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DNIC Using Deep Learning and Artificial Intelligence

Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC) Using Deep Learning and Artificial Intelligence

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04896827
Enrollment
244
Registered
2021-05-21
Start date
2022-04-05
Completion date
2028-12-01
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERConditioned 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.

Sponsors

Université de Sherbrooke
Lead SponsorOTHER
Lucine
CollaboratorINDUSTRY
Centre for Research of CHUS (CRCHUS)
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Conditioned pain modulation (CPM) profilesOnce, 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 profilesOnce, 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.

Secondary

MeasureTime frameDescription
Conditioned pain modulation (CPM) profiles of healthy volunteersOnce, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuliConditioned 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 \[most intense pain that could be tolerated\] only in healthy volunteers.
Temporal summation profiles of healthy volunteersOnce, at baseline, at recruitment (during the first stimuli test)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 \[most intense pain that could be tolerated\] only in healthy volunteers.
Conditioned pain modulation (CPM) profiles of volunteers with chronic painOnce, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)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 \[most intense pain that could be tolerated\] only in volunteers with chronic pain.
Temporal summation profiles of volunteers with chronic painOnce, at baseline, at recruitment (during the first stimuli test)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 \[most intense pain that could be tolerated\] only in volunteers with chronic pain.
Demographic factorsOnce, at baseline, at recruitmentAssociation of demographic factors (age, gender) with different response profiles of CPM and temporal summation established by the algorithm.
Psychologic factorsOnce, at baseline, at recruitmentAssociation of psychologic factors (anxiety measured with HADS questionnaire) with different response profiles of CPM and temporal summation established by the algorithm.
Physiologic factorsOnce, at baseline, at recruitmentAssociation of physiologic factors (continuous blood pressure, heart rate, electrodermal activity) with different response profiles of CPM and temporal summation established by the algorithm.
Facial expressions and posturesOnce, at baseline, at recruitmentAssociation of facial expressions and postures with different response profiles of CPM and temporal summation established by the algorithm.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORGuillaume Léonard, PhD

Université de Sherbrooke

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026