Pain Processing in Inflammatory and Non-Inflammatory Chro... | NCT05277025

Studies
Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes

NCT05277025

Sponsor

University of Florida

Status

Recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Fibromyalgia
Rheumatoid Arthritis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2022Actual

Primary Completion Date

Feb 28, 2027Estimated

Completion Date

Feb 28, 2027Estimated

First Submitted Date

Feb 28, 2022

First Submission Date that Met QC Criteria

Mar 11, 2022

First Posted Date

Mar 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

Apr 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

This is a case-control study of FM, RA and healthy controls (HC) that will be enrolled in a ratio of 1:1:1. Healthy controls will be aged/gender matched to the FM and RA groups.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roland Staud, M.D.	Contact	352-294-8200		staudr@ufl.edu
Melyssa M Godfrey, BS	Contact	352-265-8901		melyssa.m.g@ufl.edu

Overall Officials

Name	Affiliation	Role
Roland Staud, M.D.	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida	Recruiting	Gainesville	Florida	32610	United States

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided