Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT03962556
Status:
UNKNOWN
Last Update Posted:
2019-08-20
First Post:
2019-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Distribution of Trigger Points in Patient Who Have Myofascial Pain Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005157', 'term': 'Facial 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'masticatory and cervical muscles examination for determining trigger points', 'timeFrame': 'first day visit', 'description': 'detecting the trigger point (yes or no), determining the number of trigger points and determining the region on the muscle'}, {'measure': 'visual analog scale for pain (VAS)', 'timeFrame': 'first day visit', 'description': "scale to find pain amount , pain scores from 0 to 10 will be taken from patients and higher scores indicate worse pain,all of patient's mean pain score to be determined."}], 'secondaryOutcomes': [{'measure': 'prevalence of trigger points in facial pain disorder patients', 'timeFrame': '1 year', 'description': 'to compare pain scores of patients with and without trigger point,the distribution of trigger points on the masticatory and cervical muscles'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trigger point,myofacial pain'], 'conditions': ['Myofascial Pain']}, 'descriptionModule': {'briefSummary': "Myofascial pain alone covers 45.3% of the diagnosis of TMJ. It is defined as palpation sensitivity and regional muscle pain. Clinically muscle pain connects to myofascial trigger points.These trigger points are hypersensitive points located in a tense band of the skeletal muscle, which can be described, causing provoked or spontaneous pain. They are divided into two as active and latent. Those who cause spontaneous pain are active, and those who provoke pain are considered latent.Spasm in the chewing muscles with myofascial pain reduces the patient's pain threshold and quality of life.\n\nTherefore, patients with spasm and TMJ pain in the masticatory muscles should be examined for head and neck muscles, the presence of myofascial trigger points should be determined and the head and neck muscles should be included in physical therapy.\n\nThe aim of this study was to determine the presence of myofascial trigger points in patients presenting with pain in the masticatory muscles and TMJ region, and to determine the relationship between the presence of trigger point and the degree of pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Will be conducted in volunteers who applied to our clinic with complaint of TMJ', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Will be conducted in volunteers who applied to our clinic with complaint of TMJ\n\nExclusion Criteria:\n\n* Diagnosed rheumatoid diseases and fibromyalgia.\n* Psychiatric drug users.\n* Patients who use muscle relaxants.\n* TME pathology'}, 'identificationModule': {'nctId': 'NCT03962556', 'briefTitle': 'Distribution of Trigger Points in Patient Who Have Myofascial Pain Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Necmettin Erbakan University'}, 'officialTitle': 'Distribution of Trigger Points in Patient Who Have Myofascial Pain Disorder', 'orgStudyIdInfo': {'id': 'NecmettinEU1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-Trigger Point', 'interventionNames': ['Other: bimanual palpation']}, {'label': 'Trigger Point', 'interventionNames': ['Other: bimanual palpation']}], 'interventions': [{'name': 'bimanual palpation', 'type': 'OTHER', 'description': 'bimanual palpation....i..', 'armGroupLabels': ['Non-Trigger Point', 'Trigger Point']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kubilay Işık', 'role': 'CONTACT'}], 'facility': 'Necmettin Erbakan University/Dentistry Faculty', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'centralContacts': [{'name': 'Funda Basturk', 'role': 'CONTACT', 'email': 'dtfunda.basturk@gmail.com', 'phone': '+905531906023'}], 'overallOfficials': [{'name': 'Kubilay Işık', 'role': 'STUDY_CHAIR', 'affiliation': 'Necmettin Erbakan University/Dentistry Faculty'}, {'name': 'Dilek Menziletoğlu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Necmettin Erbakan University/Dentistry Faculty'}, {'name': 'Funda Basturk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necmettin Erbakan University/Dentistry Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Necmettin Erbakan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant in Oral and Maxillofacial surgery', 'investigatorFullName': 'Funda Bastürk', 'investigatorAffiliation': 'Necmettin Erbakan University'}}}}