- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02166164
Characterization of Secondary Hyperalgesia in Healthy Volunteers
In this prospective trial we aim to investigate the intra-individual and inter-individual variance in secondary hyperalgesia following pain elicited by the experimental pain model: Brief Thermal Sensitization.
Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia.
연구 개요
상태
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2100
- Department of anaesthesia and surgery, 4231, Rigshospitalet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age >18 years and <35 years
- Speak and understand Danish
- Male gender
- Test subjects who have understood and signed the informed consent
- No prescription medicine during the last 30 days
Exclusion Criteria:
- Test subjects that cannot cooperate to the test
- Test subjects with an alcohol and/or substance abuse, assessed by the investigator
- Test subjects, who have consumed one or several types of analgesics 2 <days before the study
- Test subjects, who have consumed antidepressant medication during the last 30 days before the study
- Test subjects with chronic pain
- Test subjects with psychiatric diagnoses
- Test subjects with tattoos on the extremities
- Body Mass Index of >30 or <18
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Experiemental pain models
all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold.
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연구 참가자의 피부의 작은 영역을 섭씨 45도로 3분 동안 가열한 다음 이차 통각과민을 평가합니다.
다른 이름들:
A small area of the skin of the study participants are heated to 45 degrees celsius for 1 minute.
During the 1 minute period, the study participant will continually report pain on an electronic visual analog scale.
다른 이름들:
The threshold for heat pain are evaluated by heating a small area of the study participants skin. When the study participant feels pain, the temperature (degrees celsius) is registered. 4 threshold measurements per session. Heat pain threshold is defined as the average temperature of the 4 measurements.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in area of secondary hyperalgesia following brief thermal sensitization
기간: Study day 1, 2, 3, and 4. A minimum of 4 weeks.
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To determine the intra- and inter-individual variance, and the inter- and intra-observer variance of the secondary hyperalgesia areas following brief thermal sensitization on 4 separate experimental days with two different observers.
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Study day 1, 2, 3, and 4. A minimum of 4 weeks.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Score of Pain Catastrophizing Scale
기간: 7 days
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How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia?
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7 days
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Score of Hospital Anxiety and Depression Scale
기간: 7 days
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How precise does the score of the Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia?
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7 days
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Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale
기간: 7 days
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How precise do the subscales in the two psychological tests (PCS-rumination, PCS-magnification, PCS-helplessness, and HADS-Anxiety, HADS-Depression) predict the size of the area of secondary hyperalgesia?
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7 days
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Heat-pain-detection threshold registered by degrees celsius
기간: 1 minute per session
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How precise do the Heat-pain-detection threshold evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Heat-pain-detection threshold on 4 separate experimental days with 1 session per experimental day.
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1 minute per session
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Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale
기간: 1 minute per session
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How precise does the Max.
VAS-score following Long Thermal Stimulation evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Long Thermal Stimulation on 4 separate experimental days with 1 session per experimental day.
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1 minute per session
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Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.
기간: 1 minute per session
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How precise does the VAS-Area Under the Curve following Long Thermal Stimulation evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Long Thermal Stimulation on 4 separate experimental days with 1 session per study day.
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1 minute per session
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공동 작업자 및 조사자
수사관
- 연구 책임자: Jørgen B Dahl, MD, Doc. Med, Consultant, Department of anaesthesiology, dep. Z, Bispebjerg Hospital, Denmark
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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