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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