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评估脉冲电磁疗法对疼痛性糖尿病远端对称性周围神经病变的影响:一项双盲随机对照试验。

Assessing the Effects of Pulsed Electromagnetic Therapy on Painful Diabetic Distal Symmetric Peripheral Neuropathy: A Double-Blind Randomized Controlled Trial.

作者信息

Tassone Erica E, Page Jeffrey C, Slepian Marvin J

机构信息

Regenesis Biomedical Inc., Scottsdale, AZ, USA.

Sarver Heart Center, Departments of Medicine and Biomedical Engineering, The University of Arizona, Tucson, AZ, USA.

出版信息

J Diabetes Sci Technol. 2025 Mar;19(2):361-369. doi: 10.1177/19322968231190413. Epub 2023 Aug 4.

Abstract

BACKGROUND

Significant complications of diabetes include pain and the loss of sensation in peripheral limbs. Pain management of diabetic symmetric peripheral neuropathy (DSPN) remains challenging. This study reports on utilizing pulsed electromagnetic field therapy (PEMF) to reduce pain and improve skin perfusion pressure (SPP) in subjects with DSPN.

METHODS

A randomized, sham-controlled, double-blind, clinical trial was conducted on subjects afflicted with foot pain associated with DSPN. Following informed consent, 182 subjects with diabetes and confirmed DSPN were entered into the trial for a period of 18 weeks. Subjects were randomized into active PEMF treatment or nonactive sham and instructed to treat to their feet for 30 minutes, twice daily and report daily pain scores. Some patients in the active arm experienced a transient low field strength notification (LFSN) due to improper pad placement during treatment. Skin perfusion pressure measurements were also collected at two and seven weeks to assess peripheral arterial disease effects via measurement of local microcirculatory flow and blood pressure.

RESULTS

Patients in the active arm who did not receive an LFSN experienced a clinically significant 30% reduction in pain from baseline compared to sham ( < .05). Though not statistically significant, SPP in the active group trended toward improvement compared to sham.

CONCLUSIONS

Pulsed electromagnetic field therapy appears effective as a nonpharmacological means for reduction of pain associated with diabetic peripheral neuropathy and holds promise for improvement of vascular physiology in microcirculatory dysfunction associated with diabetic peripheral arterial disease.

摘要

背景

糖尿病的严重并发症包括疼痛和外周肢体感觉丧失。糖尿病性对称外周神经病变(DSPN)的疼痛管理仍然具有挑战性。本研究报告了利用脉冲电磁场疗法(PEMF)减轻DSPN患者的疼痛并改善皮肤灌注压(SPP)。

方法

对患有与DSPN相关的足部疼痛的受试者进行了一项随机、假对照、双盲临床试验。在获得知情同意后,182名患有糖尿病且确诊为DSPN的受试者进入试验,为期18周。受试者被随机分为接受有源PEMF治疗组或无源假治疗组,并被指示对足部进行每日两次、每次30分钟的治疗,并报告每日疼痛评分。有源组中的一些患者在治疗期间由于电极片放置不当而经历了短暂的低场强通知(LFSN)。还在第2周和第7周收集了皮肤灌注压测量数据,以通过测量局部微循环血流和血压来评估外周动脉疾病的影响。

结果

未收到LFSN的有源组患者与假治疗组相比,疼痛从基线水平临床显著降低了30%(P<0.05)。虽然无统计学意义,但与假治疗组相比,有源组的SPP有改善趋势。

结论

脉冲电磁场疗法似乎是一种有效的非药物手段,可减轻与糖尿病外周神经病变相关的疼痛,并有望改善与糖尿病外周动脉疾病相关的微循环功能障碍中的血管生理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/359c/11874150/6ccf7ce364bb/10.1177_19322968231190413-fig1.jpg

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