Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC) Using Deep Learning and Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- Conditioned pain modulation (CPM) profiles
研究概览
简要总结
Chronic pain (CP) is disabling for people triggering important costs for society. A deficit of diffuse noxious inhibitory controls (DNIC) is one of the CP mechanisms. DNICs are evaluated in research setting using a CPM protocol (conditioned pain modulation). There is a lack of reference values on the effectiveness of DNICs. Wider research on DNIC will help to understand CP and to develop a clinical screening test evaluating DNICs. This study aims more specifically to determine whether it is possible to develop a facial recognition system to automate pain measurement and the effectiveness of pain control mechanisms.
详细描述
This study aims:
- To develop and validate a predictive tool (using deep learning and artificial intelligence) to estimate the efficacy of pain control mechanisms.
- To estimate references values for facial expressions of pain control mechanisms in healthy and in chronic pain participants.
The target population will be healthy volunteers and volunteers with chronic pain, male and female, stratified by age.
The reference values (healthy volunteers) will be established via a non-parametric method for a standard conditioned pain modulation (CPM) protocol in which two "stimuli tests" of the same intensity and nature (heat) will be applied before and after the application of another "conditioning stimulus" (cold water bath). The perceived pain difference between the 1st and 2nd stimuli tests will reflect the intensity of the DNICs. Participants' facial expressions will be captured simultaneously by three cameras during the CPM testing.
These results will be compared to those from volunteers suffering with chronic pain. The clinical decision rule will result from clinical and paraclinical elements correlating with the amplitude of the efficacy of CPM (serum noradrenaline, intensity of pain, heart rate and blood pressure measurements, psychometric questionnaires assessing anxiety, depressive feelings and pain catastrophizing). Logistic regression analysis will determine the best predictors of a CPM deficit.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants
- •Inclusion Criteria:
- •18-79 years old
- •No chronic pain
- •Able to provide consent
排除标准
- •Cardiovascular disease (arrhythmia, cerebrovascular accident, infarction...)
- •Raynaud syndrome
- •Severe psychiatric disease (dementia, schizophrenia, psychosis, major depression)
- •Injuries or loss sensitivity to their forearms or hands
- •Pregnant women or in post-partum period (<1 year)
- •Participants with chronic pain
- •Inclusion Criteria:
- •18-79 years old
- •Chronic pain (chronic pain is defined by any regular pain for more than 6 months)
- •Able to provide consent
- •Exclusion Criteria:
- •Cardiovascular disease (arrhythmia, cerebrovascular accident, infarction...)
- •Raynaud syndrome
- •Severe psychiatric disease (dementia, schizophrenia, psychosis, major depression)
- •Injuries or loss sensitivity to their forearms or hands
- •Pregnant women or in post-partum period (<1 year)
- •Chronic pain caused by cancer or migraine
结局指标
主要结局
Conditioned pain modulation (CPM) profiles
时间窗: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
Sensitivity and specificity of the classification algorithm according to different profiles (normal vs altered) of conditioned pain modulation, as defined by the change of pain perception before and after the cold water bath measured by computerized visual analog scale (CoVAS) ranging from 0 \[no pain\] to 100 \[most intense pain that could be tolerated\] in healthy and in chronic pain volunteers together.
Temporal summation profiles
时间窗: Once, at baseline, at recruitment (during the first stimuli test)
Sensitivity and specificity of the classification algorithm according to different profiles (normal vs altered) of temporal summation, as defined by the change of pain perception during the first stimuli test measured by computerized visual analog scale (CoVAS) ranging from 0 \[no pain\] to 100 \[most intense pain that could be tolerated\] in healthy and in chronic pain volunteers together.
次要结局
- Physiologic factors(Once, at baseline, at recruitment)
- Demographic factors(Once, at baseline, at recruitment)
- Psychologic factors(Once, at baseline, at recruitment)
- Conditioned pain modulation (CPM) profiles of healthy volunteers(Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
- Temporal summation profiles of healthy volunteers(Once, at baseline, at recruitment (during the first stimuli test))
- Conditioned pain modulation (CPM) profiles of volunteers with chronic pain(Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli))
- Temporal summation profiles of volunteers with chronic pain(Once, at baseline, at recruitment (during the first stimuli test))
- Facial expressions and postures(Once, at baseline, at recruitment)