Percutaneous Ozone Treatment for Herniated Lumbar Discs: 1-Year Follow-up of a Multicenter Pilot Study of a Handheld Disposable Ozone-Generating Device.

ABSTRACT

PURPOSE: To evaluate the safety and efficacy of oxygen-ozone treatment delivered via a novel, handheld ozone-generating device for improving pain and function in herniated disc patients. MATERIALS AND METHODS: A total of 39 patients with contained herniated lumbar discs received oxygen-ozone treatment at 1 of 3 centers. Treatment consisted of injection of 2% ozone (10 mL) 3 mL delivered into the nucleus pulposus and 7 mL delivered into the adjacent paravertebral tissues. The first 8 patients received only ozone injections, whereas subsequent patients also received periganglionic methylprednisolone (40 mg) and 0.5% bupivacaine (1 mL) injections. Patients were evaluated at baseline and at 1 month, 6 months, and 12 months after treatment using the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS) for leg pain and for back pain. Analgesic medication use was also assessed at each timepoint. RESULTS: Overall, 91% (32/35) of the per-protocol patients (those who completed follow-up and did not have significant protocol deviations) showed detectable improvement in ODI at 1-month follow-up; this increased to 93% (26/28) of patients at 12-months follow-up. At 1 month after treatment, 60% (21/35) of patients showed significant improvement in ODI scores (P = .01); 54% (19/35) showed significant improvement in VAS scores for leg pain (P = .05); and 49% (17/35) showed significant improvement in VAS scores for back pain (P = .12). At 6 months after treatment, 67% (22/33) of patients showed significant improvement in ODI scores (P = .02); 64% (21/33) showed significant improvement in VAS scores for leg pain (P = .01); and 52% (17/33) showed significant improvement in VAS scores for back pain (P = .12). At 12 months after treatment, 68% (19/28) of patients showed significant improvement in ODI scores (P < .01); 64% (18/28) showed significant improvement in VAS scores for leg pain (P < .01); and 61% (17/28) showed significant improvement in VAS scores for back pain (P = .09). Leg pain typically subsided more quickly than back pain. Use of analgesic medications also significantly decreased at all follow-up timepoints compared to baseline (P < .01). There were no adverse events or device-related issues. CONCLUSIONS: At 1, 6, and 12 months after treatment, patients experienced significant improvements in pain and function as well as significantly decreased use of analgesic medication. Taken together with the absence of adverse events at 1-year follow-up, these data suggest that oxygen-ozone treatment is a safe and effective therapy for contained herniated discs.