Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06323720
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Signs of Central Sensitization in Tension-type Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018781', 'term': 'Tension-Type Headache'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-03-14', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain sensitivity for heat stimuli', 'timeFrame': 'Baseline', 'description': 'Hypersensitivity for heat pain. The heat stimulus will be delivered with the TSA-2, using a thermode.'}, {'measure': 'Pain sensitivity for cold stimuli', 'timeFrame': 'Baseline', 'description': 'Hypersensitivity for cold pain. the cold stimulus will be delivered with the TSA-2, using a thermode.'}, {'measure': 'Pain sensitivity for electrical stimuli', 'timeFrame': 'Baseline', 'description': 'Hypersensitivity for electrical pain. The electrical stimulus will be given with the Digitimer, using an electrode.'}, {'measure': 'Pain sensitivity for pressure', 'timeFrame': 'Baseline', 'description': 'Hypersensitivity for pressure pain. Pressure will be delivered using a digital algometer.'}, {'measure': 'Function of the pain facilitating pathways', 'timeFrame': 'Baseline', 'description': 'Temporal summation will be measured. This gives an idea of the (dys)function of the endogenous pain facilitation system.'}, {'measure': 'Function of the pain inhibiting pathways', 'timeFrame': 'Baseline', 'description': 'Conditioned pain modulation will be measured. This gives an idea of the (dys)function of the endogenous pain inhibiting system. A noxious conditioning heat stimulus will be given at the tibial anterior muscle. A test heat or pressure stimulus will be given at the temporalis muscle. The pain-inhibits-pain paradigm will be tested.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tension-Type Headache']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is:\n\n\\- Are signs of central sensitization present in tension-type headache?\n\nParticipants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing).\n\nResearchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will involve participation from various populations, specifically patients with episodic tension headache, patients with chronic tension headache, and healthy pain-free controls.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of tension headache according to globally recognized criteria (ICHD-3) or verified by a physician\n2. Diagnosis of tension headache confirmed by a questionnaire (Headache Screening Questionnaire)\n3. Not pregnant or given birth in the past year since a change in hormone levels can affect pain experience\n4. Adults between the ages of 18 and 65\n5. Proficient in the Dutch language\n\nExclusion Criteria:\n\n1. Other diagnosis of headache or a mixed form\n2. Other existing condition involving central nervous system sensitivity\n3. Other structural neurological syndromes\n4. Any condition involving the brain in the past\n5. Procedure on the head, neck, or shoulder in the past 3 years\n6. Currently suffering from a psychiatric condition\n7. Athletes competing at a competitive level\n8. Not proficient in the Dutch language\n9. Currently pregnant.'}, 'identificationModule': {'nctId': 'NCT06323720', 'acronym': 'CSTTH', 'briefTitle': 'Signs of Central Sensitization in Tension-type Headache', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Are Signs of Central Sensitization Present in Tension-type Headache?', 'orgStudyIdInfo': {'id': 'ONZ-2023-0442'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Episodic tension-type headache', 'description': 'Patients with 1 - 14 days of TTH/month.', 'interventionNames': ['Other: Quantitative Sensory Testing']}, {'label': 'Chronic tension-type headache', 'description': 'Patients with more than 14 days TTH/month', 'interventionNames': ['Other: Quantitative Sensory Testing']}, {'label': 'Healthy controls', 'description': 'Participants without tension-type headache', 'interventionNames': ['Other: Quantitative Sensory Testing']}], 'interventions': [{'name': 'Quantitative Sensory Testing', 'type': 'OTHER', 'description': 'Assessment of the heat and cold pain thresholds, temporal summation, conditioned pain modulation, pressure pain thresholds, electrical pain thresholds, and withdrawal reflex.', 'armGroupLabels': ['Chronic tension-type headache', 'Episodic tension-type headache', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East-Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Jessica Van Oosterwijck, Prof.', 'role': 'CONTACT'}], 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Jessica Van Oosterwijck, Prof', 'role': 'CONTACT', 'email': 'jessica.vanoosterwijck@ugent.be', 'phone': '+32 9 332 69 19'}], 'overallOfficials': [{'name': 'Jessica Van Oosterwijck, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Revalidatiewetenschappen en kinesitherapie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}