Pain Phenotyping of Rheumatic Diseases - An Observational Study

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study ID
NCT07829497
Status
Not Yet Recruiting

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Conditions

  • Ankylosing Spondylarthritis
  • Arthritis
  • Lupus Erythematosus, Systemic
  • Lupus Vasculitis, Central Nervous System
  • Rheumatic Diseases
  • Rheumatoid Arthritis
  • Sjogren's Syndrome
  • Spondylarthritis

Eligibility Criteria

Sex
ALL
Age
9 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Bedside quantitative sensory testing — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Sep 28, 2026
Status verified
Sep 2026
Primary completion
Jun 15, 2033
Completion
Jun 15, 2036

Study Design

Enrollment
225 participants (estimated)

Arms

  • Arm: Adult patients
    Who are suspected or diagnosed with rheumatic diseases
  • Arm: Healthy adult volunteer
    Who do not have or are not suspected to have rheumatic diseases
  • Arm: Minor healthy volunteer aged 9 and above
    Who do not have or are not suspected to have rheumatic diseases
  • Arm: Minor patients aged 9 and above
    Who are suspected or diagnosed with rheumatic diseases

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 18 month visit (optional) 24 month visit Unscheduled visit (optional) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Lubna Hooda, B.S.N.
[email protected]
301-480-1391

Find similar trials in Bethesda, MD

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By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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