Rheumatic DiseasesNCT07829497
Pain Phenotyping of Rheumatic Diseases - An Observational Study
An observational study of Rheumatic Diseases and Lupus Erythematosus, Systemic, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 85 years
- Conditions the study is for
- Rheumatic Diseases, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System
- What is being tested?
- Bedside quantitative sensory testing
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 15 Jun 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Yenealem Temesgen-Oyelakin, B.S.N., 301-451-4990, yenealem.temesgen-oyelakin@nih.gov
Lubna Hooda, B.S.N., (301) 480-1391, lubna.hooda@nih.gov
About this 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.
Read more
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.
Read the 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.
- Conditions
- Rheumatic Diseases, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System, Arthritis, Spondylarthritis, Ankylosing Spondylarthritis
- Being tested
- Bedside quantitative sensory testing
- Keywords
- Pain Phenotyping, Rheumatic Diseases, Observational Study
- Medical subject headings
- Rheumatic Diseases, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System, Arthritis, Spondylarthritis, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside quantitative sensory testingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients | Who are suspected or diagnosed with rheumatic diseases Receives: Device: Bedside quantitative sensory testing | |
| Healthy adult volunteer | Who do not have or are not suspected to have rheumatic diseases Receives: Device: Bedside quantitative sensory testing | |
| Minor healthy volunteer aged 9 and above | Who do not have or are not suspected to have rheumatic diseases Receives: Device: Bedside quantitative sensory testing | |
| Minor patients aged 9 and above | Who are suspected or diagnosed with rheumatic diseases Receives: Device: Bedside quantitative sensory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment/baseline visit6 month visit (optional) 12 month visit 18 month visit (optional) 24 month visit Unscheduled visit (optional)
Secondary outcomes (1)
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.
Measured: Enrollment/baseline visit6 month visit (optional) 12 month visit 18 month visit (optional) 24 month visit Unscheduled visit (optional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start29 Oct 2026 (estimated)
- Primary completion15 Jun 2033 (estimated)
- Study completion15 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sarfaraz A Hasni, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829497
- Sponsor's protocol ID
- 10002670
- Other IDs
- 002670-AR
- Status last verified
- 22 Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Phenotyping of Rheumatic Diseases - An Observational Study
- ClinicalTrials.gov ID
- NCT07829497
- Acronym / sponsor ID
- 10002670
- Conditions
- Rheumatic Diseases, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System, Arthritis, Spondylarthritis, Ankylosing Spondylarthritis
- Keywords
- Pain Phenotyping, Rheumatic Diseases, Observational Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 15 Jun 2033 (estimated)
- Study completion
- 15 Jun 2036 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult patients | – | Device: Bedside quantitative sensory testingWho are suspected or diagnosed with rheumatic diseases |
| Healthy adult volunteer | – | Device: Bedside quantitative sensory testingWho do not have or are not suspected to have rheumatic diseases |
| Minor healthy volunteer aged 9 and above | – | Device: Bedside quantitative sensory testingWho do not have or are not suspected to have rheumatic diseases |
| Minor patients aged 9 and above | – | Device: Bedside quantitative sensory testingWho are suspected or diagnosed with rheumatic diseases |
Who may qualify
- Ages
- 9 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside quantitative sensory testingIt 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. | Device | Adult patients, Healthy adult volunteer, Minor healthy volunteer aged 9 and above, Minor patients aged 9 and above |
Primary outcome
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 18 month visit (optional) 24 month visit 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.
1 secondary outcome
Quality of life
Time frame: Enrollment/baseline visit6 month visit (optional) 12 month visit 18 month visit (optional) 24 month visit Unscheduled visit (optional)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarfaraz A Hasni, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases and Lupus Erythematosus, Systemic, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lubna K Hooda, R.N. ((301) 480-1391, lubna.hooda@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 18 month visit (optional) 24 month visit Unscheduled visit (optional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.