A Pulsed Electromagnetic Field Therapy Device for Non-Specific Low Back Pain: A Pilot Randomized Controlled Trial.

INTRODUCTION: Low back pain (LBP) poses a significant burden of disease worldwide, and identifying safe and effective non-pharmacologic treatment options for LBP is a research priority. The aim of this study was to pilot a clinical trial of a portable pulsed electromagnetic field (PEMF) therapy device for subjects with mixed duration non-specific LBP. METHODS: This work was a randomized, double-blind, sham-controlled, parallel-group study conducted at a chiropractic school outpatient clinic. The primary end point was functional capacity measured by the Oswestry Disability Index (ODI) at baseline, 6 weeks, and 12 weeks. Analysis was conducted on the intent-to-treat population and as a trend of change in pain scores over time using the Freidman test of repeated measures. RESULTS: Forty-two participants were randomized to receive usual care plus PEMF therapy or usual care plus sham, and 25 completed the study. Significant improvements in ODI scores from baseline to week 6 were reported in the experimental group (χ2 = 14.68, p < 0.001, compared with patients in the sham group, χ2 = 4.00, p = 0.135, n.s.). This difference persisted at week-12 follow-up. Adverse events were rare and mild. CONCLUSION: It is feasible to conduct a clinical trial of a PEMF therapy device for non-specific LBP. This work shows that the device was safe and provides preliminary evidence of effectiveness in improving function in patients with non-specific LBP. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03053375. FUNDING: Aerotel Ltd.