Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT03007420
Status:
TERMINATED
Last Update Posted:
2025-10-14
First Post:
2016-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051298', 'term': 'Post-Traumatic Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Pradeep.Dinakar@childrens.harvard.edu', 'phone': '857-218-3556', 'title': 'Pradeep Dinakar, MD', 'organization': "Boston Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Even though post-traumatic headache management is multimodal, we have limited evidence of any current treatment options showing longer term benefits. The trial was preliminary halted due to difficulties with patient recruitment. As such, limited results have been presented which should be interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': 'Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.', 'description': 'Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Occipital Nerve Block_Initial Treatment', 'description': 'This arm/group represents the total number of patients who were randomized to the occipital nerve block treatment at the start of the study.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cervical Medial Branch Block_Initial Treatment', 'description': 'This arm/group represents the total number of patients who were randomized to the cervical medial branch block treatment at the start of the study.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Crossover to CMBB From Initial ONB', 'description': 'This arm/group represents the total number of patients who were initially randomized to the occipital nerve block treatment at the start of the study but then crossed over to the cervical medial branch block treatment arm.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Crossover to ONB From Initial CMBB', 'description': 'This arm/group represents the total number of patients who were initially randomized to the cervical medial branch block treatment at the start of the study but then crossed over to the occipital nerve block treatment arm.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain at the site of injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding from the site of injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection (warmth, redness, swelling) at the site of injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle soreness/pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper limb numbness/weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gait instability or balance problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty swallowing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.\n\nIf patients exhibit \\< 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'OG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.\n\nIf patients exhibit \\< 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}], 'classes': [{'title': 'Numerical Rating Scale at 1 week post procedure timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '4.7'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '4.5'}]}]}, {'title': 'Numerical Rating Scale at 1 month post procedure time point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '2.4'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3.3'}]}]}, {'title': 'Numerical Rating Scale at 2 months post procedure time point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.6'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5.5'}]}]}, {'title': 'Numerical Rating Scale at 3 months post procedure time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '3'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.5'}]}]}, {'title': 'Numerical Rating Scale at 6 months post procedure time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '2.9'}]}]}, {'title': 'Numerical Rating Scale at 9 months post procedure time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3.5'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.5'}]}]}, {'title': 'Numerical Rating Scale at 12 months post procedure time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.6'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure', 'description': "Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '16 patients provided baseline pain score data that has been presented in the Baseline Demographics section. Post-procedure pain scores have been reported below.'}, {'type': 'SECONDARY', 'title': 'Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.\n\nIf patients exhibit \\< 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.\n\nOccipital Nerve Block (ONB) using lidocaine and dexamethosone: Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites."}, {'id': 'OG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.\n\nIf patients exhibit \\< 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.\n\nCervical Medial Branch Block (CMBB) using lidocaine and dexamethosone: Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side."}], 'classes': [{'title': 'MIDAS Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '94'}, {'value': '159', 'groupId': 'OG001', 'lowerLimit': '55', 'upperLimit': '168'}]}]}, {'title': 'MIDAS Score at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '59.5'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '49.5'}]}]}, {'title': 'MIDAS Score at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '124'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '18.5'}]}]}, {'title': 'MIDAS Score at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '26.75'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '60'}]}]}, {'title': 'MIDAS Score at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '13.5'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'The Migraine Disability Assessment (MIDAS) is a self-administered standardized questionnaire to quantify headache-related disability.\n\nThe MIDAS score ranges from 0 to 270. The higher the score on the MIDAS questionnaire, the greater the disability caused by headaches.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Migraine Disability Assessment (MIDAS) is validated for patients 18 years and older only.'