Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-03-02 @ 6:22 PM
Study NCT ID:
NCT02986035
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of shoulder calcifications', 'timeFrame': '2 months', 'description': 'X-ray'}, {'measure': 'Size of shoulder calcifications', 'timeFrame': '2 months', 'description': 'Ultrasonography'}], 'secondaryOutcomes': [{'measure': 'Shoulder functionality', 'timeFrame': '1 and 2 months', 'description': 'Constant Scale'}, {'measure': 'Shoulder pain', 'timeFrame': '1 and 2 months', 'description': 'Pain VAS (Visual Analogue Scale )'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Calcifying Shoulder Tendinitis']}, 'descriptionModule': {'briefSummary': 'This pilot trail aims to assess the effectiveness of ECA cream in the treatment of calcifying shoulder tendinitis in terms of:\n\n1. Reduction or removal of shoulder calcifications\n2. Functional improvements\n3. Pain improvements 10 subjects will be assessed prior and 1 and 2 months post intervention onset. The intervention will consist in the application of the ECA cream in the affected shoulder twice a day during 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients \\>=18 years\n* diagnosed of calcifying shoulder tendinitis diagnosed by a medical specialist (rehabilitation, orthopedic surgeon or rheumatologist) by x-ray\n* with disease evolution of more than 3 months and less than 12 months\n* that give their informed consent by writing\n\nExclusion Criteria:\n\n* Previous shoulder surgery patients\n* Patients with shoulder affections treated with shockwaves or corticosteroid injections.'}, 'identificationModule': {'nctId': 'NCT02986035', 'acronym': 'ECA', 'briefTitle': 'Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari del Maresme'}, 'officialTitle': 'Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis', 'orgStudyIdInfo': {'id': '46/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Other: ECA cream']}], 'interventions': [{'name': 'ECA cream', 'type': 'OTHER', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08304', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari del Maresme', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari del Maresme', 'class': 'OTHER'}, 'collaborators': [{'name': 'PRODUCTOS SANITARIOS ECA-RVB SLI', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Lluís Guirao', 'investigatorAffiliation': 'Consorci Sanitari del Maresme'}}}}