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临床试验/NCT05994118
NCT05994118招募中不适用

Exploring the Role of Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports

University of Haifa2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Within-subjects variability of day-to-day clinical pain reports

研究概览

简要总结

This study attempt to identify whether and how factors known or considered to be related with analgesic placebo effect or variability of pain reports separately, may contribute to their coupling. Among these factors - personal traits such as optimism, focus of attention, suggestibility, and short-term memory along with characteristics of stress and relaxation. Additionally, the role of pain sensitivity and the individual's pain modulation profile in the relationship between analgesic placebo effect and variability of pain reports will be examined.

详细描述

Data will be collected from 130 patients with non-specific chronic back pain that will be recruited for a prospective cross-sectional study. To characterize the main study variables, the participants will undergo the Focused analgesia selection test (FAST) which evaluates within-subjects variability of pain reports, and placebo manipulation containing administration of an inert injection accompanied by a verbal suggestion, which is expected to produce placebo effects. The involvement of additional factors considered associated with the within-subjects variability of pain reports and the placebo response will be explored. Stress and well-being characteristics will be examined by measuring cortisol levels in saliva and in hair, salivary level of Secretory Immune globulin A (SIgA), and an autonomic nervous system function and a stress perception questionnaire. Personal traits such as suggestibility, optimism, and Focus of attention, will be examined using questionnaires. Memory will be assessed by memory task, and factors related to the pain modulation system will be examined using psychophysical tests, and a pain sensitivity questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Literate adults
  • Aged 18 - 80 years
  • A diagnosis of chronic back pain
  • Sufferings from back pain during the last 3 months or more, with an intensity of 3 or more on a 0-10 NRS

排除标准

  • Mental retardation or cognitive impairment
  • Pregnancy or breast-feeding
  • Malignancy and a diagnosis of malignant disease

结局指标

主要结局

Within-subjects variability of day-to-day clinical pain reports

时间窗: 7 days before study visit

The variance of within person pain scores reported on a 0-100 Visual Analog Scale VAS during 7 days via pain-dairy at baseline

Reduction of pain following placebo injection

时间窗: Half an hour after injection

The reduction in pain intensity on the 0-100 numerical rating scale (NRS) after normal saline injection

次要结局

  • The Focused Analgesia selection task (FAST)(Once, at baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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