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- Title
Efficacy of recurrent transcutaneous magnetic stimulation in the treatment of diabetic peripheral neuropathy: Multicenter randomized trial.
- Authors
Rao, Vishnu P.; Kim, Yoon Kook; Ghazi, Anahita; Park, Jean Y.; Munir, Kashif M.
- Abstract
Aims: Transcutaneous 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. Methods: Thirty‐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. Results: Thirty‐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. Conclusion: In 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 registration: TCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy, https://clinicaltrials.gov/ct2/show/NCT03596203, ID‐NCT03596203.
- Subjects
TREATMENT of diabetic neuropathies; RESEARCH; PAIN measurement; HEALTH outcome assessment; MAGNETOTHERAPY; RANDOMIZED controlled trials; BLIND experiment; RESEARCH funding; DESCRIPTIVE statistics; FOOT; STATISTICAL sampling; PAIN management; EVALUATION
- Publication
Pain Practice, 2023, Vol 23, Issue 8, p914
- ISSN
1530-7085
- Publication type
Article
- DOI
10.1111/papr.13269