Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes

NCT ID: NCT05277025

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-22

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Fibromyalgia

Participants who fulfill the 1990 and 2011 American College of Rheumatology Criteria for FM.

No interventions assigned to this group

Rheumatoid Arthritis

Participants who fulfill the 2010 American College of Rheumatology (ACR)-European League against rheumatism (EULAR) classification criteria for RA.

No interventions assigned to this group

Healthy Volunteers

Participants who do not have significant pain/fatigue/anxiety/depression.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland Staud, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Roland Staud, M.D.

Role: CONTACT

352-294-8200

Melyssa M Godfrey, BS

Role: CONTACT

352-265-8901

Facility Contacts

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Melyssa Godfrey

Role: primary

352-265-8901

Other Identifiers

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IRB202200105

Identifier Type: -

Identifier Source: org_study_id

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