Evaluating paravertebral ozone injections versus passive physical modalities, as adjuncts to home exercise, for chronic non-specific low back pain: A randomized pilot study

Background Chronic non-specific low back pain (CNSLBP) is a major global cause of disability. While medical ozone injections have a long history, their comparative effectiveness against passive electrothermal modalities as adjuncts to exercise remains unclear. This study aimed to evaluate the preliminary clinical outcomes of these two adjunctive strategies. Methods We conducted a pilot randomized controlled trial with 64 adult patients suffering from CNSLBP. All participants were instructed in a standardized home exercise program. They were then randomly assigned to receive either three weekly sessions of paravertebral ozone injections or ten sessions of passive electrothermal modalities. The primary endpoint was functional disability measured by the Oswestry Disability Index (ODI version 2.1a) at 3 months post-intervention. Secondary outcomes included Visual Analogue Scale (VAS) pain scores at 1, 3, and 6 months. Results At the 3-month primary endpoint for disability, ANCOVA adjusting for baseline ODI score, age, and BMI revealed no statistically significant between-group difference (adjusted mean difference [MD]: 2.67, 95% CI: −1.40 to 6.74; p = 0.195 ). Similarly, no statistically significant between-group differences in pain intensity were detected at 1 month ( p = 0.095 ), 3 months (adjusted MD: 0.18, 95% CI: −1.03 to 1.39; p = 0.767 ), or 6 months ( p = 0.119 ). Conclusions In patients with CNSLBP engaged in a structured home exercise program, no statistically significant differences in pain or functional disability were detected between adding a 3-session course of paravertebral ozone injections and adding a 10-session course of passive electrothermal modalities within this pilot study. Given the study design and sample size, these findings indicate a lack of statistically significant between-group differences. Larger, multi-arm definitive trials including an exercise-only control arm are required.