Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-02 @ 5:54 PM
Study NCT ID:
NCT02169206
Status:
COMPLETED
Last Update Posted:
2014-06-23
First Post:
2014-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-19', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-06-19', 'lastUpdatePostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Center equator distance', 'timeFrame': 'one year', 'description': 'Center-equator distance (CED): On radiography, the humeral head center (HHC) is determined using a circular template. A perpendicular line to glenoid is drawn passing through its middle point which supposed to be the glenoid equator line (GEL). The distance between the HHC and GEL is measured in millimeters and considered positive if HHC is above and negative if HHC is below the GEL.'}, {'measure': 'Scapulohumeral angle', 'timeFrame': 'one year', 'description': 'Scapulohumeral angle (SHA): The angle formed between humeral shaft axis and lateral border of scapula starting from the inferior angle is called scapulohumeral angle.'}, {'measure': 'Acromiohumeral distance', 'timeFrame': 'one year', 'description': 'Acromiohumeral distance (AHD): Distance between the line drawn along the acromial lower border density and the highest point of the humeral head is measured in millimeters as acromiohumeral distance (AHD).'}], 'primaryOutcomes': [{'measure': 'Radiographic parameter (scapulothoracic angle) measured in angle', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Frozen shoulder', 'scapulothoracic angle', 'scapulohumeral angle', 'acromiohumeral distance', 'center equator distance', 'shoulder radiography'], 'conditions': ['Frozen Shoulder']}, 'descriptionModule': {'briefSummary': 'This study on frozen shoulder addressed the null hypothesis that there is no difference in the motion of scapula against the thoracic wall between affected and non-affected shoulder.', 'detailedDescription': 'Adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions will be included. Patients with bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear will be excluded. MR imaging will be done to exclude other pathologies and frank rotator cuff tear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions\n\nExclusion Criteria:\n\n* bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear. MRI will be done to rull out the rotator cuff tear.'}, 'identificationModule': {'nctId': 'NCT02169206', 'briefTitle': 'Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position', 'orgStudyIdInfo': {'id': '910177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'shoulder radiography', 'description': 'Bilateral shoulder AP standard plain x-ray in 0 and 90 degrees of arm abduction. Non-affected shoulder is used to be compared with the affected shoulder.', 'interventionNames': ['Radiation: Bilateral shoulder anteroposterior radiography']}], 'interventions': [{'name': 'Bilateral shoulder anteroposterior radiography', 'type': 'RADIATION', 'description': "1. Patient standing with the tube in front and 105 cm far from the shoulder radiating perpendicular to the cassette in the back, both arms hanging aside the trunk in 0 degrees of arm abduction, 0 degrees of rotation and 0 degrees of extension with the thumb facing forward to obtain true bilateral shoulder anteroposterior view. Voltage and exposure time differs regarding each person's body mass.\n2. In the same position, the patient only elevates the arm up to 90 degrees of abduction.", 'armGroupLabels': ['shoulder radiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91375-345', 'city': 'Mashhad', 'state': 'Khorasan-Razavi', 'country': 'Iran', 'facility': 'Mashhad University of Medical Sciences', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}], 'overallOfficials': [{'name': 'Mohammad H Ebrahimzadeh, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mashhad University of Medical Sciences'}, {'name': 'Amir R Kachooei, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mashhad University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Amir Reza Kachooei', 'investigatorAffiliation': 'Mashhad University of Medical Sciences'}}}}