Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT00812604
Status:
COMPLETED
Last Update Posted:
2014-06-23
First Post:
2008-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D010577', 'term': 'Petrolatum'}], 'ancestors': [{'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fyoung@hkucc.hku.hk', 'phone': '852-2859 0554', 'title': 'Dr. Ricky Wing Kit Wong, Associate professor in orthodontics', 'organization': 'University of Hong Kong'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'In this study, the subjects were screened by clinical examinations and self-reported questionnaires. Ideally, the diagnosis should be made with a combination of radiographs, Magnetic Resonance Imaging or Computer Tomography.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ping On Ointment Group', 'description': 'Ping On Ointment was used', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Vaseline with minor trace of Ping On Ointment was used', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Efficacy in the Treatment of TMJ and Muscle Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ping On Ointment Group', 'description': 'Ping On Ointment was used'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Vaseline with minor trace of Ping On Ointment was used'}], 'classes': [{'categories': [{'measurements': [{'value': '21.93', 'spread': '18.07', 'groupId': 'OG000'}, {'value': '40.81', 'spread': '14.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS).\n\nThe VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as "no pain" ( 0 mm) and " worst pain possible" ( 100 mm).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Mandibular Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ping On Ointment Group', 'description': 'Ping On Ointment was used'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Vaseline with minor trace of Ping On Ointment was used'}], 'classes': [{'categories': [{'measurements': [{'value': '4.435', 'spread': '6.680', 'groupId': 'OG000'}, {'value': '0.818', 'spread': '3.404', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ping On Ointment Group', 'description': 'Ping On Ointment was used'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Vaseline with minor trace of Ping On Ointment was used'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ping On Ointment Group', 'description': 'Ping On Ointment was used'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Vaseline with minor trace of Ping On Ointment was used'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.14', 'spread': '9.296', 'groupId': 'BG000'}, {'value': '43.96', 'spread': '13.127', 'groupId': 'BG001'}, {'value': '45.51', 'spread': '11.401', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-21', 'studyFirstSubmitDate': '2008-12-19', 'resultsFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2008-12-19', 'lastUpdatePostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-21', 'studyFirstPostDateStruct': {'date': '2008-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Efficacy in the Treatment of TMJ and Muscle Pain', 'timeFrame': '4 weeks', 'description': 'The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS).\n\nThe VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as "no pain" ( 0 mm) and " worst pain possible" ( 100 mm).'}], 'secondaryOutcomes': [{'measure': 'The Mandibular Function.', 'timeFrame': '4 weeks', 'description': "The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Temporomandibular Disorders']}, 'referencesModule': {'references': [{'pmid': '20001836', 'type': 'DERIVED', 'citation': 'Li LC, Wong RW, Rabie AB. Clinical effect of a topical herbal ointment on pain in temporomandibular disorders: a randomized placebo-controlled trial. J Altern Complement Med. 2009 Dec;15(12):1311-7. doi: 10.1089/acm.2009.0129.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both Ping On Ointment and Vaseline are considered intervention.', 'detailedDescription': 'Aims: To compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Methods: In this randomized, double-blinded, placebo-controlled trial, 55 subjects with TMJ and/or masticatory pain (Group 1 patients according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) received Ping On Ointment for 4 weeks; or placebo for 4 weeks. Subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analogue scale and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Self report of facial ache or pain in the muscles of mastication, the TMJ, or the region in front of ear or inside the ear\n2. Positive clinical diagnosis of TMDs. The TMD diagnosis is classified using axis I of the research diagnostic criteria ( RDC) for TMDs. The RDC diagnosis consists of joint pain at rest ( spontaneous pain) and evoked pain (hyperalgesia) on palpation of the TMJ, TMJ reduction consists of reciprocal clicking or joint noise with mandibular movement examination.\n3. For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly-daily pain.\n4. Subjects with myogenic pain will be included if they meet inclusion and exclusion criteria since patients with TMDs are known to exhibit muscle pain secondary to their joint dysfunction.\n\nExclusion Criteria:\n\n1. Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;\n2. Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;\n3. Subjects with acute infection or other significant disease of teeth, ears, eyes, nose or throats; subjects with untreated depressive disorder or not on stable antidepressant medication for more than 6 months;\n4. Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;\n5. Subjects who are not competent in giving consents.\n6. Pregnant or lactating women\n7. Subjects with sensitivity to the ingredient of Ping On Ointment will be excluded.'}, 'identificationModule': {'nctId': 'NCT00812604', 'briefTitle': 'Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Effect of an Analgesic Ointment on the Relief of Temporomandibular Joint and Masticatory Muscle Pain: a Randomized, Double Blinded, Placebo-controlled Study.', 'orgStudyIdInfo': {'id': 'HKCTR-466'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ping On Ointment', 'description': 'Ping On Ointment', 'interventionNames': ['Drug: Ping On Ointment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vaseline', 'description': 'Vaseline with minor trace of Ping On ointment to give medicinal smell', 'interventionNames': ['Drug: Vaseline']}], 'interventions': [{'name': 'Ping On Ointment', 'type': 'DRUG', 'otherNames': ['TCM topical analgesic'], 'description': 'Ping On Ointment', 'armGroupLabels': ['Ping On Ointment']}, {'name': 'Vaseline', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Vaseline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Faculty of Dentistry, The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Ricky W. K. Wong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthodontics, Faculty of Dentistry, University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Orthodontics, Faculty of Dentistry', 'investigatorFullName': 'Wong Wing Kit, Ricky', 'investigatorAffiliation': 'The University of Hong Kong'}}}}