Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes
1 other identifier
observational
150
1 country
1
Brief Summary
Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that afflicts up to 4% of the general population. The evaluation of pain mechanisms in FM has shown predominant central abnormalities and therefore has been designated as nociplastic pain syndrome. Rheumatoid arthritis (RA) is characterized by polyarthritis and pain from inflamed tissues, consistent with nociceptive pain. FM and RA patients may utilize overlapping pain mechanisms resulting in nociceptive and nociplastic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
March 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
April 28, 2026
June 1, 2025
4.9 years
February 28, 2022
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pressure Pain Thresholds
Using an algometer pressure pain thresholds will be obtained several times at the upper and lower extremities
One hour
Study Arms (3)
Fibromyalgia
Participants who fulfill the 1990 and 2011 American College of Rheumatology Criteria for FM.
Rheumatoid Arthritis
Participants who fulfill the 2010 American College of Rheumatology (ACR)-European League against rheumatism (EULAR) classification criteria for RA.
Healthy Volunteers
Participants who do not have significant pain/fatigue/anxiety/depression.
Eligibility Criteria
This is a case-control study of FM, RA and healthy controls (HC) that will be enrolled in a ratio of 1:1:1. Healthy controls will be aged/gender matched to the FM and RA groups.
You may qualify if:
- Ages 18-70
- Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM
- Fulfills the 2010 ACR-EULAR classification criteria for RA
- Healthy volunteers: No significant pain/fatigue/depression/anxiety.
You may not qualify if:
- Diabetes
- Cancer
- Advanced liver, kidney or cardiovascular disease
- Neuropathic pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland Staud, M.D.
University of Florida
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 14, 2022
Study Start
March 22, 2022
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
April 28, 2026
Record last verified: 2025-06