Exploring pain and inflammation in Veterans with fibromyalgia
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
NA · VA Office of Research and Development · NCT06574165
This study is testing how a 6-week exercise program can help reduce pain and improve emotional well-being in Veterans with fibromyalgia by looking at the connections between their feelings, inflammation in the brain, and pain levels.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06574165 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationships between emotional states, neuroinflammation, and clinical pain in Veterans diagnosed with fibromyalgia. It aims to recruit 20 Veterans with fibromyalgia and 20 without, who will undergo magnetic resonance spectroscopy imaging (MRSI) scans, pain assessments, and interviews. Participants will engage in a 6-week moderate intensity exercise program, with follow-up assessments to evaluate changes in pain and emotional well-being. The goal is to understand how exercise can influence neuroinflammation and improve pain outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates include Veterans aged 19 and older who have a diagnosis of fibromyalgia and meet specific pain severity criteria.
Not a fit: Patients with neurological disorders or a body mass index greater than 40 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies and emotional well-being for Veterans with fibromyalgia.
How similar studies have performed: Previous studies have indicated that exercise can positively affect pain and emotional states in fibromyalgia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion Criteria for Veterans living with FM: * Inclusion Criteria (FM) Age 19 years or older * Widespread pain index (WPI) 7 and symptom severity scale (SSS) score 5 OR WPI 4-6 and SSS score 9 * Generalized pain, defined as pain in at least 4 of 5 regions, is present * Symptoms have been present at a similar level for at least 3 months * A diagnosis of FM is valid irrespective of other diagnoses. A diagnosis of FM does not exclude the presence of other clinically important illnesses * PTSD Checklist-Stressor-Specific Version 1 re-experiencing (intrusion) symptom, 3 avoidance (numbing) symptoms, and 2 hyperarousal symptoms, each present at the level of moderate or higher during the past month, and if the total severity score is 50 or higher Inclusion Criteria for Veterans living without FM: * Age-matched to participant with FM Exclusion Criteria: Exclusion Criteria for Veterans living with FM: * Neurological disorder * Body mass index \> 40 * Chronic kidney disease * Severe cardiac condition (chronic heart failure, stenosis, history of cardiac arrest, defibrillator, angina) * Ischemic heart disease * 90 days of daily opioid use * Beta-blocker * Inability to consent for study participation (9) Significant cognitive impairment, defined as a known diagnosis of dementia (10) MRI contraindications (11) Pregnancy Exclusion Criteria for Veterans living without FM: * Active use of medications affecting pain responses * Neurological disorder * Body mass index \> 40 * MRI contraindications * Pregnancy
Where this trial is running
Birmingham, Alabama
- Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Taylor L Taylor — Birmingham VA Medical Center, Birmingham, AL
- Study coordinator: Taylor L Taylor
- Email: Taylor.Taylor@va.gov
- Phone: (205) 996-7937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, Chronic Pain, Inflammation, Affect, Neuroinflammation, Exercise