Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
RAN
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
October 28, 2025
October 1, 2025
1.9 years
August 21, 2024
October 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
Dispositional Trait Styles
As a measurement of affect, participants will complete the Positive and Negative Affect Schedule and indicate the frequency with which the participants generally experience 10 positive (i.e., interested, excited) and 10 negative (i.e., distressed, upset) feelings. Items are rated ranging from 1 (very slightly or not at all) to 5 (extremely) with a total subscale ranging from 10 to 50.
Baseline to 12 weeks
Feasibility
Feasibility will be percentage of exercise sessions attended.
Baseline to 12 weeks
Clinical Pain Severity
Participants will self-report a number between 0-100 describing the intensity of pain, such that 0= no pain and 100 = the most intense pain imaginable. Any integer from 0 to 100 can be provided.
Baseline to 12 weeks
Pain Threshold
Pain threshold refers to the intensity at which a stimulus is first perceived as painful. Pressure stimuli will be delivered to the participant's forearm and lower back using a handheld pressure algometer. The pressure will gradually increase until the participant responds by pressing a button on a handheld device. For pressure threshold, participants will be instructed to press the button when the sensation "first becomes painful."
Baseline to 12 weeks
Temporal Summation of Pain
Temporal summation refers to a form of endogenous pain facilitation characterized by the perception of increased pain despite constant or even reduced peripheral afferent input. Temporal summation is presumed to be the psychosocial manifestation of wind-up. Wind-up is a phenomenon where repetitive stimulation of C primary afferents at rates greater that 0.3 Hertz produces a slowly increasing response of second-order neurons in the spinal cord. Temporal summation will be assessed using a nylon monofilament calibrated to bend a 300g of pressure on the back of the hand and lower back. Participants will be instructed to provide a verbal 0-100 rating of pain following a single contact of the monofilament. Then, participants will be instructed to provide another 0-100 rating of pain following a series of 10 contacts of the monofilament. This procedure will repeated twice at each location and pain ratings will be averaged across the two trials.
Baseline to 12 weeks
Conditioned Pain Modulation
A routinely used quantitative sensory testing protocol for the measurement of endogenous pain inhibition is conditioned pain modulation, which refers to the reduction in pain from one stimulus (the test stimulus) produced by the application of a second pain stimulus at a remote body site (the conditioning stimulus). Conditioned pain modulation is believed to reflect the perceptual manifestation of diffuse noxious inhibitory controls, whereby ascending projections from one noxious stimulus activate supraspinal structures that trigger descending inhibitory projections to the dorsal horn. Participants will undergo four cold pressor immersions that consists of placing the non-dominant hand, up to the wrist, into circulating cold water for up to 1 minute and will provide a 0-100 rating of pain. Following each immersion, a handheld force algometer will be applied to either the forearm or lower back and press a handheld button to indicate when the pressure first becomes painful.
Baseline to 12 weeks
C-reactive protein
A marker of pro-inflammation from blood draws
Baseline to 12 weeks
Tumor necrosis factor- alpha
A marker of pro-inflammation from blood draws
Baseline to 12 weeks
Interleukin-6
A marker of pro-inflammation from blood draws
Baseline to 12 weeks
Interleukin- 10
A marker of pro-inflammation from blood draws
Baseline to 12 weeks
Interleukin- 8
A marker of pro-inflammation from blood draws
Baseline to 12 weeks
Myo-inositol
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
Baseline to 12 weeks
N-acetylaspartate
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
Baseline to 12 weeks
Choline
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
Baseline to 12 weeks
Lactate
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
Baseline to 12 weeks
Creatine
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
Baseline to 12 weeks
Brain Temperature
marker of neuroinflammation using absolute brain temperatures (in °C) from magnetic resonance spectroscopy imaging.
Baseline to 12 weeks
Exercise Benefits and Barriers
Participants will be asked to complete the Exercise Barriers and Benefits Scale that assesses perceived benefits and barriers to exercise to rank agreement with 29 statements, where 4='strongly agree' and 1='strongly disagree.'
Baseline to 12 weeks
Exercise Perceptions
Semi-structured interviews will be conducted around topics related to current exercise behavior and any barriers the participants have to current exercise behavior, and will elicit participants' views on what an ideal exercise program would be.
Baseline to 12 weeks
Study Arms (2)
Moderate Intensity Continuous Training
EXPERIMENTAL20 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.
Waitlist Control
NO INTERVENTION10 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
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.
Eligibility Criteria
You may qualify if:
- 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
- Age-matched to participant with FM
You may not qualify if:
- 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
- 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
- Active use of medications affecting pain responses
- Neurological disorder
- Body mass index \> 40
- MRI contraindications
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233-1927, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taylor L Taylor
Birmingham VA Medical Center, Birmingham, AL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 27, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 30, 2026
Last Updated
October 28, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share