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Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT05277025
Collaborator
(none)
150
Enrollment
1
Location
47.3
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes
    Actual Study Start Date :
    Mar 22, 2022
    Anticipated Primary Completion Date :
    Feb 28, 2026
    Anticipated Study Completion Date :
    Feb 28, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Pressure Pain Thresholds [One hour]

      Using an algometer pressure pain thresholds will be obtained several times at the upper and lower extremities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Roland Staud, M.D., University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT05277025
    Other Study ID Numbers:
    • IRB202200105
    First Posted:
    Mar 14, 2022
    Last Update Posted:
    Jun 2, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fibromyalgia
    Chronic Pain

    Study Results

    No Results Posted as of Jun 2, 2022