Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT06301620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-articular Injection: A Innovational Approach for Joint Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hong Kong']}, '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': 'D007270', 'term': 'Injections, Intra-Articular'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Friction Index', 'timeFrame': 'day 1 and day 15', 'description': 'Friction Index is used to assess temporomandibular function. The total scores range from 0 to 57, with higher scores indicating more severe temporomandibular dysfunction.'}], 'secondaryOutcomes': [{'measure': 'The Visual Analog Scale', 'timeFrame': 'day 1 and day 15', 'description': 'The Visual Analog Scale is used to assess the pain levels of two groups of patients. The total score ranges from 0 to 10, with higher scores indicating more severe pain.'}, {'measure': 'The maximum mouth opening limit', 'timeFrame': 'day 1 and day 15', 'description': 'The maximum mouth opening limit is measured with precision to 0.1 mm (the distance between the upper and lower lips).'}, {'measure': 'Mann Assessment of Swallowing Ability', 'timeFrame': 'day 1 and day 15', 'description': 'Mann Assessment of Swallowing Ability is used to assess swallowing function. The maximum score on the scale is 200. Each item on the scale is scored from 0 to 6, and the total score is calculated by summing up the scores across all items. A higher score indicates better swallowing ability, while a lower score suggests the presence of swallowing difficulties.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporomandibular Joint Dysfunction']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction\n\nThe main question it aims to answer is:\n\n• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction', 'detailedDescription': 'The background of Temporomandibular Joint Dysfunction is that it is one of the common diseases in the oral and maxillofacial region, and it is the most common among temporomandibular joint diseases. It is more prevalent in young adults, with the highest prevalence rate at 20-30 years old.\n\nThe goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction\n\nThe main question it aims to answer is:\n\n• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of significant temporomandibular disorder clinical symptoms.\n* Meeting the diagnostic criteria for Temporomandibular Joint Dysfunction and confirmed by X-ray examination.\n* Patients voluntarily participate in this study and provide signed informed consent.\n* Normal cognitive function\n\nExclusion Criteria:\n\n* Rheumatic, rheumatoid, or other severe systemic diseases.\n* Infectious temporomandibular joint arthritis or joint tumors.\n* Individuals who have recently received joint injection treatment or photodynamic therapy.'}, 'identificationModule': {'nctId': 'NCT06301620', 'briefTitle': 'Intra-articular Injection: A Innovational Approach for Joint Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Ahmadu Bello University Teaching Hospital'}, 'officialTitle': 'Impact of Intra-articular Injection on Temporomandibular Joint Disorder', 'orgStudyIdInfo': {'id': 'GUANJIEQIANG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Routine rehabilitation treatment+Intra-articular Injection', 'description': 'The patients receive a 15-day treatment and are required to stay in the hospital during this period. Patients in the experimental group are given routine rehabilitation treatment and intra-articular injections. Lidocaine is used as the injected medication at a dose of 2ml, administered once every 5 days for a total of three injections.', 'interventionNames': ['Behavioral: Routine rehabilitation treatment', 'Behavioral: Intra-articular Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine rehabilitation treatment', 'description': 'The patients receive a 15-day treatment and are required to stay in the hospital during this period. Patients are given routine rehabilitation treatment.', 'interventionNames': ['Behavioral: Routine rehabilitation treatment']}], 'interventions': [{'name': 'Routine rehabilitation treatment', 'type': 'BEHAVIORAL', 'description': 'Routine rehabilitation treatment Includes oral rehabilitation, rehabilitation training for temporomandibular disorders, orthodontic treatment, and other physical therapy methods.which can alleviate symptoms by adjusting the bite, relaxing muscles, and increasing the range of motion of the temporomandibular joint.\n\nBesides, it also Includes temporomandibular joint exercise training, relaxation training for facial muscles, and functional chewing training aimed at improving temporomandibular joint function and muscle balance.', 'armGroupLabels': ['Routine rehabilitation treatment', 'Routine rehabilitation treatment+Intra-articular Injection']}, {'name': 'Intra-articular Injection', 'type': 'BEHAVIORAL', 'description': 'The patient is positioned to maximize mouth opening, and a needle is inserted approximately 10-12 mm in front of the tragus after touching the ankle prominence. An 8# injection needle is chosen and inserted upward and slightly forward into the joint cavity. A total of 2 mL of lidocaine hydrochloride injection solution is injected, repeated once every 5 days for a total of 15 days.', 'armGroupLabels': ['Routine rehabilitation treatment+Intra-articular Injection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lavie Ce, Master', 'role': 'CONTACT', 'email': 'zenghongjixx@qq.com', 'phone': '15038177099'}], 'overallOfficials': [{'name': 'Nieto Luis, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Site Coordinator of United Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Muhammad', 'investigatorAffiliation': 'Ahmadu Bello University Teaching Hospital'}}}}