Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT06937151
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2023-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Arthrocentesis and Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069237', 'term': 'Arthrocentesis'}], 'ancestors': [{'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2023-12-03', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thera Bite RANGE OF MOTION scale', 'timeFrame': 'pre treatment and eight weeks post treatment', 'description': 'Will be used for measuring the Maximal interincisal opening, lateral movement will be measured.\n\nMeasuring Maximal Interincisal Opening :\n\n1. Patient Positioning: The patient opens their mouth as wide as possible without discomfort.\n2. Scale Placement: The range of motion scale is positioned so that the notch rests on the edge of the lower incisor.\n3. Measurement: Rotate the scale until it contacts the upper incisor, and record the reading at the point of contact.\n\nMeasuring Lateral Excursion Movement:\n\n1. Scale Alignment: Rest the range of motion scale against the lower incisors with the upper and lower teeth closed together.\n2. Arrow Alignment: Align the arrow on the scale with an interproximal space between two upper teeth.\n3. Measurement: Move the mandible laterally (side-to-side) and record the measurements on the lateral side.'}, {'measure': '8-Items Jaw Functional Limitation Scale', 'timeFrame': 'pre treatment and eight weeks post treatment', 'description': 'Disability related to orofacial pain, which makes it a generic tool that one can use it for different types of orofacial pain conditions.\n\n1. Preparation: Select a quiet and distraction-free environment.\n2. Understanding the Scale: Rate each item on a scale from 0 (no limitation) to 10 (severe limitation).\n3. Completing the Questionnaire: Carefully read each question and reflect on your jaw function over the past week.\n4. Items to Rate: Assess difficulties in chewing, mouth opening, and emotional expression.\n5. Time Required: Completion typically takes less than 5 minutes.\n6. Post-Completion: Higher scores indicate greater functional limitations.'}, {'measure': 'Visual analog scale', 'timeFrame': 'pre treatment and eight weeks post treatment', 'description': 'One of the pain rating scales,\n\n1. Preparation: Ensure the VISUAL ANALOG SCALE line is accurately printed to scale (10 cm) with endpoints labeled:\n\n * 0 = No pain.\n * 10 = Worst imaginable pain.\n2. Patient Instructions: Ask the patient to mark their current pain level on the line.\n3. Score Measurement and Interpretation: Measure the distance in centimeters from the "no pain" end (0) to the patient\'s mark to determine the score out of 10. Higher scores indicate greater pain intensity (e.g., a mark at 6 cm corresponds to a pain level of 6/10).\n4. Recall Period: Patients report either their current pain or pain experienced within the last 24 hours, depending on assessment context.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporomandibular Joint Disorders'], 'conditions': ['Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing)']}, 'descriptionModule': {'briefSummary': 'The present study will be designed to compare the short- and medium-term results of arthrocentesis and non-surgical methods Rocabado approach in early disc displacement without reduction.', 'detailedDescription': "This study will be designed to provide a comparison between the effect of the Rocabado approach as a conservative treatment and temporomandibular joint arthrocentesis in temporomandibular joint disc displacement without reduction.\n\nDelimitations:\n\nThis study will be delimited in the following aspects:\n\n1. Patients:\n\n The study group will be composed of sixty-eight patients with temporomandibular joint disc displacement without reduction will be enrolled in the study. Group A: It will be composed of thirty-four patients with TMJ disc displacement without reduction who are started on the Rocabado approach- 4 - 6×6 exercise program. Include therapeutic exercise, and patient education focusing on the temporomandibular joint. Repeat measurements will be performed on 1st measurement at the baseline before any intervention, 2nd measurement after 8 weeks of treatment by a physiotherapist. Group B: It will be composed of thirty-four patients with disc displacement without reduction who are started on TMJ arthrocentesis procedure with medical and nursing care.\n2. Equipment and tools:\n\n2.1-Measurement equipment: Thera bite ROM scale 8-Item Jaw Functional Limitation Scale (JFLS-8) (Valid Arabic version) visual anlogue scale 2.2-Therapeutic procedures: Rocabado's 6X6 Exercise Program and manibulation"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of a sudden reduction in the mandibular opening. Unassisted mandibular opening 35 mm.\n* Mandibular opening with assistance increased by ≥3 mm from\n* unassisted opening, with a prior history of click, click disappearance, and a sudden decrease in opening.\n* Magnetic resonance imaging (MRI) diagnosis of Disc displacement without reduction.\n* Persistence of the symptoms indicated in the first item for a Maximum of 3 weeks.\n* clinical diagnosis of unilateral Disc displacement without reduction of the temporomandibular joint.\n\nExclusion Criteria:\n\n* History of major jaw trauma.\n* Dentofacial deformity.\n* Psychiatric illness.\n* Chronic headache. Presence of other disorders involving the TMJ.'}, 'identificationModule': {'nctId': 'NCT06937151', 'briefTitle': 'Comparison Between Arthrocentesis and Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Arthrocentesis Versus Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003932'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Study group) ROCABADO APPROACH :', 'description': 'Group A (Study group):\n\nThis group includes thirty-four patients with temporomandibular joint disc displacement without reduction, who will receive the Rocabado approach exercise program 6×6 AND MANIPULATION', 'interventionNames': ['Procedure: Rocabado approach exercise program 6×6 and manibulation .']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Control group) ARTHOROCENTESIS:', 'description': 'This group includes thirty-four patients with temporomandibular joint disc displacement without reduction who will receive TMJ Arthrocentesis', 'interventionNames': ['Procedure: Arthrocentesis']}], 'interventions': [{'name': 'Rocabado approach exercise program 6×6 and manibulation .', 'type': 'PROCEDURE', 'description': "Rocabado's approach (Rocabado's 6 × 6 Exercises and manipulation). This program included 6 exercises to be performed 6 times a day, repeated 6 times, and three gliding exercises.", 'armGroupLabels': ['Group A (Study group) ROCABADO APPROACH :']}, {'name': 'Arthrocentesis', 'type': 'PROCEDURE', 'otherNames': ['TMJ joint washing'], 'description': "Participants in the Control Group underwent arthrocentesis of the affected temporomandibular joint. The procedure was performed as follows:\n\nAnesthesia: Local anesthesia was administered to the area surrounding the TMJ.\n\nNeedle Insertion: A 20-gauge needle was inserted into the upper joint space approximately 10 mm anterior to the tragus.\n\nLavage: The joint was lavaged with lactated Ringer's solution to reduce inflammation and remove debris. The joint was irrigated with lactated Ringer's solution.", 'armGroupLabels': ['Group B (Control group) ARTHOROCENTESIS:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13715', 'city': 'Banhā', 'state': 'Banha', 'country': 'Egypt', 'facility': 'Kafer Shoukr Spechialized Hospital', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}, {'zip': '13715', 'city': 'Banhā', 'state': 'Qalubiah', 'country': 'Egypt', 'facility': 'Kafer Shoukr Spechialized Hospital', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapist', 'investigatorFullName': 'Eman Shawkey Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}