Safety and Efficacy of Magnetic Peripheral Nerve Stimulation for Treating Painful Diabetic Neuropathy.

OBJECTIVES

Current treatments for painful diabetic neuropathy (PDN) have variable effectiveness and known side effects. Noninvasive magnetic peripheral nerve stimulation (mPNS) provides effective pain relief without the side effects associated with interventional approaches. This study measured the differences in pain relief, sensory, and quality of life improvements using mPNS and conventional medical management (CMM) compared with sham and CMM in patients with PDN.

MATERIALS AND METHODS

A multicenter, randomized clinical trial was conducted from December 2022 to November 2023. Patients were randomized to receive either mPNS and CMM or sham and CMM. Subjects were randomized to treatment groups in a 3:1 ratio to mPNS+CMM or Sham+CMM and observed for 30 days during the double-blinded phase (phase 1). At 30 days, the subjects in the Sham+CMM group could cross over to the mPNS group, initiating phase 2. All patients were followed up for 90 days after the first mPNS treatment. The primary end point was the between-group comparison of the proportion of responders, a subject who experienced ≥50% reduction from baseline in neuropathic pain measured by visual analog scale on day 30. Secondary end points included between-group comparison of percentage change from baseline for pain and numbness scores (days 30/90), responders to mPNS (day 90), and results from other quality-of-life measures (day 90).

RESULTS

After 92 subjects were screened, 71 met the study inclusion/exclusion criteria and were treated. Subjects were similar in the groups, except for sex: 24 men (48%) in the mPNS group (n = 50) and 18 (85.7%) in the sham group (n = 21) (p = 0.0096). In the per-protocol analysis set, the mPNS group had a 72.3% responder rate (day 30) compared with 0% for sham (72.3% difference; 95% CI, 54.3-84.8; p < 0.0001), and 57.8% pain reduction from baseline, with 12.1% for sham. At day 90, mPNS had an 81.4% responder rate with 75.7% average pain reduction.

CONCLUSIONS

The data revealed that mPNS+CMM is superior to Sham+CMM at day 30 when used for treating pain from PDN. mPNS should be considered earlier in the treatment algorithm for PDN.

CLINICAL TRIAL REGISTRATION

The Clinicaltrials.gov registration number for the study is NCT05620225 (https://clinicaltrials.gov/study/NCT05620225). The study was first posted on November 9, 2022, and the first patient was enrolled on December 15, 2022.