Journal of Diabetic Complications & Medicine

A Randomized, Sham-Controlled, Double-Blind Pilot Study of Pulsed Electromagnetic Field Therapy to Evaluate Small Fiber Nerve Growth and Function and Skin Perfusion in Subjects with Painful Peripheral Diabetic Neuropathy

Abstract

Tallis AJ, Jacoby R, Muhlenfeld J and Smith APS

Purpose: The objective of this study was to determine the potential efficacy and safety of dual energy pulsed electromagnetic field therapy (PEMF) on painful distal symmetric diabetic sensorimotor polyneuropathy (DSPN).

Methodology: Subjects with Type 2 diabetes and painful DSPN were randomized to receive either an active or sham PEMF device. Objective measures of efficacy (skin biopsy, nerve conduction velocity (NCV) studies, dorsal and plantar foot skin perfusion pressure (SPP) were performed prior to and following 60-days of twice daily 30 minute treatments. Patient reported outcomes included perception of pain, concomitant medication use and adverse events.

Major findings: Dorsal foot SPP improved with PEMF (n=11), change from baseline=19.6 mmHg) vs. sham (n=7, change=-17.4 mmHg), p=0.03. Trends in favor of PEMF vs sham were observed for medial nerve (n=4), planter nerve (n=4) and sural nerve (n=15) onset time and amplitude (p>0.05) other than medial planter onset time (p=0.04). Although change in pain scores were similar, compliance with device use was higher in the active group compared to the sham control. The series of tests and long-term use of PEMF was well-tolerated and feasible. No device related adverse effects were recorded.

Principal conclusions: Twice daily PEMF therapy was feasible, well-tolerated, and associated with trends suggesting improved nerve function and microcirculation in patients with painful DSPN. Future, large randomized controlled trials are necessary to confirm these findings and evaluate the potential longer term benefits on symptoms and pathology of DSPN.