Clinical trial NCT04896827: DNIC Using Deep Learning and Artificial Intelligence
Official title: Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC) Using Deep Learning and Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Chronic Pain
Keywords: Conditioned pain modulation (CPM)
Diffuse Noxious Inhibitory Controls (DNIC)
Pressure pain threshold (PPT)
Reference values
Clinical decision rule
Deep learning
Artificial intelligence
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Lucine
name: Centre for Research of CHUS (CRCHUS)
First posted: 2021-05-21
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female volunteers, with and without chronic pain.

Brief summary: 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.

Detailed description: This study aims:

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.

Eligibility criteria: Healthy participants

Inclusion Criteria:

* 18-79 years old
* No chronic pain
* 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)

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

Primary outcomes:
measure: Conditioned pain modulation (CPM) profiles
timeFrame: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
measure: Temporal summation profiles
timeFrame: Once, at baseline, at recruitment (during the first stimuli test)
Secondary outcomes:
measure: Conditioned pain modulation (CPM) profiles of healthy volunteers
timeFrame: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli
measure: Temporal summation profiles of healthy volunteers
timeFrame: Once, at baseline, at recruitment (during the first stimuli test)
measure: Conditioned pain modulation (CPM) profiles of volunteers with chronic pain
timeFrame: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
measure: Temporal summation profiles of volunteers with chronic pain
timeFrame: Once, at baseline, at recruitment (during the first stimuli test)
measure: Demographic factors
timeFrame: Once, at baseline, at recruitment
measure: Psychologic factors
timeFrame: Once, at baseline, at recruitment
measure: Physiologic factors
timeFrame: Once, at baseline, at recruitment
measure: Facial expressions and postures
timeFrame: Once, at baseline, at recruitment
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Guillaume Léonard, PhD
role: PRINCIPAL_INVESTIGATOR
References: