Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Protocol for a Multicenter Pragmatic Trial.

Researchers in South Korea are launching a major study to compare two different approaches for treating lumbar disc herniation (a herniated disc in the lower back) that causes back and leg pain. This study will involve 200 patients across four hospitals and compare non-drug treatments like acupuncture and spinal manipulation against standard medical treatments such as injections and nerve blocks. Currently, most people with herniated discs receive invasive medical procedures, but scientists aren't sure how well these actually work compared to hands-on therapies. Participants will receive eight weeks of treatment—either acupuncture with spinal manipulation or standard medical care—and will be followed for three years. Researchers will measure pain levels, disability, quality of life, and treatment costs to determine which approach works better and is more cost-effective. The study will track patients' ability to perform daily activities and their overall pain improvement at 13 weeks and beyond. This is the first large-scale trial designed to rigorously compare these two treatment strategies for disc herniation. The results could provide important evidence about whether non-drug approaches centered on acupuncture and manual therapy are as effective or better than conventional medical treatments for herniated discs. If you're considering acupuncture for back pain, seek treatment from a licensed acupuncturist with experience treating spinal conditions.

This multicenter pragmatic RCT protocol describes a comparison of non-pharmacological versus pharmacological interventions for non-acute lumbar disc herniation (LDH) confirmed by MRI. The study will randomize 200 patients across four South Korean hospitals into two arms: acupuncture plus spinal manipulation versus active pharmacological interventions (injections, nerve blocks). Treatment duration is 8 weeks with 3-year follow-up. Primary outcomes are Oswestry Disability Index and Numerical Rating Scale scores at 13 weeks. Secondary measures include EQ-5D-5L, SF-12v2, and PGIC, with economic evaluation via cost survey. Analysis will use intention-to-treat with linear mixed models. This represents the first adequately powered, rigorous trial comparing manual therapy-centered approaches to conventional pharmacological management for LDH. Given current uncertainty regarding efficacy of invasive interventions, results may significantly inform treatment guidelines and provide evidence for acupuncture and manipulation as first-line alternatives to pharmacological management in non-acute LDH patients.