Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT02266433
Status:
TERMINATED
Last Update Posted:
2020-11-02
First Post:
2014-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}, {'id': 'D052582', 'term': 'Trigger Finger Disorder'}, {'id': 'D013717', 'term': 'Tenosynovitis'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D053682', 'term': 'Tendon Entrapment'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D020911', 'term': 'Ketorolac Tromethamine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], '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': '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': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Anthony.Sapienza@nyulangone.org', 'phone': '212 737 3301', 'title': 'Anthony Sapienza, MD / Assistant Professor', 'organization': 'New York University School of Medicine - Division of Hand Surgery'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 2, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin discoloration', 'notes': 'minor skin discoloration at the site of injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness and itching', 'notes': 'developed redness and an itch in an adjacent finger several minutes after injection which resolved without further issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EQVAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '82.07', 'spread': '16.25', 'groupId': 'OG000'}, {'value': '82.30', 'spread': '13.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EQVAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '82.79', 'spread': '13.48', 'groupId': 'OG000'}, {'value': '82.56', 'spread': '13.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EQVAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '82.17', 'spread': '13.31', 'groupId': 'OG000'}, {'value': '81.61', 'spread': '13.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EQVAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '93.50', 'spread': '6.35', 'groupId': 'OG000'}, {'value': '83.91', 'spread': '7.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EQVAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '90.25', 'spread': '8.48', 'groupId': 'OG000'}, {'value': '75.79', 'spread': '14.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '28.56', 'spread': '19.46', 'groupId': 'OG000'}, {'value': '27.38', 'spread': '20.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '28.73', 'spread': '20.03', 'groupId': 'OG000'}, {'value': '27.56', 'spread': '18.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '23.61', 'spread': '17.55', 'groupId': 'OG000'}, {'value': '21.88', 'spread': '15.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '15.65', 'spread': '18.01', 'groupId': 'OG000'}, {'value': '28.27', 'spread': '28.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '21.04', 'spread': '21.08', 'groupId': 'OG000'}, {'value': '25.90', 'spread': '22.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: VAS Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '5.41', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '4.79', 'spread': '2.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: VAS Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '4.20', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: VAS Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '4.23', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '2.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: VAS Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '2.25', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: VAS Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '3.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1.37', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.55', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1.63', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minimum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.'}, {'type': 'PRIMARY', 'title': "DeQuervain's Treatment Group: EQ-VAS Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.16', 'spread': '13.91', 'groupId': 'OG000'}, {'value': '79.45', 'spread': '19.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There were not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "DeQuervain's Treatment Group: EQ-VAS Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.19', 'spread': '18.58', 'groupId': 'OG000'}, {'value': '52.93', 'spread': '14.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There were not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "DeQuervain's Treatment Group: EQ-VAS Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.2', 'spread': '12.68', 'groupId': 'OG000'}, {'value': '87.33', 'spread': '7.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There were not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "De Quervain's Treatment Group: QuickDASH Scores", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '39.05', 'spread': '19.51', 'groupId': 'OG000'}, {'value': '47.40', 'spread': '16.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8.\n\nThere were not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "De Quervain's Treatment Group: QuickDASH Scores", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '26.19', 'spread': '18.58', 'groupId': 'OG000'}, {'value': '52.93', 'spread': '14.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8.\n\nThere were not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "De Quervain's Treatment Group: QuickDASH Scores", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '23.61', 'spread': '16.18', 'groupId': 'OG000'}, {'value': '68.34', 'spread': '19.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8.\n\nThere were not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "DeQuervain's Treatment Group: EQ-5D Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8.\n\nThere was not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "DeQuervain's Treatment Group: EQ-5D Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8.\n\nThere was not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "DeQuervain's Treatment Group: EQ-5D Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8.\n\nThere was not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "De Quervain's Treatment Group: VAS Pain Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '7.03', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '6.94', 'spread': '1.