An observational study in Rheumatic Diseases, Lupus Erythematosus, Systemic and Lupus Vasculitis, Central Nervous System, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Recruiting at 1 site in United States. Open to participants aged 9 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Observational
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 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:
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:
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
This study's planned enrollment of 225 is above the median of 139 across 100 observational studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Compared within Sjogren's Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Rheumatic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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:
Inclusion Criteria Healthy Volunteers
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Who are suspected or diagnosed with rheumatic diseases
Device: Bedside quantitative sensory testing
Who do not have or are not suspected to have rheumatic diseases
Device: Bedside quantitative sensory testing
Who do not have or are not suspected to have rheumatic diseases
Device: Bedside quantitative sensory testing
Who are suspected or diagnosed with rheumatic diseases
Device: Bedside quantitative sensory testing
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.
Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST).
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.
Time frame: Enrollment/baseline visit6 month visit (optional) 12 month visit (optional)18 month visit (optional) 24 month visit (optional)Unscheduled visit (optional)
Quality of life
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.
Time frame: Enrollment/baseline visit6 month visit (optional) 12 month visit (optional)18 month visit (optional) 24 month visit (optional)Unscheduled visit (optional)
Plan to share: No
Start is estimated for Nov 2026; primary completion for Jun 2033, 78 months later.
Of 39 observational studies under Sjogren's Syndrome, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 21. This study's planned 78 months is above that.
Start moved 27 times since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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