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Pain Phenotyping of Rheumatic Diseases - An Observational Study

31 października 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

225

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

9 lat do 85 lat (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

  • 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Adult patients

Who are suspected or diagnosed with rheumatic diseases
Urządzenie: 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
Urządzenie: 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
Urządzenie: 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
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST).
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Quality of life
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

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

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

16 listopada 2026

Zakończenie podstawowe (Szacowany)

15 czerwca 2033

Ukończenie studiów (Szacowany)

15 czerwca 2036

Daty rejestracji na studia

Pierwszy przesłany

17 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 września 2026

Pierwszy wysłany (Rzeczywisty)

21 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 października 2026

Ostatnia weryfikacja

30 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 10002670
  • 002670-AR

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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