Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT07232303
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Cervical Stabilization Exercises in Temporomandibular Joint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'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': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A Visual Analogue Scale', 'timeFrame': 'Change from initial assessment to 6 weeks after initial assessment', 'description': 'A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.The TMJ pain caused by resting and activity of the individuals was measured using the Visual Analogue Scale (VAS) (0-10 interval scale) and was valued according to VAS.'}], 'secondaryOutcomes': [{'measure': 'ROM TMJ', 'timeFrame': 'Change from initial assessment to 6 weeks after initial assessment.', 'description': 'A 15 centimeter plastic ruler was used for ROM evaluation for TMJ. Depression of the active and passive mandible, lateral deviation (right and left), and protrusion were measured'}, {'measure': 'Cervical ROM', 'timeFrame': 'Change from initial assessment to 6 weeks after initial assessment', 'description': 'Cervical region ROM was evaluated with goniometer. Flexion, extension, rotation and lateral flexion (right and left) were measured. Each measurement was made 3 times and the mean value was recorded'}, {'measure': 'Tampa Kinesiophobia Scale in Temporomandibular Disorders', 'timeFrame': 'Change from initial assessment to 6 weeks after initial assessment', 'description': 'A 12-question questionnaire developed by Visscher and his friends, used in temporomandibular joint dysfunctions. 4-point Likert-type scoring is used. A total score of 12-48 is obtained. The higher the score a person receives, the higher the kinesiophobia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporomandibular joint'], 'conditions': ['Temporomandibular Joint Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is; to determine the efficacy of cervical stabilization exercises in the treatment of patients with temporomandibular joint disfunction', 'detailedDescription': 'Thirty patients diagnosed with temporomandibular joint dysfunction who were included in the study were randomly assigned to the 15-person control group and the study group. Patient training and home exercises for jaw joint were given to the control group while cervical stabilization exercise program was given to the study group. The program was administered by the patients for 6 weeks. Pre-treatment and post-treatment evaluations; active and passive maximum mouth openness, joint sounds, cervical range of motion, Visual Analogue Scale (VAS), Short Form Quality of Life Scale (Short Form-36), Tampa Kinesophobia Scale in Temporomandibular Disorders (TKS-TMD) and Pain Catastrophizing Scale (PCS), and the data obtained were analyzed statistically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a complaint of temporomandibular joint for more than 3 months.\n* To be literate in Turkish.\n* Having signed the Informed Consent Form.\n\nExclusion Criteria:\n\n* -Those with active infection\n* Presence of neurological, rheumatological and musculoskeletal problems that prevent exercise\n* Vertebrobasilar artery insufficiency'}, 'identificationModule': {'nctId': 'NCT07232303', 'briefTitle': 'The Effect of Cervical Stabilization Exercises in Temporomandibular Joint', 'organization': {'class': 'OTHER', 'fullName': 'Bahçeşehir University'}, 'officialTitle': 'The Effect of Cervical Stabilization Exercises on Pain, Mobility and Functionality in Temporomandibular Joint Dysfunction', 'orgStudyIdInfo': {'id': 'KumruA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical Stabilization Group', 'description': 'cervical stabilization exercises, home exercises and patient education', 'interventionNames': ['Other: Cervical stabilization', 'Other: Home exercises', 'Other: Patient educating']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Home exercises and patient education', 'interventionNames': ['Other: Home exercises', 'Other: Patient educating']}], 'interventions': [{'name': 'Cervical stabilization', 'type': 'OTHER', 'description': 'Cervical range of motion exercises with craniocervical flexion, unilateral, bilateral and reciprocal shoulder flexion and abduction exercises, cervical isometric exercises with an exercise ball, unilateral, bilateral and reciprocal shoulder abduction when the exercise ball is between the wall and the head, and flexion exercises, exercise band and shoulder joint range of motion exercises with the exercise ball between the wall and the head were given to the study group. In the 3rd week, exercises were started with an exercise ball and elastic bands. All exercises were applied 3 times a day for 10 repetitions for 6 weeks.', 'armGroupLabels': ['Cervical Stabilization Group']}, {'name': 'Home exercises', 'type': 'OTHER', 'description': 'The exercise program included mouth opening and closing against resistance, right-left lateral flexion movements, active mouth opening and closing, bilateral lateral flexion, protrusion, and retrusion. Stretching required the patient to perform the restricted movement, pushing their jaw toward the restricted direction with their hand, holding for 10 seconds, relaxing, and repeating. It also included self-massage in the form of stroking. All exercises were performed three times a day for 6 weeks, with 10 repetitions.', 'armGroupLabels': ['Cervical Stabilization Group', 'Control Group']}, {'name': 'Patient educating', 'type': 'OTHER', 'description': 'The training content includes information about the disease, recommendations for a soft diet, avoidance of parafunctional habits, demonstration of diaphragmatic breathing, and notifications to ensure correct posture.', 'armGroupLabels': ['Cervical Stabilization Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Yeniyüzyıl University Gaziosmanpaşa Hospital Dental Polyclinic', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bahçeşehir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kumru Ateş', 'investigatorAffiliation': 'Bahçeşehir University'}}}}