(CR-034) Pulsed Electromagnetic Therapy: A Non-Opioid Means of Reducing Pain and Improving Skin Perfusion Pressure in Diabetic Symmetric Peripheral Neuropathy

In January 2023 the Centers for Disease Control and Prevention estimated 37.3 million Americans have diabetes, with approximately 28.7 million diagnosed and 8.5 million undiagnosed¹. Diabetic neuropathies are the most prominent, disabling, complications of diabetes, specifically distal symmetric peripheral neuropathy (DSPN)². Pain associated with DSPN is attributed to damage of the unmyelinated and small myelinated cutaneous nerve fibers. With progression, the loss of protective sensation leads to further complication, including diabetic foot ulcers, leading to amputations and death³. Current DSPN treatment relies on custom pharmacotherapy, which often includes addictive agents. There continues to be an unmet need for newer safer therapies for DSPN and its underlying pathology. This clinical trial (identifier: NCT03455543, clinicaltrials.gov) was conducted to evaluate the utility of pulsed electromagnetic field therapy (PEMF) for treatment of DSPN pain and examine potential physiological improvements. It was hypothesized that PEMF may reduce pain associated with DPN, providing symptomatic relief, as well as enhancing regional blood flow.

Methods:

A randomized, sham-controlled, double blind, clinical trial was conducted on patients suffered with foot pain associated with DSPN.  Following informed consent, 181 patients with confirmed DSPN were entered into the trial.  Patients were randomized and instructed to apply therapy - i.e. blinded as to either active PEMF* (frequency of 27.12 MHz, pulse duration of 42 ± 4 microseconds, repeated every 1000 ± 25 microseconds), or non-active sham, to their feet for 30 minutes, twice daily and report daily pain scores. Skin perfusion pressure measurements were also collected to assess peripheral arterial disease (PAD) effects.

Results:

Patients in the active arm experienced a 30% reduction in pain from baseline compared to sham (p < 0.05). Though not significant, SPP in the active group trended towards improvement, compared to sham, which trended towards deterioration.

Discussion:

PEMF appears effective as a means to reduce pain associated with DSPN.  PEMF also appears to have some modulatory affect enhancing blood flow in affected tissue. PEMF holds promise for improvement of vascular physiology in microcirculatory dysfunction associated with diabetic PAD, potentially delaying further complications such as DFUs, and warrants additional investigation as to underlying mechanisms and further clinical translation.

Trademarked Items:

References: 1. Centers for Disease Control and Prevention. National Diabetes Statistics Report website. Published May 3, 2023. Accessed May 2, 2023. https://www.cdc.gov/diabetes/data/statistics-report/index.html
2. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: A position statement by the American diabetes association. Diabetes Care. 2017;40(1):136-154. doi:10.2337/dc16-2042
3. Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. New England Journal of Medicine. 2017;376(24):2367-2375. doi:10.1056/nejmra1615439