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