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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Miroslav Backonja, M.D.
- 电话号码:(301) 402-5679
- 邮箱:misha.backonja@nih.gov
学习地点
-
-
Maryland
-
Bethesda、Maryland、美国、20892
- National Institutes of Health Clinical Center
-
接触:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- 电话号码:TTY dial 711 800-411-1222
- 邮箱:ccopr@nih.gov
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
- 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).
学习计划
研究是如何设计的?
设计细节
- 观测模型:OTHER
- 时间观点:CROSS_SECTIONAL
队列和干预
团体/队列 |
|---|
|
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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Screening classification of participant health and pain status
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-reported pain and symptom measures
大体时间:Up to 3 days
|
Standardized questionnaires assessing pain and related symptoms. |
Up to 3 days
|
|
Quantitative sensory testing measures
大体时间:Up to 3 days
|
Standardized sensory testing assessing pain-related and sensory responses. |
Up to 3 days
|
合作者和调查者
调查人员
- 首席研究员:Miroslav Backonja, M.D.、National Center for Complementary and Integrative Health (NCCIH)
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 10002552
- 002552-AT
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.