Actively Recruiting

Phase Not Applicable
Age: 19Years - 85Years
All Genders
Healthy Volunteers
NCT06574165

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

Led by VA Office of Research and Development · Updated on 2025-10-28

60

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Veterans with fibromyalgia aged 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 in at least 4 of 5 regions
  • Symptoms present at a similar level for at least 3 months
  • Diagnosis of fibromyalgia valid despite other illnesses
  • PTSD symptoms with moderate or higher severity and total severity score 50 or higher
  • Age-matched Veterans without fibromyalgia
Not Eligible

You will not qualify if you...

  • Neurological disorder
  • Body mass index over 40
  • Chronic kidney disease
  • Severe cardiac conditions including chronic heart failure, stenosis, history of cardiac arrest, defibrillator, or angina
  • Ischemic heart disease
  • Daily opioid use for 90 days
  • Use of beta-blockers
  • Inability to consent or significant cognitive impairment such as dementia
  • MRI contraindications
  • Pregnancy
  • For Veterans without fibromyalgia: active use of medications affecting pain responses

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States, 35233-1927

Actively Recruiting

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Research Team

T

Taylor L Taylor

CONTACT

A

Alayne D Markland, DO MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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