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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT02979925

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2019-09-30

Results submitted2021-05-25

View on ClinicalTrials.gov More Neuropathic Pain trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.