Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06148818
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2023-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Progressive Neck Motor Control Exercises on Temporomandibular Joint Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013706', 'term': 'Temporomandibular Joint Dysfunction Syndrome'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010353', 'term': 'Patient Education as Topic'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fonseca Anamnestic Index', 'timeFrame': '1st, sixth week, first mont', 'description': 'Assessment of Temporomandibular Dysfunction Severity'}, {'measure': 'Numeric Pain Scale', 'timeFrame': '1st, sixth week, first mont', 'description': 'Assessment of Pain, 0: No pain, 10: Maximum pain'}, {'measure': 'Pressure pain threshold', 'timeFrame': '1st, sixth week, first mont', 'description': 'Assessment of Pressure pain threshold'}, {'measure': 'Range of motion', 'timeFrame': '1st, sixth week, first mont', 'description': 'Assessment of Temporomandibular joint and neck range of motion'}, {'measure': 'Joint position error test', 'timeFrame': '1st, sixth week, first mont', 'description': 'Assessment of Cervical proprioception'}, {'measure': 'Endurance', 'timeFrame': '1st, sixth week, first mont', 'description': 'Assessment of Deep neck flexor endurance'}, {'measure': 'Photographic Posture Analysis', 'timeFrame': '1st, sixth week, first mont', 'description': 'Assessment of head and neck posture'}, {'measure': 'Mandibular Function Impairment Questionnaire', 'timeFrame': '1st, sixth week, first mont', 'description': 'Assessment of Mandibular Function'}], 'secondaryOutcomes': [{'measure': 'Tampa kinesiophobia scale', 'timeFrame': '1st, sixth week, first mont', 'description': 'Assessment of kinesiophobia for temporomandibular joint, 12 points: low kinesiophobia; 48 points:high kinesiophobia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporomandibular Joint Dysfunction Syndrome', 'Pain', 'neck motor control exercise', 'posture', 'kinesiophobia', 'function'], 'conditions': ['Temporomandibular Joint Dysfunction Syndrome']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study was to investigate the effects of progressive neck motor control exercises on craniocervical pain, posture, function and kinesiophobia in different types of temporomandibular dysfunction. The secondary aim of the study was to examine the differences between the effects of progressive neck motor control exercises on different types of temporomandibular dysfunction.', 'detailedDescription': 'In this randomised controlled study, the effects of progressive neck motor control exercise therapy on craniocervical pain, posture, function and kinesiophobia in individuals with different types of temporomandibular dysfunction (myofascial, disc displacement with reduction, disc displacement without reduction) and their differences with the control group will be compared. Participants diagnosed by a dentist according to three different types of temporomandibular dysfunction will be included in the study. Participants will be divided into groups by block randomisation method. A total of 6 groups will be included in the study, including participants with three different types of temporomandibular dysfunction who voluntarily agree to participate in the study and meet the inclusion criteria, and the control group of each group. The study groups will receive the same treatment and patient education for 6 weeks, while the control groups will receive only patient education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 55 years old,\n* Temporomandibular joint-related complaints for at least 3 months,\n* Temporomandibular dysfunction is diagnosed as a result of clinical and radiological evaluation by the dentist,\n* Neck pain of 3 or more according to the numeric pain scale\n\nExclusion Criteria:\n\n* Cognitive problems,\n* The one with the splint,\n* Those who have used painkillers or muscle relaxants for temporomandibular dysfunction complaints in the last 1 week,\n* With any systematic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),\n* Those with serious systemic diseases,\n* Any neurological disorder (e.g. trigeminal neuralgia),\n* Pregnancy or breastfeeding,\n* Treated for Temporomandibular joint or orofacial muscle pain in the last 3 months,\n* Has undergone an operation/trauma to the cervical region and/or temporomandibular joint,\n* Positive vertebrobasilar artery test'}, 'identificationModule': {'nctId': 'NCT06148818', 'briefTitle': 'Effect of Progressive Neck Motor Control Exercises on Temporomandibular Joint Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Investigation of the Effect of Progressive Neck Motor Control Exercises on Craniocervical Pain, Posture, Function and Kinesiophobia in Different Types of Temporomandibular Joint Dysfunction', 'orgStudyIdInfo': {'id': '2023/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myofascial', 'description': 'Myofascial Temporomandibular Dysfunction', 'interventionNames': ['Other: Progressive neck motor control exercise therapy', 'Other: Patient education']}, {'type': 'EXPERIMENTAL', 'label': 'disc displacement with reduction', 'description': 'Temporomandibular joint disc displacement with reduction', 'interventionNames': ['Other: Progressive neck motor control exercise therapy', 'Other: Patient education']}, {'type': 'EXPERIMENTAL', 'label': 'disc displacement without reduction', 'description': 'Temporomandibular joint disc displacement without reduction', 'interventionNames': ['Other: Progressive neck motor control exercise therapy', 'Other: Patient education']}, {'type': 'OTHER', 'label': 'Myofascial2', 'description': 'Myofascial Temporomandibular Dysfunction', 'interventionNames': ['Other: Patient education']}, {'type': 'OTHER', 'label': 'disc displacement with reduction2', 'description': 'Temporomandibular joint disc displacement with reduction', 'interventionNames': ['Other: Patient education']}, {'type': 'OTHER', 'label': 'disc displacement without reduction2', 'description': 'Temporomandibular joint disc displacement without reduction', 'interventionNames': ['Other: Patient education']}], 'interventions': [{'name': 'Progressive neck motor control exercise therapy', 'type': 'OTHER', 'description': 'The exercise programme will be conducted as a single session two days a week for 6 weeks. The sessions will always be conducted by the same physiotherapist. Each exercise session will consist of 10 minutes of warm-up exercises, 40 minutes of neck motor control exercises and 10 minutes of cool down exercises. Each exercise will be performed as 2 sets of 10 repetitions.', 'armGroupLabels': ['Myofascial', 'disc displacement with reduction', 'disc displacement without reduction']}, {'name': 'Patient education', 'type': 'OTHER', 'description': 'The content of this education consists of information about the disease and symptoms, chewing recommendations, dietary changes, parafunctional habits, activities to be avoided, posture recommendations.', 'armGroupLabels': ['Myofascial', 'Myofascial2', 'disc displacement with reduction', 'disc displacement with reduction2', 'disc displacement without reduction', 'disc displacement without reduction2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trabzon', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nurhayat Korkmaz, Msc', 'role': 'CONTACT', 'phone': '+90462377', 'phoneExt': '2471'}, {'name': 'Nurhayat korkmaz, Msc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karadeniz Technical University', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'centralContacts': [{'name': 'nurhayat korkmaz, PhDstudent', 'role': 'CONTACT', 'email': 'krkmznrhyt@gmail.com', 'phone': '+90538736', 'phoneExt': '9062'}, {'name': 'Nurhayat Korkmaz, MSc', 'role': 'CONTACT', 'email': 'krkmznrhyt@gmail.com', 'phone': '+90538736', 'phoneExt': '9062'}], 'overallOfficials': [{'name': 'Nurhayat Korkmaz, PhDstudent', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karadeniz Technical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assisstant', 'investigatorFullName': 'Nurhayat KORKMAZ', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}