Recruiting

Pain Assessment

Sponsor:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Code:

NCT07829497

Conditions

Rheumatic Diseases

Lupus Erythematosus, Systemic

Lupus Vasculitis, Central Nervous System

Arthritis

Spondylarthritis

Eligibility Criteria

Sex: All

Age: 9 - 70+

Healthy Volunteers: Not accepted

Interventions

Bedside quantitative sensory testing

Study Details

Brief summary:

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.

Conditions

Rheumatic Diseases

Lupus Erythematosus, Systemic

Lupus Vasculitis, Central Nervous System

Arthritis

Spondylarthritis

Study ID

NCT07829497

Start date

Nov 16, 2026

Status verified date

Oct 30, 2026

Completion date

Jun 15, 2036

Anticipated

Primary completion date

Jun 15, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 70+

Healthy Volunteers: Not accepted

  • 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. To be enrolled in either of the ongoing NIAMS protocols 01-AR-0227, 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.

Study Design

Enrollment

225 participants

Anticipated

Interventions and Outcome Measures

Arms

Adult patients

Who are suspected or diagnosed with rheumatic diseases

Healthy adult volunteer

Who do not have or are not suspected to have rheumatic diseases

Minor healthy volunteer aged 9 and above

Who do not have or are not suspected to have rheumatic diseases

Minor patients aged 9 and above

Who are suspected or diagnosed with rheumatic diseases

Interventions

Bedside quantitative sensory testing

It involves measuring a participant's response to standardized stimuli such as light touch, vibration, heat, cold, pressure, and sharp sensation. A qualified health professional will use various tools to stimulate the participant's nerves and record their response.

Primary outcome measure

  • Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST). [ Time Frame: Enrollment/baseline visit6 month visit (optional) 12 month visit (optional)18 month visit (optional) 24 month visit (optional)Unscheduled visit (optional) ]

Central Contacts and Locations

Central contacts

Lubna K Hooda, R.N.

(301) 480-1391lubna.hooda@nih.gov

Sarfaraz A Hasni, M.D.

(301) 451-1599hasnisa@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Yenealem Temesgen-Oyelakin, B.S.N.

301-451-4990yenealem.temesgen-oyelakin@nih.gov

Lubna Hooda, B.S.N.

(301) 480-1391lubna.hooda@nih.gov

More Information

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Last update posted

Nov 3, 2026

Last verified

Oct 30, 2026

Keywords

  • Pain Phenotyping
  • Rheumatic Diseases
  • Observational Study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.