• Eleonora Latini, Giulia Bonasia, Ludovica Petroselli, Melissa Mazzola, Francesca Musa, Flavia Santoboni, Donatella Trischitta, Maria Nusca Sveva, Mario Vetrano, and Maria Chiara Vulpiani.
• Physical Medicine & Rehabilitation Unit, Department of Medical and Surgical Sciences and Translational Medicine, Sant'Andrea University Hospital, Sapienza University of Rome, Rome, Italy.
• Pain Physician. 2023 Jul 1; 26 (4): E363E373E363-E373.

BackgroundNeuropathic mechanisms largely contribute to radicular Low Back Pain (LBP) and an increase in oxidative stress is recognized as one of the possible causes of nerve damage, inducing axonal degeneration and myelin degradation of nerve fibers.ObjectivesWe investigated whether a combination of nutraceutical supplements and oxygen-ozone (O2-O3) therapy might reduce disability and improve clinical effects of pharmacological therapy in patients with acute radicular LBP.Study DesignThis is a prospective, open-label, comparative observational study approved by the Institutional Review Board of the Sapienza University of Rome (RS 6285/2021).SettingPhysical Medicine and Rehabilitation Unit of Sant'Andrea Hospital.MethodsWithin the scope of this study, 62 patients with acute radicular LBP diagnosed with disc herniation were assigned into 4 groups. The first group was assigned pharmacological therapy (n = 16), the second group was assigned pharmacological therapy and nutraceutical supplements (n = 15), the third group was assigned pharmacological therapy and O2-O3 therapy (n = 15), and the fourth group was assigned pharmacological therapy, nutraceutical supplements, and O2-O3therapy (n = 16). All patients who participated in the study were evaluated at the beginning of the study, 2 weeks, and 4 weeks (T2) after the beginning of treatment using the Numeric Rating Scale (NRS-11), Oswestry Disability Index (ODI), and 12-item Short-Form Health Survey. Opioid analgesic intake was noted from baseline to end of treatment (T2).ResultsIn each group was observed a statistically significant difference for all measures compared to the baseline. At the T2 evaluation time between groups for the Mann-Whitney U test, a statistically significant difference was found: in the ODI scale between groups B and A (P = 0.004), groups C and A (P < 0.001), and groups D and A (P < 0.001); in the NRS-11 between groups B and A (P = 0.017), groups C and A (P = 0.002), and groups D and A (P < 0.001); in the 12-item Physical Component Summary score between groups B and A (P = 0.003), groups C and A (P = 0.002), and groups D and A (P < 0.001), while no significant differences between groups were observed in the 12-item Mental Component Summary score. The average days of opioid usage were similar in the 4 groups (8.33 in group A, 8.33 in group B, 8.33 in group C, and 8.75 in group D). However, the percentage of patients requiring adjuvant opioid therapy differed remarkably: 60% in group A, 40% in group B, 20% in group C, and 25% in group D.LimitationsA small number of patients were recruited, and we did not perform long-term follow-up.ConclusionsThis study supports a multimodal approach combining nutraceutical supplements and O2-O3 therapy with pharmacological therapy in the treatment of acute radicular LBP secondary to disc herniation. The combination of neurotrophic and antioxidant therapies represents an etiopathogenetic approach, not purely symptomatic, that reduces symptomatology and avoids progression of the nerve damage.

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