FibromyalgiaNCT05277025
Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes
An observational study of Fibromyalgia and Rheumatoid Arthritis, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Rheumatoid Arthritis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 28 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- Diabetes
- Cancer
- Advanced liver, kidney or cardiovascular disease
- Neuropathic pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Melyssa Godfrey, 352-265-8901, Melyssa.Godfrey@medicine.ufl.edu
Roland Staud, MD
About this study
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
- Medical subject headings
- Fibromyalgia, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Thresholds
Using an algometer pressure pain thresholds will be obtained several times at the upper and lower extremities
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start22 Mar 2022
- Primary completion28 Jul 2027 (estimated)
- Study completion28 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Staud, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277025
- Sponsor's protocol ID
- IRB202200105
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes
- ClinicalTrials.gov ID
- NCT05277025
- Acronym / sponsor ID
- IRB202200105
- Conditions
- Fibromyalgia, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 28 Jul 2027 (estimated)
- Study completion
- 28 Jul 2027 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Diabetes
- Cancer
- Advanced liver, kidney or cardiovascular disease
- Neuropathic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pressure Pain Thresholds
Time frame: One hour
Using an algometer pressure pain thresholds will be obtained several times at the upper and lower extremities
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roland Staud, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Rheumatoid Arthritis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland Staud, M.D. (352-294-8200, staudr@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Thresholds (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.