Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-27 @ 11:05 PM
Study NCT ID:
NCT03677895
Status:
UNKNOWN
Last Update Posted:
2018-10-10
First Post:
2018-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'outcome assessor does not know the rotator cuff condition of patients'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'patients with rotator cuff disorders receving subacromial hyaluronic acid injection'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-08', 'studyFirstSubmitDate': '2018-09-09', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'constant shoulder score', 'timeFrame': '12 weeks', 'description': 'the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength'}], 'secondaryOutcomes': [{'measure': 'pain intensity measured by visual analog scale', 'timeFrame': '0, 6, 12 weeks', 'description': 'pain intensity was measured by visual analog scale. the total score ranges from 0 to 10 points, with higher scores indicative of more painful'}, {'measure': 'Shoulder Pain And disability index', 'timeFrame': '0, 6, 12 weeks', 'description': "The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder."}, {'measure': 'glenohumeral joint range of motion', 'timeFrame': '0, 6, 12 weeks', 'description': 'Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rotator cuff disorder'], 'conditions': ['Rotator Cuff Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'To evaluate the correlations between structure of supraspinatus tendon (impingement, tendinopathy or partial tear, as well as full thickness tear) on ultrasonography and its response to subacromial hyaluronic acid injection in rotator cuff disease patients', 'detailedDescription': 'Objective: To evaluate the correlations between structure of supraspinatus tendon (impingement, tendinopathy or partial tear, as well as full thickness tear) on ultrasonography and its response to subacromial hyaluronic acid injection in rotator cuff disease patients and also investigate the factors associated with clinically important improvement after subdeltoid hyaluronic acid for rotator cuff disorder.\n\nDesign: Prospective, longitudinal comparison study.\n\nParticipants: Patients with rotator cuff disease\n\nIntervention: Three subacromial injection with hyaluronic acid with 2 week-interval.\n\nMain Outcome Measures: Visual analog scale (VAS) of the shoulder pain, Constant score, SPADI score, and angles of active shoulder range of motion (flexion, abduction, external rotation, and internal rotation) at pre-treatment, post-treatment at week 4 and post-treatment at week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria were patients\n\n1. with clinically and ultrasonographically diagnosed rotator cuff disease of the shoulder-impingement, tendinosis and tear;\n2. who reported shoulder pain more than 3 months;\n\nExclusion Criteria:\n\n1. presence of another medical or psychological condition, including cancer, rheumatoid arthritis, endocrine disease (i.e., diabetes), major depression, or schizophrenia;\n2. previous major trauma history at currently affected shoulder; 3 primary osteoarthritis of the glenohumeral joint in a simple radiograph; 4previous injection history at the affected shoulder within 3 months'}, 'identificationModule': {'nctId': 'NCT03677895', 'briefTitle': 'What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection', 'orgStudyIdInfo': {'id': '2017-02-006C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with rotator cuff disorders', 'description': 'patients with rotator cuff disorders, including impingment, rotator cuff disorders and rotator cuff tear receiving hyaluronic acid injection over subacromial bursa', 'interventionNames': ['Drug: Hyaluronic Acid']}], 'interventions': [{'name': 'Hyaluronic Acid', 'type': 'DRUG', 'otherNames': ['hyruan'], 'description': 'Hyaluronic Acid 2cc into subacromial bursa at weeks 0, 2 and 4', 'armGroupLabels': ['patients with rotator cuff disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jia chi c Wang, MD', 'role': 'CONTACT', 'email': 'jcwang0726@gmail.com', 'phone': '886-2-28757361'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jia Chi Wang, MD', 'role': 'CONTACT', 'email': 'jcwang0726@gmail.com', 'phone': '886-2-28757361'}], 'overallOfficials': [{'name': 'Jia Chi Wang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}