Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT03913702
Status:
TERMINATED
Last Update Posted:
2025-01-03
First Post:
2019-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}}}, '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': 'D020911', 'term': 'Ketorolac Tromethamine'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jesomers@utmb.edu', 'phone': '409-747-5701', 'title': 'Dr. Jeremy Somerson', 'organization': 'University of Texas Medical Branch Galveston'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The protocol was terminated early due inadequate patient enrollment.'}}, 'adverseEventsModule': {'timeFrame': 'up to 12 weeks', 'description': 'The protocol was discontinued early.', 'eventGroups': [{'id': 'EG000', 'title': 'Ketorolac', 'description': 'Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)\n\nKetorolac Tromethamine: 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Methylprednisolone', 'description': 'Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)\n\nMethylprednisolone Acetate: 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'American Shoulder and Elbow Surgeon (ASES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac', 'description': 'Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)\n\nKetorolac Tromethamine: 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).'}, {'id': 'OG001', 'title': 'Methylprednisolone', 'description': 'Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)\n\nMethylprednisolone Acetate: 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)'}], 'timeFrame': '12 weeks', 'description': 'The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected.'}, {'type': 'SECONDARY', 'title': 'American Shoulder and Elbow Surgeon (ASES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac', 'description': 'Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)\n\nKetorolac Tromethamine: 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).'}, {'id': 'OG001', 'title': 'Methylprednisolone', 'description': 'Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)\n\nMethylprednisolone Acetate: 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)'}], 'timeFrame': '2 weeks', 'description': 'The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected.'}, {'type': 'SECONDARY', 'title': 'American Shoulder and Elbow Surgeon (ASES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac', 'description': 'Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)\n\nKetorolac Tromethamine: 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).'}, {'id': 'OG001', 'title': 'Methylprednisolone', 'description': 'Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)\n\nMethylprednisolone Acetate: 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)'}], 'timeFrame': '4 weeks', 'description': 'The ASES is a self-assessment score, ranging between 0 and 100, (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected.'}, {'type': 'SECONDARY', 'title': 'Range of Motion (ROM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac', 'description': 'Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)\n\nKetorolac Tromethamine: 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).'}, {'id': 'OG001', 'title': 'Methylprednisolone', 'description': 'Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)\n\nMethylprednisolone Acetate: 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)'}], 'timeFrame': '12 weeks', 'description': 'The range of motion is a function-related measure, that reflects the extent of shoulder movement (measured in degrees, in forward flexion, and abduction with internal/external rotation of the shoulder)', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketorolac', 'description': 'Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)\n\nKetorolac Tromethamine: 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).'}, {'id': 'FG001', 'title': 'Methylprednisolone', 'description': 'Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)\n\nMethylprednisolone Acetate: 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Early termination due to inadequate patient enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketorolac', 'description': 'Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)\n\nKetorolac Tromethamine: 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).'}, {'id': 'BG001', 'title': 'Methylprednisolone', 'description': 'Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)\n\nMethylprednisolone Acetate: 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One participant enrolled in the protocol.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-17', 'size': 289453, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-19T16:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "Neither the treating physician nor the patient will have access to drug-related details. Data will only be retrieved by the coordinating institution's research coordinator."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Inadequate patient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2019-04-10', 'resultsFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-23', 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeon (ASES)', 'timeFrame': '12 weeks', 'description': 'The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.'}], 'secondaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeon (ASES)', 'timeFrame': '2 weeks', 'description': 'The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.'}, {'measure': 'American Shoulder and Elbow Surgeon (ASES)', 'timeFrame': '4 weeks', 'description': 'The ASES is a self-assessment score, ranging between 0 and 100, (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.'}, {'measure': 'Range of Motion (ROM)', 'timeFrame': '12 weeks', 'description': 'The range of motion is a function-related measure, that reflects the extent of shoulder movement (measured in degrees, in forward flexion, and abduction with internal/external rotation of the shoulder)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketorolac', 'Methylprednisolone', 'Subacromial impingement syndrome'], 'conditions': ['Subacromial Impingement', 'Subacromial Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome.', 'detailedDescription': 'Because of the current conflicting evidence, the lack of long-term follow-up, and the multiple potential benefit benefits to the society, the investigators aim to compare subacromial ketorolac versus methylprednisolone for the treatment of shoulder impingement syndrome. The investigators hypothesize that patients with shoulder impingement treated with a subacromial methylprednisolone versus ketorolac have similar outcomes based on the ASES (American Shoulder and Elbow Surgeon) self-assessment score. The study will be performed at one institution, the University of Texas Medical Branch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Severe or recalcitrant shoulder impingement syndrome\n* Subacromial injection is a therapeutic option\n\nExclusion Criteria:\n\n* Allergy or intolerance to steroids within less than 1 month\n* Allergy or intolerance to NSAIDs within less than 1 month\n* Pregnancy\n* Breastfeeding\n* Pre-existing asthma\n* Uncontrolled psychiatric illness\n* Previous shoulder injection within the past 3 months\n* Evidence of confounding shoulder pathology on imaging\n* History of a full-thickness rotator cuff tear\n* Ipsilateral cervical radiculopathy\n* Moderate to severe glenohumeral arthritis\n* Systemic inflammatory conditions\n* Kidney disease\n* Liver disease\n* Gastrointestinal ulcer\n* Bleeding disorder\n* Pending litigation or work-related claims related to the shoulder\n* Previous shoulder surgery on the affected shoulder\n* Evidence of local infection\n* Evidence of adhesive capsulitis\n* Evidence of shoulder instability'}, 'identificationModule': {'nctId': 'NCT03913702', 'briefTitle': 'Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UTMB IRB #: 18-0156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketorolac', 'description': 'Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)', 'interventionNames': ['Drug: Ketorolac Tromethamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone', 'description': 'Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)', 'interventionNames': ['Drug: Methylprednisolone Acetate']}], 'interventions': [{'name': 'Ketorolac Tromethamine', 'type': 'DRUG', 'otherNames': ['Toradol'], 'description': '2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).', 'armGroupLabels': ['Ketorolac']}, {'name': 'Methylprednisolone Acetate', 'type': 'DRUG', 'otherNames': ['DepoMedrol'], 'description': '1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)', 'armGroupLabels': ['Methylprednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Universtiy of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Jeremy Somerson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': '20 weeks from the last patient enrollment', 'ipdSharing': 'YES', 'description': 'At the end of this investigation, IPD-related results will be tabulated and submitted to clinicaltrials.gov to report. This would help evaluate the effects and safety of interventions administered.', 'accessCriteria': 'At the end of this investigation, all results will be tabulated and submitted to clinicaltrials.gov to report.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}