Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05277025
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Roland Staud, M.D.
Principal Investigator Affiliation University of Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia, Rheumatoid Arthritis
Arms & Interventions

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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Florida, Gainesville, Florida

Status

Recruiting

Address

University of Florida

Gainesville, Florida, 32610

Site Contact

Melyssa Godfrey

[email protected]

352-265-8901