Trial Outcomes & Findings for Improving Functions in Veterans With Post-traumatic Peripheral Neuropathic Pain (NCT NCT02979925)
NCT ID: NCT02979925
Last Updated: 2021-07-12
Results Overview
Spontaneous pain rating: Spontaneous pain level will be measured by using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
COMPLETED
NA
57 participants
Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
2021-07-12
Participant Flow
Participants were recruited from October 2016 to June 2018 at the VA San Diego Medical Center.
Participant milestones
| Measure |
Active Transcutaneous Magnetic Stimulation
Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
|
Sham Transcutaneous Magnetic Stimulation
Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
28
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Functions in Veterans With Post-traumatic Peripheral Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Active Transcutaneous Magnetic Stimulation
n=28 Participants
Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
|
Sham Transcutaneous Magnetic Stimulation
n=23 Participants
Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.11 years
STANDARD_DEVIATION 17.02 • n=93 Participants
|
50.78 years
STANDARD_DEVIATION 14.04 • n=4 Participants
|
52.61 years
STANDARD_DEVIATION 15.68 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Spontaneous Pain Score
|
53.52 score on a scale
STANDARD_DEVIATION 21.01 • n=93 Participants
|
49.13 score on a scale
STANDARD_DEVIATION 22.61 • n=4 Participants
|
50.44 score on a scale
STANDARD_DEVIATION 22.69 • n=27 Participants
|
PRIMARY outcome
Timeframe: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.Spontaneous pain rating: Spontaneous pain level will be measured by using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
Outcome measures
| Measure |
Active Transcutaneous Magnetic Stimulation
n=28 Participants
Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
|
Sham Transcutaneous Magnetic Stimulation
n=23 Participants
Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
|---|---|---|
|
Evaluation of Spontaneous Pain Scores
Baseline
|
53.52 score on a scale
Standard Deviation 21.01
|
49.13 score on a scale
Standard Deviation 22.61
|
|
Evaluation of Spontaneous Pain Scores
1 week post treatment
|
41.41 score on a scale
Standard Deviation 30.09
|
46.17 score on a scale
Standard Deviation 26.54
|
|
Evaluation of Spontaneous Pain Scores
4 weeks post treatment
|
38.92 score on a scale
Standard Deviation 29.16
|
37.52 score on a scale
Standard Deviation 30.01
|
SECONDARY outcome
Timeframe: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.Stroking evoked pain will be assessed by gently moving a paintbrush over the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
Outcome measures
| Measure |
Active Transcutaneous Magnetic Stimulation
n=28 Participants
Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
|
Sham Transcutaneous Magnetic Stimulation
n=23 Participants
Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
|---|---|---|
|
Evaluation of Evoked Pain Scores: Stroking
Baseline
|
33.55 score on a scale
Standard Deviation 31.07
|
24.78 score on a scale
Standard Deviation 25.59
|
|
Evaluation of Evoked Pain Scores: Stroking
1 week post treatment
|
30.74 score on a scale
Standard Deviation 23.78
|
20.04 score on a scale
Standard Deviation 24.10
|
|
Evaluation of Evoked Pain Scores: Stroking
4 weeks post treatment
|
26.92 score on a scale
Standard Deviation 21.90
|
21.35 score on a scale
Standard Deviation 25.21
|
SECONDARY outcome
Timeframe: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.Punctate evoked pain will be conducted by gently pressing a 5.18 von Frey monofilament against the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
Outcome measures
| Measure |
Active Transcutaneous Magnetic Stimulation
n=28 Participants
Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.
|
Sham Transcutaneous Magnetic Stimulation
n=23 Participants
Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
|
|---|---|---|
|
Evaluation of Evoked Pain Scores: Von Frey
Baseline
|
53.97 score on a scale
Standard Deviation 27.04
|
43.13 score on a scale
Standard Deviation 26.84
|
|
Evaluation of Evoked Pain Scores: Von Frey
1 week post treatment
|
46.89 score on a scale
Standard Deviation 25.98
|
36.22 score on a scale
Standard Deviation 26.22
|
|
Evaluation of Evoked Pain Scores: Von Frey
4 weeks post treatment
|
49.27 score on a scale
Standard Deviation 24.72
|
38.26 score on a scale
Standard Deviation 23.08
|
Adverse Events
Active Transcutaneous Magnetic Stimulation
Sham Transcutaneous Magnetic Stimulation
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 restrictions are in place