NCT02809911

A Study to Evaluate PEMF Therapy on Experimentally Inducted Pain in Subjects With Painful Peripheral Diabetic Neuropathy

A Randomized, Sham-Controlled, Double-Blind, Crossover Study to Evaluate PEMF Therapy on Pain Sensitivity to Different Qualities of Experimentally Induced Pain in Subjects With Painful Peripheral Diabetic Neuropathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Regenesis Biomedical, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity and nervous system response to various qualities of experimentally induced pain in the upper and lower extremities of subjects with painful peripheral diabetic neuropathy.

Detailed description

This is a multi-center, randomized, double-blind, sham-controlled crossover clinical trial conducted on subjects with painful peripheral diabetic neuropathy. Eligible subjects will include those between 22 and 80 years of age with Type 2 diabetes having persistent pain, numbness, tingling, and/or burning in at least one foot. Pain threshold, tolerance to thermal stimuli and pressure response to the induced pain stimuli will be measured at three time points using five standardized experimental pain measures: baseline, after a single 30 minute treatment with active PEMF or sham treatment and after a second 30 minute treatment with active PEMF or sham treatment. Eligible subjects with painful peripheral diabetic neuropathy will undergo Diabetic Screening (Nerve Conduction Velocity, Skin Perfusion Pressure, Ankle-Brachial Index, and Vibratory Testing) in the index foot prior to randomization. Following the Diabetic Screening tests, subjects will return to the research center for the Enrollment/Randomization Visit and complete measures of pain by completing the Brief Pain Inventory (BPI) and functional assessments. Subjects will then be randomly assigned to one of the two groups; control (sham) or experimental (active) device by a research assistant blinded to the device status. Patients will also be randomly assigned to the sequence order of experimental induced pain tests. The ischemic pain testing (SMET) will always be conducted last. Patients will return to the research center within 7 days after the Enrollment/Randomization Visit where they will be crossed over to the other treatment assignment and be randomly assigned to the sequence order of experimental induced pain tests on the same extremity as previously randomized.

Conditions

• Painful Peripheral Diabetic Neuropathy

Interventions

Type	Name	Description
DEVICE	Provant

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-06-22
• Last updated: 2017-03-31
• Results posted: 2017-02-13

Locations

2 sites across 1 country: United States