Pain Phenotyping of Rheumatic Diseases - An Observational Study
Who can join
Ages 9 to 85 · All sexes · Healthy volunteers welcome
Full eligibility criteria
* INCLUSION CRITERIA Inclusion Criteria for Subjects Suspected or Diagnosed with Rheumatic Diseases In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Aged 9-85 years 3. Diagnosed or suspected of having a rheumatic disease. 4. Ability of the subject to understand and the willingness to sign a written informed consent document or assent. 5. Must be enrolled in one of the NIAMS protocols (01-AR-0227, 94-AR-0066, 11-AR-0223) 6. To be able to answer PRO questionnaires in either English and/or Spanish languages. Inclusion Criteria Healthy Volunteers 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Aged 9-85 years 3. No known history of a rheumatic disease or any other chronic medical illness. 4. Ability of the subject to understand and the willingness to sign a written informed consent document or assent. 5. May also be enrolled in either of the ongoing NIAMS protocols 94-AR-0066 or 11-AR-0223. 6. To be able to answer PRO questionnaires in either English and/or Spanish languages. EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. Treatment with investigational drug or other investigational intervention while enrolled in this study. 2. Any physical exam finding that precludes bedside QST. 3. Developmental delay or cognitive impairment that interfere with following or understanding the test instructions. 4. Subjects using illicit or street drugs will be excluded. Subjects taking prescribed pain medications will not be excluded. 5. Any chronic medical condition that may hinder participation in the study as determined by the study PI.
About the study
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.
What is being tested
- Bedside quantitative sensory testing (device)
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Participants: 225 · Started: Nov 9, 2026
Contact the study team
- Lubna K Hooda, R.N. · Phone: (301) 480-1391
- Sarfaraz A Hasni, M.D. · Phone: (301) 451-1599
Official record on ClinicalTrials.gov — NCT07829497
Locations in the U.S.
| Maryland | National Institutes of Health Clinical Center, Bethesda |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.