Comparative Effectiveness of Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation:...

Background/Objectives: We aimed to compare non-pharmacological (non-PHM) and pharmacological (PHM) treatment for patients with non-acute lumbar disc herniation (LDH) and determine the feasibility of a large-scale study. Methods: This was a two-armed, parallel, multicenter, pragmatic controlled trial performed in South Korea. All patients underwent magnetic resonance imaging (MRI) scans both at the screening stage and the last follow-up. Patients with LDH findings on MRI were randomly assigned to non-PHM and PHM groups. Treatment was administered twice a week for a total of 8 weeks, and follow-up assessments were performed at weeks 9, 13, and 27 post-randomization. The primary outcome was the Oswestry Disability Index (ODI) score. A linear mixed model was used for primary analysis from intention-to-treat perspectives. The incremental cost-effectiveness ratio (ICER) was calculated for economic evaluation. Results: Thirty-six patients were enrolled, and thirty-five were included in the final analysis. At Week 9, the difference in ODI scores between the two groups was 5.17 (95% CI: -4.00 to 14.35, p = 0.262), and the numeric rating scale scores for lower back and leg pains were 1.89 (95% CI: 0.68 to 3.10, p = 0.003) and 1.52 (95% CI: 0.27 to 2.77, p = 0.018), respectively, confirming greater improvement in the non-PHM group than in the PHM group. The non-PHM group showed lower costs and higher quality-adjusted life years than the PHM group. The ICER calculated using the EuroQoL-5 Dimension (EQ-5D) was USD 20,926. Conclusions: We confirm the possibility that a non-PHM strategy could be a more effective and cost-effective treatment option than PHM for patients with non-acute lumbar disc herniation. Furthermore, this pilot study confirmed the feasibility of the main study in terms of design and patient compliance.