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Clinical Trials/NCT03376867
NCT03376867
Active, not recruiting
Not Applicable

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

Université de Sherbrooke1 site in 1 country468 target enrollmentNovember 27, 2017
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Université de Sherbrooke
Enrollment
468
Locations
1
Primary Endpoint
Conditioned pain modulation
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 27, 2017
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Conditioned pain modulation

Time Frame: Once, 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 Outcomes

  • pressure points threshold(Twice, at baseline, at recruitment (before and after the conditioning stimuli))

Study Sites (1)

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