Screening Protocol

Официальное название

Screening Evaluation of Volunteers for Studies of Pain

Обзор

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....

Подробное описание

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.

Первичные конечные точки

• Screening classification of participant health and pain status [Срок оценки: Up to 3 days]

Вторичные конечные точки (2)

• Patient-reported pain and symptom measures [Срок оценки: Up to 3 days]
• Quantitative sensory testing measures [Срок оценки: Up to 3 days]

Критерии участия

• 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.

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• National Institutes of Health Clinical Center — Bethesda

Идентификаторы

NCT: NCT07712874 · 10002552 · 002552-AT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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