Ozone Therapy as a Minimally-invasive Alternative in patients with Acute Lumbar Disc Herniation: A Randomized Clinical Trial

Background: Low back pain (LBP) management via conservative therapy with intervention fails in some cases. However, there are still many challenges to choose the best choice. Minimally-invasive techniques such as ozone therapy are emerging choices for surgery.Objective: We evaluated the effects of ozone therapy on patients with LBP with protruding disc herniation who failed to respond to medical treatment.Methods: In this Randomized phase III clinical trial (2017-19), one hundred patients admitted to Imam Reza Hospital (Tabriz-Iran) for herniated disk-induced LBP were randomly divided (shape- and color-identical envelopes) into two case and control groups. Patients in the case group were treated with ozone therapy (25 mcg/mL in 5 cc volume) plus medical therapy (naproxen 500 mg and baclofen 10 mg, both two times a day). Alternatively, patients in the control group received only conventional medical therapy. Primary outcomes such as changes in pain intensity (VAS) and basal test before and after treatment and also secondary outcomes like the amount of analgesic used were evaluated in the patients during two weeks, three months and six months after surgery. Student T-test and Chi-square were compared for comparing the data.Results: Mean pain intensities estimated by VAS and improvement of restless leg syndrome were not significantly different between the two groups during two weeks (p =0.8), three months (p =0.5) and six months (p =0.9) after the intervention. Pain intensity was found to be lower in both groups after the intervention compared with before treatment (p =0.001 for both). Moreover, significant differences were found between two groups in the Lasegue test during two weeks (p =0.02) and six months (p =0.01) after the intervention.Conclusion: Application of ozone therapy not only improves clinical pain syndrome in LBP patients but also leads to improved medical treatment in these patients.