Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Protocol for a Multicenter Pragmatic Trial
Abstract
Purpose Lower back and radiating leg pain are common worldwide. Most cases are treated with invasive treatments, including injection therapy and nerve blocks; however, their efficacy remains unclear. In the present study, we describe a study protocol for comparing the effectiveness, cost-effectiveness, and safety of non-pharmacological treatment strategies with those of active pharmacological treatment strategies for non-acute lumbar disc herniation (LDH). Patients and Methods The primary outcomes of this study are the Oswestry Disability Index and Numerical Rating Scale scores at 13 weeks from baseline. This two-arm, parallel, multicenter, pragmatic, randomized trial will be conducted in four hospitals in South Korea. Two hundred patients with LDH symptoms confirmed via magnetic resonance imaging will be randomly assigned to either a non-pharmacological or pharmacological treatment group. The non-pharmacological group will receive acupuncture and spinal manipulation therapy, whereas the pharmacological group will receive active pharmacological interventions for 8 weeks with a follow-up period of 3 years. Secondary outcomes include the European Quality of Life 5 Dimensions 5 Level Version, Short Form-12 Health Survey Version 2, and Patient Global Impression of Change. A cost survey will be conducted for economic evaluation. The primary analysis will involve the intention-to-treat approach, and differences between the two groups will be analyzed using a linear mixed model.…
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