Pain Phenotyping of Rheumatic Diseases - An Observational Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lubna K Hooda, R.N.
- Phone Number: (301) 480-1391
- Email: lubna.hooda@nih.gov
Study Contact Backup
- Name: Sarfaraz A Hasni, M.D.
- Phone Number: (301) 451-1599
- Email: hasnisa@mail.nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
Contact:
- Yenealem Temesgen-Oyelakin, B.S.N.
- Phone Number: 301-451-4990
- Email: yenealem.temesgen-oyelakin@nih.gov
-
Contact:
- Lubna Hooda, B.S.N.
- Phone Number: (301) 480-1391
- Email: lubna.hooda@nih.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study team will contact participants who are 9 years and older and are enrolled in NIH protocols 01-AR-0227, 94-AR-0066, and 11-AR-0223, because affected participants in this study must have an established or suspected rheumatologic disease and must also be co-enrolled in one of these protocols. Healthy volunteers may include family members of participants enrolled in these studies. Potential participants may also be identified through the Office of Patient Recruitment, direct outreach to local rheumatologists, internists, and university hospital clinics, or referrals from health care providers. However, these individuals must first be enrolled in one of the NIH protocols listed above before joining this study.
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adult patients
Who are suspected or diagnosed with rheumatic diseases |
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. |
|
Healthy adult volunteer
Who do not have or are not suspected to have rheumatic diseases |
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. |
|
Minor healthy volunteer aged 9 and above
Who do not have or are not suspected to have rheumatic diseases |
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. |
|
Minor patients aged 9 and above
Who are suspected or diagnosed with rheumatic diseases |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 (optional)18 month visit (optional) 24 month visit (optional)Unscheduled visit (optional)
|
Ratings of stimulus intensity and pain will be captured using a 0 (no sensation/no pain) to 10 (most intense sensation/pain imaginable) numerical rating scale. |
Enrollment/baseline visit6 month visit (optional) 12 month visit (optional)18 month visit (optional) 24 month visit (optional)Unscheduled visit (optional)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: Enrollment/baseline visit6 month visit (optional) 12 month visit (optional)18 month visit (optional) 24 month visit (optional)Unscheduled visit (optional)
|
Patient questionnaires will be used to characterize pain and associated symptoms in participants across 10 core pain domains (pain intensity, pain interference, physical functioning, sleep, pain catastrophizing, depression, anxiety, global satisfaction with treatment, substance use screener, and quality of life). Age-specific measures will be utilized according to best practices when necessary. |
Enrollment/baseline visit6 month visit (optional) 12 month visit (optional)18 month visit (optional) 24 month visit (optional)Unscheduled visit (optional)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarfaraz A Hasni, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neuroinflammatory Diseases
- Axial Spondyloarthritis
- Bone Diseases
- Musculoskeletal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Joint Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Infections
- Eye Diseases
- Autoimmune Diseases of the Nervous System
- Spinal Diseases
- Spondylarthropathies
- Ankylosis
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Lacrimal Apparatus Diseases
- Spondylitis
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Encephalitis
- Vasculitis
- Vasculitis, Central Nervous System
- Meningitis
- Meningoencephalitis
- Skin and Connective Tissue Diseases
- Arthritis
- Lupus Erythematosus, Systemic
- Spondylarthritis
- Spondylitis, Ankylosing
- Sjogren's Syndrome
- Arthritis, Rheumatoid
- Rheumatic Diseases
- Lupus Vasculitis, Central Nervous System
Other Study ID Numbers
- 10002670
- 002670-AR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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