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NCT02979925: PTP-NP

Improving Functions in Veterans With Post-traumatic Peripheral Neuropathic Pain

Completed NA Results posted Last updated 12 July 2021
What this trial tests

NA trial testing Active Transcutaneous Magnetic Stimulation in Neuropathic Pain in 57 participants. Completed in 30 September 2019.

Timeline
1 November 2016
Primary endpoint
30 September 2019
30 September 2019

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment57
Start date1 November 2016
Primary completion30 September 2019
Estimated completion30 September 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

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 Scores Primary · 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
GroupValue95% CI
Active Transcutaneous Magnetic Stimulation53.52± 21.01
Sham Transcutaneous Magnetic Stimulation49.13± 22.61
1 week post treatment
GroupValue95% CI
Active Transcutaneous Magnetic Stimulation41.41± 30.09
Sham Transcutaneous Magnetic Stimulation46.17± 26.54
4 weeks post treatment
GroupValue95% CI
Active Transcutaneous Magnetic Stimulation38.92± 29.16
Sham Transcutaneous Magnetic Stimulation37.52± 30.01
Evaluation of Evoked Pain Scores: Stroking Secondary · 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
GroupValue95% CI
Active Transcutaneous Magnetic Stimulation33.55± 31.07
Sham Transcutaneous Magnetic Stimulation24.78± 25.59
1 week post treatment
GroupValue95% CI
Active Transcutaneous Magnetic Stimulation30.74± 23.78
Sham Transcutaneous Magnetic Stimulation20.04± 24.10
4 weeks post treatment
GroupValue95% CI
Active Transcutaneous Magnetic Stimulation26.92± 21.90
Sham Transcutaneous Magnetic Stimulation21.35± 25.21
Evaluation of Evoked Pain Scores: Von Frey Secondary · 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
GroupValue95% CI
Active Transcutaneous Magnetic Stimulation53.97± 27.04
Sham Transcutaneous Magnetic Stimulation43.13± 26.84
1 week post treatment
GroupValue95% CI
Active Transcutaneous Magnetic Stimulation46.89± 25.98
Sham Transcutaneous Magnetic Stimulation36.22± 26.22
4 weeks post treatment
GroupValue95% CI
Active Transcutaneous Magnetic Stimulation49.27± 24.72
Sham Transcutaneous Magnetic Stimulation38.26± 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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Other recruiting trials for Neuropathic Pain

Currently open trials in the same condition.

Other VA Office of Research and Development trials

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing