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临床试验/NCT05161286
NCT05161286已完成不适用

The Influence of Expectations, Attention and Test Paradigm on the Efficacy of the Pain Processing System

University Ghent1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Conditioned pain modulation (CPM) magnitude (kg/cm²)

研究概览

简要总结

Conditioned pain modulation (CPM) is the endogenous pain relief mechanism responsible for the "pain-inhibits-pain" phenomenon. This mechanism can be activated experimentally, and its efficiency evaluated by experimental pain tests. According to the "pain-inhibits-pain" principle, during such an experimental testing paradigm, a painful test stimulus is typically applied, followed by a conditioning stimulus. The effect of the conditioning stimulus on the test stimulus is examined to determine whether or not the conditioning stimulus elicits an inhibitory effect. With this study, the investigators want to examine in pain-free adults whether and to what extend the efficacy of CPM is influenced by 1) attention (focus versus distraction), 2) intrinsic expectations (pain reduction versus no change versus pain increase) with regard to pain due to the CPM paradigm used, and 3) the order of application of the test stimulus and conditioning stimulus (sequential versus parallel paradigm).

详细描述

Despite the widespread use of CPM by researchers, there is still no gold standard for conducting this test. Both a sequential and a parallel application of the test stimulus and the conditioning stimulus are often used interchangeably and side by side. In both paradigms, the pain intensity or pain threshold of the test stimulus is first determined. Subsequently, in the parallel protocol, the test stimulus is reapplied while simultaneously applying the conditioning stimulus. In the sequential protocol, the conditioning stimulus is applied first, and after removing the latter stimulus, the test stimulus is reapplied (the CPM effect is visible up to 5 minutes after removal of the conditioning stimulus). The difference between the initial and repeated test stimulus (during or after conditioning) is quantified to express the CPM effect.

Even the publication of an expert opinion, which decided in favor of the sequential paradigm, has so far changed little in the use of the two paradigms. In that same publication, international CPM experts considered the sequential order 'purer' than the parallel order, as the results of the latter can be attributed to a shift of attention to the conditioning stimulus. However, this claim has little support from the literature. Some researchers even argue that cognitive mechanisms such as attentional shift might be part of the underlying mechanism of the CPM effect. Existing research also shows that CPM effectiveness is influenced by expectations. For this, previous studies conditioned test subjects by telling them in advance that the conditioning stimulus would reduce or increase pain. However, when the experimental CPM paradigm is used to investigate the effectiveness of the pain-inhibiting system, no such suggestions are made. However, this does not preclude that when the test protocol is explained to the subject, he or she does not create intrinsic expectations regarding the pain that is provoked. However, few studies have investigated this and the results of these studies are inconsistent and therefore do not allow conclusions to be drawn.

The aim of this study is to compare a sequential protocol with a parallel protocol on the one hand, and to measure the influence of expectations, attention and distraction on the CPM effect on the other.

In this study, the test stimulus of the CPM measurement will consist of a mechanical stimulus applied with an analog algometer (Force Dial model FDK 10 and 40 Push Pull Force Gage, Wagner instruments, Greenwich, Connecticut) on the Brachioradialis and Quadriceps muscle of the dominant side. The pressure pain threshold will be determined and used as an outcome measure. The conditioning stimulus consists of immersing the hand (up to 10 cm above the wrist) of the non-dominant side in warm water at a temperature of 45,5°C for 6 minutes. This temperature has been proven to be a reliable stimulus, eliciting solid effects.

At the time of testing, the CPM measurement will therefore be performed four times, each time with a small variation. The order of the variations is determined at random. There is a break of 10 minutes between each performance, so that the effect of the previous performance has worn off. The four variations of the CPM paradigm are the following:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dutch speaking participants (age between 18 and 65 years)
  • Healthy volunteers who have no pain complaints

排除标准

  • Not speaking Dutch
  • A history of serious health issues (e.g. cancer, stroke, epilepsy, diabetes, depression, etc...)
  • History of pain complaints or current pain (e.g. people who suffer from severe migraine, low back pain, neck pain, frozen shoulder, meniscectomy,...)
  • Cognitive, arithmetic or attention disorders
  • Pregnancy or breastfeeding in the past year

结局指标

主要结局

Conditioned pain modulation (CPM) magnitude (kg/cm²)

时间窗: cross-sectional (single test session, day 0)

CPM magnitude is evaluated during 4 different CPM test protocols (sequential, focus, distraction, parallel) and will be compared between these protocols to answer the research questions. The test stimulus (i.e. mean mechanical pain pressure threshold measured at the Brachioradialis and Quadriceps muscle of the dominant side expressed in kg/cm²) is assessed before the application (minute 0) of the conditioning stimulus (i.e. hot thermal water immersion of the hand), and once again at minute 4 during conditioning stimulation (parallel protocol) or at 6 minutes 30 seconds which is 30 seconds after removal of the conditioning stimulus (sequential, focus and distraction protocol). CPM (kg/cm²) magnitude is calculated by subtracting the first test stimulus from the second test stimulus assessment, with a negative CPM value (kg/cm²) denoting pain inhibition, and a positive CPM (kg/cm²) value denoting pain facilitation.

次要结局

  • Sociodemographic and health-related characteristics(cross-sectional (single test session, day 0))
  • Hospital Anxiety and Depression Scale (HADS)(cross-sectional (single test session, day 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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