The 8-Week Efficacy of Frequency Rhythmic Electrical Modulated System (FREMS) as an Add-on Therapy in the Treatment of Symptomatic Diabetic Peripheral Polyneuropathy

Abstract

Background: Frequency Rhythmic Electrical Modulated System (FREMS) is a method of transcutaneous treatment based on frequency-modulated electromagnetic neural stimulation. Its efficacy in neuropathic pain in diabetes mellitus still lacks enough research. Methods: A randomized, single-blind, sham-controlled trial in individuals with symmetric distal polyneuropathy (SDPN) as an add-on therapy compared to standard therapy with alpha-lipoic acid. Participants were randomized to FREMS and standard of care (SOC) versus SOC only. The primary outcome was a change from baseline in perceived pain assessed by visual analogue scale (VAS) after 5 days of treatment and after 8 weeks of follow-up between treatment groups. Results: After 5 days of treatment, patients in both groups felt significant reduction in pain as measured by VAS, although only FREMS treatment lasted for 8 weeks and induced a significant improvement in quality of life measured by EuroQol 5-Dimension 5-Level (EQ-5D-5L) and Clinical Global Impression of Change (CGI-C) questionnaires. There were non-significant differences observed in the instrument pain assessment. No relevant side effects were recorded during the study. Conclusions: FREMS as an addition to alpha-lipoic acid therapy occurred to be a beneficial method of treatment in individuals with SDPN and was associated with improvements in pain severity, quality of life and clinical global improvement.