Randomized Controlled Trial of CES for Fibromyalgia
Fibromyalgia
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Pain, Fibromyalgia, Magnetic Resonance Imaging, Cranial Electrical Stimulation, Myofascial Pain Syndromes, Veterans
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Atlanta VA Medical and Rehab Center, Decatur, GA
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
True CES
Sham CES
Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to cranial electrical stimulation (CES), which involves transfer of current from the alpha-stim device using earclip electrodes. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. The treatments can be self administered by the participants. The rs-fcMRI evaluation of neural changes and assessment of clinical pain, function, and quality of life will be performed at the beginning and end of the study.
Veterans with fibromyalgia who meet study criteria and are randomized to the sham comparator group will receive standard therapy in addition to a CES device that does not deliver active electrical stimulation. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. The rs-fcMRI evaluation of neural changes and assessment of clinical pain, function, and quality of life will be performed at the beginning and end of the study.