18 and older, any sex, with Neuropathic Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Evaluation of Spontaneous Pain ScoresPrimary· 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 wit
Baseline
Group
Value
95% CI
Active Transcutaneous Magnetic Stimulation
53.52
± 21.01
Sham Transcutaneous Magnetic Stimulation
49.13
± 22.61
1 week post treatment
Group
Value
95% CI
Active Transcutaneous Magnetic Stimulation
41.41
± 30.09
Sham Transcutaneous Magnetic Stimulation
46.17
± 26.54
4 weeks post treatment
Group
Value
95% CI
Active Transcutaneous Magnetic Stimulation
38.92
± 29.16
Sham Transcutaneous Magnetic Stimulation
37.52
± 30.01
Evaluation of Evoked Pain Scores: StrokingSecondary· 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 represe
Baseline
Group
Value
95% CI
Active Transcutaneous Magnetic Stimulation
33.55
± 31.07
Sham Transcutaneous Magnetic Stimulation
24.78
± 25.59
1 week post treatment
Group
Value
95% CI
Active Transcutaneous Magnetic Stimulation
30.74
± 23.78
Sham Transcutaneous Magnetic Stimulation
20.04
± 24.10
4 weeks post treatment
Group
Value
95% CI
Active Transcutaneous Magnetic Stimulation
26.92
± 21.90
Sham Transcutaneous Magnetic Stimulation
21.35
± 25.21
Evaluation of Evoked Pain Scores: Von FreySecondary· 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 sens
Baseline
Group
Value
95% CI
Active Transcutaneous Magnetic Stimulation
53.97
± 27.04
Sham Transcutaneous Magnetic Stimulation
43.13
± 26.84
1 week post treatment
Group
Value
95% CI
Active Transcutaneous Magnetic Stimulation
46.89
± 25.98
Sham Transcutaneous Magnetic Stimulation
36.22
± 26.22
4 weeks post treatment
Group
Value
95% CI
Active Transcutaneous Magnetic Stimulation
49.27
± 24.72
Sham Transcutaneous Magnetic Stimulation
38.26
± 23.08
Sponsor's own description
The proposed study will set the foundation for future multi-center studies. To validate tMS as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with PTP-NP and improving their overall functions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 12 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02979925.