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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 their 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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 85
Healthy Volunteers: t
View:

• Inclusion Criteria (FM)(1) 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 their total severity score is 50 or higher.

⁃ (1) Age-matched to participant with FM.

Locations
United States
Alabama
Birmingham VA Medical Center, Birmingham, AL
RECRUITING
Birmingham
Contact Information
Primary
Taylor L Taylor
Taylor.Taylor@va.gov
(205) 996-7937
Backup
Alayne D Markland, DO MSc
alayne.markland@va.gov
(205) 933-8101
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 40
Treatments
Experimental: Moderate Intensity Continuous Training
20 Veterans living with fibromyalgia and 20 Veterans living without fibromyalgia will undergo a 6-week structured exercise intervention. The intervention will include twice weekly, center-based, aerobic exercise consisting of continuous treadmill walking. Each center-based session will include 45 minutes of aerobic exercise in addition to balance and flexibility exercises to promote cool-down. During each exercise session, they will also be asked to wear a heart rate monitor to measure mean pulse during their exercise sessions.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov