Evaluation of the efficacy and safety of herbal medicine for treating work-related chronic low back pain: A study protocol for a multicenter, randomized, controlled, clinical trial

INTRODUCTION: In Korea, low back pain (LBP) which is occupation-related symptom is one of the major health issues owing to rapid industrialization. Even traditional Korean medicine has the long history in pain treatment, there still has been lack of supporting evidence on herbal prescription itself. Sogyeonghwalhyeol-tang, a Korean herbal medicine prescription, has been suggested as a medication for treating chronic LBP as well as work-related pains. OBJECTIVE: This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang on work-related chronic LBP patients. METHOD: This trial is designed as a multicenter, randomized, controlled, clinical trial. Seventy-two participants who have chief complaint of LBP in Korean medicine rehabilitation center will be randomly assigned to ether Sogyeonghwalhyeol-tang group or placebo group with a ratio of 1:1. They will receive assigned drugs in 4 weeks and follow-up for 2 weeks. DISCUSSION: The result of this study will provide the valuable information for efficacy and safety of Sogyeonghwalhyeol-tang for patients with work-related chronic LBP.