Trial Outcomes & Findings for A Study to Evaluate PEMF Therapy on Experimentally Inducted Pain in Subjects With Painful Peripheral Diabetic Neuropathy (NCT NCT02809911)

Last Updated: 2017-03-31

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-03-31

Participant Flow

Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.

Participant milestones

Participant milestones
Measure	Sham of Provant Sham of Provant Therapy System Provant	Active Provant Active Provant Treatment Provant
Overall Study STARTED	22	19
Overall Study COMPLETED	22	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham of Provant n=22 Participants Sham of Provant Therapy System Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.	Active Provant n=19 Participants Active Provant Treatment Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.	Total n=41 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 12.14 • n=5 Participants	63.8 years STANDARD_DEVIATION 12.38 • n=7 Participants	63.4 years STANDARD_DEVIATION 12.10 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	19 participants n=7 Participants	41 participants n=5 Participants
BMI	30.6 kg/m^2 STANDARD_DEVIATION 4.89 • n=5 Participants	29.4 kg/m^2 STANDARD_DEVIATION 5.17 • n=7 Participants	30 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.

Outcome measures

Outcome measures
Measure	Sham of Provant n=22 Participants Sham of Provant Therapy System Provant	Active Provant n=19 Participants Active Provant Treatment Provant
Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli	6 Number of tests favoring arm/group	14 Number of tests favoring arm/group

PRIMARY outcome

Timeframe: 4 weeks

Population: Includes subjects in the Initial Treatment Group (Those subjects treated with either Provant or Sham at the Enrollment Visit)

Outcome measures

Outcome measures
Measure	Sham of Provant n=22 Participants Sham of Provant Therapy System Provant	Active Provant n=19 Participants Active Provant Treatment Provant
Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli	16 Number of tests favoring arm/group	4 Number of tests favoring arm/group

Adverse Events

Sham of Provant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Provant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather Vander Ploeg

Regenesis Biomedical

Phone: 602-4287041

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication Rights. Independent analysis and/or publication of data is not permitted without the prior written consent of the sponsor. Such consent may be contingent on sponsor review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.
Publication restrictions are in place

Restriction type: OTHER