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临床试验/NCT02157389
NCT02157389已完成不适用

Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain

Central Institute of Mental Health, Mannheim2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Changes in pain intensity and pain unpleasantness ratings after placebo intervention

研究概览

简要总结

Placebo and nocebo responses have mainly been studied in healthy humans for pharmacological rather than psychological interventions. Moreover, only few studies examined patients or tested how previous experience and attitudes affect placebo and nocebo responses. On the psychological level expectancy and classical conditioning have been identified as two primary mechanisms. Both seem to be important with classical conditioning potentially having more long-term effects and expectancy being more important in nocebo effects. There is some initial evidence from the investigators own research that patients may be more prone to these effects and the investigators have also shown that placebo effects may last up to several years after treatment. The investigators therefore examine previous attitudes to pharmacological interventions for chronic pain in patients with chronic back pain and subdivide them into groups with high of low belief in the respective treatment modality. The investigators then apply a pharmacological placebo and study the interaction between the prevailing attitude (implicit and explicit) and the placebo effect with respect to pain perception but also to neurobiological mechanisms using functional magnetic resonance imaging. In addition to expectancy, conditioning of placebo will be examined and the long-term effects of the intervention will be determined.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female human subjects with chronic back pain (chronic persistent and recurrent pain > 6 months)
  • Age between 18 and 65
  • Voluntary participation.

排除标准

  • Acute or chronic somatic diseases and inflammatory, neuropathic or tumor-related pain
  • Acute and chronic mental disorders according to DSM-IV (except for comorbid anxiety or depression, which are frequent in chronic pain)
  • Insufficient German language skills
  • Cognitive limitations
  • Intake of opioid medication or tranquilizers
  • Metal implants or electric implants that cannot be removed
  • Pregnancy
  • Claustrophobia
  • History of epilepsy, brain trauma, or brain tumor

结局指标

主要结局

Changes in pain intensity and pain unpleasantness ratings after placebo intervention

时间窗: immediatey to one week

次要结局

  • Changes in neuronal activity in response to painful stimulation after placebo administration(immediately)
  • Changes in movement abilities after placebo administration(immediately to one week)

研究者

发起方
Central Institute of Mental Health, Mannheim
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Herta Flor

Prof. Dr. Herta Flor

Central Institute of Mental Health, Mannheim

研究点 (2)

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