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

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ClinicalTrials.gov Identifier: NCT03376867
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Pain 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 Design

Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reference Values of Diffuse Noxious Inhibitory Controls (DNIC) Intensity in a Healthy Adult Population and Develop a Clinical Test to Evaluate DNIC
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Healthy volunteers
Conditionned 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 Name: Pressure points
Volunteers with chronic pain
Conditionned 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 Name: Pressure points


Outcome Measures

Primary Outcome Measures :
  1. Conditioned pain modulation [ Time Frame: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli) ]
    Alteration (reduction or augmentaiton) 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 Outcome Measures :
  1. pressure points threshold [ Time Frame: Twice, at baseline, at recruitment (before and after the conditioning stimuli) ]
    On both trapezius muscles


Biospecimen Retention:   Samples With DNA
Blood samples will be preserved as plasma (for biochemical analysis) and as Buffy coat cells (for genetic analysis on specific genes)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • 18-79 years old
  • Able to provide consent

Exclusion Criteria:

  • cardiovascular disease
  • Raynaud syndrome
  • severe psychiatric disease (dementia, schizophrenia)
  • injuries or impaired sensitivity to their forearms or hands
  • pregnant women or in post-partum period (<1 year)
  • breastfeeding women
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376867


Contacts
Contact: Amelie Tetu, MSc 819-346-1110 ext 15571 atetu.chus@ssss.gouv.qc.ca
Contact: Marie-Claude Battista, PhD 819-346-1110 ext 12480 marie-claude.battista@usherbrooke.ca

Locations
Canada, Quebec
Universite de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Amelie Tetu, MSc    819-346-1110 ext 15571    atetu.chus@ssss.gouv.qc.ca   
Sponsors and Collaborators
Université de Sherbrooke
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
More Information

Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT03376867     History of Changes
Other Study ID Numbers: 2018-2422
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Université de Sherbrooke:
conditioned pain modulation (CPM)
Diffuse Noxious Inhibitory Controls (DNIC)
pressure pain threshold (PPT)
reference values
clinical decision rule

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms