Fibromyalgia Clinical Trial
— fMRIOfficial title:
Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia
Verified date | July 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 difficult to treat chronic pain condition that is often treated with opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans returning from the gulf war and is already a significant burden in senior Veterans who may have suffered with chronic pain for decades already. Many treatment options for fibromyalgia carry intolerable side effects. PENFS (percutaneous electrical neural field stimulation) is a FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA system, but sufficient evidence regarding its outcomes and neural mechanisms have not been adequately investigated. An understanding of its neural underpinnings and analgesic effects could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3) development of new techniques to address pain.
Status | Completed |
Enrollment | 27 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
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. 70,71 - 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 implantation. - 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. - Subjects must not have a concurrent autoimmune or inflammatory disease that causes pain such as systemic lupus erythematosus, inflammatory bowel disease or rheumatoid arthritis, since this could decrease the effect of treatment. |
Country | Name | City | State |
---|---|---|---|
United States | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Gebre M, Woodbury A, Napadow V, Krishnamurthy V, Krishnamurthy LC, Sniecinski R, Crosson B. Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. JMIR Res Protoc. 2018 Feb 6;7(2):e39. doi: 10.2196/resprot.8692. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fcMRI as a Biomarker to Investigate Functionally Correlated Neural Substrates of Pain in Patients Undergoing PENFS | 2 weeks following the final treatment, subjects in the PENFS group were be evaluated for changes in functional connectivity between the right posterior insula seed and other areas of the DMN as evaluated by fcMRI relative to standard treatment controls, using whole brain analysis. The measurement is increase/decrease of signal in a given region, thresholded at p <0.05, summarized into a value representing 'size of region of increase' or 'size of region of decrease' after subjects scans were combined/mapped onto a standard MNI brain. Only clusters of over 40 voxels were included, and the size of the region is reported in voxel size. The averaged brains for baseline fcMRI was subtracted from post-treatment for each group, and then these averaged differences were subtracted from each other. While other areas of the brain met threshold criteria in the analysis, only areas belonging to the DMN are reported. | baseline and 2 weeks post-treatment | |
Secondary | Change in Defense Veterans Pain Rating Scale (DVPRS) From Baseline | For fibromyalgia patients, pain will be assessed in the PENFS group relative to standard treatment controls, as indicated by analgesic Defense and Veterans Pain Rating Scale (DVPRS) at 2, 6 and 12 weeks follow-up. This is a validated pain measure that includes a 0-10 scale where 0 means no pain and 10 means greatest pain imaginable. Higher scores indicate worse reported pain outcomes. | 2, 6 and 12 weeks follow-up | |
Secondary | Change in Pain Interference With "Activity," "Sleep," "Mood", and "Stress" From Baseline | Pain interference scores were measured using supplemental questions on the Defense and Veterans Pain Rating Scale (DVPRS). Participants were asked to evaluate on a scale of 0-10 the level to which pain interfered with their "activity," "sleep," "mood", and "stress," with 10 being the worst interference, and 0 being no interference. | 2, 6 and 12 weeks follow-up | |
Secondary | Change in Number of Bicep Curls From Baseline (Left Arm) | Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (left arm) participants could perform using were measured over a 30-second period at each visit. | 2, 6 and 12 weeks follow-up | |
Secondary | Change in Number of Bicep Curls From Baseline (Right Arm) | Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (right arm) participants could perform using were measured over a 30-second period at each visit. | 2, 6 and 12 weeks follow-up | |
Secondary | Change in Sit-to Stand Test From Baseline | Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full sit-to-stands participants could perform were measured over a 30-second period at each visit. | 2, 6 and 12 weeks follow-up |
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