Status:
RECRUITING
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
Lead Sponsor:
VA Office of Research and Development
Conditions:
Fibromyalgia
Eligibility:
All Genders
19-85 years
Phase:
NA
Brief Summary
Fibromyalgia (FM) is a chronic pain condition that disproportionately impacts Veterans. Individuals diagnosed with FM patients experience lower self-esteem and positive affect, as well as greater leve...
Detailed Description
The investigators propose to recruit 30 Veterans with FM and 30 Veterans without FM who will undergo magnetic resonance spectroscopy imaging (MRSI) scans, pain assessments, and semi-structured intervi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06574165
Start Date
November 1 2024
End Date
October 30 2026
Last Update
October 28 2025
Active Locations (1)
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1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233-1927