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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05277025
Other study ID # IRB202200105
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 22, 2022
Est. completion date February 28, 2026

Study information

Verified date June 2024
Source University of Florida
Contact Roland Staud, M.D.
Phone 352-294-8200
Email staudr@ufl.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date February 28, 2026
Est. primary completion date February 28, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Diabetes - Cancer - Advanced liver, kidney or cardiovascular disease - Neuropathic pain

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure Pain Thresholds Using an algometer pressure pain thresholds will be obtained several times at the upper and lower extremities One hour
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