Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT01735058
Status:
UNKNOWN
Last Update Posted:
2012-12-04
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease
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'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-01', 'studyFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2012-11-22', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in pain severity after 3 weeks.', 'timeFrame': 'Up to 3 weeks', 'description': 'The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Subacromial Impingement Syndrome']}, 'referencesModule': {'references': [{'pmid': '15756189', 'type': 'BACKGROUND', 'citation': 'Andrews JR. Diagnosis and treatment of chronic painful shoulder: review of nonsurgical interventions. Arthroscopy. 2005 Mar;21(3):333-47. doi: 10.1016/j.arthro.2004.11.003.'}, {'pmid': '18096343', 'type': 'BACKGROUND', 'citation': 'Meloni F, Milia F, Cavazzuti M, Doria C, Lisai P, Profili S, Meloni GB. Clinical evaluation of sodium hyaluronate in the treatment of patients with sopraspinatus tendinosis under echographic guide: experimental study of periarticular injections. Eur J Radiol. 2008 Oct;68(1):170-3. doi: 10.1016/j.ejrad.2007.11.001. Epub 2007 Dec 21.'}, {'pmid': '22366365', 'type': 'BACKGROUND', 'citation': 'Kim YS, Park JY, Lee CS, Lee SJ. Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study. J Shoulder Elbow Surg. 2012 Jun;21(6):722-7. doi: 10.1016/j.jse.2011.11.009. Epub 2012 Feb 25.'}, {'pmid': '19963403', 'type': 'BACKGROUND', 'citation': 'Chou WY, Ko JY, Wang FS, Huang CC, Wong T, Wang CJ, Chang HE. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg. 2010 Jun;19(4):557-63. doi: 10.1016/j.jse.2009.08.006. Epub 2009 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'This study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.', 'detailedDescription': 'Rotator cuff disease in particular is a common cause of shoulder pain and weakness and comprises a significant proportion of the musculoskeletal complaints presenting to primary care doctors. Ultrasound is a readily available and cheap modality for looking more specifically at the rotator cuff and surrounding structures. More recently, ultrasound guidance has become a commonly employed method to perform diagnostic or therapeutic interventions. Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there are a few high-quality studies demonstrating the efficacy of sodium hyaluronate injection for rotator cuff disease, this study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>= 18 years\n* subacromial impingement syndrome\n* without a complete tear of rotator cuff\n* willingness to participate\n\nExclusion Criteria:\n\n* had any rheumatic disease, glenohumeral osteoarthritis, full-thickness rotator cuff tears, fractures, diabetes mellitus, infections, or tumors.\n* had hypersensitivity to hyaluronate\n* had participated in any other study within 6 months\n* had received a subacromial injection within 8 weeks\n* were pregnant or planned to become pregnant\n* were at risk of complications of intra-articular injections such as patients who received anti-coagulant drugs.'}, 'identificationModule': {'nctId': 'NCT01735058', 'briefTitle': 'Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of Rotator Cuff Disease', 'orgStudyIdInfo': {'id': '13912134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium hyaluronate', 'description': 'Ultrasound guided injection of sodium hyaluronate', 'interventionNames': ['Drug: Sodium Hyaluronate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Ultrasound guided injection of normal saline', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Sodium Hyaluronate', 'type': 'DRUG', 'description': 'Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.', 'armGroupLabels': ['Sodium hyaluronate']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Alireza Moghtaderi, MD', 'role': 'CONTACT', 'email': 'moghtaderia@yahoo.com'}, {'name': 'Alireza Moghtaderi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Rehabilitation, Alzahra Hospital', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'centralContacts': [{'name': 'Farnaz Dehghan, MD', 'role': 'CONTACT', 'email': 'dr.farnaz.dehghan@gmail.com'}], 'overallOfficials': [{'name': 'Farnaz Dehghan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isfahan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Farnaz Dehgan Hosseinabadi', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}