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Pain Phenotyping of Rheumatic Diseases - An Observational Study

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Start date: Oct 19, 2026 to Oct 20, 2026
  2. Minor Start date: Oct 18, 2026 to Oct 19, 2026
  3. Notable Primary endpoints: details revised at 1 of 1 entry Show 4 more changesShow less
    • Start date: Oct 14, 2026 to Oct 18, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 4 words
  4. Minor Start date: Oct 13, 2026 to Oct 14, 2026v15
  5. Minor Start date: Oct 12, 2026 to Oct 13, 2026v14
Show 12 earlier versionsHide 12 earlier versions
  1. Minor Start date: Oct 11, 2026 to Oct 12, 2026v13
  2. Minor Start date: Oct 8, 2026 to Oct 11, 2026v12
  3. Minor Start date: Oct 7, 2026 to Oct 8, 2026v11
  4. Minor Start date: Oct 6, 2026 to Oct 7, 2026v10
  5. Minor Start date: Oct 5, 2026 to Oct 6, 2026v9
  6. Minor Start date: Oct 4, 2026 to Oct 5, 2026v8
  7. Minor Start date: Oct 1, 2026 to Oct 4, 2026v7
  8. Minor Start date: Sep 30, 2026 to Oct 1, 2026
    • Site contact updated
    v6
  9. Minor Start date: Sep 29, 2026 to Sep 30, 2026v5
  10. Minor Start date: Sep 28, 2026 to Sep 29, 2026
    • Site contact updated
    v4
  11. Minor Start date: Sep 27, 2026 to Sep 28, 2026v3
  12. Minor Start date: Sep 24, 2026 to Sep 27, 2026v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07829497
Lead Sponsor National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions
(from sponsor)
Rheumatic Diseases, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System, Arthritis, Spondylarthritis, Ankylosing Spondylarthritis, Rheumatoid Arthritis, Sjogren's Syndrome
Related terms Arthritis, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System, Rheumatic Diseases, Sjogren's Syndrome, Spondylarthritis, Spondylitis, Ankylosing
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov