Pulsed Electromagnetic Fields to Reduce Diabetic Neuropathic Pain and Stimulate Neuronal Repair: A Randomized Controlled Trial

• Published in: Archives of physical medicine and rehabilitation Vol. 90; no. 7; pp. 1102 - 1109
• Main Authors: Weintraub, Michael I., MD, Herrmann, David N., MD, Smith, A. Gordon, MD, Backonja, Misha M., MD, Cole, Steven P., PhD
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.07.2009; Elsevier
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Cranial nerves. Spinal roots. Peripheral nerves. Autonomic nervous system. Gustation. Olfaction; Diabetes. Impaired glucose tolerance; Diabetic Neuropathies - complications; Diabetic Neuropathies - pathology; Diabetic Neuropathies - physiopathology; Diabetic Neuropathies - therapy; Diseases of the osteoarticular system; Double-Blind Method; Electromagnetic fields; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Female; Foot; Humans; Male; Medical sciences; Middle Aged; Nerve Fibers - pathology; Nervous system (semeiology, syndromes); Neural Conduction; Neurology; Neurons - pathology; Pain - etiology; Pain Management; Physical Medicine and Rehabilitation; Rehabilitation; Skin - innervation; Skin - physiopathology; Transcranial Magnetic Stimulation; diabetic peripheral neuropathy; IGF-I; NP; DPN; insulin-like growth factor I; ENFD; VAS; NPS; nerve growth factor; Neuropathy Pain Scale; epidermal nerve fiber density; glycosylated hemoglobin; VEGF; PEMF; Patient's Global Impression of Change; Electromagnetic fields; NGF; visual analog scale; neuropathic pain; pulsed electromagnetic fields; PGIC; vascular endothelial growth factor; Rehabilitation; insulin-like growth factor II; HbA1C; IGF-II; Endocrinopathy; Nervous system diseases; Diabetes mellitus; Pain; Reeducation; Orthopedics; Pulsed field; Electromagnetic field; Neuralgia; Neurological disorder; Repair
• ISSN: 0003-9993; 1532-821X
• DOI: 10.1016/j.apmr.2009.01.019

Abstract Weintraub MI, Herrmann DN, Smith AG, Backonja MM, Cole SP. Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial. Objective To determine whether repetitive and cumulative exposure to low-frequency pulsed electromagnetic fields (PEMF) targeting painful feet can reduce neuropathic pain (NP), influence sleep in symptomatic diabetic peripheral neuropathy (DPN), and influence nerve regeneration. Design Randomized, double-blind, placebo-controlled parallel study. Setting Sixteen academic and clinical sites in 13 states. Participants Subjects (N=225) with DPN stage II or III were randomly assigned to use identical devices generating PEMF or sham (placebo) 2 h/d to feet for 3 months. Interventions Nerve conduction testing was performed serially. Main Outcome Measures Pain reduction scores using a visual analog scale (VAS), the Neuropathy Pain Scale (NPS), and the Patient's Global Impression of Change (PGIC). A subset of subjects underwent serial 3-mm punch skin biopsies from 3 standard lower limb sites for epidermal nerve fiber density (ENFD) quantification. Results Subjects (N=225) were randomized with a dropout rate of 13.8%. There was a trend toward reductions in DPN symptoms on the PGIC, favoring the PEMF group (44% vs 31%; P =.04). There were no significant differences between PEMF and sham groups in the NP intensity on NPS or VAS. Twenty-seven subjects completed serial biopsies. Twenty-nine percent of PEMF subjects had an increase in distal leg ENFD of at least 0.5 SDs, while none did in the sham group ( P =.04). Increases in distal thigh ENFD were significantly correlated with decreases in pain scores. Conclusions PEMF at this dosimetry was noneffective in reducing NP. However neurobiological effects on ENFD, PGIC and reduced itching scores suggest future studies are indicated with higher dosimetry (3000–5000 G), longer duration of exposure, and larger biopsy cohort.