Effect of Acupuncture for Chronic Nonspecific Low Back Pain: Study Protocol for a Randomized Double-Blind, Placebo-Controlled Trial.

Background: Chronic nonspecific low back pain (CNSLBP) is the most common chronic condition worldwide. Although recommended in several clinical guidelines, high-quality double-blind studies supporting the evidence for acupuncture remain limited. Objective: This study aims to test the efficacy of penetrating acupuncture for CNSLBP using double-blind needles that blind both the acupuncturist and the participant, which provides the most rigorous methodology for acupuncture trials to date. Methods: This study was a randomized double-blind (acupuncturist-patient) placebo-controlled trial conducted at the Tokyo Ariake University of Medical and Health Sciences Acupuncture Clinic. Seventy-five adult participants with CNSLBP were randomized to genuine penetrating, skin-touch placebo, and no-touch placebo needles that do not touch the skin. Consistent with prior studies and clinical practice, acupoints on the bladder meridian were mainly used. The study has 2 primary outcomes: an objective outcome and a subjective outcome. The primary objective outcome is the flexion-relaxation phenomenon, an index associated with low back pain, assessed using surface electromyography (sEMG) recordings of the bilateral lumbar erector spinae muscles and hamstrings. The primary subjective outcome is pain intensity measured using a visual analog scale (VAS) before and after the intervention. Results: The Ethics Committee approved the study protocol of Tokyo Ariake University of Medical and Health Sciences in April 2018 (approval number: 0246). This study started in July 2018 and was completed in March 2025. Conclusions: This trial used a double-blind design and objective outcome measures to rigorously evaluate the efficacy of acupuncture for CNSLBP.