Work

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

Year: 2025

Type: article

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. This is the first well-designed, large-scale clinical trial comparing non-pharmacological and pharmacological strategies in patients with non-acute LDH. The findings of this study may provide high-quality evidence on the effectiveness, cost-effectiveness, and safety of non-pharmacological strategies centered on manual therapy. Ethics and Dissemination: All participants will provide written informed consent. The study protocol, case report form, informed consent form, and all other study-related documents are approved by the IRB of Jaseng Hospital of Korean Medicine. Approval numbers: JASENG 2023-05-001 (Jaseng hospital of Korean Medicine), 2023-05-002 (Daejeon Jaseng hospital of Korean Medicine), 2023-05-003 (Haeundae Jaseng Hospital of Korean Medicine), 2023-05-004 (Bucheon Jaseng hospital of Korean Medicine). Registration Details: The protocol has been registered on ClinicalTrials.gov (number: NCT06024460; July 20, 2023).

Source: Journal of Pain Research

DOI: 10.2147/jpr.s568386