Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Low Back Pain: A Study Protocol for a Pragmatic Randomized Controlled Trial

Background: Low back pain (LBP) is a common musculoskeletal disorder worldwide, with a lifetime prevalence of up to 80%. Among nonsurgical treatments for chronic LBP, Korean medicine treatments are highly preferred, and pharmacopuncture therapy combining acupuncture and herbal medicine is widely used. However, no evidence-based study has focused on the use of various types of pharmacopuncture. Methods: The pragmatic randomized controlled clinical trial will include 44 participants; recruitment will start in July 2023. All participants will receive integrated Korean medicine treatment including acupuncture, cupping, and infrared therapy, and the intervention group will also receive pharmacopuncture. After 16 treatment sessions, twice a week for 8 weeks, follow-up assessments will be performed at week 9. As a pragmatic randomized controlled clinical protocol, the type, dose, and acupoints of acupuncture and pharmacopuncture are not determined in advance but are selected and recorded according to the clinical judgment of the Korean medicine doctor. Results: The primary outcome will be measured using a visual analog scale score, and the secondary outcomes include the Oswestry disability index, patient global impression of change, no worse than mild pain, and range of motion. Safety will be assessed by examining participants’ self-reported adverse events and vital signs and conducting blood tests before and after the test. Conclusion: This study aims to provide clinical evidence of the effectiveness and safety of pharmacopuncture for chronic LBP.