- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03484728
The Interaction Between Conditioned Pain Modulation and Expectation in Understanding the Placebo Effect of Pain Reduction
연구 개요
상세 설명
Conditioned pain modulation (CPM) has recently been coined for the psychophysical protocols that assess the functioning of descending pain inhibitory pathways in humans. There is a growing body of evidence points to the important role of spinal serotonin (5-HT) and noradrenaline (NA) in mediation of pain inhibition via CPM. On the other hand, there is also evidence on synergistic modulatory effect of the opioidergic control on CPM, however this issue is under debates. It seems therefore, that pre-treatment CPM assessment may be relevant for prediction of analgesic drug interaction and additive effects.
Placebo effects are inherent to every treatment and significantly contribute to clinical outcomes even in the presence of strong verum analgesic effects. From a psychological point of view, a series of recent studies supported the nature of the placebo effect as a learning phenomenon wherein verbally-induced expectations, cued and contextual conditioning or social learning are considered as the core mechanisms to produce a benefit. Placebo analgesic effects can be elicited by verbal instructions that generate anticipation for a benefit, thus creating expectations of analgesia. The effect of placebo is, primarily mediated by mu-receptors associated opioidergic neurotransmission. Alike brain structures activated by placebo manipulations, prefrontal cortex, cingulate cortex, PAG and RVM are the most important brain structures involved in initiating of opioid-mediated anti-nociception.
An interesting question that emerges is the extent of overlap between the serotono-noradrenergic analgesia represented by CPM, and opioidergic analgesia represented by expectation-based placebo manipulation, for pain reduction. It seems that the final pathway for the two systems is the descending analgesia tract(s). It is unclear, though, if such final common pathway dictates a limited analgesic effect, i.e., it can only be activated to a certain extent, regardless of which system activates it, and therefore additive effects of expectation and CPM are limited to a certain ceiling. Alternatively, different tracts of descending pain inhibition are activated by each system, and the analgesic effect is additive.
Cognitive cortical brain potentials (especially, a P300 waveform) evoked in response to a combination of rare and frequent innocuous sensory stimuli represent a neurophysiological tool for assessment attention. As this test bases on uncertainty and the expectation of upcoming stimuli, the recording of P300 may be relevant for evaluation cognitive processes associated with expectation-related placebo analgesia.
The main aim of this study is to explore the interaction between serotono-noradrenergic and opioidergic systems of analgesia in healthy subjects. More specifically, the investigator will study whether these two systems work in an additive or a complementary way, and whether the neurophysiological assessment of individual expectation capabilities can predict the placebo magnitude.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Haifa, 이스라엘
- Rambam Medical center, Neurology Department
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- attention deficit.
- pain disorders.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: High-expectation placebo manipulation
application of nonactive body cream on forearm for 10 minutes
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application of nonactive body cream on forearm
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다른: Low-expectation placebo manipulation
application of nonactive body cream on forearm for 10 minutes
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application of nonactive body cream on forearm
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in pain perception
기간: up to 2 weeks
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pain units on a scale of 0-100.
0 no pain.
100 = the maximum pain
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up to 2 weeks
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Change in conditioned pain modulation (CPM)
기간: up to 2 weeks
|
change in pain units on a scale of 0-100.
0 no pain.
100 = the maximum pain
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up to 2 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 574-17_RMB_CTIL
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
placebo manipulation에 대한 임상 시험
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SEFA HAKTAN HATIK완전한
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Newish Biotech (Wuxi) Co., Ltd.아직 모집하지 않음
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Chiesi Farmaceutici S.p.A.아직 모집하지 않음
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Nature's Sunshine Products, Inc.아직 모집하지 않음