Effectiveness and Safety of an Herbal Medicine Strategy for Chronic Low Back Pain: Protocol for a Prospective, Multicenter, Pragmatic, Randomized, Non-Inferiority Trial

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Ju Yeon Kim,1 Sook-Hyun Lee,1 Su Won Lee,1 Ye-Seul Lee,1 Yoon Jae Lee,1 In Heo,2 Woo-Chul Shin,3 Jae-Heung Cho,4 Byung-Kwan Seo,5 In-Hyuk Ha1 1Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea; 2Department of Korean Medicine Rehabilitation, Pusan National University Korean Medicine Hospital, Yangsan, Kyungnam, Republic of Korea; 3Department of Korean Medicine Rehabilitation, Kyung Hee University Medical Center, Seoul, Republic of Korea; 4Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea; 5Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University, Seoul, Republic of KoreaCorrespondence: In-Hyuk Ha, Email hanihata@gmail.comIntroduction: Chronic low back pain (CLBP) is associated with reduced quality of life and increased risk of physical and psychological comorbidities. Current pharmacological and non-pharmacological treatments offer limited symptom relief and are often associated with poor patient compliance. Herbal medicines (HMs) have been shown to improve pain and function in patients with LBP.Objective: Given the wide variety of HMs used in practice, we designed a pragmatic clinical trial to evaluate the effectiveness and safety of an herbal medicine strategy (HMS) for CLBP.Methods and Analysis: This protocol describes a multicenter, pragmatic, parallel-group, assessor-blinded, non-inferiority randomized controlled trial with a 1:1 allocation ratio. A total of 150 participants with LBP (numeric rating scale [NRS] ≥ 5) persisting for at least 3 months will be enrolled. Participants in the HMS group will receive individualized HMS treatment for 30 days, while those in the non-pharmacological Korean medicine treatment (NPKM) group will receive NPKM, such as acupuncture, cupping, moxibustion, physiotherapy, twice weekly for 5 weeks. The primary outcomes will be the change in the NRS score for LBP and the Oswestry Disability Index from baseline to week 7. Secondary outcomes include NRS for radiating leg pain, visual analog scale for pain, Roland-Morris Disability Questionnaire-6, Patient Global Impression of Change, 5-Level EuroQol-5 Dimension, Health-related Quality of Life Instrument with 8 Items, and Patient Health Questionnaire-15. Cost data and adverse events will also be analyzed.Conclusion: This pragmatic non-inferiority trial was designed to assess whether the HMS is not clinically inferior to routine NPKM, reflecting real-world clinical practice to enhance the external applicability.Keywords: herbal medicine, chronic low back pain, randomized controlled trial, pragmatic clinical study

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