ArticleJournal of pain research2025
Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Protocol for a Multicenter Pragmatic Trial.
Article in Journal of pain research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06024460 (Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation: a Multi-centered, Pragmatic Randomized Controlled, Parallel-grouped Study
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Authors and funding
9 authors.
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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).
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