}, {'type': 'SECONDARY', 'title': 'Pediatric Migraine Disability Assessment (PedMIDAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'OG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}], 'classes': [{'title': 'PedsMIDAS at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000', 'lowerLimit': '205', 'upperLimit': '248'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '151.5'}]}]}, {'title': 'PedsMIDAS at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '88.5'}, {'value': '217', 'groupId': 'OG001', 'lowerLimit': '217', 'upperLimit': '217'}]}]}, {'title': 'PedsMIDAS at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '75'}]}]}, {'title': 'PedsMIDAS at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '72'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '67'}]}]}, {'title': 'PedsMIDAS at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'The Pediatric Migraine Disability Assessment (PedsMIDAS) is a self-administered standardized questionnaire to quantify headache related disability.\n\nThe PedsMIDAS score ranges from 0 to 240. The higher the score on the PedsMIDAS questionnaire, the greater the disability caused by headaches.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PedsMIDAS is only validated for patients for patients under the age of 18 years.'}, {'type': 'SECONDARY', 'title': 'Headache Severity Assessed by Migraine Disability Assessment (MIDAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'OG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}], 'classes': [{'title': 'MIDAS severity at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '7'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}, {'title': 'MIDAS severity at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '4'}]}]}, {'title': 'MIDAS severity at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.25', 'upperLimit': '5.75'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '4.5'}]}]}, {'title': 'MIDAS severity at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '6'}]}]}, {'title': 'MIDAS severity at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Self-administered questionnaire to quantify headache-severity using the following question:\n\nOn a scale of 0 - 10, on average how painful were these headaches? (where 0=no pain at all, and 10=pain as bad as it can be)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Migraine Disability Assessment (MIDAS) is validated for patients 18 years and older only.'}, {'type': 'SECONDARY', 'title': 'Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'OG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}], 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Self-administered questionnaire to quantify headache-related disability', 'reportingStatus': 'POSTED', 'populationDescription': 'Although the investigators initially intended to assess headache severity using the PedsMIDAS questionnaire, it was discovered the specific headache severity assessment question was not included in the validated PedsMIDAS questionnaire. Consequently, we are unable to report data for this measure. Other alternate measures are reported. This was identified and reported as a minor deviation.'}, {'type': 'SECONDARY', 'title': 'Functional Disability Inventory Scores (FDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'OG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}], 'classes': [{'title': 'FDI Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '18.5'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '26.5'}]}]}, {'title': 'FDI Score at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '19.5'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '30'}]}]}, {'title': 'FDI Score at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '22'}]}]}, {'title': 'FDI Score at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'FDI Score at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'The Functional Disability Inventory (FDI) was used to assess functional disability.\n\nThe FDI is scored by summing the ratings for each of its 15 items, with scores ranging from 0 to 60.\n\nHigher scores indicate greater perceived functional disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FDI is validated in patients under the age 18 years.'}, {'type': 'SECONDARY', 'title': 'Pain Disability Index (PDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.\n\nIf patients exhibit \\< 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.\n\nOccipital Nerve Block (ONB) using lidocaine and dexamethosone: Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites."}, {'id': 'OG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.\n\nIf patients exhibit \\< 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.\n\nCervical Medial Branch Block (CMBB) using lidocaine and dexamethosone: Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side."}], 'classes': [{'title': 'PDI Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '33'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '37'}]}]}, {'title': 'PDI Score at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '22'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.5'}]}]}, {'title': 'PDI Score at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '21.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11'}]}]}, {'title': 'PDI Score at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '3.75'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'PDI Score at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.5'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'The Pain Disability Index (PDI) was used to assess functional disability in adults.\n\nThe PDI is scored by summing the ratings of seven different life domains, each scored on a scale of 0 to 10, with higher scores indicating greater pain-related disability.\n\nThe total score can range from 0 to 70. A higher score reflects a greater impact of pain on daily activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PDI is validated in patients 18 years of age or older.'