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Screening Protocol

17. september 2026 oppdatert av: National Center for Complementary and Integrative Health (NCCIH)

Screening Evaluation of Volunteers for Studies of Pain

This study is a screening evaluation for volunteers who are interested in participating in National Center for Complementary and Integrative Health (NCCIH) research studies about pain and related processes, such as emotion, mood, and decision-making. Screening may include review of medical history, physical exam, vital signs, questionnaires, blood and urine tests, and optional sensory testing to better understand pain and related symptoms. The purpose is to identify and characterize healthy volunteers and people with pain who may be eligible for future NCCIH research studies. This screening study does not test a treatment and has no formal hypothesis.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Smerte

Detaljert beskrivelse

Study Description:

This protocol will serve as a volunteer screening protocol for intramural NCCIH. It will provide a vehicle for recruiting, examination, and preliminary testing of research volunteers for NCCIH studies.

Objectives:

To provide a centralized and standardized service for recruiting, screening, and characterizing volunteers interested to participate in studies of pain and related processes (e.g., emotion, affect, decision-making). Depending on their screening characteristics participants will then be offered opportunities to participate in one or more of the current studies of pain and related processes.

Endpoints:

While records of demographics are kept, there is no planned endpoint.

Studietype

Observasjonsmessig

Registrering (Antatt)

10000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Miroslav Backonja, M.D.
Telefonnummer: (301) 402-5679
E-post: misha.backonja@nih.gov

Studiesteder

Forente stater
- Maryland
  - Bethesda, Maryland, Forente stater, 20892
    - National Institutes of Health Clinical Center
    - Ta kontakt med:
      
      NIH Clinical Center Office of Patient Recruitment (OPR)
      
      Telefonnummer: TTY dial 711 800-411-1222
      
      E-post: ccopr@nih.gov

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

No biospecimens will be retained for future use under this protocol. Blood and urine samples, if collected, are used only for screening or clinical testing and are not stored for future research.

Beskrivelse

INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

Stated interest in, and availability for, participating in NCCIH studies and willingness to comply with the procedures of this protocol.
At least 12 years of age
No identified acute health concerns (i.e. symptomatic uncontrolled diabetes mellitus, congestive heart failure, liver cirrhosis, ongoing cancer (excluding skin basal cell carcinoma and squamous cell carcinoma) as evidenced by screening medical history
Ability to understand and able to provide written informed consent form.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

Have active medical or psychiatric health issues that create additional and substantial adverse risks related to study procedures. Medical examples are the acute complications of medical disease, such as asymptomatic hypertensive urgency, diabetic ketoacidosis, symptomatic hyperthyroidism, and unstable angina. Psychiatric examples are the acute complications of psychiatric disease, such as acute mania, paranoid delusions, or having active panic attacks.
Ongoing substance uses disorder or illicit substance use
Pregnancy

Additional exclusion from optional QST procedures:

Has a major medical condition or medical history that in a clinician's assessment could affect heat sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, or neurological conditions (including stroke and blindness or deafness, a history of brain damage, or psychosis).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Healthy Volunteers Individuals screened under this protocol who are determined to be in good health and without a pain history that would classify them as a participant with pain. These participants may be considered for future NCCIH studies as healthy controls.
Participants With Pain Individuals screened under this protocol who have a current or prior pain history or pain symptoms identified through medical history, examination, questionnaires, or sensory testing. These participants may be considered for future NCCIH studies of pain and related processes.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Screening classification of participant health and pain status Tidsramme: Up to 3 days	Classification of participants as healthy volunteers or participants with pain based on screening history, exam, and protocol-specified assessments.	Up to 3 days

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Patient-reported pain and symptom measures Tidsramme: Up to 3 days	Standardized questionnaires assessing pain and related symptoms.	Up to 3 days
Quantitative sensory testing measures Tidsramme: Up to 3 days	Standardized sensory testing assessing pain-related and sensory responses.	Up to 3 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Etterforskere

Hovedetterforsker: Miroslav Backonja, M.D., National Center for Complementary and Integrative Health (NCCIH)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

NIH Clinical Center Detailed Web Page

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

23. september 2026

Primær fullføring (Antatt)

2. juli 2050

Studiet fullført (Antatt)

2. juli 2050

Datoer for studieregistrering

Først innsendt

16. juli 2026

Først innsendt som oppfylte QC-kriteriene