Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05893251
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2023-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013706', 'term': 'Temporomandibular Joint Dysfunction Syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Using the "Random Team Generator" mobile application.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The present study is an experimental, analytical, longitudinal, and prospective controlled randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2023-05-29', 'studyFirstSubmitQcDate': '2023-05-29', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain pressure threshold in myofascial trigger points of the masticatory muscles.', 'timeFrame': 'a week after treatment', 'description': 'In TMD, myofascial pain of the masticatory muscles is the most relevant clinical entity that affects the masticatory system. It will be measured using a pressure algometer.'}], 'primaryOutcomes': [{'measure': 'Cranio facial pain and disability inventory', 'timeFrame': 'a week after treatment', 'description': "CF-PDI (Craniofacial Pain and Disability Inventory): This questionnaire focuses on pain as a common symptom of TMD (Temporomandibular Disorders). It is self-administered and designed to assess patients' perception of their physical and psychosocial health in relation to craniofacial pain. It consists of 21 questions regarding the impact of pain on activities involving the use of the temporomandibular joint, with a scoring range from 0 to 63 in ascending order, where 0 indicates no impact and 63 indicates maximum impact. This questionnaire demonstrates good structure, internal consistency, reproducibility, and validity, making it an objective tool that can be used in research and clinical practice for evaluating patients with craniofacial pain and disability. It is easy to administer and requires a short amount of time. The CF-PDI was created and developed in Spain, based on a biopsychosocial approach."}], 'secondaryOutcomes': [{'measure': 'Maximum mouth opening.', 'timeFrame': 'a week after treatment', 'description': 'The measurement of maximum mouth opening (MMO) is the distance in centimeters between the upper and lower incisor teeth when the subject actively opens their mouth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TEMPOROMANDIBULAR JOINT', 'Cervical Posture', 'wind Musician'], 'conditions': ['Temporomandibular Joint Dysfunction Syndrome']}, 'descriptionModule': {'briefSummary': 'Temporomandibular dysfunction (TMD) consists of a series of multifactorial signs and symptoms that occur in the orofacial region, with pain being the most common symptom. There is a close biomechanical and anatomical relationship between the cervical region and the temporomandibular joint (TMJ) through the trigemino-spinal nucleus.\n\nObjectives: To comparatively assess the improvement in subjects with TMD when adding cervical manual therapy to a postural treatment. Additionally, to determine if both cervical treatments separately produce changes in the TMJ.\n\nMaterials and methods: An experimental study of randomized controlled clinical trial type was conducted. The study involved 30 wind instrument players randomly assigned to an experimental group (EG) and a control group (CG). After obtaining consent, measurements were taken for maximum mouth opening (MMO), cervical range of motion, and pain threshold to pressure (PTP) in the masseter and temporalis muscles. Both groups underwent active cervical postural treatment for 4 weeks, and the EG additionally received a cervical manual therapy protocol. An initial assessment was conducted before the intervention, and a final assessment was done one week after the last intervention. The statistical program SPSS was used for data analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acceptance of written informed consent.\n* Playing a wind instrument.\n* Age between 18-40 years.\n* Pain in the cranio-cervico-mandibular region and/or masticatory muscles.\n* Hypertrophy in the masticatory muscles.\n\nExclusion Criteria:\n\n* History of trauma and/or fracture in the cranial and/or facial region.\n* Rheumatic injury or degenerative disease.\n* Surgical intervention on the temporomandibular joint (TMJ).\n* Malformations of the cervical or cranial spine.\n* Vestibular, circulatory, or neurological disorders.\n* Degenerative or infectious joint diseases.\n* Current orthodontic treatment.\n* Receiving physiotherapy treatment during the two weeks prior to the study or during the study.'}, 'identificationModule': {'nctId': 'NCT05893251', 'acronym': 'ANAISATM', 'briefTitle': 'Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction', 'orgStudyIdInfo': {'id': 'ANAISATM'}, 'secondaryIdInfos': [{'id': 'ANAISATM', 'type': 'OTHER', 'domain': 'UNIVERSITY OF MURCIA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Protocol group', 'description': 'The treatment plan includes active postural exercises for the cervical spine.', 'interventionNames': ['Other: Postural exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Manual therapy group', 'description': 'The treatment plan includes active postural exercises and manual therapy for the cervical spine.', 'interventionNames': ['Other: Manual therapy']}], 'interventions': [{'name': 'Manual therapy', 'type': 'OTHER', 'description': 'Within the manual therapy protocol carried out in the experimental group, we performed a series of passive maneuvers. The patient remains in supine position on a treatment table throughout the treatment, while the therapist sits at the head of the patient on a stool. The sequence of application is as follows:\n\nSuboccipital inhibition technique Cervical spinal mobilization Posterior fascia stretching', 'armGroupLabels': ['Manual therapy group']}, {'name': 'Postural exercises', 'type': 'OTHER', 'description': 'The treatment plan includes active postural exercises for the cervical spine.', 'armGroupLabels': ['Protocol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'facility': 'University Of Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}