title: Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial.
abstract: 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.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled parallel study.
  
  
  METHODS
  Sixteen academic and clinical sites in 13 states.
  
  
  METHODS
  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.
  
  
  METHODS
  Nerve conduction testing was performed serially.
  
  
  METHODS
  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.
authors: Department of Neurology, New York Medical College, Valhalla, NY, USA. miwneuro@pol.net
authors: Michael I
authors: MI
authors: Weintraub
authors: David N
authors: DN
authors: Herrmann
authors: A Gordon
authors: AG
authors: Smith
authors: Misha M
authors: MM
authors: Backonja
authors: Steven P
authors: SP
authors: Cole
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003929:Diabetic Neuropathies / Q000150:complications / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005528:Foot; D006801:Humans; D008297:Male; D008875:Middle Aged; D009412:Nerve Fibers / Q000473:pathology; D009431:Neural Conduction; D009474:Neurons / Q000473:pathology*; D010146:Pain / Q000209:etiology; D059408:Pain Management; D012867:Skin / Q000294:innervation / Q000503:physiopathology; D050781:Transcranial Magnetic Stimulation