Improving Functions in Veterans With Post-traumatic Peripheral Neuropathic Pain (NCT02979925) | Clinical Trial Compass
CompletedNot Applicable
Improving Functions in Veterans With Post-traumatic Peripheral Neuropathic Pain
United States57 participantsStarted 2016-11-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
* Subject is willing and able to comply with scheduled visits, treatment plan, daily pain, sleep and all study related assessments and procedures
* Subjects must be literate in the language used in the assessments and pain diary
* Veterans (men or women) of any race or ethnicity who are at least 18 years of age
* Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 7 days after the last session of the assigned treatment
* A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active
* Subject must have chronic peripheral neuropathic pain present for more than 4 months after a traumatic or surgical event per medical history, this may include, for example:
* motor vehicle accident
* fall
* sports injury
* knee or hip replacement
* hernia repair
* thoracotomy
* mastectomy
* focal/localized burns or crush injury
* In addition, to be eligible for inclusion in the study, all subjects must:
* have an average daily Numerical Pain Rating Scale (NPRS) score \>3 during B1; and
* have a spontaneous pain intensity \>30 on 0-100 Mechanical Visual Analogue Scale (M-VAS) to be eligible for randomization
* Must have their…
What they're measuring
1
Evaluation of Spontaneous Pain Scores
Timeframe: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.