Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
- NCT ID
- NCT06574165
- Registry status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- VA Office of Research and Development
- Conditions
- Fibromyalgia
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 60 participants (Estimated).
What is being studied
- Behavioral: Moderate Intensity Continuous Training
Who may be eligible
- Ages
- 19 Years to 85 Years
- Sex
- All
- Healthy volunteers accepted
- Yes
ClinicalTrials.gov lists the following eligibility 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
Study locations
1 study location is listed.
Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.
Countries: United States
- Alabama, United States: 1
Sample of listed locations
- Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, 35233-1927, United States — Recruiting
Study details
- Start date
- November 1, 2024
- Primary completion date
- October 1, 2026
- Completion date
- October 30, 2026
- First posted
- August 27, 2024
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT06574165
- Registry last updated
- October 28, 2025
- QualifiedStudies registry data refreshed
- October 2, 2026
- QualifiedStudies record fetched
- October 2, 2026
View NCT06574165 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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