Recruiting

Chronic Pain

Sponsor:

University of Florida

Code:

NCT05277025

Conditions

Fibromyalgia

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Fibromyalgia

Rheumatoid Arthritis

Study ID

NCT05277025

Start date

Mar 22, 2022

Status verified date

Aug, 2026

Completion date

Jul 28, 2027

Anticipated

Primary completion date

Jul 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Pressure Pain Thresholds [ Time Frame: One hour ]

Central Contacts and Locations

Central contacts

Roland Staud, M.D.

352-294-8200staudr@ufl.edu

Melyssa M Godfrey, BS

352-265-8901melyssa.m.g@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Melyssa Godfrey

352-265-8901Melyssa.Godfrey@medicine.ufl.edu

Principal Investigator:

Roland Staud, MD

More Information

Sponsor

University of Florida

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-19.