Efficacy and safety of electromagnetic acupuncture using an electromagnetic therapy stimulator (Whata153) for the treatment of chronic low back pain: Study protocol for a single-center, parallel-arm, randomized clinical trial

BACKGROUND: Chronic low back pain is one of the major conditions causing serious personal and social difficulties in modern society. There are several noninvasive therapies for chronic low back pain; however, the effects of electromagnetic acupuncture have not been studied. Here, we describe the protocol for a study that will investigate the efficacy and safety of electromagnetic acupuncture for patients with chronic low back pain. METHODS: The study has been designed as a double-blind, single-center, parallel-arm, sham-controlled, randomized clinical trial. A total of 104 patients with chronic low back pain who meet the criteria for selection and exclusion will be enrolled in a 1:1 ratio in an electromagnetic acupuncture group or a sham group. Sterilized disposable needles will be inserted at 6 acupoints, following which stimulation via an electromagnetic (Whata153) or a placebo (sham) stimulator will be applied. The 2 groups will receive a total of 6 treatment sessions over 3 weeks, with 1 follow-up visit within 3 days after the final treatment. The primary outcome will be the change in the visual analog scale (VAS) score for pain from baseline (visit 1, first treatment session) to the follow-up visit (visit 7, after treatment completion). The secondary outcomes will be as follows: changes in the VAS score for pain from baseline (visit 1) to visits 3 (third session) and 5 (fifth session); changes in the VAS score for pain at all assessment points from baseline (visit 1) to the follow-up visit (visit 7); changes in the Oswestry Disability Index (ODI) from visit 1 to visits 3, 5, and 7; and the change in ODI at all assessment points from visit 1 to visit 7. DISCUSSION: The results of this trial are expected to provide important clinical information on the efficacy and safety of electromagnetic acupuncture for patients with chronic low back pain.