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8.\n\nThere was not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "De Quervain's Treatment Group: VAS Pain Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '4.35', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '5.35', 'spread': '3.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8.\n\nThere was not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': "De Quervain's Treatment Group: VAS Pain Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '3.05', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '7.33', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8.\n\nThere was not enough data points for 12-week and 6-month statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) in Lateral Epicondyle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: EQ-5D Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: EQ-5D Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: EQ-5D Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: VAS Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: VAS Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: VAS Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: EQ-VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: EQ-VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}, {'type': 'PRIMARY', 'title': 'Lateral Epicondylitis Treatment Group: EQ-VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised'}, {'id': 'OG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nDexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.'}, {'id': 'FG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Patients will be enrolled from the private office of orthopaedic hand surgeons (Dr. Paksima and Dr. Sapienza) and the resident hand clinic at NYU Hospital for Joint Diseases held at the 23rd street clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.'}, {'id': 'BG001', 'title': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.\n\nKetorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], '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': '93', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-31', 'size': 365551, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-13T20:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'whyStopped': "due to PI's change to private practice", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2014-09-18', 'resultsFirstSubmitDate': '2020-09-13', 'studyFirstSubmitQcDate': '2014-10-16', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-08', 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trigger Finger Treatment Group: EQVAS Score', 'timeFrame': 'Baseline', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': 'Trigger Finger Treatment Group: EQVAS Score', 'timeFrame': '4 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': 'Trigger Finger Treatment Group: EQVAS Score', 'timeFrame': '8 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': 'Trigger Finger Treatment Group: EQVAS Score', 'timeFrame': '12 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': 'Trigger Finger Treatment Group: EQVAS Score', 'timeFrame': '6 months', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'timeFrame': 'Baseline', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'timeFrame': '4 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'timeFrame': '8 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'timeFrame': '12 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': 'Trigger Finger Treatment Group: QuickDASH Functional Scores', 'timeFrame': '6 months', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'timeFrame': 'Baseline', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'timeFrame': '4 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'timeFrame': '8 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'timeFrame': '12 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': 'Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score', 'timeFrame': '6 months', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': 'Trigger Finger Treatment Group: VAS Pain Scores', 'timeFrame': 'Baseline', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': 'Trigger Finger Treatment Group: VAS Pain Scores', 'timeFrame': '4 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': 'Trigger Finger Treatment Group: VAS Pain Scores', 'timeFrame': '8 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': 'Trigger Finger Treatment Group: VAS Pain Scores', 'timeFrame': '12 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': 'Trigger Finger Treatment Group: VAS Pain Scores', 'timeFrame': '6 months', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'timeFrame': 'Baseline', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.'}, {'measure': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'timeFrame': '4 weeks', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.'}, {'measure': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'timeFrame': '8 weeks', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.'}, {'measure': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'timeFrame': '12 weeks', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.'}, {'measure': 'Trigger Finger Treatment Group: Quinnell Grading Scores', 'timeFrame': '6 months', 'description': 'The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minimum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.'