JMIR Publications

ABSTRACT

Background:

Chronic non-specific low back pain (CNSLBP) is the most common chronic condition worldwide. Acupuncture has been recommended in many guidelines for CNSLBP because it is a safe, effective treatment. The efficacy of acupuncture for CNSLBP is unclear due to a lack of high-quality evidence.

Objective:

This study aims to test the efficacy of penetrating acupuncture for CNSLBP using double-blind needles that blind both acupuncturist and participant, which provides the most rigorous methodology for acupuncture trials to date.

Methods:

This study is a randomized double-blind (acupuncturist-patient) placebo-controlled trial, conducted at Tokyo Ariake University of Medical and Health Sciences Acupuncture Clinic. Seventy-five adult participants with CNSLBP will be randomized to genuine penetrating, skin-touch, and no-touch placebo needles that do not touch the skin. Consistent with prior studies and clinical practice, acupoints on the bladder meridian are mainly used. The primary objective outcome is flexion relaxation, which is an index of low back pain; recordings from surface electromyography of the bilateral lumbar erector muscles of the spine and hamstrings; and the primary outcome by self-report is pain intensity recorded on a visual analogue 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:

We solve several critical methodological problems plaguing acupuncture research, employing double-blind needles and objective indicators to show the genuine efficacy of acupuncture in CNSLBP. Clinical Trial: This study was registered in the University Hospital Medical Information Network (UMIN ID: 000043725).