Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-28 @ 3:47 AM
Study NCT ID:
NCT03726060
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2018-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
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': 'D035061', 'term': 'Control Groups'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-10-30', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain', 'timeFrame': 'Change from initial VAS at 3 and 6 months from the beginning of the treatment', 'description': 'The VAS measures the intensity of the pain that thethe patient perceived and it is represented by a 10 cm long scale with a score from 0 to 10. The VAS will be evaluated in 3 times: at rest; during the maximum buccal opening; during chewing'}], 'secondaryOutcomes': [{'measure': 'ROM (range of motion)', 'timeFrame': 'The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment', 'description': 'The ROM measures the joint function. It provides the analytical and millimetric measurement of functional movements with a precision gauge positioned between the incisal edges of the upper and lower anterior groups.\n\nIt should be noted: maximum buccal opening; deviation of the median line; left and right lateral movements; overjet and overbite.\n\nIt should also be noted the extent of final elasticity (or end-feel test and its nature (elastic, painful, hard)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporomandibular Disorder']}, 'referencesModule': {'references': [{'pmid': '38757854', 'type': 'DERIVED', 'citation': 'Romeo A, Incorvati C, Vanti C, Turolla A, Marinelli F, Defila L, Gulotta C, Marchetti C, Pillastrini P. Physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: A randomised controlled trial. J Oral Rehabil. 2024 Aug;51(8):1566-1578. doi: 10.1111/joor.13729. Epub 2024 May 17.'}, {'pmid': '32792449', 'type': 'DERIVED', 'citation': 'Incorvati C, Romeo A, Fabrizi A, Defila L, Vanti C, Gatto MRA, Marchetti C, Pillastrini P. Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial. BMJ Open. 2020 Aug 13;10(8):e038438. doi: 10.1136/bmjopen-2020-038438.'}]}, 'descriptionModule': {'briefSummary': 'The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders.\n\nThey will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale).\n\nThe second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale - HADS questionnaire).', 'detailedDescription': "Randomized controlled clinical trial with randomization according to a multi-phase design.\n\nPhase 1 involves the enrollment of patients with DTMs based on diagnostic criteria.\n\nPhase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients.\n\nPhase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list.\n\nThe 2 therapeutic protocols are:\n\n* gnathological therapy (splint) associated with education and physiotherapy (test group);\n* gnathological therapy (splint) associated with education (control group). During the first visit the patient will be enlisted by evaluating the inclusion and exclusion criteria and signed the informed consent, he / she will be assigned a unique identification code.\n\nThe code consists of a progressive number followed by the patient's initials (eg 01-F.R.).\n\nSubsequently, the patients will be randomized blinded and assigned to one of the two study groups.\n\nRandomization will be performed using random, computer-generated, centralized numbers placed in sealed opaque envelopes provided by the study coordinator.\n\nBoth types of treatment will be performed by a single operator respectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with myogenic temporomandibular disorders assessed with clinical examination as established by the DC / TMD1;\n* patients older than 18 years;\n* good knowledge of Italian language;\n* patients who have signed informed consent\n\nExclusion Criteria:\n\n* edentulism which makes it impossible to apply gnathological bite;\n* patients with psychiatric problems;\n* patients included in other experimental protocols;\n* patients already undergoing surgical and / or radial therapy of the cervical and facial areas;\n* other temporomandibular disorders without a myogenic component;\n* treatment of the cervical and TMJ district in the previous 3 months;\n* history of drug abuse.'}, 'identificationModule': {'nctId': 'NCT03726060', 'briefTitle': 'Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders', 'orgStudyIdInfo': {'id': '47/2018/SPER/AUSLBO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'splint therapy', 'description': 'Alginate impressions will be taken and the plaster models of the dental arches will be made.\n\nThe splint will be subsequently delivered to the patient with the relative indications of use.\n\nThe splint therapy consist in the use of neuromuscoral splint every the night for 6 months.', 'interventionNames': ['Other: control group']}, {'type': 'OTHER', 'label': 'physical therapy with splint therapy', 'description': 'The treatment consists of a series of interventions: advice on self-treatment techniques to be performed at home and administering manual therapy techniques addressed to: temporomandibular district, cervical and cervico-thoracic junction.\n\nEach session will be carried out individually and will last for 45 minutes. This duration will be divided as follows: 25 minutes dedicated to the temporomandibular district, 15 minutes to the cervical and cervico-thoracic junction, 5 minutes to teaching self-treatment techniques to be carried out at home and to verify the correct way of performing them.\n\nThe cycle will consist of 10 sessions distributed over 3 months.', 'interventionNames': ['Other: test group']}], 'interventions': [{'name': 'control group', 'type': 'OTHER', 'otherNames': ['splint therapy'], 'description': 'In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months', 'armGroupLabels': ['splint therapy']}, {'name': 'test group', 'type': 'OTHER', 'otherNames': ['splint therapy with physical therapy'], 'description': 'In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy', 'armGroupLabels': ['physical therapy with splint therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paolo Pillastrini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Paolo Pillastrini', 'investigatorAffiliation': 'University of Bologna'}}}}