Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia (RAN)

VA Office of Research and Development

Status: Enrolling

Conditions: Fibromyalgia

Treatments: Behavioral: Moderate Intensity Continuous Training

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06574165

IK1RX004807-01A2 (Other Grant/Funding Number)

F4807-M

Details and patient eligibility

About

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.

Full description

The investigators propose to recruit 30 Veterans with FM and 30 Veterans without FM who will undergo magnetic resonance spectroscopy imaging (MRSI) scans, pain assessments, and semi-structured interviews. The participants 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Moderate Intensity Continuous Training

Experimental group

Description:

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.

Treatment:

Behavioral: Moderate Intensity Continuous Training

Waitlist Control

No Intervention group

Description:

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.