Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-03-09 @ 4:29 AM
Study NCT ID:
NCT02746250
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2016-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000639', 'term': 'Amitriptyline'}, {'id': 'D000929', 'term': 'Antidepressive Agents, Tricyclic'}], 'ancestors': [{'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000928', 'term': 'Antidepressive Agents'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Tenderness Score', 'timeFrame': 'March 2016 to march 2018. Up to 4 months.', 'description': 'The soreness of the muscle is reported by the patient on a scale from 0-3 (0= no pain, 1= mild pain, 2= moderate pain and 3= severe pain) when pressure is applied at eight different locations on both sides of the face and neck (m. masseter, m. frontalis, m. pterygoideus lateralis, m. temporalis, m. sternocleidomastoid, pros. mastoideus, m. trapezius and the insertions of the neck muscles at the base of the scull.) The sum of the individual scores make up the total tenderness.'}, {'measure': 'Change in muscle stiffness', 'timeFrame': 'March 2016 to march 2018. Up to 4 months.', 'description': 'The stiffness is measured in terms of the speed of the shear waves (meter/second) the higher the speed the stiffer the muscle.'}, {'measure': 'Change in Local Tenderness Score', 'timeFrame': 'March 2016 to march 2018. Up to 4 months.', 'description': 'Aided by a palpometer a pressure of 160 U is applied to four different locations (m. masseter, m. sternocleidomastoid, the lateral part of m. trapezius and the medial part of the m. trapezius.) At each location the patient report the pain intensity on a scale from 0-10.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Tension-type Headache']}, 'descriptionModule': {'briefSummary': 'The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent Episodic Tension Type Headache before and after treatment with amitriptyline - and to compare the results with healthy individuals.', 'detailedDescription': 'The muscle stiffness is measured with ultrasonic shear wave elastography in m. masseter, m. sternocleidomastoid and m. Trapezius.\n\nThe muscle soreness is measured by palpation of the muscles aided by a so called palpometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Tension type headache or frequent episodic tension type headache with at least ten episodes or more per month throughout three months or more.\n* Pericranial muscle tenderness\n\nExclusion Criteria:\n\n* Other primary headache disorder (with the exception of episodic migraine.)\n* Pregnancy or ongoing breastfeeding\n* Heart disease that contradicts treatment with amitriptyline\n* Drug or substance abuse'}, 'identificationModule': {'nctId': 'NCT02746250', 'briefTitle': 'Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.', 'orgStudyIdInfo': {'id': 'H-16000619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tension type headache', 'description': 'The investigator measures the muscle soreness and muscle stiffness before the patients starts their prescribed treatment with amitriptyline - and again after they have reached their optimal dosage of amitriptyline.', 'interventionNames': ['Drug: Amitriptyline']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy controls', 'description': 'The investigator measures the muscle soreness and muscle stiffness once.'}], 'interventions': [{'name': 'Amitriptyline', 'type': 'DRUG', 'otherNames': ['Saroten', 'Tricyclic antidepressants'], 'description': 'The investigator recruits patients who have already discussed and agreed to the amitriptyline treatment with their physician. The patients start the treatment after the investigator have measured them once.', 'armGroupLabels': ['Tension type headache']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Headache center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Henrik W Schytz, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headache Center, Department of neurology, Rigshospitalet Glostrup'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical student', 'investigatorFullName': 'Lærke Tørring Kolding', 'investigatorAffiliation': 'Danish Headache Center'}}}}