At a glance
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A Multi-Center, Double-Blind, Sham-Controlled, Randomized Trial of Dual Field PEMF Therapy [Provant® Therapy System] in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy (DSPN) (The RELIEF Trial)
In Brief
A clinical study evaluating Active Provant Therapy System and Inactive (sham) Provant Therapy System for Diabetic Neuropathy Peripheral. Completed, enrolled 182 participants across 18 sites.
Detailed Summary
Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled, randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment is administered 30 minutes twice daily through a 120-day period (4 months). Part B is a 8-month open-label active treatment extension period designed to collect longer-term data on pain, medication use, quality of life and safety (Part B).Part B of this trial is a an extension period upon completion of Part A.
Study Details
Timeline
Interventions
Treatment with active Provant Therapy System
Treatment with inactive Provant Therapy System