological Ozone Research
article

Critical comments on ultrasound-guided paravertebral oxygen-ozone injections

Francesco Vaiano, Luigi Valdenassi, Salvatore Chirumbolo, Umberto Tirelli, Marianno Franzini
article en

Abstract

The randomized controlled trial by Forogh and Kazemi compared ultrasound-guided "paravertebral" ozone-oxygen injections with pure oxygen in patients with chronic discogenic low back pain. While the study addresses an important clinical question, its methodological limitations constrain the reliability of its conclusions. The sample size of only 30 participants provides insufficient statistical power, and the justification for effect size and minimal clinically important difference is inadequate. Blinding was not verified, raising concerns that sensory cues from ozone injections may have compromised masking. The use of pure oxygen as a control, though novel, is problematic since oxygen is not biologically inert, and the absence of a true placebo arm prevents disentangling ozone-specific effects from contextual or procedural influences. Outcomes were limited to subjective measures (VAS and ODI) without objective functional or imaging endpoints. Overall, enthusiasm for ozone therapy is premature, and larger, rigorously designed trials are essential before clinical adoption.

Journal of Back and Musculoskeletal Rehabilitation
University of Verona (IT), University of Pavia (IT)
Good health and well-being
Openalex Percentile: Top 18%
Medical and Biological Ozone Research
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