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

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ClinicalTrials.gov Identifier: NCT02809911
Recruitment Status : Completed
First Posted : June 22, 2016
Results First Posted : February 13, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Regenesis Biomedical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Painful Peripheral Diabetic Neuropathy
Intervention Device: Provant
Enrollment 41
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Sham of Provant Active Provant
Hide Arm/Group Description

Sham of Provant Therapy System

Provant

Active Provant Treatment

Provant

Period Title: Overall Study
Started 22 [1] 19 [1]
Completed 22 [2] 19 [2]
Not Completed 0 0
[1]
This is the Initial Treatment Population (subjects that started the Enrollment Visit / Visit 2)
[2]
This is the Initial Treatment Population (subjects that completed the Enrollment Visit / Visit 2)
Arm/Group Title Sham of Provant Active Provant Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 22 19 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 19 participants 41 participants
63  (12.14) 63.8  (12.38) 63.4  (12.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
Female
14
  63.6%
9
  47.4%
23
  56.1%
Male
8
  36.4%
10
  52.6%
18
  43.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
Hispanic or Latino
11
  50.0%
7
  36.8%
18
  43.9%
Not Hispanic or Latino
11
  50.0%
11
  57.9%
22
  53.7%
Unknown or Not Reported
0
   0.0%
1
   5.3%
1
   2.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   9.1%
3
  15.8%
5
  12.2%
White
19
  86.4%
16
  84.2%
35
  85.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.5%
0
   0.0%
1
   2.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 19 participants 41 participants
22 19 41
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 22 participants 19 participants 41 participants
30.6  (4.89) 29.4  (5.17) 30  (5)
1.Primary Outcome
Title Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sham of Provant Active Provant
Hide Arm/Group Description:

Sham of Provant Therapy System

Provant

Active Provant Treatment

Provant

Overall Number of Participants Analyzed 22 19
Measure Type: Number
Unit of Measure: Number of tests favoring arm/group
6 14
2.Primary Outcome
Title Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes subjects in the Initial Treatment Group (Those subjects treated with either Provant or Sham at the Enrollment Visit)
Arm/Group Title Sham of Provant Active Provant
Hide Arm/Group Description:

Sham of Provant Therapy System

Provant

Active Provant Treatment

Provant

Overall Number of Participants Analyzed 22 19
Measure Type: Number
Unit of Measure: Number of tests favoring arm/group
16 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham of Provant Active Provant
Hide Arm/Group Description

Sham of Provant Therapy System

Provant

Active Provant Treatment

Provant

All-Cause Mortality
Sham of Provant Active Provant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sham of Provant Active Provant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham of Provant Active Provant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Heather Vander Ploeg
Organization: Regenesis Biomedical
Phone: 602-4287041
Responsible Party: Regenesis Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02809911     History of Changes
Other Study ID Numbers: RBI.2016.002
First Submitted: June 20, 2016
First Posted: June 22, 2016
Results First Submitted: October 26, 2016
Results First Posted: February 13, 2017
Last Update Posted: March 31, 2017