Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
244 participants
OBSERVATIONAL
2022-04-05
2025-12-31
Brief Summary
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Detailed Description
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1. To develop and validate a predictive tool (using deep learning and artificial intelligence) to estimate the efficacy of pain control mechanisms.
2. 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.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Chronic pain
Patients with chronic pain (n=100)
Conditioned pain modulation test
Conditioned pain modulation (CPM) protocol consist of evaluating pain during a heat test, before and after one conditioning stimulus (cold water bath); 3 cameras will be capturing participants' facial expressions during the tests.
Healthy participants
Healthy participants (n=144)
Conditioned pain modulation test
Conditioned pain modulation (CPM) protocol consist of evaluating pain during a heat test, before and after one conditioning stimulus (cold water bath); 3 cameras will be capturing participants' facial expressions during the tests.
Interventions
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Conditioned pain modulation test
Conditioned pain modulation (CPM) protocol consist of evaluating pain during a heat test, before and after one conditioning stimulus (cold water bath); 3 cameras will be capturing participants' facial expressions during the tests.
Eligibility Criteria
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Inclusion Criteria
* No chronic pain
* Able to provide consent
* 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
* 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
* 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
18 Years
79 Years
ALL
Yes
Sponsors
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Lucine
INDUSTRY
Centre for Research of CHUS (CRCHUS)
UNKNOWN
Université de Sherbrooke
OTHER
Responsible Party
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Principal Investigators
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Guillaume Léonard, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
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Université de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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2021-4227
Identifier Type: -
Identifier Source: org_study_id