Clinical and Scientific Assessment of Pain and Painful Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- To enable for the deep, broad, and targeted phenotyping of individuals, in particular those with rare and unusual pain disorders.
研究概览
简要总结
Background:
Researchers want to better understand pain by studying people with and without different kinds of pain. To do this, researchers will expose people to pleasant and unpleasant sensations. They will ask them questions about their pain. Researchers also want to see if these people are eligible for other research studies at the National Center for Complementary and Integrative Health.
Objectives:
To study the experience of pain. Also to find people eligible to join other NIH studies.
Eligibility:
People 12 years and older with and without pain disorders.
Design:
Participants will be screened by phone.
Participants will have one required visit lasting about 2 hours. This may include:
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Medical history
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Physical exam
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Questionnaires about themselves and their pain experience
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Blood and urine tests
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MRI: They will lie on a table that slides into a cylinder. They will feel different sensations while completing tasks on a computer. This lasts 15 minutes to 2 hours.
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Quantitative sensory testing: They will be exposed to different pictures, sounds, tastes, and smells. They will also be exposed to pleasant and unpleasant sensations. These could include:
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Burning, itching, or cold sensations
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Pinpricks
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Pressure and pinches
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Electrocardiogram: Stickers on the chest record heart activity.
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Straps placed around the chest to measure breathing.
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Small sensors on the fingers or palms to measure pulse and sweating.
Participants may have up to 12 other outpatient study visits.
Participants may be recorded at the visits.
详细描述
Objective:
The purpose of this study is to allow for the deep, broad, and targeted phenotyping of persons with or without pain disorders. This protocol will enable NCCIH investigators to describe the clinical aspects of pain disorders, collect scientific measurements for the purpose of making deep phenotypic descriptions, and use the collected data to perform descriptive analyses of pain disorders. The study will also facilitate obtaining information relevant to determining if a person is potentially eligible to participate in other research protocols at NIH, in particular those of the Office of the Clinical Director (OCD) at the National Center for Complementary and Integrative Health (NCCIH). The specific goals of this protocol are the following:
Research:
- To enable the clinical description and phenotyping of research participants, in particular those with pain disorders.
- To facilitate obtaining information relevant to determining potential eligibility of consenting participants to participate in other IRB-approved NIH protocols that focus on pain and related disorders.
- To perform descriptive analyses of painful experiences within discrete pain disorders.
Study Population: The study population will consist of up to 10,000 persons with or without pain disorders, who seek to participate in research protocols at NIH, primarily those sponsored by NCCIH Division of Intramural Research investigators. Human beings of adolescence age or older (>= 12 years) that are willing to provide assent and/or consent may participate in the study. This protocol is open to participants of any ethnicity, gender, or nationality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Are >= 12 years of age
排除标准
- •Have difficulties with communication that make subjective pain assessment impossible or unreliable.
- •Have acute 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 acute panic attacks.
- •Are participating in other ongoing research protocols such that phenotypic measurements would interfere with the conduct of an ongoing protocols or the receipt of a research treatment would influence the phenotypic measurements.
- •Employees or staff that work at NCCIH.
- •Pregnant women
研究组 & 干预措施
Persons, with or without pain disorders
Adults and adolescents with or without pain disorders.
结局指标
主要结局
To enable for the deep, broad, and targeted phenotyping of individuals, in particular those with rare and unusual pain disorders.
时间窗: 36 months
Data are to be collected via medical history, physical examinations, questionnaires, laboratory samples and MRI imaging.
次要结局
- To facilitate obtaining information relevant to determining potential eligibility in IRB-approved NIH protocols, in particular those of the Clinical Investigations Branch of NCCIH.(36 months)