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Active Not Recruiting NCT06574165

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

Conditions: Fibromyalgia

Sex: All
Ages: 19 Years – 85 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: VA Office of Research and Development

Location: Birmingham VA Medical Center, Birmingham, AL Birmingham Alabama

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 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.

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria for Veterans living with fibromyalgia (FM): * 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 fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses --Post-Traumatic Stress Disorder (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 fibromyalgia (FM): * Age-matched to participant with fibromyalgia Exclusion Criteria: Exclusion Criteria for Veterans living with fibromyalgia (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 * Significant cognitive impairment, defined as a known diagnosis of dementia * Magnetic resonance imaging (MRI) contraindications * Pregnancy Exclusion Criteria for Veterans living without fibromyalgia (FM): * Active use of medications affecting pain responses * Neurological disorder * Body mass index \> 40 * Magnetic resonance imaging (MRI) contraindications * Pregnancy

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06574165). StuddyBuddy aggregates publicly available trial information.