Comparative Effectiveness of Nucleoplasty and Intradiscal Ozone Therapy for Lumbar Disc Herniation: A Double-Blind, Randomized, Controlled Trial.

BACKGROUND: Lumbar disc herniation (LDH) is responsible for more than 60% of chronic low back and leg pain. Although some patients respond to conservative treatment, a considerable proportion require surgical or minimally invasive interventions. The demand for minimally invasive procedures has increased; these procedures have high success rates in appropriately selected patients. OBJECTIVE: To compare the clinical outcomes of intradiscal ozone therapy and percutaneous lumbar nucleoplasty in patients with LDH. STUDY DESIGN: Prospective, double-blind, randomized controlled trial. SETTING: A tertiary care center. METHODS: Ninety patients with low back pain due to lumbar disc herniation were assigned to intradiscal ozone therapy (Group I) or percutaneous lumbar nucleoplasty (Group II). Pain was assessed using the Visual Analog Scale (VAS), disability using the Oswestry Disability Index (ODI), and quality of life using the Short Form-36 (SF-36) at baseline, and at postprocedure months one and 12. All procedures were performed under sterile conditions with C-arm fluoroscopy. RESULTS: Significant postprocedure improvements in pain, disability, and quality of life were observed in both groups. Both groups had statistically significant decreases in VAS and ODI scores at the postprocedure one-month and 12-month follow-ups (P < 0.001). However, when the postprocedure one-month scores were compared, it was evident that Group II had lower VAS and ODI scores than Group I; this difference is statistically significant (P < 0.001). This difference was maintained at 12 months and became more pronounced, with a greater improvement favoring Group II, particularly in the VAS scores (P < 0.001). While both methods are effective in the short term, nucleoplasty yields better long-term results than intradiscal ozone therapy (12 months). This finding supports the idea that nucleoplasty may have a longer-lasting effect on pain control and functional improvement. LIMITATIONS: The main limitations of our study are the limited number of patients and the short follow-up time. CONCLUSION: Our study compared the efficacy of percutaneous lumbar nucleoplasty and intradiscal ozone therapy. Both procedures were efficacious in reducing patients' pain and improving their quality of life. However, percutaneous lumbar nucleoplasty had superior long-term outcomes compared to intradiscal ozone therapy.