• Youme Ko, Bo-Hyoung Jang, Min-Seok Oh, Sun Joong Kim, Yeon-Seok Ko, In-Hyuk Ha, Eun Jung Lee, Me-Riong Kim, Yun-Kyung Song, and Seong-Gyu Ko.
• aDepartment of Science in Korean Medicine, Graduate School, Kyung Hee University, Seoul bDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Dae-Jeon University, Daejeon cDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Semyung University, Jecheon dDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Woosuk University, Jecheon eJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul fJaseng Hospital of Korean Medicine, Seoul gDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Gachon University, Seongnam-si, Republic of Korea.
• Medicine (Baltimore). 2020 Jul 24; 99 (30): e21260.

IntroductionChronic non-specific low back pain is one of the common health issues which reduce the quality of life and in working population. While combined therapeutic treatment method is widely used for musculoskeletal related disorders in Korea, well-developed trials on the efficacy of single or combine therapy on herbal medicine and Chuna manual therapy (CMT) are scarce.ObjectiveThis study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang (SGHH) on work related chronic low back pain patients. The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone. The secondary aim is to examine the naïve direct comparison between SGHH and placebo.MethodThis trial is designed as a multicenter, randomized, controlled, clinical trial. A total of 150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center will be randomly assigned to 1 of 3 treatments with a ratio of 1:1:1. Eligible participant will be randomized to treatment arm A receive single treatment of Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy are administered concurrently, in treatment arm C, where individuals receive placebo with Chuna manual therapy. They will receive assigned treatment in 4 weeks and follow-up for 4 weeks. The primary endpoint is to assess the change in severity of low back pain from baseline. The secondary endpoints are the following: the changes in disability and health related quality of life. Adverse events will also be reported.DiscussionThe study result will provide the valuable information for efficacy and safety of monotherapy and multiple therapy of herbal medicinal extract and Chuna manual therapy on chronic non-specific low back pain.Trial RegistrationClinicalTrials.gov Identifier: NCT03132974.

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