Trial Outcomes & Findings for Nociceptive Pain Fiber Response (NCT NCT02696070)
NCT ID: NCT02696070
Last Updated: 2018-01-12
Results Overview
The mean percent change in intraepidermal nerve fiber density mean values for mean nerve fibers per millimeter squared from baseline to Day 60 was calculated for each treatment group (value at 60 days minus value at baseline).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
60 days
Results posted on
2018-01-12
Participant Flow
Participant milestones
| Measure |
Sham of Provant
Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
|
Active Treatment
Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
14
|
|
Overall Study
COMPLETED
|
7
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nociceptive Pain Fiber Response
Baseline characteristics by cohort
| Measure |
Sham of Provant
n=8 Participants
Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
|
Active Treatment
n=14 Participants
Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.14 Years
n=5 Participants
|
59 Years
n=7 Participants
|
60.14 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (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
|
8 Count of Participants
n=5 Participants
|
14 Count of Participants
n=7 Participants
|
22 Count of Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 daysThe mean percent change in intraepidermal nerve fiber density mean values for mean nerve fibers per millimeter squared from baseline to Day 60 was calculated for each treatment group (value at 60 days minus value at baseline).
Outcome measures
| Measure |
Sham of Provant
n=7 Participants
Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
|
Active Treatment
n=12 Participants
Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
|
|---|---|---|
|
Changes in Small Nerve Fiber Density by Assessment of a Skin Biopsy Comparing Baseline to Day 60
|
.1 nerve fibers / mm squared
Standard Deviation .53
|
.1 nerve fibers / mm squared
Standard Deviation .45
|
Adverse Events
Sham of Provant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Treatment
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
Results disclosure agreements
- Principal investigator is a sponsor employee Publication Rights. Independent analysis and/or publication of data generated or arising from the performance of this Agreement is not permitted without the prior written consent of Regenesis. Such consent may be contingent on Regenesis' 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