NCT07829497

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Oct 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

October 7, 2026

Expected
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2033

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2036

Last Updated

October 2, 2026

Status Verified

September 22, 2026

Enrollment Period

6.7 years

First QC Date

September 17, 2026

Last Update Submit

October 1, 2026

Conditions

Rheumatic DiseasesLupus Vasculitis, Central Nervous SystemAnkylosing SpondylarthritisSjogren's SyndromeSpondylarthritisRheumatoid ArthritisLupus Erythematosus, SystemicArthritis

Keywords

Pain PhenotypingRheumatic DiseasesObservational Study

Outcome Measures

Primary Outcomes (1)

  • Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST).

    Ratings of stimulus intensity and pain will be captured using a 0 (no sensation/no pain) to 10 (most intense sensation/pain imaginable) numerical rating scale.

    Enrollment/baseline visit6 month visit (optional) 12 month visit 18 month visit (optional) 24 month visit Unscheduled visit (optional)

Secondary Outcomes (1)

  • Quality of life

    Enrollment/baseline visit6 month visit (optional) 12 month visit 18 month visit (optional) 24 month visit Unscheduled visit (optional)

Study Arms (4)

Adult patients

Who are suspected or diagnosed with rheumatic diseases

Device: Bedside quantitative sensory testing

Healthy adult volunteer

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

Device: Bedside quantitative sensory testing

Minor healthy volunteer aged 9 and above

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

Device: Bedside quantitative sensory testing

Minor patients aged 9 and above

Who are suspected or diagnosed with rheumatic diseases

Device: Bedside quantitative sensory testing

Interventions

Bedside quantitative sensory testingDEVICE

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.

Adult patientsHealthy adult volunteerMinor healthy volunteer aged 9 and aboveMinor patients aged 9 and above

Eligibility Criteria

Age9 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study team will contact participants who are 9 years and older and are enrolled in NIH protocols 01-AR-0227, 94-AR-0066, and 11-AR-0223, because affected participants in this study must have an established or suspected rheumatologic disease and must also be co-enrolled in one of these protocols. Healthy volunteers may include family members of participants enrolled in these studies. Potential participants may also be identified through the Office of Patient Recruitment, direct outreach to local rheumatologists, internists, and university hospital clinics, or referrals from health care providers. However, these individuals must first be enrolled in one of the NIH protocols listed above before joining this study.

You may qualify if:

  • 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.

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Treatment with investigational drug or other investigational intervention while enrolled in this study.
  • Any physical exam finding that precludes bedside QST.
  • Developmental delay or cognitive impairment that interfere with following or understanding the test instructions.
  • Subjects using illicit or street drugs will be excluded. Subjects taking prescribed pain medications will not be excluded.
  • Any chronic medical condition that may hinder participation in the study as determined by the study PI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Rheumatic DiseasesLupus Erythematosus, SystemicLupus Vasculitis, Central Nervous SystemArthritisSpondylarthritisSpondylitis, AnkylosingArthritis, RheumatoidSjogren's Syndrome

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMeningoencephalitisCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsVasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesEncephalitisNeuroinflammatory DiseasesMeningitisVascular DiseasesCardiovascular DiseasesVasculitisJoint DiseasesSpondylitisSpinal DiseasesBone DiseasesAxial SpondyloarthritisSpondylarthropathiesAnkylosisXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Sarfaraz A Hasni, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lubna K Hooda, R.N.

CONTACT

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

Sarfaraz A Hasni, M.D.

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 21, 2026

Study Start (Estimated)

October 7, 2026

Primary Completion (Estimated)

June 15, 2033

Study Completion (Estimated)

June 15, 2036

Last Updated

October 2, 2026

Record last verified: 2026-09-22

Locations

US(1)