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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Conditioned pain modulation

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.

• Study Type: Observational
• Enrollment (Estimated): 468

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Université de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy male and female volunteers (with no pain) will provide reference values to further study volunteers with chronic pain.

People with chronic pain will constitute a second group to associate the conditioned pain modulation to their pain (chronic pain is defined by any regular pain for more than 6 months except pain caused by cancer or migraine)

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers; Conditioned pain modulation (2 stimuli test: heat and pressure points) before and after conditioning stimuli (cold water bath).	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.; Other Names: Pressure points
Volunteers with chronic pain; Conditioned pain modulation (2 stimuli test: heat and pressure points) before and after conditioning stimuli (cold water bath).	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.; Other Names: Pressure points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pressure points threshold	On both trapezius muscles	Twice, at baseline, at recruitment (before and after the conditioning stimuli)

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Canadian Institutes of Health Research (CIHR); Centre for Research of CHUS (CRCHUS); CIHR/SPOR - chronic pain network
• Investigators: Principal Investigator: Louis Gendron, PhD, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): February 28, 2022
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: reference values; conditioned pain modulation (CPM); Diffuse Noxious Inhibitory Controls (DNIC); pressure pain threshold (PPT); clinical decision rule
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2018-2422

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No