Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-30 @ 7:11 AM
Study NCT ID:
NCT01538758
Status:
UNKNOWN
Last Update Posted:
2012-07-12
First Post:
2011-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-11', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2012-02-18', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS score on long term', 'timeFrame': '1 year'}, {'measure': 'Constant score on long term', 'timeFrame': '1 year', 'description': 'The constant score is a validated scale, measuring the shoulder function. It is a objective measurement independent of the shoulder pain.'}], 'secondaryOutcomes': [{'measure': 'Constant score', 'timeFrame': 'baseline,6 weeks, 3 months and 6 months', 'description': 'To have a more insight over time the constant score will be measured at baseline, 6 weeks, 3 months and 6 months'}, {'measure': 'VAS score', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 3 months and 6 months', 'description': 'To have a more insight over time the VAS score will be measured at baseline, 6 weeks, 3 months and 6 months.\n\nIn practice patients seem to have a maximum pain shortly after the us guided needling. To measure this a VAS score will be taken after two weeks.'}, {'measure': 'DASH score', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months and 1 year.', 'description': 'This score measures the disability of the shoulder in daily life, work, sports and hobby over time.'}, {'measure': 'Gärtner score of the shoulder calcifications on x-ray', 'timeFrame': 'at baseline, directly post-interventional, at 6 weeks and one year.'}, {'measure': 'Scoring system presented by Chiou et all. of the calcifications of the supraspinatus tendon on ultrasound', 'timeFrame': 'at baseline, directly post-interventional, at 6 weeks and one year.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['calcifying tendinitis', 'rotator cuff'], 'conditions': ['Calcific Tendinitis']}, 'descriptionModule': {'briefSummary': 'Ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain due to calcifying tendinitis. However, evidence for this treatment is lacking. The investigators expect that patients treated with us guided needling with corticosteroid injection compared with patients treated with only corticosteroid injections in the subacromial bursa have better clinical outcome after one year follow-up.', 'detailedDescription': 'Calcifying tendinitis of the shoulder is a common cause of shoulder pain with an incidence ranging from 2.7 % to 6.8 %. This disease of the rotator cuff tendons is characterised by calcifications in the tendons, most commonly in the supraspinatus tendon up to 82%. The aetiology remains unclear.\n\nCalcifying tendinitis is regarded as a self-healing condition with usually spontaneous resolution of the calcifications. But some patients have chronic or recurrent pain and disability of the shoulder which requires treatment. The treatment should be minimally invasive and effective in short and long term. Symptomatic treatment is indicated first using non-steroidal anti-inflammatory drugs, therapeutic exercise and non ultrasound guided subacromial corticosteroids injection.\n\nThe role of corticosteroid injections is unknown due to the lack of good studies. Family doctors and orthopaedic surgeons inject corticosteroids in the shoulder without the guidance of ultrasound; with this method accurate needle placement in the subacromial bursa is not possible. When this treatment fails other therapeutical methods can be used. Ultrasound guided needling is a percutaneous technique of fragmentation or extraction of calcifications in the rotator cuff tendon.\n\nLiterature shows favourable results but only a few randomized controlled trials were executed. Randomised controlled trials are needed to give more insight in the effectiveness of us guided needling. Comparing two groups of patients treated with us guided corticosteroid injection and one group combined with us guided needling can provide information of the usefulness of us guided needling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Shoulder pain without improvement after 3 months despite conservative treatment\n* Calcification on x-ray (Gartner type I of II) and ultrasound in the supraspinatus tendon less than 6 weeks before the treatment\n* All patients are first seen and included by the orthopaedic surgeon\n\nExclusion Criteria:\n\n* Previous operation of the shoulder\n* Previous ultrasound guided needling of the shoulder\n* Frozen shoulder\n* Last corticosteroid injection less than 3 months ago\n* Comorbidities of the painful shoulder on x-ray or ultrasound ( ruptured tendon, fracture, bursitis,...)\n* No informed consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01538758', 'acronym': 'BARB-01', 'briefTitle': 'Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Medisch Spectrum Twente'}, 'officialTitle': 'Treatment of Calcifying Tendinitis of the Shoulder: Ultrasound Guided Needling With Subacromial Corticosteroid Injection Versus Ultrasound Guided Subacromial Corticosteroid Injection Only, a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'P12-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Us guided needling', 'description': 'Us guided needling is a therapeutical technique treating calcifying tendinitis of the shoulder. Calcifications in the rotator cuff tendon are visualised with ultrasound. Under ultrasound guidance a 20 gauge needle is inserted in the calcification. Lidocaine 1% in a 1cc syringe is injected in the calcification and aspirated. The calcification is flushed until the fluid is clear. Sometimes it is not possible to flush the calcification. In this case the calcification will be fragmented.\n\nAfter flushing or fragmentation of the calcification, 20 mg triamcinolone with 1cc lidocaine 1% will be injected in de subacromial bursa under us guidance.', 'interventionNames': ['Other: Us guided needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'corticosteroid injection', 'description': 'Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.', 'interventionNames': ['Other: corticosteroid injection']}], 'interventions': [{'name': 'Us guided needling', 'type': 'OTHER', 'otherNames': ['Barbotage'], 'description': 'Us guided needling is a therapeutical technique treating calcifying tendinitis of the shoulder. Calcifications in the rotator cuff tendon are visualised with ultrasound. Under ultrasound guidance a 20 gauge needle is inserted in the calcification. Lidocaine 1% in a 1cc syringe is injected in the calcification and aspirated. The calcification is flushed until the fluid is clear. Sometimes it is not possible to flush the calcification. In this case the calcification will be fragmented.\n\nAfter flushing or fragmentation of the calcification, 20 mg triamcinolone with 1cc lidocaine 1% will be injected in de subacromial bursa under us guidance.', 'armGroupLabels': ['Us guided needling']}, {'name': 'corticosteroid injection', 'type': 'OTHER', 'description': 'Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.', 'armGroupLabels': ['corticosteroid injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7513 ER', 'city': 'Enschede', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Eva Genbrugge, MD', 'role': 'CONTACT', 'email': 'eva_genbrugge@hotmail.com', 'phone': '+31 534872000'}, {'name': 'Eva Genbrugge, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}], 'centralContacts': [{'name': 'Eva Genbrugge, MD', 'role': 'CONTACT', 'email': 'eva_genbrugge@hotmail.com', 'phone': '+31 53 4 87 20 00'}], 'overallOfficials': [{'name': 'Eva Genbrugge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MST'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medisch Spectrum Twente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Eva Genbrugge', 'investigatorAffiliation': 'Medisch Spectrum Twente'}}}}