}, {'type': 'SECONDARY', 'title': 'World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'OG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}], 'classes': [{'title': 'WHOQOL-BREF Physical Health Scores at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '11.4'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '13.7'}]}]}, {'title': 'HOQOL-BREF Psychological Health Scores at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '12'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '15.3'}]}]}, {'title': 'HOQOL-BREF Social Relationship Scores at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '16'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '16'}]}]}, {'title': 'HOQOL-BREF Environment Scores at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '16.5'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '16'}]}]}, {'title': 'HOQOL-BREF Physical Health Scores at 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '12.9'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '13.9'}]}]}, {'title': 'HOQOL-BREF Psychological Health Scores at 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '12.7'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '14.7'}]}]}, {'title': 'HOQOL-BREF Social Relationships Scores at 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '16'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '15'}]}]}, {'title': 'HOQOL-BREF Environment Scores at 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '15.8'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '17.4'}]}]}, {'title': 'HOQOL-BREF Physical Health Scores at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '13.1'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '14.6'}]}]}, {'title': 'HOQOL-BREF Psychological Health Scores at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '12.7'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '16.2'}]}]}, {'title': 'WHOQOL-BREF Social Relationship Scores at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '16.7'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '18'}]}]}, {'title': 'WHOQOL-BREF Environment Scores at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '16.8'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '19'}]}]}, {'title': 'WHOQOL-BREF Physical Health Scores at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '12.6'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '14'}]}]}, {'title': 'WHOQOL-BREF Psychological Health Scores at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '13.7'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '16'}]}]}, {'title': 'WHOQOL-BREF Social Relationship Scores at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '14.7'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '17.8'}]}]}, {'title': 'WHOQOL-BREF Environment Scores at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '15.8'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '17.8'}]}]}, {'title': 'WHOQOL-BREF Physical Health Scores at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '13.6'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '12.6'}]}]}, {'title': 'WHOQOL-BREF Psychological Health Scores at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '15.2'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '12'}]}]}, {'title': 'WHOQOL-BREF Social Relationship Scores at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '16'}]}]}, {'title': 'WHOQOL-BREF Environment Scores at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '16.6'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '16'}]}]}, {'title': 'WHOQOL-BREF Physical Health Scores at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '14.7'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '12'}]}]}, {'title': 'WHOQOL-BREF Psychological Health Scores at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '16'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '11.3'}]}]}, {'title': 'WHOQOL-BREF Social Relationship Scores at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '15.3'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '14.7'}]}]}, {'title': 'WHOQOL-BREF Environment Scores at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '16.3'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 months, 3 months, 6 months, 9 months, 12 months', 'description': 'The WHOQOL-BREF produces four domain scores (Physical health, Psychological, Social Relationships, and Environment) and two overall items (overall quality of life and general health). The scores range from 4-20 with higher scores indicating a better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'WHOQOL-BREF is validated in adults 18 years of age or older.'}, {'type': 'SECONDARY', 'title': 'Pediatric Quality of Life Assessment (PedsQL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'OG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}], 'classes': [{'title': 'PedsQL Physical Functioning at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000', 'lowerLimit': '53.1', 'upperLimit': '70.3'}, {'value': '43.6', 'groupId': 'OG001', 'lowerLimit': '40.6', 'upperLimit': '68.8'}]}]}, {'title': 'PedsQL Emotional Functioning at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '77.5'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '82.5'}]}]}, {'title': 'PedsQL Social Functioning at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '82.5', 'upperLimit': '100'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '67.5', 'upperLimit': '90'}]}]}, {'title': 'PedsQL School Functioning at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '50'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '42.5', 'upperLimit': '65'}]}]}, {'title': 'PedsQL Physical Functioning at 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '68.6'}, {'value': '34.4', 'groupId': 'OG001', 'lowerLimit': '34.4', 'upperLimit': '34.4'}]}]}, {'title': 'PedsQL Emotional Functioning at 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '85'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '90'}]}]}, {'title': 'PedsQL Social Functioning at 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '95'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '70'}]}]}, {'title': 'PedsQL School Functioning at 