NCT03376867

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
468

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

4.3 years

First QC Date

December 7, 2017

Last Update Submit

February 13, 2024

Conditions

Keywords

conditioned pain modulation (CPM)Diffuse Noxious Inhibitory Controls (DNIC)pressure pain threshold (PPT)reference valuesclinical decision rule

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • pressure points threshold

    Twice, at baseline, at recruitment (before and after the conditioning stimuli)

Study Arms (2)

Healthy volunteers

Conditioned pain modulation (2 stimuli test: heat and pressure points) before and after conditioning stimuli (cold water bath).

Other: Conditioned pain modulation

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

Interventions

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.

Also known as: Pressure points
Healthy volunteersVolunteers with chronic pain

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • years old
  • Able to provide consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universite de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • Vincenot M, Leonard G, Cloutier-Langevin C, Bordeleau M, Gendron L, Camirand Lemyre F, Marchand S. Exploring the Spectrum of Temporal Summation and Conditioned Pain Modulation Responses in Pain-Free Individuals Using a Tonic Heat Pain and Cold Pressor Test Paradigms. Eur J Pain. 2025 May;29(5):e70019. doi: 10.1002/ejp.70019.

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)

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Louis Gendron, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 19, 2017

Study Start

November 27, 2017

Primary Completion

February 28, 2022

Study Completion

December 30, 2024

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations