Archives of Physical Medicine and Rehabilitation
Volume 90, Issue 7 , Pages 1102-1109 , July 2009

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

Presented in part to the American Academy of Neurology, April 15–16, 2008, Chicago, IL.

  • Michael I. Weintraub, MD

      Affiliations

    • Departments of Neurology and Medicine, New York Medical College, Valhalla, NY
    • Corresponding Author InformationCorrespondence to Michael I. Weintraub, MD, 325 S Highland Ave, Briarcliff, NY 10510
  • ,
  • David N. Herrmann, MD

      Affiliations

    • Department of Neurology, University of Rochester, Rochester, NY
  • ,
  • A. Gordon Smith, MD

      Affiliations

    • Department of Neurology, University of Utah, Salt Lake City, UT
  • ,
  • Misha M. Backonja, MD

      Affiliations

    • Department of Neurology, University of Wisconsin, Madison, WI
  • ,
  • Steven P. Cole, PhD

      Affiliations

    • Department of Psychology, Emory University, Atlanta, GA

  • Image Result

    The CONSORT diagram revealing enrollment and outcomes. A total of 245 subjects were screened, and 225 were randomized and enrolled. A 13.8% dropout occurred (31/225) with no safety issues.

    The CONSORT diagram revealing enrollment and outcomes. A total of 245 subjects were screened, and 225 were randomized and enrolled. A 13.8% dropout occurred (31/225) with no safety issues.

  • Image Result

    Device: Body Energizer.a (A), PEMF and/or identical sham demagnetized device. (B), Subject with feet in place.

    Device: Body Energizer.a (A), PEMF and/or identical sham demagnetized device. (B), Subject with feet in place.

  • Image Result

    Biopsy consort.

    Biopsy consort.

  • Image Result

    Number of ENFD distal leg crossings in (A) PEMF and (B) sham groups. Dark lines indicate increase in density from baseline to 3 months; light lines indicate decrease or no change.

    Number of ENFD distal leg crossings in (A) PEMF and (B) sham groups. Dark lines indicate increase in density from baseline to 3 months; light lines indicate decrease or no change.

  • Image Result

    Scatterplot of total distal thigh ENFD: increase in ENFD was significantly associated with a decrease in NPS 10 (difference) scores (r=−.53; P=.006).

    Scatterplot of total distal thigh ENFD: increase in ENFD was significantly associated with a decrease in NPS 10 (difference) scores (r=−.53; P=.006).

 Supported by Nu-Magnetics, Inc, who shipped coded devices to various sites under the supervision of a statistician. Nu-Magnetics played no role in the study design, data analysis, interpretation of data, or article development.

 Investigational Review Boards at Phelps Memorial Hospital, Sleepy Hollow, NY, and each participating clinical site approved the study protocol and informed consent forms. The clinical trial was preregistered at www.clinicaltrials.gov (NCT 00123136).

 No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.

 Reprints are not available from the author.

PII: S0003-9993(09)00217-2

doi: 10.1016/j.apmr.2009.01.019

Archives of Physical Medicine and Rehabilitation
Volume 90, Issue 7 , Pages 1102-1109 , July 2009