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Pain Phenotyping of Rheumatic Diseases - An Observational Study

31 oktober 2026 bijgewerkt door: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

225

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

9 jaar tot 85 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Adult patients

Who are suspected or diagnosed with rheumatic diseases
Apparaat: 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.
Healthy adult volunteer

Who do not have or are not suspected to have rheumatic diseases
Apparaat: 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.
Minor healthy volunteer aged 9 and above

Who do not have or are not suspected to have rheumatic diseases
Apparaat: 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.
Minor patients aged 9 and above

Who are suspected or diagnosed with rheumatic diseases
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST).
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of life
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Onderzoekers

  • Hoofdonderzoeker: Sarfaraz A Hasni, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

16 november 2026

Primaire voltooiing (Geschat)

15 juni 2033

Studie voltooiing (Geschat)

15 juni 2036

Studieregistratiedata

Eerst ingediend

17 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 september 2026

Eerst geplaatst (Werkelijk)

21 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

31 oktober 2026

Laatst geverifieerd

30 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 10002670
  • 002670-AR

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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