Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial

Arch Phys Med Rehabil. 2009 Jul;90(7):1102-9. doi: 10.1016/j.apmr.2009.01.019.


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.

Trial registration: ClinicalTrials.gov NCT00123136.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Diabetic Neuropathies / complications
  • Diabetic Neuropathies / pathology
  • Diabetic Neuropathies / physiopathology
  • Diabetic Neuropathies / therapy*
  • Double-Blind Method
  • Female
  • Foot
  • Humans
  • Male
  • Middle Aged
  • Nerve Fibers / pathology
  • Neural Conduction
  • Neurons / pathology*
  • Pain / etiology
  • Pain Management*
  • Skin / innervation
  • Skin / physiopathology
  • Transcranial Magnetic Stimulation*

Associated data

  • ClinicalTrials.gov/NCT00123136