Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-26 @ 5:08 PM
Study NCT ID:
NCT01333150
Status:
UNKNOWN
Last Update Posted:
2012-03-26
First Post:
2011-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Propranolol on the Autonomic Nervous System and Muscle Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D005157', 'term': 'Facial Pain'}], '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': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2011-03-30', 'studyFirstSubmitQcDate': '2011-04-08', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Participants will be asked to score their actual pain level in both of the two experimental sessions they will participate in; an expected average of two weeks between the two sessions', 'description': 'Numeric Rating Scale 0-10'}], 'secondaryOutcomes': [{'measure': 'Haemodynamic parameters', 'timeFrame': 'Participants will be monitored during the entire session in both of the two experimental sessions they will participate in; an expected average of two weeks between the two sessions', 'description': 'Monitoring of pulse and blodpressurevariability, respiration, baroreceptor sensitivity, measured non-invasively by Task Force Monitor.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Temporomandibular disorders', 'Orofacial pain'], 'conditions': ['Temporomandibular Joint Disorders', 'Myofascial Temporomandibular Disorders']}, 'descriptionModule': {'briefSummary': "The project's primary purpose is to test the hypothesis that oral administration of a low single dose of β-antagonist propranolol (40 mg) reduces pain sensitivity in patients with masticatory muscle pain."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) for myofascial TMD diagnosis corresponding to group 1a or 1b\n* Characteristic Pain Intensity (CPI) more than or equal to 20 (Axe II, RDC/TMD questionnaire)\n* Women of childbearing potential must use adequate contraception\n* Signed consent statement\n\nExclusion Criteria:\n\n* Other acute pain cause such as acute toothache or a pain condition the investigator estimates to be contraindicated for participation in the experiment\n* Recognized existing malignancy or within last 5 years\n* Known HIV\n* Abuse of drugs including alcohol\n* Recognized Raynaud's syndrome\n* Former sympathectomy\n* Known cardiovascular disease including abnormal EKG and blood pressure (ECG-12 is recorded before the first trial session and assessed by the physician)\n* Recognized lung insufficience, including bronchial asthma\n* Known severe hepatic or renal dysfunction\n* Known diabetes mellitus\n* Known severe depression\n* Pregnancy (tests performed in both sessions 1 and 2 before the start of a session)\n* Fertility Treatment\n* Lactation\n* Post-menopausal\n* Previous adverse reaction when taking beta-blocker, including hypersensitivity to propranolol or to any of the excipients\n* Patients who can not read and understand the written information\n* Patients who can not follow the protocol\n* Patients who do not agree to comply with the requirements for participation in both studies regarding food intake, physical activity, etc."}, 'identificationModule': {'nctId': 'NCT01333150', 'briefTitle': 'Effect of Propranolol on the Autonomic Nervous System and Muscle Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain', 'orgStudyIdInfo': {'id': 'M-20090062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propranolol', 'interventionNames': ['Drug: Propranololhydrochlorid']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Propranololhydrochlorid', 'type': 'DRUG', 'otherNames': ['Propranolol "DAK" 40 mg, Nycomed Denmark ApS'], 'description': 'One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions', 'armGroupLabels': ['Propranolol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One single dose of placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Karina Bendixen, DDS, PhD fellow', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8000', 'city': 'Aarhus C', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Karina H. Bendixen, PhD fellow', 'role': 'CONTACT', 'email': 'karina.bendixen@odontologi.au.dk', 'phone': '+004587168259'}, {'name': 'Peter Svensson, DDS, PhD, Dr.Odont.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karina H. Bendixen, DDS, PhD fellow', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Section of Clinical Oral Physiology, Aarhus University', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'centralContacts': [{'name': 'Karina H. Bendixen, DDS, PhD fellow', 'role': 'CONTACT', 'email': 'karina.bendixen@odontologi.au.dk', 'phone': '+004587168259'}], 'overallOfficials': [{'name': 'Peter Svensson, DDS, PhD, Dr.Odont', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}