Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT04640220
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Adhesive capsulitis patients who underwent breast cancer operation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2020-11-17', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of motion of shoulder joint', 'timeFrame': 'Change from baseline at 3 months', 'description': 'A goniometer is an instrument which measures the available range of motion at a joint.Flexion, Extension,Adduction,Abduction, Internal Rotation,External rotation'}], 'secondaryOutcomes': [{'measure': 'Change in score on Shoulder Pain and Disability Index (SPADI)', 'timeFrame': 'Change from baseline at 3 months', 'description': 'SPADI is a scale consisting of 0-10; 0 being the best and 10 being the worse pain ever; higher scores mean a worse outcome.'}, {'measure': 'Axillary recess capsule thickness', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Ultrasound measurements of axillary recess capsule thickness in unilateral frozen shoulder'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Neoplasm', 'Shoulder Capsulitis', 'Range of Motion']}, 'descriptionModule': {'briefSummary': 'The prevalence of shoulder joint disease is high in breast cancer patients. The cause of adhesive capsulitis is not clearly identified. However, the following are known as relevant factors that are the restriction of the use of the arm after surgery, inflammation due to autoimmune action, radiation therapy, and adhesion of the surgical site. The purpose of this study is to compare and analyze the effect of intrathecal steroid injection in breast cancer survivors with adhesive capsulitis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent breast cancer surgery within 6 months.\n* Patients with shoulder pain and limited range of motion\n\nExclusion Criteria:\n\n* Patients with infection\n* Bilateral shoulder pain patient\n* Patients with uncontrolled diabetes'}, 'identificationModule': {'nctId': 'NCT04640220', 'briefTitle': 'Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Yeungnam University Hospital'}, 'officialTitle': 'The Effectiveness of Intra-articular Steroid Injection in Breast Cancer Survivors With Adhesive Capsulitis According to the Thickness of Axillary Capsulitis Thickness', 'orgStudyIdInfo': {'id': '2020-07-064-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adhesive capsulitis in breast cancer survivors', 'description': 'Intra-articular steroid injection', 'interventionNames': ['Procedure: Intra-articular steroid injection']}], 'interventions': [{'name': 'Intra-articular steroid injection', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided Gleno-humeral joint steroid (Triamcinolone 40mg with 0.5% lidocaine ) injection', 'armGroupLabels': ['Adhesive capsulitis in breast cancer survivors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42127', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Dong Gyu Dong Gyu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of medicine, Yeungnam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeungnam University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Dong Gyu Lee', 'investigatorAffiliation': 'Yeungnam University Hospital'}}}}