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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

Inclusion Criteria for Veterans living with FM:

- 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.

Inclusion Criteria for Veterans living without FM:

(1) 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: 1. Active use of medications affecting pain responses. 2. Neurological disorder. 3. Body mass index > 40. 4. MRI contraindications. 5. Pregnancy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06574165
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	VA Office of Research and Development
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Taylor L Taylor
Principal Investigator Affiliation	Birmingham VA Medical Center, Birmingham, AL
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	U.S. Fed
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibromyalgia

Additional Details

The investigators propose to recruit 20 Veterans with FM and 20 Veterans without FM who will undergo magnetic resonance spectroscopy imaging (MRSI) scans, pain assessments, and semi-structured interviews. They will undergo a 6-week moderate intensity continuous training exercise intervention and follow-up MRSI scans, pain assessments, and semi-structured interviews. The investigators central hypothesis is that dispositional trait styles, neuroinflammation, and inflammation will be associated with pain outcomes and exercise will induce beneficial anti-inflammatory changes. The research objective of this proposal is two-fold: 1) to acquire data on the associations between dispositional trait styles, neuroinflammation, inflammation, and pain in Veterans with FM and 2) to develop a Veteran-informed exercise program with potential to modify dispositional trait styles, neuroinflammation, inflammation, and pain in Veterans with FM.

Arms & Interventions

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

Interventions

Behavioral: - 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, they will also be asked to wear a heart rate monitor to measure mean pulse during their exercise sessions.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Recruiting

Address

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233-1927

Site Contact

Taylor L Taylor

[email protected]

205-996-7937

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