}, {'measure': "DeQuervain's Treatment Group: EQ-VAS Score", 'timeFrame': 'Baseline', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': "DeQuervain's Treatment Group: EQ-VAS Score", 'timeFrame': '4 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': "DeQuervain's Treatment Group: EQ-VAS Score", 'timeFrame': '8 weeks', 'description': 'The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': "De Quervain's Treatment Group: QuickDASH Scores", 'timeFrame': 'Baseline', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': "De Quervain's Treatment Group: QuickDASH Scores", 'timeFrame': '4 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': "De Quervain's Treatment Group: QuickDASH Scores", 'timeFrame': '8 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': "DeQuervain's Treatment Group: EQ-5D Score", 'timeFrame': 'Baseline', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': "DeQuervain's Treatment Group: EQ-5D Score", 'timeFrame': '4 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': "DeQuervain's Treatment Group: EQ-5D Score", 'timeFrame': '8 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': "De Quervain's Treatment Group: VAS Pain Score", 'timeFrame': 'Baseline', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': "De Quervain's Treatment Group: VAS Pain Score", 'timeFrame': '4 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': "De Quervain's Treatment Group: VAS Pain Score", 'timeFrame': '8 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle', 'timeFrame': 'Baseline', 'description': 'Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.'}, {'measure': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) in Lateral Epicondyle', 'timeFrame': '4 weeks', 'description': 'Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.'}, {'measure': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle', 'timeFrame': '8 weeks', 'description': 'Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.'}, {'measure': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension', 'timeFrame': 'Baseline', 'description': 'The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.'}, {'measure': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension', 'timeFrame': '4 weeks', 'description': 'The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.'}, {'measure': 'Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension', 'timeFrame': '8 weeks', 'description': 'The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.'}, {'measure': 'Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores', 'timeFrame': 'Baseline', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': 'Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores', 'timeFrame': '4 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': 'Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores', 'timeFrame': '8 weeks', 'description': "The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit."}, {'measure': 'Lateral Epicondylitis Treatment Group: EQ-5D Scores', 'timeFrame': 'Baseline', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': 'Lateral Epicondylitis Treatment Group: EQ-5D Scores', 'timeFrame': '4 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': 'Lateral Epicondylitis Treatment Group: EQ-5D Scores', 'timeFrame': '8 weeks', 'description': "The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys."}, {'measure': 'Lateral Epicondylitis Treatment Group: VAS Pain Score', 'timeFrame': 'Baseline', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': 'Lateral Epicondylitis Treatment Group: VAS Pain Score', 'timeFrame': '4 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': 'Lateral Epicondylitis Treatment Group: VAS Pain Score', 'timeFrame': '8 weeks', 'description': "VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit."}, {'measure': 'Lateral Epicondylitis Treatment Group: EQ-VAS Score', 'timeFrame': 'Baseline', 'description': 'The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': 'Lateral Epicondylitis Treatment Group: EQ-VAS Score', 'timeFrame': '4 weeks', 'description': 'The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}, {'measure': 'Lateral Epicondylitis Treatment Group: EQ-VAS Score', 'timeFrame': '8 weeks', 'description': 'The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DeQuervains Tenosynovitis', 'Lateral Epicondylitis', 'Tennis Elbow', 'Trigger Finger', 'Tenosynovitis', 'Inflammatory Disease', 'Dexamethasone', 'Ketorolac', 'Toradol'], 'conditions': ['DeQuervains Tenosynovitis', 'Lateral Epicondylitis', 'Tennis Elbow', 'Trigger Finger', 'Tenosynovitis', 'Inflammatory Disease']}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to compare local corticosteroid hand and elbow injections to placebo or ketorolac to determine if there is an equal or better reduction of symptoms for common orthopaedic upper extremity disorders including: De Quervain's tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators will enroll 780 subjects, divided equally into three arms for each disease process, and compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 month followup periods, prospectively over time.", 'detailedDescription': "Objectives: The primary objective of this study is to compare local corticosteroid hand and elbow injections to placebo or ketorolac to determine if there is an equal or better reduction of symptoms for common orthopaedic upper extremity disorders including: De Quervain's tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis).\n\nNumber of Subjects: 780 total subjects:\n\n• 260 subjects in each of the 3 treatment groups (De Quervain's tenosynovitis, trigger fingers and lateral epicondylitis) Diagnosis and Main Inclusion Criteria Subjects 18 years or older, with any of the following diagnoses: De Quervain's tenosynovitis, trigger fingers, or lateral epicondylitis\n\nStudy Product, Dose, Route, Regimen: Peritendinous soft tissue injection for De Quervain's tenosynovitis, trigger fingers and lateral epicondylitis:\n\n• 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine Duration of administration Single administration, with a second injection permitted only once as subject desires due to no major clinical response at the 4 or 8-week follow-up.\n\nReference therapy: Standard of care peritendinous soft tissue injection for De Quervain's tenosynovitis, trigger fingers, and lateral epicondylitis:\n\n• 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nStatistical Methodology: The sample size as stated above was derived by a power analysis. A power analysis indicated that a total sample size of 200 patients randomized equally (1:1 randomization) to each treatment arm (i.e trigger finger, De Quervain's disease, and tennis elbow) without any blocking or stratification would provide 80% statistical power (alpha=.05, beta=0.20) to detect a 10% difference in mean Quick Disabilities of the Arm, Shoulder and Hand (quickDASH) scores between cohorts assuming a common standard deviation of 25% (effect size = 10/25 = 0.4). To account for an estimated 30% loss to follow-up, the investigators plan to enroll a total of 260 patients per treatment arm (i.e. trigger finger, De Quervain's disease, and tennis elbow). In total, there will be approximately 780 patients enrolled among all treatment arms.\n\n1.1 Background Many orthopaedic hand disorders are comprised of different forms of tendonitis, tenosynovitis, and arthritis. The inflammatory processes of these disorders cause discomfort and functional impairment for patients. Decreasing the inflammatory response by use of splinting, physiotherapy, systemic anti-inflammatory agents, and local anti-inflammatory injections helps to alleviate some or all of the discomfort (2-4). Steroid injections are not entirely benign, and complications include tendon ruptures, subcutaneous fat atrophy, skin pigmentation changes, cartilage damage, and hyperglycemic responses in diabetics (9-11, 22-23). Studies have shown that ketorolac, a non-steroidal anti-inflammatory agent has a potent anti-inflammatory effect comparable to corticosteroids and a strong analgesic effect allowing for reduced opioid consumption postoperatively (7, 8). One could argue that the potent anti-inflammatory properties of ketorolac could be used to substitute for local corticosteroid injections in treating certain hand disorders. Given the side-effect profile for corticosteroids it may be beneficial to treat inflammatory disorders with local ketorolac injections. Nonsteroidal anti-inflammatory agents also have their known systemic adverse effects including gastric ulceration and intestinal bleeding as well as impairment of renal function. Most of these side effects are theoretically avoided with local tissue injections.\n\n1.2 Study Drugs\n\nKetorolac:\n\nThe proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study\n\nKetorolac is a non-steroidal anti-inflammatory drug (NSAID). The approved indication for Ketorolac is for the short-term (≤5 days) management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. It is highly protein bound (99%) and is largely metabolized by the liver. In it's approved indication it is contraindicated for those with renal impairment, active peptic ulcer disease, pregnant or nursing females, individuals with NSAID hypersensitivity, or individuals at high risk for bleeding/clotting disorders.\n\nDexamethasone:\n\nDexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised individuals, pregnant females, persons with allergy to steroids, individuals with systemic fungal infections, and individuals with cerebral malaria. It is contra-indicated in systemic fungal infections, and hypersensitivity to any component of this product, including sulfites.\n\nLidocaine:\n\nLidocaine is a local anesthetic of the amide type, and will be used within its labeled indication for this study: production of local or regional anesthesia by infiltration techniques such as percutaneous injection. It is to be given as concomitant therapy with both the investigational agent, ketorolac injection, and the standard of care therapy, dexamethasone injection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must be diagnosed with at least one of the following: trigger finger, de quervain's tenosynovitis, or tennis elbow (lateral epicondylitis)\n* Patients age 18 years of age or older from all racial/ethnic types\n* Patient who are both males and females\n* Study participants will include any New York University employee or students as these individuals also can get hand and upper extremity pathology. It will be specifically reiterated to them that their academic status or grades, or employment will not be affected by their decision to participate in this study. Record of the participation cannot be linked to an academic record.\n\nExclusion Criteria:\n\n* Patients had previous steroid injection at the site in question within 90 days of enrollment\n* Patients with a history of gastric ulcers, renal impairment, allergy/hypersensitivity to non-steroidal anti-inflammatory (NSAID) or lidocaine derivative medications, immunocompromised patients (HIV/AIDs) and pregnant females"}, 'identificationModule': {'nctId': 'NCT02266433', 'briefTitle': 'Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Double-blinded, Prospective, Randomized, Controlled Trial Comparing Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders', 'orgStudyIdInfo': {'id': '12-00878'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm Receiving Dexamethasone Injection', 'description': 'Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nDexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Arm Receiving Ketorolac Injection', 'description': 'Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.\n\nPatients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.', 'interventionNames': ['Drug: Ketorolac']}], 'interventions': [{'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['Toradol'], 'description': "The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study\n\nKetorolac is a non-steroidal anti-inflammatory drug (NSAID). The approved indication for Ketorolac is for the short-term (≤5 days) management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. It is highly protein bound (99%) and is largely metabolized by the liver. In it's approved indication it is contraindicated for those with renal impairment, active peptic ulcer disease, pregnant or nursing females, individuals with NSAID hypersensitivity, or individuals at high risk for bleeding/clotting disorders.", 'armGroupLabels': ['Arm Receiving Ketorolac Injection']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.\n\nIn its approved indication there use limitations for immunocompromised individuals, pregnant females, persons with allergy to steroids, individuals with systemic fungal infections, and individuals with cerebral malaria. It is contra-indicated in systemic fungal infections, and hypersensitivity to any component of this product, including sulfites.', 'armGroupLabels': ['Arm Receiving Dexamethasone Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Anthony Sapienza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Hospital for Joint Diseases; NYULMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}