Study Comparing JHG002 Pharmacopuncture and Physical Therapy for Adults with Chronic Low Back Pain

What this Trial Is About

Researchers are conducting a multicenter randomized controlled trial to compare the effectiveness and safety of JHG002 pharmacopuncture with standard physical therapy using transcutaneous electrical nerve stimulation TENS in adults experiencing chronic low back pain lasting more than six months. The study aims to assess pain intensity changes and other functional and quality of life outcomes over time. Ninety-six participants will be enrolled and randomly assigned to one of two treatment groups. Participants in the JHG002 group will receive ten treatment sessions over five weeks, administered twice weekly. Each session involves injecting 0.05-0.1 mL of JHG002, a purified Hominis placenta extract, into 8-10 acupuncture points commonly targeted for lumbar pain. The control group will undergo standardized TENS therapy twice weekly for 15 minutes per session across the same five-week period. Both treatments are delivered in a clinical setting following a unified protocol. Throughout the study, participants will undergo evaluations at baseline and multiple time points up to 25 weeks, including assessments of low back and radiating leg pain using the Numeric Rating Scale NRS and Visual Analogue Scale VAS, disability questionnaires, quality of life measures, and tracking of analgesic use and economic impacts. Safety monitoring includes recording adverse events, vital signs, laboratory tests, and medication reviews. The entire study is planned to last four years from approval through final follow-up.

Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial