Exercise and Fibromyalgia in Veterans
This study is looking at how a 6-week exercise program called Moderate Intensity Continuous Training affects pain, emotions, and brain inflammation (neuroinflammation) in Veterans with fibromyalgia. Researchers want to see if this exercise can help improve pain and emotional well-being by changing these factors. You may be able to join if you are a Veteran aged 19 to 85 with fibromyalgia, experiencing widespread pain and other specific symptoms for at least three months. The study aims to understand the connections between emotions, inflammation, and pain, and to develop an exercise program that could help Veterans with fibromyalgia. The current recruitment status is unclear.
- Study design
- This study plans to enroll 60 Veterans, 30 with fibromyalgia and 30 without. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- Participants will undergo magnetic resonance spectroscopy imaging (MRSI) scans, pain assessments, and semi-structured interviews. They will also participate in a 6-week Moderate Intensity Continuous Training exercise program, with follow-up scans, assessments, and interviews.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 weeks, with assessments at baseline and 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Taylor L Taylor · PRINCIPAL_INVESTIGATOR · Birmingham VA Medical Center, Birmingham, AL
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Dispositional Trait StylesBaseline to 12 weeks
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.
- FeasibilityBaseline to 12 weeks
Feasibility will be percentage of exercise sessions attended.
- Clinical Pain SeverityBaseline to 12 weeks
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.
- Pain ThresholdBaseline to 12 weeks
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."
- Temporal Summation of PainBaseline to 12 weeks
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.
- Conditioned Pain ModulationBaseline to 12 weeks
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.
- C-reactive proteinBaseline to 12 weeks
A marker of pro-inflammation from blood draws
- Tumor necrosis factor- alphaBaseline to 12 weeks
A marker of pro-inflammation from blood draws
- Interleukin-6Baseline to 12 weeks
A marker of pro-inflammation from blood draws
- Interleukin- 10Baseline to 12 weeks
A marker of pro-inflammation from blood draws
- Interleukin- 8Baseline to 12 weeks
A marker of pro-inflammation from blood draws
- Myo-inositolBaseline to 12 weeks
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
- N-acetylaspartateBaseline to 12 weeks
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
- CholineBaseline to 12 weeks
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
- LactateBaseline to 12 weeks
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
- CreatineBaseline to 12 weeks
marker of neuroinflammation measured via magnetic resonance spectroscopy imaging.
- Brain TemperatureBaseline to 12 weeks
marker of neuroinflammation using absolute brain temperatures (in °C) from magnetic resonance spectroscopy imaging.
- Exercise Benefits and BarriersBaseline to 12 weeks
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.'
- Exercise PerceptionsBaseline to 12 weeks
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.