Fibromyalgia
Conditions
Keywords
Chronic Pain, Inflammation, Affect, Neuroinflammation, Fibromyalgia, Exercise
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.
Detailed 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.
Interventions
BEHAVIORALModerate 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
6-week structured exercise intervention. The intervention will include twice weekly, center-based, aerobic exercise consisting of continuous treadmill walking. 6-week waitlist control group including phone calls twice weekly. The participants will be offered the exercise intervention at the completion of the final study visit.
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creatine | Baseline to 12 weeks | marker of neuroinflammation measured via magnetic resonance spectroscopy imaging. |
| Dispositional Trait Styles | Baseline 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. |
| Feasibility | Baseline to 12 weeks | Feasibility will be percentage of exercise sessions attended. |
| Clinical Pain Severity | Baseline 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 Threshold | Baseline 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 Pain | Baseline 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 Modulation | Baseline 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 protein | Baseline to 12 weeks | A marker of pro-inflammation from blood draws |
| Tumor necrosis factor- alpha | Baseline to 12 weeks | A marker of pro-inflammation from blood draws |
| Interleukin-6 | Baseline to 12 weeks | A marker of pro-inflammation from blood draws |
| Interleukin- 10 | Baseline to 12 weeks | A marker of pro-inflammation from blood draws |
| Interleukin- 8 | Baseline to 12 weeks | A marker of pro-inflammation from blood draws |
| Myo-inositol | Baseline to 12 weeks | marker of neuroinflammation measured via magnetic resonance spectroscopy imaging. |
| N-acetylaspartate | Baseline to 12 weeks | marker of neuroinflammation measured via magnetic resonance spectroscopy imaging. |
| Choline | Baseline to 12 weeks | marker of neuroinflammation measured via magnetic resonance spectroscopy imaging. |
| Lactate | Baseline to 12 weeks | marker of neuroinflammation measured via magnetic resonance spectroscopy imaging. |
| Brain Temperature | Baseline to 12 weeks | marker of neuroinflammation using absolute brain temperatures (in °C) from magnetic resonance spectroscopy imaging. |
| Exercise Benefits and Barriers | Baseline 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 Perceptions | Baseline 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. |
Countries
United States
Contacts
Primary ContactTaylor L Taylor
Backup ContactAlayne D Markland, DO MSc
Outcome results
None listed