Chronic PainDNICNCT03376867
Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC)
An observational study of Chronic Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Conditioned pain modulation
- How many people
- 468 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2017to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 18-79 years old
- Able to provide consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This study aims:
- To establish baseline values of DNICs using CPM protocol
- 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.
- Conditions
- Chronic Pain
- Being tested
- Conditioned pain modulation
- Keywords
- conditioned pain modulation (CPM), Diffuse Noxious Inhibitory Controls (DNIC), pressure pain threshold (PPT), reference values, clinical decision rule
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioned pain modulationOther
Also called Pressure points
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Conditioned pain modulation (2 stimuli test: heat and pressure points) before and after conditioning stimuli (cold water bath). Receives: 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). Receives: Other: Conditioned pain modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
Secondary outcomes (1)
pressure points threshold
On both trapezius muscles
Measured: Twice, at baseline, at recruitment (before and after the conditioning stimuli)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start27 Nov 2017
- Primary completion28 Feb 2022
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre for Research of CHUS (CRCHUS), CIHR/SPOR - chronic pain network
- Responsible party
- Sponsor
- Investigators
- Louis Gendron, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376867
- Sponsor's protocol ID
- 2018-2422
- Acronym
- DNIC
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2017
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40176749
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values of Diffuse Noxious Inhibitory Controls (DNIC) Intensity in a Healthy Adult Population and Develop a Clinical Test to Evaluate DNIC
- ClinicalTrials.gov ID
- NCT03376867
- Acronym / sponsor ID
- DNIC / 2018-2422
- Conditions
- Chronic Pain
- Keywords
- conditioned pain modulation (CPM), Diffuse Noxious Inhibitory Controls (DNIC), pressure pain threshold (PPT), reference values, clinical decision rule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre for Research of CHUS (CRCHUS), CIHR/SPOR - chronic pain network
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To establish baseline values of DNICs using CPM protocol
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: Conditioned pain modulationConditioned pain modulation (2 stimuli test: heat and pressure points) before and after conditioning stimuli (cold water bath). |
| Volunteers with chronic pain | – | Other: Conditioned pain modulationConditioned pain modulation (2 stimuli test: heat and pressure points) before and after conditioning stimuli (cold water bath). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 18-79 years old
- Able to provide consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditioned pain modulationAlso: Pressure pointsConditioned 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 | Healthy volunteers, Volunteers with chronic pain |
Primary outcome
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]
1 secondary outcome
pressure points threshold
Time frame: Twice, at baseline, at recruitment (before and after the conditioning stimuli)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 40176749Vincenot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Gendron, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned pain modulation (time frame: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.