Improving Functions in Veterans With Post-Traumatic Peripheral Neuropathic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuropathic Pain
- Sponsor
- VA Office of Research and Development
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Evaluation of Spontaneous Pain Scores
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
This study will only be conducted at the VA hospital in San Diego.
Investigators
Eligibility Criteria
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
- •sports injury
- •knee or hip replacement
Exclusion Criteria
- •Subjects presenting with ANY of the following will NOT be included in the study:
- •Subjects with neuropathic pain due to:
- •diabetic peripheral neuropathy
- •post herpetic neuralgia
- •Human Immunodeficiency Virus
- •chemo/anti-viral therapy
- •trigeminal neuralgia
- •carpal tunnel syndrome
- •subjects whose post-traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral
- •Subjects with pain due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
Outcomes
Primary Outcomes
Evaluation of Spontaneous Pain Scores
Time Frame: 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.
Secondary Outcomes
- Evaluation of Evoked Pain Scores: Stroking(Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.)
- Evaluation of Evoked Pain Scores: Von Frey(Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.)