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

Chronic Pain Clinical Trial

— DNIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03376867
• Other study ID #: 2018-2422
• Status: Active, not recruiting
• Start date: November 27, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 468
• Est. completion date: December 30, 2024
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Conditioned pain modulation
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.

Locations

Country	Name	City	State
Canada	Universite de Sherbrooke	Sherbrooke	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Université de Sherbrooke	Canadian Institutes of Health Research (CIHR), Centre for Research of CHUS (CRCHUS), CIHR/SPOR - chronic pain network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conditioned pain modulation	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]	Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
Secondary	pressure points threshold	On both trapezius muscles	Twice, at baseline, at recruitment (before and after the conditioning stimuli)