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Screening Protocol

2 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Pijn

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Geschat)

10000

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

Naam: Miroslav Backonja, M.D.
Telefoonnummer: (301) 402-5679
E-mail: misha.backonja@nih.gov

Studie Locaties

Verenigde Staten
- Maryland
  - Bethesda, Maryland, Verenigde Staten, 20892
    - National Institutes of Health Clinical Center
    - Contact:
      
      NIH Clinical Center Office of Patient Recruitment (OPR)
      
      Telefoonnummer: TTY dial 711 800-411-1222
      
      E-mail: ccopr@nih.gov

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

12 jaar tot 100 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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).

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: OTHER
Tijdsperspectieven: CROSS_SECTIONAL

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Screening classification of participant health and pain status Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Patient-reported pain and symptom measures Tijdsspanne: Up to 3 days	Standardized questionnaires assessing pain and related symptoms.	Up to 3 days
Quantitative sensory testing measures Tijdsspanne: Up to 3 days	Standardized sensory testing assessing pain-related and sensory responses.	Up to 3 days

Medewerkers en onderzoekers

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

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Onderzoekers

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

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

<p>NIH Clinical Center Detailed Web Page</p>

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)

8 november 2026

Primaire voltooiing (Geschat)

2 juli 2050

Studie voltooiing (Geschat)

2 juli 2050

Studieregistratiedata

Eerst ingediend

16 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria