Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-27 @ 1:19 PM
Study NCT ID:
NCT01725867
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2010-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-08', 'studyFirstSubmitDate': '2010-05-30', 'studyFirstSubmitQcDate': '2012-11-08', 'lastUpdatePostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'stress', 'timeFrame': '5 mins', 'description': 'Chinese 14-item perceived stress scale (PSS-14)'}], 'primaryOutcomes': [{'measure': 'Pain status', 'timeFrame': '20 mins', 'description': 'Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands'}], 'secondaryOutcomes': [{'measure': 'range of motion (ROM)', 'timeFrame': '5 mins', 'description': 'active and passive maximal mouth opening range'}, {'measure': 'muscle strength', 'timeFrame': '5 mins', 'description': 'maximal bite force'}, {'measure': 'muscle endurance', 'timeFrame': '10 mins', 'description': 'endurance of jaw closers'}, {'measure': 'muscle stiffness', 'timeFrame': '10 mins', 'description': 'stiffness of masseter taut band'}, {'measure': 'Quality of life (QoL)', 'timeFrame': '15 mins', 'description': 'quality of life measured by Short form-36 (SF-36) Taiwanese version'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['temporomandibular joint disorder', 'myofascial pain', 'manual myofascial release', 'physical therapy', 'oral appliance'], 'conditions': ['Temporomandibular Disorder']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to compare the effect of physical therapy (PT) program and oral appliance on patients with temporomandibular disorder (TMD)-related myofascial pain (MFP).', 'detailedDescription': 'The details of each intervention are listed as following:\n\n* physical therapy program group (PT): manual myofascial release over craniomandibular system, chin-in exercise and self-care education\n* oral appliance group (splint): custom-made stabilization splint and self-care education'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) 20-65 years old female, (2) diagnosed as MFP subtype of TMD according to Research Diagnostic Criteria for TMD (RDC/TMD), (3) pain duration over 3 month, (4) palpable taut band in masseter, (5) Asymmetrical pain intensity, (6) subsided symptoms of joint inflammation.\n\nExclusion Criteria:\n\n* (1) traumatic TMD from external impact force, (2) history of traumatic cervical injury, (3) presence of systemic disease, (4) fibromyalgia, (5) co-interventions for cervical problems or TMD during study period, (6) signs of psychosomatic illness, (7) unwilling to be randomized, (8) unable to wear the splint or received intraoral myofascial release, (9)pregnancy.'}, 'identificationModule': {'nctId': 'NCT01725867', 'briefTitle': 'Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain', 'orgStudyIdInfo': {'id': '201003038R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PT program', 'description': 'manual myofascial release for craniomandibular system for 30\\~40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks', 'interventionNames': ['Other: PT program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Splint group', 'description': 'custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education', 'interventionNames': ['Device: oral appliance']}], 'interventions': [{'name': 'PT program', 'type': 'OTHER', 'description': 'manual myofascial release for craniomandibular system for 30\\~40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks', 'armGroupLabels': ['PT program']}, {'name': 'oral appliance', 'type': 'DEVICE', 'description': 'custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education', 'armGroupLabels': ['Splint group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'National Taiwan University Hospital', 'investigatorFullName': 'National Taiwan University Hospital', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}