Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-02 @ 1:48 AM
Study NCT ID:
NCT06493656
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation
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': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A final number of 50 patients were enrolled in the trial and randomly assigned to either the isolated corticosteroid injection group (Group CS) or the concomitant hydrodilatation group (Group CSHD). Double-blinded randomization was performed by an independent nurse using a computer-generated random sequence. A musculoskeletal radiologist, blinded to group allocation, performed the diagnostic ultrasound and MRI interpretations. A blinded orthopaedic nurse carried out the physical examination and clinical scoring.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study group underwent ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline.\n\nControl group underwent ultrasound-guided posterior approach of glenohumeral space HYDRODILATATION for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 15 mL normal saline.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2015-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-07', 'studyFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2024-07-07', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale (VAS) for pain', 'timeFrame': 'Change from the baseline to 6 months', 'description': 'Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain'}], 'secondaryOutcomes': [{'measure': 'Range of motion (ROM)', 'timeFrame': 'Change from the baseline to 6 months', 'description': 'ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90)'}, {'measure': 'American Shoulder and Elbow Surgeons (ASES) shoulder score', 'timeFrame': 'Change from the baseline to 6 months', 'description': 'Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.'}, {'measure': 'Constant-Murley score', 'timeFrame': 'Change from the baseline to 6 months', 'description': 'Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glenohumeral injection', 'Hydrodilatation', 'Corticosteroid injection'], 'conditions': ['Adhesive Capsulitis', 'Adhesive Capsulitis of Shoulder']}, 'referencesModule': {'references': [{'pmid': '20110457', 'type': 'RESULT', 'citation': 'Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.'}, {'pmid': '32117540', 'type': 'RESULT', 'citation': 'Cho CH, Lee YH, Kim DH, Lim YJ, Baek CS, Kim DH. Definition, Diagnosis, Treatment, and Prognosis of Frozen Shoulder: A Consensus Survey of Shoulder Specialists. Clin Orthop Surg. 2020 Mar;12(1):60-67. doi: 10.4055/cios.2020.12.1.60. Epub 2020 Feb 13.'}, {'pmid': '30632986', 'type': 'RESULT', 'citation': 'Redler LH, Dennis ER. Treatment of Adhesive Capsulitis of the Shoulder. J Am Acad Orthop Surg. 2019 Jun 15;27(12):e544-e554. doi: 10.5435/JAAOS-D-17-00606.'}, {'pmid': '29129609', 'type': 'RESULT', 'citation': 'Catapano M, Mittal N, Adamich J, Kumbhare D, Sangha H. Hydrodilatation With Corticosteroid for the Treatment of Adhesive Capsulitis: A Systematic Review. PM R. 2018 Jun;10(6):623-635. doi: 10.1016/j.pmrj.2017.10.013. Epub 2017 Nov 10.'}, {'pmid': '21816628', 'type': 'RESULT', 'citation': 'Oh JH, Oh CH, Choi JA, Kim SH, Kim JH, Yoon JP. Comparison of glenohumeral and subacromial steroid injection in primary frozen shoulder: a prospective, randomized short-term comparison study. J Shoulder Elbow Surg. 2011 Oct;20(7):1034-40. doi: 10.1016/j.jse.2011.04.029. Epub 2011 Aug 4.'}, {'pmid': '28002160', 'type': 'RESULT', 'citation': 'Kim DY, Lee SS, Nomkhondorj O, Cho MG, Lee JJ, Hwang JT, Hong MS. Comparison Between Anterior and Posterior Approaches for Ultrasound-Guided Glenohumeral Steroid Injection in Primary Adhesive Capsulitis: A Randomized Controlled Trial. J Clin Rheumatol. 2017 Jan;23(1):51-57. doi: 10.1097/RHU.0000000000000475. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial investigates whether concomitant capsule-preserving hydrodilatation (CSHD) is more effective than isolated glenohumeral corticosteroid injection (CS) in treating shoulder adhesive capsulitis. The main questions it aims to answer are\n\n* Is CSHD inferior to CS in immediate pain relief as the solution is diluted?\n* Is CSHD superior to CS in improving the range of motion as the contracted capsule is dilated?\n\nGroup CS will receive an ultrasound-guided glenohumeral corticosteroid injection only, with a solution of 5 mL.\n\nGroup CSHD will receive an ultrasound-guided glenohumeral corticosteroid with hydrodilatation, with a solution of 20 mL.\n\nClinical scores and range of motion will be compared between the groups up to six months post-injection.', 'detailedDescription': 'A single-centre, double-blinded, prospective randomised controlled trial involving patients diagnosed with adhesive capsulitis of the shoulder (AC).\n\nPatients were randomly allocated to either corticosteroid injection with hydrodilatation (group CSHD) or corticosteroid injection only (group CS).