Effectiveness and Safety of Pharmacopuncture therapy for chronic low back pain: A protocol for an assessor-blinded, pragmatic randomized controlled, pilot trial

Background: Low back pain is a common musculoskeletal disorder worldwide with a lifetime prevalence of up to 80%, and Korean medicine treatment is often used for it. Chronic low back pain results in great personal, social, and economic burden. However, its cause is known to be non-specific. We will investigate the effectiveness and safety of pharmacopuncture for chronic low back pain since there is a current lack of research on this topic. Methods This will be a pragmatic randomized, and assessor-blinded pilot clinical study. The participants will be randomly allocated to the treatment group (pharmacoupunture therapy with traditional Korean medicine) or to the control group (traditional Korean medicine). The duration of the clinical trial will be 9 weeks. The primary outcome will be measured using the visual analog scale; the secondary outcomes will include the Oswestry Disability Index, Patient Global Impression of Change, no worse than mild pain, and range of motion. Conclusions We will evaluate the efficacy and safety of pharmacopuncture for chronic low back pain and will contribute to knowledge on the evidence-based treatment for it. Abberviations: LBP: low back pain, IRB: Institutional Review Board, KMD: Korean medical doctor, TKM: Traditional Korean medicine, VAS: Visual Analog Scale, ODI: Oswestry Disability Index, PGIC: Patient Global Impression of Change, ROM: Range of motion, PRCT: pragmatic randomized controlled trial, SAE: serious adverse event Trial registration: This study protocol was registered with the Korean National Clinical Research Information Service (CRIS) on July 17, 2023 (CRIS-KCT0008620). The participants will be retrospectively registered. https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25180&search_page=L