Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT03626805
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2018-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Tenderness and Hardness in Migraine Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D063806', 'term': 'Myalgia'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-24', 'studyFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation analysis of muscle hardness and headache frequency', 'timeFrame': '3 hours', 'description': 'Muscle hardness will be measured with ultrasound elastography. Headache frequency is self-reported'}, {'measure': 'Correlation analysis of muscle hardness and muscle tenderness assessed with the total tenderness score.', 'timeFrame': '3 hours', 'description': 'Muscle hardness will be measured with ultrasound elastography.'}, {'measure': 'Correlation analysis of muscle hardness and pressure pain threshold assessed with an pressure algometer.', 'timeFrame': '3 hours', 'description': 'Muscle hardness will be measured with ultrasound elastography'}], 'primaryOutcomes': [{'measure': 'Logistic regression model, Neck Stiffness', 'timeFrame': '3 hours', 'description': 'We would like to examine the relationship between the variable variable: Neck stiffness during migraine attack (Yes/No) and the Independent variables: Total Tenderness Score (summed score from 8 points bilateral, each point can score 0-3), Migraine localisation (occipital: Yes/No), Tension Type Headache, Allodynia (yes/No), Stimulus response curve (Pressure and Pain).\n\nThe result shows how much of the variability in neck stiffness that can be explained by the independent variables.'}, {'measure': 'Pericranial Muscle Tenderness', 'timeFrame': '3 hours', 'description': 'We will examine whether patients with neck stiffness during migraine attack (yes/no) have higher tenderness scores compared to patients without neck stiffness during migraine attacks, when correcting for headache frequency.'}, {'measure': 'Muscle Hardness measured by ultrasound elastography', 'timeFrame': '3 hours', 'description': 'Muscle hardness (m/s) in migraine patients compared to healthy controls.corrected for age, BMI and sex'}, {'measure': 'Muscle hardness measured by ultrasound elastography in migaine patients', 'timeFrame': '3 hours', 'description': 'Muscle hardness (m/s) in migraine patients with neck stiffness during migraine attacks compared to migraine patients without neck stiffness during migraine attacks. Corrected for age, BMI and sex.'}], 'secondaryOutcomes': [{'measure': 'Multiple Regression model, Total Tenderness Score', 'timeFrame': '3 hours', 'description': 'We would like to examine the relationship between the dependent variable: Total Tenderness Score(summed score from 8 points bilateral, each point can score 0-3), and the Independent variables: Neck Pain in general(Yes/No), Migraine localisation (occipital: Yes/No), Headache Frequency(days/month), Allodynia (Yes/No), Years with Migraine(Number of years)'}, {'measure': 'Logistic regression model, Neck pain in general', 'timeFrame': '3 hours', 'description': 'We would like to examine the relationship between the variable variable: Neck pain in general (Yes/No) and the independent variables: Tension Type Headache(yes/no), Migraine localisation, Headache Frequency(Headache days/month), Allodynia(yes/No), Years with Migraine(number of years)'}, {'measure': 'Next migraine attack, Cox proportional hazards model', 'timeFrame': '3 hours', 'description': 'Using the prospective diary, we will examine the relationship between pericranial muscle tenderness and the next migraine attack, when correcting for headache frequency'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine Disorders', 'Muscle Tenderness', 'Headache Disorders, Primary', 'Nervous System Diseases', 'Headache, Migraine']}, 'referencesModule': {'references': [{'pmid': '32295400', 'type': 'DERIVED', 'citation': 'Hvedstrup J, Kolding LT, Ashina M, Schytz HW. Increased neck muscle stiffness in migraine patients with ictal neck pain: A shear wave elastography study. Cephalalgia. 2020 May;40(6):565-574. doi: 10.1177/0333102420919998. Epub 2020 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine symptomatology, quantitative sensory test (QST) parameters, muscle tenderness and muscle hardness in migraine patients interictally and compare with healthy controls', 'detailedDescription': 'Migraine patients exhibit different symptomatology and responses to treatment. For example do many migraine patients have neck symptoms, despite they apparently do not have any neck disorders.Furthermore the response to treatment differs between patients. Differences in symptomatology, QST parameters and muscle stiffness can be used to subdivide and phenotype migraine patients.\n\nThe investigators are examining migraine patients with:\n\nA semistructured interview, Quantitative sensory testing (cold pain threshold, heat pain threshold and Pin Prick), Muscle tenderness (total tenderness score, local tenderness score and stimulus response curve), and muscle hardness with ultrasound elastography. All tests are performed the same day'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Migraine patients are recruited from the out-patient clinic at the Danish Headache Center.\n\nHealthy controls are recruited through web-sites.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Migraine Patients from the Danish Headache Centre. Migraine classified using the International Classification of Headache Disorders (ICHD3) criteria.\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Musculoskeletal injuries in the neck or shoulder\n* Other primary headache disorders than migraine or Tension Type Headache\n* On the time of examination: Migraine free for at least 48 hours\n* On the time of examination: haven't trained the upper body for at least 48 hours\n* On the time of examination: haven't used painkillers for at least 48 hours\n\nHealthy controls:\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Musculoskeletal injuries in the neck or shoulder\n* Migraine disorders\n* 1\\. degree relatives with migraine disorders\n* Over 1 day of tension type headache a month.\n* On the time of examination: haven't trained the upper body for at least 48 hours\n* On the time of examination: haven't used painkillers for at least 48 hours"}, 'identificationModule': {'nctId': 'NCT03626805', 'briefTitle': 'Muscle Tenderness and Hardness in Migraine Patients', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Muscle Tenderness and Hardness in Migraine Patients', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Migraine patients', 'description': 'Migraine patients attending the Danish Headache Centre'}, {'label': 'Healthy Controls', 'description': 'Age and sex matched'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Jeppe H Mann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headache Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Jeppe Hvedstrup Mann', 'investigatorAffiliation': 'Danish Headache Center'}}}}