\n\nFor the CS group, a solution of 1 mL triamcinolone (40mg) and 4 mL 1% lidocaine, 5 mL in total, was injected intraarticularly through the posterior approach using ultrasound guidance.\n\nThe CSHD group received an injection of 20 mL with 15 mL of normal saline added to the abovementioned 5 mL solution. The dilatation of the joint capsule was confirmed by the increase in distance between the capsule and the humeral head.\n\nPatients underwent the following assessments just before the injection, and at post-injection three weeks, seven weeks, three months, and six months.\n\nRange of motion in forward elevation, external rotation, and internal rotation Clinical scores include the pain visual analogue scale (pVAS), the American Shoulder and Elbow Surgeons score, and the Constant-Murley score.\n\nSubjective patient satisfaction was recorded on a scale from 0 to 100, with 100 being the most satisfied.\n\nThe recorded data were compared within each group before and after the injection, and also between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTwo or more of the following criteria within the shoulder's range of motion:\n\n* Abduction and forward elevation below 100˚\n* External rotation at the side below 30˚\n* Internal rotation at 90˚ of abduction below 30˚\n\nExclusion Criteria:\n\n* History of shoulder surgery, trauma, nerve injury\n* Concomitant rotator cuff/biceps lesions in ultrasound or MRI\n* Glenohumeral arthritis in simple X-ray\n* Calcific tendinosis in simple X-ray\n* Underlying conditions: cancer, mental illness, hormonal imbalance\n* Diabetes with HbA1c levels exceeding 7.0%"}, 'identificationModule': {'nctId': 'NCT06493656', 'acronym': 'CSvsCSHD', 'briefTitle': 'Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation', 'organization': {'class': 'OTHER', 'fullName': 'Chuncheon Sacred Heart Hospital'}, 'officialTitle': 'The Efficacy of Single-shot Capsule-preserving Hydrodilatation With Corticosteroids in Treating Adhesive Capsulitis of the Shoulder: A Randomized Controlled Trial Versus Isolated Corticosteroid Injection', 'orgStudyIdInfo': {'id': 'CSvsCSHD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isolated corticosteroid injection', 'description': 'Ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine.', 'interventionNames': ['Procedure: Ultrasound-guided glenohumeral space isolated corticosteroid injection', 'Drug: 1mL of Triamcinolone (40mg/1mL) Injectable Solution', 'Drug: 4mL of Lidocaine 1% Solution Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Concomitant hydrodilatation with corticosteroid injection', 'description': 'Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline', 'interventionNames': ['Procedure: Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection', 'Drug: 1mL of Triamcinolone (40mg/1mL) Injectable Solution', 'Drug: 4mL of Lidocaine 1% Solution Injectable Solution', 'Drug: 15mL of Normal Saline']}], 'interventions': [{'name': 'Ultrasound-guided glenohumeral space isolated corticosteroid injection', 'type': 'PROCEDURE', 'description': 'Using a 21-gauge spinal needle, the predefined steroid solution was injected under ultrasound guidance using 5- to 13-MHz linear probe into the glenohumeral space through the posterior approach.', 'armGroupLabels': ['Isolated corticosteroid injection']}, {'name': 'Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection', 'type': 'PROCEDURE', 'description': 'Using a 21-gauge spinal needle, the predefined steroid solution with additional 15 mL of normal saline was injected under ultrasound guidance using 5- to 13-MHz linear probe into the glenohumeral space through the posterior approach.', 'armGroupLabels': ['Concomitant hydrodilatation with corticosteroid injection']}, {'name': '1mL of Triamcinolone (40mg/1mL) Injectable Solution', 'type': 'DRUG', 'description': '1mL of Triamcinolone 40mg/1mL solution was included in the injection/hydrodilatation regimen.', 'armGroupLabels': ['Concomitant hydrodilatation with corticosteroid injection', 'Isolated corticosteroid injection']}, {'name': '4mL of Lidocaine 1% Solution Injectable Solution', 'type': 'DRUG', 'description': '4mL of 1% Lidocaine solution was included in the injection/hydrodilatation regimen.', 'armGroupLabels': ['Concomitant hydrodilatation with corticosteroid injection', 'Isolated corticosteroid injection']}, {'name': '15mL of Normal Saline', 'type': 'DRUG', 'description': '15mL of 1% Lidocaine solution was included in the hydrodilatation regimen.', 'armGroupLabels': ['Concomitant hydrodilatation with corticosteroid injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-204', 'city': 'Chuncheon', 'state': 'Gangwondo', 'country': 'South Korea', 'facility': 'Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}], 'overallOfficials': [{'name': 'Jung Taek Hwang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chuncheon Sacred Heart Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jung-Taek Hwang', 'investigatorAffiliation': 'Chuncheon Sacred Heart Hospital'}}}}