Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-03 @ 3:53 PM
Study NCT ID:
NCT03389620
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2017-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transforaminal Versus Lateralized Interlaminar Cervical Epidurals
Sponsor:
Organization:
Raw JSON
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Amrhein, M.D.', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 days post-procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 6, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 8, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'OG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.38', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '-2.30', 'spread': '2.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.057', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Based on previous literature indicating that the minimum clinical threshold for change in NRS pain score is 2 points, a non-inferiority margin of differential change between treatment arms of 2 points at the 2 month time point following the surgical procedure was specified, assuming the true difference between treatment arms is zero.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 2 months', 'description': 'The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients\' pain. 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The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Neck Disability Index (NDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'OG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'classes': [{'title': 'Baseline to 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.97', 'spread': '15.62', 'groupId': 'OG000'}, {'value': '-9.30', 'spread': '12.58', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.24', 'spread': '16.03', 'groupId': 'OG000'}, {'value': '-8.00', 'spread': '16.51', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.25', 'spread': '22.04', 'groupId': 'OG000'}, {'value': '-14.00', 'spread': '16.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.613', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.565', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.958', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 4 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': 'The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'OG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'classes': [{'title': 'Baseline to 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.49', 'spread': '25.40', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '21.51', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.79', 'spread': '23.58', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '20.69', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.48', 'spread': '37.45', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '18.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.287', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.365', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.867', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 4 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. 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It is a well-validated tool for health status measurement, and for health quality-of-life in cervicogenic radicular pain. The index score was derived using the time trade-off (TTO) valuation method and ranges from approximately 0 (dead) to 1 (full health), with negative values indicating health states worse than death.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Work Ability Index (WAI) Absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'OG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'classes': [{'title': 'Baseline to 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.76', 'spread': '31.82', 'groupId': 'OG000'}, {'value': '-8.81', 'spread': '35.85', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.66', 'spread': '30.09', 'groupId': 'OG000'}, {'value': '-11.40', 'spread': '38.96', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.09', 'spread': '25.09', 'groupId': 'OG000'}, {'value': '-12.37', 'spread': '27.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.794', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.843', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.713', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 4 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Employed participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Work Ability Index (WAI) Presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'OG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'classes': [{'title': 'Baseline to 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.95', 'spread': '21.58', 'groupId': 'OG000'}, {'value': '-19.55', 'spread': '27.68', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.95', 'spread': '22.58', 'groupId': 'OG000'}, {'value': '-19.09', 'spread': '40.93', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.50', 'spread': '43.44', 'groupId': 'OG000'}, {'value': '-18.82', 'spread': '24.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.177', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.505', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 4 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Employed participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Work Ability Index (WAI) Work Productivity Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'OG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'classes': [{'title': 'Baseline to 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.97', 'spread': '18.80', 'groupId': 'OG000'}, {'value': '-20.79', 'spread': '34.32', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.95', 'spread': '22.58', 'groupId': 'OG000'}, {'value': '-19.09', 'spread': '40.93', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.16', 'spread': '25.84', 'groupId': 'OG000'}, {'value': '-26.37', 'spread': '45.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.811', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.674', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 4 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Employed participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Work Ability Index (WAI) Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'OG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'classes': [{'title': 'Baseline to 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.51', 'spread': '31.20', 'groupId': 'OG000'}, {'value': '-12.70', 'spread': '25.35', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.12', 'spread': '32.13', 'groupId': 'OG000'}, {'value': '-14.32', 'spread': '32.54', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.18', 'spread': '32.74', 'groupId': 'OG000'}, {'value': '-21.11', 'spread': '33.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.903', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.500', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 2 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.716', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline to 4 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Employed participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Minor Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'OG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'classes': [{'title': 'Immediately post-procedure', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '2 days post procedure', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.461', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Immediately post-procedure', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '2 days post procedure', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post-procedure, 2 days post procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'OG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'classes': [{'title': 'Immediately post-procedure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 days post procedure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post-procedure, 2 days post procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Inadvertent Intravascular Contrast Injections', 'timeFrame': 'During procedure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Contrast Spread Into the Medial Half of the Neuroforamen', 'timeFrame': 'During procedure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'FG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients with unilateral cervicogenic radiculopathy referred for a cervical epidural steroid injection were recruited from the outpatient Duke Radiology Spine Intervention Clinic.', 'preAssignmentDetails': 'This is not a crossover study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'BG001', 'title': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'description': 'dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.68', 'spread': '14.11', 'groupId': 'BG000'}, {'value': '54.49', 'spread': '11.94', 'groupId': 'BG001'}, {'value': '55.58', 'spread': '13.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-15', 'size': 114425, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-11T13:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2017-12-26', 'resultsFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-04', 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Inadvertent Intravascular Contrast Injections', 'timeFrame': 'During procedure'}, {'measure': 'Number of Participants With Contrast Spread Into the Medial Half of the Neuroforamen', 'timeFrame': 'During procedure'}], 'primaryOutcomes': [{'measure': 'Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)', 'timeFrame': 'Baseline to 2 months', 'description': 'The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients\' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)', 'timeFrame': 'Baseline, 2 weeks, 4 months', 'description': 'The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients\' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")'}, {'measure': 'Change in Neck Disability Index (NDI)', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': 'The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.'}, {'measure': 'Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. It is a well-validated tool for health status measurement, and for health quality-of-life in cervicogenic radicular pain. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labeled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0)."}, {'measure': 'Change in EuroQol-5 Dimension (EQ-5D) Index Score', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': 'EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. It is a well-validated tool for health status measurement, and for health quality-of-life in cervicogenic radicular pain. The index score was derived using the time trade-off (TTO) valuation method and ranges from approximately 0 (dead) to 1 (full health), with negative values indicating health states worse than death.'}, {'measure': 'Change in Work Ability Index (WAI) Absenteeism', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability."}, {'measure': 'Change in Work Ability Index (WAI) Presenteeism', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability."}, {'measure': 'Change in Work Ability Index (WAI) Work Productivity Loss', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability."}, {'measure': 'Change in Work Ability Index (WAI) Activity Impairment', 'timeFrame': 'Baseline, 2 weeks, 2 months, 4 months', 'description': "The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability."}, {'measure': 'Number of Participants With Minor Adverse Events', 'timeFrame': 'Immediately post-procedure, 2 days post procedure'}, {'measure': 'Number of Participants With Major Adverse Events', 'timeFrame': 'Immediately post-procedure, 2 days post procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CT-fluoroscopy', 'Corticosteroid injection'], 'conditions': ['Cervicogenic Upper Extremity Radiculopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two methods of giving epidural steroid injections for nerve pain in the arm that comes from the neck. An epidural steroid injection can be given in two different ways, either in the back of the spine within the neck or in the neck next to the nerve root going to the arm. Both are standard medical treatments. The investigators would like to see how effective these treatments are, and if there are any differences in effectiveness or safety between these two routes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)\n* Baseline numerical pain scale (NRS) score \\> 4\n\nExclusion Criteria:\n\n* Recent (i.e., \\< 2 months) cervical spine surgery\n* Recent (i.e., \\< 1 month) cervical epidural or upper extremity corticosteroid injection\n* Contraindication or inability to the undergo procedure\n* Inability to provide informed consent\n* Expected inability to complete follow-up assessment\n* Contraindication to receiving contrast material (precluding an epidurogram)'}, 'identificationModule': {'nctId': 'NCT03389620', 'briefTitle': 'Transforaminal Versus Lateralized Interlaminar Cervical Epidurals', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Comparison of Cervical Transforaminal Epidural Corticosteroid Injections With Lateralized Interlaminar Epidural Corticosteroid Injections for Treatment of Cervicogenic Upper Extremity Radiculopathy', 'orgStudyIdInfo': {'id': 'Pro00083262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transforaminal Cervical Epidural Corticosteroid Injections', 'interventionNames': ['Drug: dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Lateralized Interlaminar Epidural Corticosteroid Injections', 'interventionNames': ['Drug: dexamethasone']}], 'interventions': [{'name': 'dexamethasone', 'type': 'DRUG', 'description': '0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds', 'armGroupLabels': ['Lateralized Interlaminar Epidural Corticosteroid Injections', 'Transforaminal Cervical Epidural Corticosteroid Injections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Radiology and Orthopaedic Clinic', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Timothy Amrhein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}