Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-06 @ 11:08 AM
Study NCT ID:
NCT01144533
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2010-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis
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'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2010-06-08', 'studyFirstSubmitQcDate': '2010-06-14', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPADI Score (Shoulder Pain and Disability Index)', 'timeFrame': 'Postinjection 1month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adhesive Capsulitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of intra-articular steroid injection, sodium hyaluronate injection, a combination of the two, and placebo in the treatment of adhesive capsulitis of the shoulder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis : Adhesive Capsulitis of the Shoulder\n* defining of adhesive capsulitis\n\n * the presence of shoulder pain\n * limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions(abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder\n* duration : symptomatic for \\< 1 year\n\nExclusion Criteria:\n\n* bilateral symptoms\n* uncontrolled diabetes mellitus\n* overt hypothyroidism or hyperthyroidism\n* previous shoulder surgery\n* previous glenohumeral joint injection within recent 6months\n* trauma to the shoulder the last six months that required hospital care\n* neurological symptoms\n* allergy to injection material\n* secondary adhesive capsulitis\n* systemic inflammatory ds including rheumatoid arthritis\n* degenerative arthritis of shoulder joint\n* infectious arthritis of shoulder joint\n* dislocation of shoulder joint\n* blood coagulation disease\n* rotator cuff tear\n* serious mental illness\n* pregnancy\n* fracture in shoulder lesion\n* CVA'}, 'identificationModule': {'nctId': 'NCT01144533', 'briefTitle': 'Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'BRM-10-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic saline', 'interventionNames': ['Procedure: isotonic saline injection into the glenohumeral joint']}, {'type': 'EXPERIMENTAL', 'label': 'Steroid', 'interventionNames': ['Procedure: steroid injection into the glenohumeral joint']}, {'type': 'EXPERIMENTAL', 'label': 'Hyaluronate', 'interventionNames': ['Procedure: sodium hyaluronate injection into the glenohumeral joint']}, {'type': 'EXPERIMENTAL', 'label': 'Steroid + Hyaluronate', 'interventionNames': ['Procedure: steroid and hyaluronate injection into the glenohumeral joint']}], 'interventions': [{'name': 'isotonic saline injection into the glenohumeral joint', 'type': 'PROCEDURE', 'description': '* Total volume of injection drugs: 8ml\n* isotonic saline 4ml + telebrix(contrast media) 4ml\n* The number of injections : only once during the study period\n* Injection site : glenohumeral joint\n* Material : 22-gauze spinal needle\n* Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.', 'armGroupLabels': ['Isotonic saline']}, {'name': 'steroid injection into the glenohumeral joint', 'type': 'PROCEDURE', 'description': '* Total volume of injection drugs: 8ml\n* triamcinolone(40mg)1ml + isotonic saline 3ml + telebrix(contrast media)4ml\n* The number of injections : only once during the study period\n* Injection Site : glenohumeral joint\n* Material : 22-gauze spinal needle\n* Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.', 'armGroupLabels': ['Steroid']}, {'name': 'sodium hyaluronate injection into the glenohumeral joint', 'type': 'PROCEDURE', 'description': '* Total volume of injection drugs: 8ml\n* sodium hyaluronate 2ml + isotonic saline 2ml + telebrix(contrast media)4ml\n* The number of injections : only once during the study period\n* Injection Site : glenohumeral joint\n* Material : 22-gauze spinal needle\n* Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.', 'armGroupLabels': ['Hyaluronate']}, {'name': 'steroid and hyaluronate injection into the glenohumeral joint', 'type': 'PROCEDURE', 'description': '* Total volume of injection drugs: 8ml\n* triamcinolone(40mg)1ml + sodium hyaluronate 2ml + isotonic saline 1ml + telebrix(contrast media)4ml\n* The number of injections : only once during the study period\n* Injection Site : glenohumeral joint\n* Material : 22-gauze spinal needle\n* Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.', 'armGroupLabels': ['Steroid + Hyaluronate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chris H. Jo, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, SMG-SNU Boramae Medical Center.', 'investigatorFullName': 'Hyunchul Jo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}