Screening Protocol
Screening Evaluation of Volunteers for Studies of Pain
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Miroslav Backonja, M.D.
- 電話番号:(301) 402-5679
- メール:misha.backonja@nih.gov
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892
- National Institutes of Health Clinical Center
-
コンタクト:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- 電話番号:TTY dial 711 800-411-1222
- メール:ccopr@nih.gov
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
- 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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Screening classification of participant health and pain status
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient-reported pain and symptom measures
時間枠:Up to 3 days
|
Standardized questionnaires assessing pain and related symptoms.
|
Up to 3 days
|
|
Quantitative sensory testing measures
時間枠:Up to 3 days
|
Standardized sensory testing assessing pain-related and sensory responses.
|
Up to 3 days
|
協力者と研究者
捜査官
- 主任研究者:Miroslav Backonja, M.D.、National Center for Complementary and Integrative Health (NCCIH)
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 10002552
- 002552-AT
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。