Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-01 @ 4:28 AM
Study NCT ID:
NCT03794505
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2019-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-05', 'studyFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain before', 'timeFrame': 'VAS before intervention', 'description': 'visual analogue scale'}, {'measure': 'Pain 2 months after', 'timeFrame': 'VAS 2 months after', 'description': 'Visual analogue scale 2 months after procedure'}, {'measure': 'Pain 6 months after', 'timeFrame': 'VAS 6 months after', 'description': 'Visual analogue scale 6 months after procedure'}], 'secondaryOutcomes': [{'measure': 'Quality of life before procedure', 'timeFrame': 'SF12v2 before procedure', 'description': 'SF12v2 Health related quality of life before procedure'}, {'measure': 'Quality of life 2 months after procedure', 'timeFrame': 'SF12v2 2 months after', 'description': 'SF12v2 Health related quality of life 2 months after'}, {'measure': 'Quality of life 6 months after procedure', 'timeFrame': 'SF12v2 6 months after', 'description': 'SF12v2 Health related quality of life 6 months after'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Arthritis']}, 'descriptionModule': {'briefSummary': 'Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in glenohumeral arthritis', 'detailedDescription': 'To describe the efficacy in pain management and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with glenohumeral arthritis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IMSS affiliated\n* Glenohumeral arthritis diagnosed\n\nExclusion Criteria:\n\n* Previusly treatment for the same disease\n* No follow up\n* Dead'}, 'identificationModule': {'nctId': 'NCT03794505', 'briefTitle': 'Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis', 'orgStudyIdInfo': {'id': 'F-2018-3401-056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Shoulder infiltration', 'description': 'Shoulder infiltration using 2 ml of Lidocaine 2% Injectable Solution and methylprednisolone acetate 40 mg', 'interventionNames': ['Drug: Methylprednisolone Acetate', 'Drug: Lidocaine 2% Injectable Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Suprascapular nerve block', 'description': 'Suprascapular nerve block ultrasound guided using 25 mg of Ropivacaine HCl Inj 7.5 MG/ML and methylprednisolone acetate 40 mg', 'interventionNames': ['Drug: Methylprednisolone Acetate', 'Drug: Ropivacaine HCl Inj 7.5 MG/ML']}], 'interventions': [{'name': 'Methylprednisolone Acetate', 'type': 'DRUG', 'otherNames': ['depo-medrol 40 mg'], 'description': 'depo-medrol 40 mg', 'armGroupLabels': ['Shoulder infiltration', 'Suprascapular nerve block']}, {'name': 'Lidocaine 2% Injectable Solution', 'type': 'DRUG', 'otherNames': ['xilocaine'], 'description': '2ml of 2% lidocaine', 'armGroupLabels': ['Shoulder infiltration']}, {'name': 'Ropivacaine HCl Inj 7.5 MG/ML', 'type': 'DRUG', 'otherNames': ['Ropivacaine'], 'description': '25 mg', 'armGroupLabels': ['Suprascapular nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07760', 'city': 'Mexico City', 'state': 'Gustavo A Madero', 'country': 'Mexico', 'facility': 'Department of Orthopedics, UMAE "Dr. Victorio de la Fuente Narváez" IMSS-UNAM. Ciudad de México, México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Luis Alonso Calderon Cordova, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMSS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Luis Alonso Calderon Cordova', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}