Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-01-02 @ 2:11 PM
Study NCT ID:
NCT02974166
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2016-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D003147', 'term': 'Communication 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'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'C004704', 'term': 'cyclobenzaprine'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-22', 'studyFirstSubmitDate': '2016-11-16', 'studyFirstSubmitQcDate': '2016-11-22', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '4 weeks', 'description': 'Pain assessed by visual analogue scale.'}], 'secondaryOutcomes': [{'measure': '(RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Temporomandibular Disorder', 'Osteopathic Manipulative Treatment', 'Rigid Splint', 'Speech Therapy'], 'conditions': ['Temporomandibular Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether osteopathic manipulative treatment associated to Dentistry care and speech therapy improves pain and function in individuals with temporomandibular disorders.', 'detailedDescription': 'A standardized TMD examination was executed in all patients by a dentist following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/ TMD) questionnaire, Axis I and II, portuguese version. The RDC/ TMD is compound by a 31 items questionnaire and a ten items clinical exam. All these items are related to patients symptoms and signs; to mandibular functional impairment; and social-demographics, social-economics, psychological e psychosocial data. The first part as Axis I tend to clinical assess and classify the TMD and the second, as Axis II propose a chronic pain score that could quantify the psychosocial impairment and present a subjects profile.\n\nOthers assessment instruments utilized on the research were the VAS consists in a 10 cm horizontal line with "no pain" on the left side and "worst pain" on right side, then the subjects were instructed to vertical risk the level of pain. The digital caliper with a 0,03 mm precision was used to measure the maximal mouth opening (MMO) as the maximal inter-incisal vertical distance of the incisors. The subjects were seated at 90° with neutral head position and solicited to open their mouths the maximum they can unassisted and without pain, maximum unassisted opening and maximum assisted opening. Also, a portable digital pressure algometer for measuring sensitivity to pressure before it became painful. The masseters and temporalis muscles trigger point location were used as reference to guarantee the reproducibility of the proceeding as well as to assess the always the same site. The statistical analysis was performed using the means comparisons for the parametric tests through Student T test and for the non-parametrical data, Wilcoxon. Also, it was made the descriptive statistical with frequencies analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects of both genders with TMD diagnosed and minimum pain intensity of 40 mm on a visual analogue scale (VAS) who need dental treatment.\n\nExclusion Criteria:\n\n* continuous use of analgesic medication, mouth opening above 40 mm, presence of any other orofacial pain not related to TMD and being under orthodontic or TMD treatment.'}, 'identificationModule': {'nctId': 'NCT02974166', 'briefTitle': 'Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Brasileiro de Osteopatia'}, 'officialTitle': 'Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'InstitutoBOsteopatia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Group', 'description': 'Individuals with temporomandibular disorder were used rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions during four weeks.', 'interventionNames': ['Other: Conventional Group', 'Drug: Ibuprofen', 'Drug: Cyclobenzaprine Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Osteopathic Group', 'description': 'Individuals with temporomandibular disorder received the same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week until the end of dental and speech therapy treatments (4 weeks).', 'interventionNames': ['Other: Osteopathic Group', 'Drug: Ibuprofen', 'Drug: Cyclobenzaprine Hydrochloride']}], 'interventions': [{'name': 'Conventional Group', 'type': 'OTHER', 'description': 'Rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) were made and prescribed under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions.', 'armGroupLabels': ['Conventional Group']}, {'name': 'Osteopathic Group', 'type': 'OTHER', 'description': 'Same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week during four weeks. The osteopathic treatment consisted in an individualized assessment of mobility restrictions of myofascial tissues and joints and the application of smooth techniques such myofascial release, membranous strain and counterstrain, muscle energy, cranial and high velocity and low amplitude.', 'armGroupLabels': ['Osteopathic Group']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['anti-inflammatory drug'], 'description': 'The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.', 'armGroupLabels': ['Conventional Group', 'Osteopathic Group']}, {'name': 'Cyclobenzaprine Hydrochloride', 'type': 'DRUG', 'otherNames': ['muscle relaxer'], 'description': 'The medication was prescribed by the dentist as muscle relaxer if necessary.', 'armGroupLabels': ['Conventional Group', 'Osteopathic Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Brazilian Institute of Osteopathy', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Thiago B Susin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IBO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Brasileiro de Osteopatia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, DO', 'investigatorFullName': 'Thiago Boeira Susin, PT, DO', 'investigatorAffiliation': 'Instituto Brasileiro de Osteopatia'}}}}