Efficacy of recurrent transcutaneous magnetic stimulation in the treatment of diabetic peripheral neuropathy: Multicenter randomized trial

Abstract

AbstractAimsTranscutaneous magnetic stimulation (TCMS) is successful in decreasing pain in several neurologic conditions. This multicenter parallel double‐blind phase II clinical trial is a follow‐up to a pilot study that demonstrated pain relief in patients with diabetic peripheral neuropathy (DPN) treated with TCMS.MethodsThirty‐four participants with confirmed DPN and baseline pain score ≥ 5 were randomized to treatment at two sites. Participants were treated with either TCMS (n = 18) or sham (n = 16) applied to each foot once a week for four weeks. Pain scores using the Numeric Pain Rating Scale after 10 steps on a hard floor surface and answers to Patient‐Reported Outcomes Measurement Information System pain questions were recorded by participants daily for 28 days.ResultsThirty‐one participants completed the study and were analyzed. Average pain scores decreased from baseline in both the groups. The difference in pain scores between TCMS and sham treatments was −0.55 for morning, −0.13 for evening, and −0.34 overall, below the pre‐determined clinically relevant difference of −2. Moderate adverse events that resolved spontaneously were experienced in both treatment arms.ConclusionIn this two‐arm trial, TCMS failed to demonstrate a significant benefit over sham in patient reported pain suggesting a substantial placebo effect in our previous pilot study.Trial registrationTCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy, https://clinicaltrials.gov/ct2/show/NCT03596203, ID‐NCT03596203.