Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-05 @ 11:35 AM
Study NCT ID:
NCT03459495
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2018-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Ultrasound in the Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}], 'ancestors': [{'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective,randomized,placebo- controlled, double blind'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2018-03-01', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric rating scale (NRS)', 'timeFrame': '4 months', 'description': "It is commonly used to measure the severity of the patients' pain. It consists of a line 10 cm. long and marked with numbers from 0 to 10. The patient is asked to mark the point corresponding to the severity of the pain on this line in the range from 0 (no pain) to 10 (most severe pain)."}, {'measure': 'Migraine Disability Assessment Questionnaire Score (MIDAS)', 'timeFrame': '4 months', 'description': 'The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period. The MIDAS score is based on five disability questions in three dimensions: questions one and two assess the number of missed or significant limitations to activity (defined as at least 50% reduced productivity) days due to headache in school or paid work activities (school/job dimension); questions three and four assess the number of missed or significant limitations to activity (defined as at least 50% reduced productivity) days due to headache in housework activities (housework dimension); question five assesses missed days due to headache in family, social, or leisure activities (social dimension).\n\n0 to 5 - MIDAS Grade I, Little or no disability 6 to 10 - MIDAS Grade II, Mild disability 11 to 20 - MIDAS Grade III, Moderate disability 21+ - MIDAS Grade IV, Severe disability'}], 'secondaryOutcomes': [{'measure': 'paracetamol consumption', 'timeFrame': '4 months'}, {'measure': 'the number of migraine attacks per month.', 'timeFrame': '4 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['migraine, therapeutic ultrasound, pain, disability'], 'conditions': ['Migraine', 'Ultrasound']}, 'descriptionModule': {'briefSummary': 'Headache affects the daily quality of life of patients. It has been reported that headaches may be associated with neck muscles, neck movements and trigger points in the neck Drug and non-drug treatments can be used today in the treatment of headaches. Various physical therapies are applied to cranial and cervical regions in non-drug therapies. Therapeutic ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), Hotpack and manipulation are some of them.This is a randomised placebo- controlled trial to determine the efficacy of the therapeutic ultrasound in the treatment of migraine.', 'detailedDescription': 'Evidence from controlled studies suggests that non-invasive physical therapies may help prevent headaches. Therapeutic ultrasound studies have generally been used in combination with other physical therapies.\n\nTherapeutic ultrasound is known to act in two different ways, thermal and non-thermal. With thermal effect, it is possible to reduce pain and joint joints and increase local blood flow, while stimulating tissue regeneration, soft tissue repair, blood flow regulation in chronic ischemic tissues and protein synthesis with nonthermal effect. In addition, its effect on inflammation accelerated repair by affecting cell activities, altering platelet membrane permeability, leading to the release of serotonin and accelerating wound healing.\n\nThe aim of this study is to determine whether therapeutic ultrasound is superior to placebo ultrasound in the treatment of migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 20-65 years\n* Patients diagnosed with migraine according to the International Headache Society (IHS) criteria\n\nExclusion Criteria:\n\n* Patients with bleeding disorders,\n* Patients with mental disorders,\n* Patients with malignancy,\n* Patients with uncontrolled hypertension,\n* Patients with uncontrolled diabetes mellitus,\n* Patients with infection,\n* Patients who underwent surgery in the posterior cranial region and cervical vertebra.'}, 'identificationModule': {'nctId': 'NCT03459495', 'briefTitle': 'Therapeutic Ultrasound in the Treatment of Migraine', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Investigation of the Efficacy of Therapeutic Ultrasound in the Treatment of Migraine; Prospective, Randomized, Placebo Controlled, Double-blind Study', 'orgStudyIdInfo': {'id': '2011-KAEK-2018-1/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Group A: ultrasound group', 'interventionNames': ['Device: therapeutic ultrasound']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group P', 'description': 'Group P: placebo ultrasound group', 'interventionNames': ['Device: placebo ultrasound']}], 'interventions': [{'name': 'therapeutic ultrasound', 'type': 'DEVICE', 'description': 'Patients in the ultrasound group will be administered to the posterior neck region for 5 minutes in pulsed mode (pulse rate 1: 1) at 1 MHz, 1.5 W / cm2. The treatment will be done 5 days a week for a total of 10 days', 'armGroupLabels': ['Group A']}, {'name': 'placebo ultrasound', 'type': 'DEVICE', 'description': 'When the ultrasonic device is in the closed position, the ultrasonic probe will be applied for 5 minutes in the posterior neck region of the patients. The treatment will be done 5 days a week for a total of 10 days.', 'armGroupLabels': ['Group P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16330', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Burcu Metin Ökmen', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Burcu Metin Ökmen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Burcu Metin Ökmen', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}