Pain patterns in rheumatic diseases: see if pain works differently in patients and healthy people

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study aims to characterize pain mechanisms in rheumatic diseases using patient-reported outcomes and bedside quantitative sensory testing. It enrolls participants aged 9 to 85 with diagnosed or suspected rheumatic conditions as well as healthy controls, and follows them across up to six visits about six months apart. All visits include patient questionnaires and bedside sensory testing to define pain phenotypes and compare them to age- and sex-matched controls. Primary goals are to establish pain phenotypes and normal reference values, with secondary aims exploring links between pain types and disease activity, progression, and quality of life.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Sarfaraz A Hasni, M.D. — National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Study coordinator: Lubna K Hooda, R.N.
• Email: lubna.hooda@nih.gov
• Phone: (301) 480-1391

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.