Related Experiment Video
Updated: May 3, 2026
A Mobile Outside-in Technique of Transforaminal Lumbar Endoscopy for Lumbar Disc Herniations
Published on: August 7, 2018
Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Protocol for a Multicenter
Doori Kim1, Yoon Jae Lee1, Changsop Yang2
1Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
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).
