Pain Phenotyping of Rheumatic Diseases - An Observational Study

Study Description:

Pain is one of the most common presenting complaints across all rheumatic diseases. Pain is often complex, and can be debilitating with symptoms resulting from a combination of underlying mechanisms, such as nociceptive pain, neuropathic pain, and nociplastic pain. A better characterization of pain in rheumatic diseases is needed to improve pain management. With this study we aim to better phenotype pain in rheumatic diseases by using patient reported outcomes and bedside quantitative sensory testing.

Objectives:

Primary Objective:

To gain a deeper understanding of the distinct pain mechanisms in rheumatic diseases to ultimately improve pain management and treatment outcomes for individuals with these conditions. To compare these measures with age- and sex-matched healthy controls.

Secondary Objectives:

• Explore associations between pain phenotypes and disease activity/progression.
• Investigate the impact of pain phenotypes on patient-reported outcomes (PROs) and quality of life (QOL) in comparison with the age and sex matched healthy volunteers

Endpoints:

Primary Endpoint:

Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST). Establish age- and sex-adjusted norms derived from healthy volunteers.

Secondary Endpoints:

• Explore associations between pain phenotypes and disease activity/progression. Investigate the impact of pain phenotypes on patient-reported outcomes (PROs) and quality of life (QOL).
• Establish an age- and sex-matched baseline for QOL. Patient demographics and standard measures of disease activity and damage are to be collected at the time of performing QST.

• 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:

• 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.

Inclusion criteria

Healthy Volunteers

• 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.

Exclusion criteria

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.