Faculty of Human Sciences, University of Economics and Innovation, St. 4 Projektowa, 20-209 Lublin, Poland.
Int J Environ Res Public Health. 2022 Dec 22;20(1):111. doi: 10.3390/ijerph20010111.
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.
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.
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.
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.
频率节律电调制系统（FREMS）是一种基于调频电磁神经刺激的经皮治疗方法。其在糖尿病周围神经病变性疼痛中的疗效仍缺乏足够的研究。
一项在对称性远端多发性神经病（SDPN）患者中进行的随机、单盲、假对照试验，将其作为附加疗法与α-硫辛酸的标准疗法进行比较。参与者被随机分配到 FREMS 和标准治疗（SOC）与仅 SOC 组。主要结局是治疗 5 天后和 8 周随访期间，治疗组之间通过视觉模拟量表（VAS）评估的感知疼痛与基线相比的变化。
治疗 5 天后，两组患者的疼痛均明显减轻，尽管只有 FREMS 治疗持续 8 周，并通过欧洲五维健康量表 5 级（EQ-5D-5L）和临床总体印象变化（CGI-C）问卷测量的生活质量显著改善。仪器疼痛评估未见显著差异。在研究期间未记录到相关的不良反应。
FREMS 作为α-硫辛酸治疗的附加疗法，对 SDPN 患者是一种有益的治疗方法，与疼痛严重程度、生活质量和临床总体改善相关。
