Screening Protocol
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Miroslav Backonja, M.D.
- Número de teléfono: (301) 402-5679
- Correo electrónico: misha.backonja@nih.gov
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center
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Contacto:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Número de teléfono: TTY dial 711 800-411-1222
- Correo electrónico: ccopr@nih.gov
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
- 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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: CROSS_SECTIONAL
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Screening classification of participant health and pain status
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient-reported pain and symptom measures
Periodo de tiempo: Up to 3 days
|
Standardized questionnaires assessing pain and related symptoms. |
Up to 3 days
|
|
Quantitative sensory testing measures
Periodo de tiempo: Up to 3 days
|
Standardized sensory testing assessing pain-related and sensory responses. |
Up to 3 days
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Miroslav Backonja, M.D., National Center for Complementary and Integrative Health (NCCIH)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 10002552
- 002552-AT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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