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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
Sun Research Institute
San Antonio, Texas, United States
Multi-Phase Trials, LLC
San Antonio, Texas, United States
Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli
Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored).
Time frame: 4 weeks
Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli
Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored). .
Time frame: 4 weeks
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