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Pain Phenotyping of Rheumatic Diseases - An Observational Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
9 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Procedures mentioned: Questionnaires, Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients with rheumatic diseases may have up to 2 more visits if they have a disease flare-up."
  • "Questionnaires: They will rate their overall health, quality of life, and any disease activity."
  • "Physical exam and History review: They will provide information about their medical history and physical exam will be performed by a clinician."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the body and brain feel pain in people with and without rheumatic diseases. These diseases can affect joints, muscles, bones, and other body parts. The study is for people ages 9 to 85 with a known or suspected rheumatic disease and ongoing pain, and for healthy volunteers.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 9 to 85 years old.
  • For the disease group: have a known or suspected rheumatic disease and ongoing pain.
  • For healthy volunteers: have no known rheumatic disease or other long-term illness.
  • Be willing to follow all study steps and be available for the whole study.
  • Be able to understand and willing to sign a form agreeing to take part.
  • Be enrolled in NIAMS study 01-AR-0227, 94-AR-0066, or 11-AR-0223.
  • Be able to answer questions about your health in English or Spanish.

Who can't join

  • Receive an experimental drug or other experimental treatment during this study.
  • Have a finding on a physical exam that makes touch, heat, cold, or pressure testing unsuitable.
  • Have a delay in development or problems with thinking that make it hard to understand or follow test instructions.
  • Use illegal or street drugs. Taking prescribed pain medicine does not rule you out.
  • Have a long-term health problem that the study leader decides may make it hard to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. 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 sites (1)

MD