RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-01
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06574165

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Inclusion Criteria (FM)(1) Age 19 years or older;
  2. * Widespread pain index (WPI) 7 and symptom severity scale (SSS) score 5 OR WPI 4-6 and SSS score 9;
  3. * Generalized pain, defined as pain in at least 4 of 5 regions, is present;
  4. * Symptoms have been present at a similar level for at least 3 months;
  5. * A diagnosis of FM is valid irrespective of other diagnoses. A diagnosis of FM does not exclude the presence of other clinically important illnesses;
  6. * 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.
  1. * Neurological disorder
  2. * Body mass index \> 40
  3. * Chronic kidney disease
  4. * Severe cardiac condition (chronic heart failure, stenosis, history of cardiac arrest, defibrillator, angina)
  5. * Ischemic heart disease
  6. * 90 days of daily opioid use
  7. * Beta-blocker
  8. * Inability to consent for study participation (9) Significant cognitive impairment, defined as a known diagnosis of dementia (10) MRI contraindications (11) Pregnancy
  9. 1. Active use of medications affecting pain responses
  10. 2. Neurological disorder
  11. 3. Body mass index \> 40
  12. 4. MRI contraindications
  13. 5. Pregnancy

Contacts and Locations

Study Contact

Taylor L Taylor
CONTACT
(205) 996-7937
Taylor.Taylor@va.gov
Alayne D Markland, DO MSc
CONTACT
(205) 933-8101
alayne.markland@va.gov

Principal Investigator

Taylor L Taylor
PRINCIPAL_INVESTIGATOR
Birmingham VA Medical Center, Birmingham, AL

Study Locations (Sites)

Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233-1927
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Taylor L Taylor, PRINCIPAL_INVESTIGATOR, Birmingham VA Medical Center, Birmingham, AL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2026-10-30

Terms related to this study

Keywords Provided by Researchers

  • Chronic Pain
  • Inflammation
  • Affect
  • Neuroinflammation
  • Fibromyalgia
  • Exercise

Additional Relevant MeSH Terms

  • Fibromyalgia