Status:
ACTIVE_NOT_RECRUITING
Randomized Controlled Trial of CES for Fibromyalgia
Lead Sponsor:
VA Office of Research and Development
Conditions:
Fibromyalgia
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
Given recent increasing opioid-related deaths and evidence showing against the use of opioids for non-malignant chronic pain, there is growing need for non-narcotic pain management. Fibromyalgia is a ...
Detailed Description
RESEARCH PLAN: In the setting of the opioid epidemic, it is crucial to develop non-pharmacologic treatments for pain and biomarkers to accurately assess pain treatment outcomes. In the present investi...
Eligibility Criteria
Inclusion
- Subjects must be male and female Veterans age 20-60 with a diagnosis of fibromyalgia as diagnosed by a clinician, by chart review, and by the most recent American College of Rheumatology 2010 criteria for the diagnosis of fibromyalgia.
- Subjects must self-report consistent, daily pain (greater than 5 on the VAS) \>90 days.
- Subjects must have intact skin free of infection at the site of electrode placement.
- Subjects must be willing to participate and understand the consent.
- Subjects must be right-handed in order to provide consistency in brain structure and function.
Exclusion
- Subjects must not be currently pregnant, since effects of fMRI and electrical current on the developing fetus are not well-known.
- Subjects must not have an implanted electrical device such as a vagal stimulator, pacemaker, or spinal pain pump, which are not compatible with MRI.
- Subjects must not have a history of seizures or neurologic condition that may alter the structure of the brain.
- Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation.
- Subjects must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.
- Subjects must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will be determined after discussion with the patient regarding their own perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications.
- Subjects must not introduce new medications or treatments for fibromyalgia symptoms during the course of the study to prevent confounding results.
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04115033
Start Date
March 2 2020
End Date
October 31 2025
Last Update
November 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004