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Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC)

Reference Values of Diffuse Noxious Inhibitory Controls (DNIC) Intensity in a Healthy Adult Population and Develop a Clinical Test to Evaluate DNIC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03376867
Acronym
DNIC
Enrollment
468
Registered
2017-12-19
Start date
2017-11-27
Completion date
2024-12-30
Last updated
2024-02-15

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

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.

Detailed description

This study aims: 1. To establish baseline values of DNICs using CPM protocol 2. To identify the variables that will be integrated in the algorithm of the clinical screening test (clinical decision rule). First the target population will be healthy volunteers, male and female, stratified by age. The reference values will be established via a non-parametric method for a standard CPM protocol in which two different pain stimuli are applied. 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. Secondly, these results will be compared to those from volunteers suffering of 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

Conditioned pain modulation (CPM) protocol consist of evaluating pain during two stimuli test (heat and pressure point), before and after one conditioning stimulus (cold water bath); Blood analyses for biochemistry and genes polymorphisms.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Centre for Research of CHUS (CRCHUS)
CollaboratorUNKNOWN
CIHR/SPOR - chronic pain network
CollaboratorUNKNOWN
Université de Sherbrooke
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* 18-79 years old * 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)

Design outcomes

Primary

MeasureTime frameDescription
Conditioned pain modulationOnce, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)Alteration (reduction or augmentation) of pain sensitivity after activation of endogenous pain-inhibitory system, measured by computerized visual analog scale (CoVAS) ranging from 0 \[no pain\] to 100 \[most intense pain that could be tolerated\]

Secondary

MeasureTime frameDescription
pressure points thresholdTwice, at baseline, at recruitment (before and after the conditioning stimuli)On both trapezius muscles

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026