NCT07829497Recruiting
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
Background: Rheumatic diseases can affect the joints, ligaments, tendons, bones, muscles, and skin. They can also cause inflammation, damage body tissues, and change nerve signals in the brain. This can lead to ongoing pain that interferes with daily life. Researchers want to know more about how pain affects the lives of those with rheumatic diseases. Objective: To learn how the body and brain experience pain in people with and without rheumatic diseases. Eligibility: People aged 9 to 85 years with a diagnosed or suspected rheumatic disease and ongoing pain. They must be enrolled in protocols 01-AR-0227, 94-AR-0066, or 11-AR-0223. Healthy volunteers are also needed. Design: All participants will have an initial visit and may have up to 5 follow-up clinic visits spaced about 6 months apart. Each visit may last 3 to 4 hours. Patients with rheumatic diseases may have up to 2 more visits if they have a disease flare-up. All participants will have these procedures at each visit: Bedside quantitative sensory testing (B-QST): The participant's body will be touched with various probes: a cotton tip, a tuning fork, an ice-cold tuning fork, a heat probe, a device that applies pressure, and a probe with a sharp tip. These probes will not cause injury. Participants will describe how the touches feel and rate the intensity on a scale of 1 to 10. Questionnaires: They will rate their overall health, quality of life, and any disease activity. Research blood: Blood will be collected during the visits. Some blood will be used for how environmental factors affect our genes. Physical exam and History review: They will provide information about their medical history and physical exam will be performed by a clinician.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 225 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- 16 Nov 2026
- Primary completion date
- 15 Jun 2033
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Diseases
- Sjögren's disease, Rheumatoid arthritis
- NCT number
- NCT07829497
What you commit to
- Study type: Observational
- Planned participants: 225
- From 16 Nov 2026 to the primary completion date, 15 Jun 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with investigational drug or other investigational intervention while enrolled in this study.
- Subjects using illicit or street drugs will be excluded. Subjects taking prescribed pain medications will not be excluded.
Other illness
- Developmental delay or cognitive impairment that interfere with following or understanding the test instructions.
- Any chronic medical condition that may hinder participation in the study as determined by the study PI.
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any physical exam finding that precludes bedside QST.
Who the study is looking for
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged 9-85 years
- Diagnosed or suspected of having a rheumatic disease.
- Ability of the subject to understand and the willingness to sign a written informed consent document or assent.
- Must be enrolled in one of the NIAMS protocols (01-AR-0227, 94-AR-0066, 11-AR-0223)
- To be able to answer PRO questionnaires in either English and/or Spanish languages.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged 9-85 years
- No known history of a rheumatic disease or any other chronic medical illness.
- Ability of the subject to understand and the willingness to sign a written informed consent document or assent.
- To be enrolled in either of the ongoing NIAMS protocols 01-AR-0227, 94-AR-0066, or 11-AR-0223.
- To be able to answer PRO questionnaires in either English and/or Spanish languages.
Criteria the registry did not label
- INCLUSION CRITERIA
Age in the registry: 9 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.