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '35'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '30'}]}]}, {'title': 'PedsQL Physical Functioning at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '57.8', 'upperLimit': '81.3'}, {'value': '40.6', 'groupId': 'OG001', 'lowerLimit': '40.6', 'upperLimit': '40.6'}]}]}, {'title': 'PedsQL Emotional Functioning at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '85'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '65'}]}]}, {'title': 'PedsQL Social Functioning at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '95'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '60'}]}]}, {'title': 'PedsQL School Functioning at 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '37.5', 'upperLimit': '72.5'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '40'}]}]}, {'title': 'PedsQL Physical Functioning at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '82.8'}]}]}, {'title': 'PedsQL Emotional Functioning at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '72.5', 'upperLimit': '87.5'}]}]}, {'title': 'PedsQL Social Functioning at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'PedsQL Sleep Functioning at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '47.5', 'upperLimit': '75'}]}]}, {'title': 'PedsQL Physical Functioning at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '82.8'}, {'value': '65.6', 'groupId': 'OG001', 'lowerLimit': '65.6', 'upperLimit': '65.6'}]}]}, {'title': 'PedsQL Emotional Functioning at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '80'}]}]}, {'title': 'PedsQL Social Functioning at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '80'}]}]}, {'title': 'PedsQL School Functioning at 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '75'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '80'}]}]}, {'title': 'PedsQL Physical Functioning at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '84.4', 'groupId': 'OG001', 'lowerLimit': '84.4', 'upperLimit': '84.4'}]}]}, {'title': 'PedsQL Emotional Functioning at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '80'}]}]}, {'title': 'PedsQL Social Functioning at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '85'}]}]}, {'title': 'PedsQL School Functioning at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure', 'description': "The Pediatric Quality of Life Assessment (PedsQL) is a standardized questionnaire that assesses a pediatric patient's perceptions of health-related quality of life (HRQOL) with chronic health conditions using 4 domains (Physical, Emotional, Social, School Functioning).\n\nPedsQL scores range from 0-100 where higher scores indicate better health-related quality of life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PEDsQL assessment is validated in patients under the age 18 years.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'FG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Crossover', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': "Patients were recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center. Eligibility Criteria included:\n\n* Age 14 - 45 years.\n* History of post-traumatic headache or neck pain following a concussion or head injury within the last 2 years.\n* Self-reported lack of meaningful benefit with at least one previous treatment trial."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'BG001', 'title': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.\n\nIf patients exhibited \\< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '6', 'groupId': 'BG000'}, {'value': '21', 'spread': '7', 'groupId': 'BG001'}, {'value': '22', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pain Score at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'BG000', 'lowerLimit': '2.5', 'upperLimit': '5.6'}, {'value': '4.9', 'groupId': 'BG001', 'lowerLimit': '3.5', 'upperLimit': '5.8'}, {'value': '4.6', 'groupId': 'BG002', 'lowerLimit': '2.7', 'upperLimit': '5.8'}]}]}], 'paramType': 'MEDIAN', 'description': "Pain Scores were assessed using the Numerical Rating Scale 0-10 with 0 being 'no pain' and 10 being 'worst pain imaginable'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', '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'}], 'populationDescription': 'This study was terminated early due to slow patient recruitment. Given this, data has been analyzed for all patients enrolled.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-14', 'size': 420777, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-16T10:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Study terminated prematurely by the study Principal Investigator due to slow patient recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2016-12-22', 'resultsFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2016-12-29', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-24', 'studyFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure', 'description': "Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'."}], 'secondaryOutcomes': [{'measure': 'Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'The Migraine Disability Assessment (MIDAS) is a self-administered standardized questionnaire to quantify headache-related disability.\n\nThe MIDAS score ranges from 0 to 270. The higher the score on the MIDAS questionnaire, the greater the disability caused by headaches.'}, {'measure': 'Pediatric Migraine Disability Assessment (PedMIDAS)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'The Pediatric Migraine Disability Assessment (PedsMIDAS) is a self-administered standardized questionnaire to quantify headache related disability.\n\nThe PedsMIDAS score ranges from 0 to 240. The higher the score on the PedsMIDAS questionnaire, the greater the disability caused by headaches.'