Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-01-04 @ 1:08 AM
Study NCT ID:
NCT03376867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2017-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be preserved as plasma (for biochemical analysis) and as Buffy coat cells (for genetic analysis on specific genes)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 468}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2017-12-07', 'studyFirstSubmitQcDate': '2017-12-12', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conditioned pain modulation', 'timeFrame': 'Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)', 'description': '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\\]'}], 'secondaryOutcomes': [{'measure': 'pressure points threshold', 'timeFrame': 'Twice, at baseline, at recruitment (before and after the conditioning stimuli)', 'description': 'On both trapezius muscles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['conditioned pain modulation (CPM)', 'Diffuse Noxious Inhibitory Controls (DNIC)', 'pressure pain threshold (PPT)', 'reference values', 'clinical decision rule'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '40176749', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This study aims:\n\n1. To establish baseline values of DNICs using CPM protocol\n2. To identify the variables that will be integrated in the algorithm of the clinical screening test (clinical decision rule).\n\nFirst 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.\n\nSecondly, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy male and female volunteers (with no pain) will provide reference values to further study volunteers with chronic pain.\n\nPeople 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)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-79 years old\n* Able to provide consent\n\nExclusion Criteria:\n\n* cardiovascular disease (arrhythmia, cerebrovascular accident, infarction...)\n* Raynaud syndrome\n* severe psychiatric disease (dementia, schizophrenia, psychosis, major depression)\n* injuries or loss sensitivity to their forearms or hands\n* pregnant women or in post-partum period (\\<1 year)'}, 'identificationModule': {'nctId': 'NCT03376867', 'acronym': 'DNIC', 'briefTitle': 'Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC)', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Reference Values of Diffuse Noxious Inhibitory Controls (DNIC) Intensity in a Healthy Adult Population and Develop a Clinical Test to Evaluate DNIC', 'orgStudyIdInfo': {'id': '2018-2422'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': 'Conditioned pain modulation (2 stimuli test: heat and pressure points) before and after conditioning stimuli (cold water bath).', 'interventionNames': ['Other: Conditioned pain modulation']}, {'label': 'Volunteers with chronic pain', 'description': 'Conditioned pain modulation (2 stimuli test: heat and pressure points) before and after conditioning stimuli (cold water bath).', 'interventionNames': ['Other: Conditioned pain modulation']}], 'interventions': [{'name': 'Conditioned pain modulation', 'type': 'OTHER', 'otherNames': ['Pressure points'], 'description': '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.', 'armGroupLabels': ['Healthy volunteers', 'Volunteers with chronic pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Universite de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Louis Gendron, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Centre for Research of CHUS (CRCHUS)', 'class': 'UNKNOWN'}, {'name': 'CIHR/SPOR - chronic pain network', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}