Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT02403856
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2015-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}], 'ancestors': [{'id': 'D002805', 'term': 'Chondrocalcinosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}, {'id': 'D007507', 'term': 'Therapeutic Irrigation'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2015-03-20', 'studyFirstSubmitQcDate': '2015-03-30', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum pain (VAS scale)', 'timeFrame': '7 days', 'description': 'Maximum pain on a VAS scale (0-10) reported by the patient in the seven days following the needling.'}], 'secondaryOutcomes': [{'measure': 'Anti-inflammatory and analgesic intake', 'timeFrame': '7 days'}, {'measure': 'Size of the calcific deposit', 'timeFrame': '7 days'}, {'measure': 'Size of the calcific deposit', 'timeFrame': '3 months'}, {'measure': 'Size of the calcific deposit', 'timeFrame': '12 months'}, {'measure': 'Number of frozen shoulder in each group', 'timeFrame': '7 days'}, {'measure': 'Number of frozen shoulder in each group', 'timeFrame': '6 weeks'}, {'measure': 'Number of frozen shoulder in each group', 'timeFrame': '3 months'}, {'measure': 'Number of frozen shoulder in each group', 'timeFrame': '6 months'}, {'measure': 'Number of frozen shoulder in each group', 'timeFrame': '12 months'}, {'measure': 'VAS pain during daily activity', 'timeFrame': '7 days'}, {'measure': 'VAS pain during daily activity', 'timeFrame': '6 weeks'}, {'measure': 'VAS pain during daily activity', 'timeFrame': '3 months'}, {'measure': 'VAS pain during daily activity', 'timeFrame': '6 months'}, {'measure': 'VAS pain during daily activity', 'timeFrame': '12 months'}, {'measure': 'VAS pain at rest', 'timeFrame': '7 days'}, {'measure': 'VAS pain at rest', 'timeFrame': '6 weeks'}, {'measure': 'VAS pain at rest', 'timeFrame': '3 months'}, {'measure': 'VAS pain at rest', 'timeFrame': '6 months'}, {'measure': 'VAS pain at rest', 'timeFrame': '12 months'}, {'measure': 'The Disabilities of the Arm, Shoulder and Hand (DASH) Score', 'timeFrame': '7 days'}, {'measure': 'The Disabilities of the Arm, Shoulder and Hand (DASH) Score', 'timeFrame': '6 weeks'}, {'measure': 'The Disabilities of the Arm, Shoulder and Hand (DASH) Score', 'timeFrame': '3 months'}, {'measure': 'The Disabilities of the Arm, Shoulder and Hand (DASH) Score', 'timeFrame': '6 months'}, {'measure': 'The Disabilities of the Arm, Shoulder and Hand (DASH) Score', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['calcifying tendinitis', 'Needle lavage', 'Shoulder', 'Corticosteroid injection', 'Ultrasound-guided'], 'conditions': ['Calcifying Tendinitis of Shoulder']}, 'referencesModule': {'references': [{'pmid': '33719606', 'type': 'DERIVED', 'citation': 'Dumoulin N, Cormier G, Varin S, Coiffier G, Albert JD, Le Goff B, Darrieutort-Laffite C. Factors Associated With Clinical Improvement and the Disappearance of Calcifications After Ultrasound-Guided Percutaneous Lavage of Rotator Cuff Calcific Tendinopathy: A Post Hoc Analysis of a Randomized Controlled Trial. Am J Sports Med. 2021 Mar;49(4):883-891. doi: 10.1177/0363546521992359.'}, {'pmid': '30975645', 'type': 'DERIVED', 'citation': 'Darrieutort-Laffite C, Varin S, Coiffier G, Albert JD, Planche L, Maugars Y, Cormier G, Le Goff B. Are corticosteroid injections needed after needling and lavage of calcific tendinitis? Randomised, double-blind, non-inferiority trial. Ann Rheum Dis. 2019 Jun;78(6):837-843. doi: 10.1136/annrheumdis-2018-214971. Epub 2019 Apr 11.'}]}, 'descriptionModule': {'briefSummary': "Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder. Needling and lavage of the calcification is one of the therapeutic options after failure of conservative management with physiotherapy and anti-inflammatory drugs. Needling is usually followed by a corticosteroid injection in the subacromial bursae in order to prevent acute pain reaction due to the intervention. However, the relevance of this injection has never been proven. Moreover, corticosteroid could prevent the inflammatory reaction induced by the needling and thus the body's natural calcium resorption processes. Finally, corticosteroids could have deleterious effect on the tendon structures and favour local infection. Our hypothesis is that corticosteroid have no significant effect on acute pain after needling and therefore should not been performed systematically after needling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Shoulder pain for at least 3 month\n* Positive Hawkins, Yocum and/or Neer test for impingement\n* Calcific deposit \\>= 5 mm on shoulder x-ray in one the tendon of the rotator cuff\n\nExclusion Criteria:\n\n* Allergy to lidocaïne or methylprednisolone acetate\n* Acute pain suggestive of resorption of the calcification with ill-defined - calcification on X-Ray\n* Other shoulder diseases : ostearthritis of the gleno-humeral or acromio-clavicular joint\n* Sonographic findings of rotator cuff tear\n* Subacromial steroid injection in the previous month\n* Uncontrolled diabetes\n* Pregnant women\n* Contraindication for the use of nonsteroidal antiinflammatory drugs or paracetamol/acetaminophene'}, 'identificationModule': {'nctId': 'NCT02403856', 'acronym': 'CALCECHO', 'briefTitle': 'Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection: A Double Blind Controlled Study', 'orgStudyIdInfo': {'id': 'RC15_0019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group (Sodium Chloride 0.9%)', 'description': 'Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sterile physiological Saline (Sodium Chloride 0.9%) in the subacromial bursae.', 'interventionNames': ['Drug: Sodium Chloride 0.9%', 'Procedure: Ultrasound-guided Needling and Lavage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group (Methylprednisolone Acetate)', 'description': 'Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae', 'interventionNames': ['Drug: Methylprednisolone acetate', 'Procedure: Ultrasound-guided Needling and Lavage']}], 'interventions': [{'name': 'Sodium Chloride 0.9%', 'type': 'DRUG', 'otherNames': ['NaCl 0.9%'], 'description': 'Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sterile physiological Saline (Sodium Chloride 0.9%) in the subacromial bursae.', 'armGroupLabels': ['Experimental group (Sodium Chloride 0.9%)']}, {'name': 'Methylprednisolone acetate', 'type': 'DRUG', 'otherNames': ['Dépomédrol'], 'description': 'Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae', 'armGroupLabels': ['Control group (Methylprednisolone Acetate)']}, {'name': 'Ultrasound-guided Needling and Lavage', 'type': 'PROCEDURE', 'armGroupLabels': ['Control group (Methylprednisolone Acetate)', 'Experimental group (Sodium Chloride 0.9%)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'La Roche sur Yon Hospital', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}