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Critical comments on ultrasound-guided paravertebral oxygen-ozone injections
Marianno Franzini1, Luigi Valdenassi1, Francesco Vaiano1
1Italian Scientific Society of Oxygen-Ozone Therapy (SIOOT), Bergamo and High Master School of Oxygen-Ozone Therapy, University of Pavia, Pavia, Italy.
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.
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