Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia

Study acronym: RAN
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Enrollment closed, study ongoing Show 4 more changesShow less
    • Final enrollment: 30 participants (planned 60)
    • Study completion pushed from Oct 30, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 23 words
    • Site details revised
  2. Notable Enrollment target: 40 to 60
    • Study arms: 1 to 2
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 1 word
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 1, 2024 to Oct 1, 2026
    • Site details revised
    v3
  4. Minor Study arms: 2 to 1
    • Study description shortened, about 4 words
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 levels of depression, anxiety, negative affect, and pain catastrophizing. Among those experiencing FM, clinical and experimental pain are associated with specific dispositional trait profiles, which are indexed by levels of negative affect and positive affect. Neuroinflammation and inflammation also play a role in FM- related affect and pain. Recent studies that have highlighted neuroinflammation and inflammation as physiological mechanisms associated with changes in dysregulated affect and chronic pain. Veterans with FM can ameliorate dispositional traits-i.e., increasing positive affect and reducing negative affect-by participating in exercise. However, a gap exists regarding how to optimally engage Veterans with FM in an exercise program. Thus, to fully take advantage of all potential therapeutic benefits of exercise for FM, there is a critical need to identify those factors underlying exercise engagement for FM pain management. The purpose for this study is to 1) determine associations of dispositional trait styles, neuroinflammation, and inflammation with pain outcomes in Veterans with FM; and 2) develop and design a Veteran-informed exercise program.
Trial Details
NCT Number NCT06574165
Lead Sponsor VA Office of Research and Development
Conditions
(from sponsor)
Fibromyalgia
Related terms Chronic Pain, Fibromyalgia, Inflammation, Motor Activity, Neuroinflammatory Diseases
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov