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

Last updated: February 13, 2024
Sponsor: Université de Sherbrooke
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Conditioned pain modulation

Clinical Study ID

NCT03376867
2018-2422
  • Ages 18-79
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-79 years old
  • Able to provide consent

Exclusion

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 Design

Total Participants: 468
Treatment Group(s): 1
Primary Treatment: Conditioned pain modulation
Phase:
Study Start date:
November 27, 2017
Estimated Completion Date:
December 30, 2024

Study 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.

Connect with a study center

  • Universite de Sherbrooke

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

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