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The Use of Transcutaneous Magnetic Stimulation to Treat Painful Diabetic Neuropathy

Peripheral neuropathy is the most common complication in individuals with diabetes.1 Less than one third of individuals with painful diabetic peripheral neuropathy (DPN) achieve greater than 50% pain relief with pharmacologic treatment.2 There is an unmet need for therapies that manage pain and improve quality of life. Transcutaneous magnetic stimulation (TCMS) is effective in treating multiple neurologic conditions.3,4 Studies assessing the effect of TCMS on pain associated with DPN have used low intensity stimulation with conflicting results.5,6 Thus far, no studies have examined peripherally delivered high intensity (1.2 Telsa) TCMS in painful DPN. This pilot study evaluated the safety and efficacy of high intensity TCMS delivered to the feet of participants with painful DPN and was approved by the University of Maryland School of Medicine Institutional Review Board. Treatment consisted of a single session of 1.2 Tesla magnetic pulses delivered to the plantar and dorsal surfaces of the foot. Each surface received 50 pulses with a 6 second pulse period over 5 minutes. Pain was measured using the Numeric Pain Rating Scale (pain level: 1-10) after 10 steps in stocking feet on a hard floor surface. Pain scores were collected from each foot and then averaged. Scores were recorded before treatment and followed for 28 days after treatment. Funding for the TCMS device was provided by Zygood, LLC. Study data were independently collected and analyzed by investigators. A total of ten participants were enrolled, one of which was lost to follow-up. For the nine individuals who completed the study, the mean duration of diabetes was 24.3 years and the mean duration of neuropathy was 11.7 years. Baseline hemoglobin A1c (HbA1c) was 7.77%, (only available for 7 of the participants). Prior to treatment, baseline pain in each foot was measured. Participants had an average pain score of 5.72 ± 0.97 (mean ± SD). Immediately post-treatment, pain decreased to 1.22 ± 1.79, a 78% improvement, with 5 individuals reporting no pain, i.e., 100% improvement. Reductions in pain were significant up to 7 days post-treatment (P = .0295) (Figure 1). Treatment success, a 3 point or greater decrease in pain from baseline one day post-treatment, was experienced by 6 participants. Immediately after TCMS treatment, pain improvement did not correlate with diabetes duration (P = .3818), neuropathy duration (P = .5704), or HbA1c (P = .4409) At 7 days post-treatment, pain improvement correlated with lower HbA1c (P = .0297). 1026943 DSTXXX10.1177/19322968211026943Journal of Diabetes Science and TechnologyRao et al. research-article2021