Recruiting

Observational StudyRelationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia

Sponsor:

VA Office of Research and Development

Code:

NCT06574165

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Interventions

Moderate Intensity Continuous Training

Study Details

Brief 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.

Conditions

Fibromyalgia

Study ID

NCT06574165

Start date

Nov 1, 2024

Status verified date

Oct, 2025

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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, participants will also be asked to wear a heart rate monitor to measure mean pulse during exercise sessions.

no intervention: Waitlist Control

10 Veterans living with fibromyalgia and 10 Veterans living without fibromyalgia will undergo a 6-week waitlist control. This will include phone call check-ins on the participant's pain symptoms twice weekly. At completion of the final study visit the participants will be offered the option to participate in the exercise intervention.

Interventions

Moderate Intensity Continuous Training

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, participants will also be asked to wear a heart rate monitor to measure mean pulse during exercise sessions.

Primary outcome measure

Dispositional Trait Styles [ Time Frame: Baseline to 12 weeks ]
Feasibility [ Time Frame: Baseline to 12 weeks ]
Clinical Pain Severity [ Time Frame: Baseline to 12 weeks ]
Pain Threshold [ Time Frame: Baseline to 12 weeks ]
Temporal Summation of Pain [ Time Frame: Baseline to 12 weeks ]
Conditioned Pain Modulation [ Time Frame: Baseline to 12 weeks ]
C-reactive protein [ Time Frame: Baseline to 12 weeks ]
Tumor necrosis factor- alpha [ Time Frame: Baseline to 12 weeks ]
Interleukin-6 [ Time Frame: Baseline to 12 weeks ]
Interleukin- 10 [ Time Frame: Baseline to 12 weeks ]
Interleukin- 8 [ Time Frame: Baseline to 12 weeks ]
Myo-inositol [ Time Frame: Baseline to 12 weeks ]
N-acetylaspartate [ Time Frame: Baseline to 12 weeks ]
Choline [ Time Frame: Baseline to 12 weeks ]
Lactate [ Time Frame: Baseline to 12 weeks ]
Creatine [ Time Frame: Baseline to 12 weeks ]
Brain Temperature [ Time Frame: Baseline to 12 weeks ]
Exercise Benefits and Barriers [ Time Frame: Baseline to 12 weeks ]
Exercise Perceptions [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Taylor L Taylor

(205) 996-7937 Taylor.Taylor@va.gov

Alayne D Markland, DO MSc

(205) 933-8101 alayne.markland@va.gov

Locations

Birmingham VA Medical Center, Birmingham, AL

Recruiting

Birmingham, Alabama, United States, 35233-1927

Contacts

Taylor L Taylor

205-996-7937 Taylor.Taylor@va.gov

Alayne D Markland, DO MSc

(205) 933-8101 alayne.markland@va.gov

Principal Investigator:

Taylor L Taylor

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

Chronic Pain
Inflammation
Affect
Neuroinflammation
Fibromyalgia
Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-28.