}, {'measure': 'Headache Severity Assessed by Migraine Disability Assessment (MIDAS)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Self-administered questionnaire to quantify headache-severity using the following question:\n\nOn a scale of 0 - 10, on average how painful were these headaches? (where 0=no pain at all, and 10=pain as bad as it can be)'}, {'measure': 'Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Self-administered questionnaire to quantify headache-related disability'}, {'measure': 'Functional Disability Inventory Scores (FDI)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'The Functional Disability Inventory (FDI) was used to assess functional disability.\n\nThe FDI is scored by summing the ratings for each of its 15 items, with scores ranging from 0 to 60.\n\nHigher scores indicate greater perceived functional disability.'}, {'measure': 'Pain Disability Index (PDI)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'The Pain Disability Index (PDI) was used to assess functional disability in adults.\n\nThe PDI is scored by summing the ratings of seven different life domains, each scored on a scale of 0 to 10, with higher scores indicating greater pain-related disability.\n\nThe total score can range from 0 to 70. A higher score reflects a greater impact of pain on daily activities.'}, {'measure': 'World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)', 'timeFrame': 'Baseline, 2 months, 3 months, 6 months, 9 months, 12 months', 'description': 'The WHOQOL-BREF produces four domain scores (Physical health, Psychological, Social Relationships, and Environment) and two overall items (overall quality of life and general health). The scores range from 4-20 with higher scores indicating a better quality of life.'}, {'measure': 'Pediatric Quality of Life Assessment (PedsQL)', 'timeFrame': 'Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure', 'description': "The Pediatric Quality of Life Assessment (PedsQL) is a standardized questionnaire that assesses a pediatric patient's perceptions of health-related quality of life (HRQOL) with chronic health conditions using 4 domains (Physical, Emotional, Social, School Functioning).\n\nPedsQL scores range from 0-100 where higher scores indicate better health-related quality of life."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Traumatic Headaches']}, 'descriptionModule': {'briefSummary': "Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for PTH management except for conservative modalities, such as cognitive rest, physical therapy, and neuropathic pain medications, all of which have minimal evidence to support them.\n\nThe investigators propose a randomized, controlled, clinical trial and prospective follow-up study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and cervical medial branch block (CMBB) in the management of PTH.\n\nAdolescents and adults (14-45 years of age) will be recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache clinics.", 'detailedDescription': 'Headaches and neck pain following a concussion are potentially treatable and resolve over time. Nerve blockade may enhance the recovery of appropriate neural circuits involved in the pathophysiology of a chronic headache. Currently, no evidence-based guidelines exist for treatment of PTH. Adoption of "brain rest" for 1-2 weeks, followed by gradual return to activity and avoiding "second-impact syndrome" are current practice. The use of medications controlling neuropathic pain is of partial benefit for some. Adverse effects like sedation, mood changes, cardiac side effects of pharmacologic agents are often not compatible with the demands of athletics. For those patients where sports performance is paramount, they may therefore not be able to tolerate regular medications. The incidence of chronic post-concussive headaches (\\> 3 months) at one year is 8.4% - 35% and at four years is up to 25%. Therefore, patients can have a significant disability from their post-traumatic headaches for many years after their injury. Without appropriate treatment, these headaches can remain as chronic headaches. Over-the-counter and other symptomatic medication overuse can exacerbate and prolong PTH significantly, secondary to rebound headaches. Successful treatment is essential since PTH limits return to sports as well as more general activities of living, such as work and school. Most interventions currently in use partially help and take several weeks to months for a noticeable benefit. PTH interventions, including ONB and CMBB, are employed in the treatment of primary headache disorders and neck pain from cervical arthritis and may provide more improved, faster and more sustained pain relief in many patients. Also, given that most of the action of the nerve blocks is local, there are significantly fewer side effects than in more standard headache medications. Injections that use corticosteroids may be beneficial in a post-traumatic headache by reducing inflammation and therefore mechanical allodynia. Injection of corticosteroids in the cervical facet joint area has shown up to 13 months of pain relief. This prolonged effect may be secondary to central pain modulation. Ultimately, nerve blocks may be a more effective and efficient post-traumatic headache given the onset of effect and the minimal side effects.\n\nTo date, there have been no prospective studies of procedural treatments for medically refractory PTH and none in the adolescent and young adult population in whom football injuries are common. Despite the frequent clinical practice of using ONB and CMBB for occipital neuralgia, cervical arthritis, and cervicogenic headaches, there has been no adequate scientific investigation into the use of these interventions for PTH. Given that PTH is typically felt to be secondary to an inflammatory reaction to trauma, the use of injection of corticosteroids may be more effective in PTH than in common headache disorders.\n\nThe investigators propose a randomized, prospective, controlled treatment trial to evaluate the efficacy of minimally invasive nerve block interventions (ONB and CMBB) as treatments for PTH and neck pain in adolescents and adults aged 14-45 years of age with PTH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 14 - 45 years\n* History of post-traumatic headache or neck pain following a concussion or head injury within the last 12 months\n* Self-reported lack of meaningful benefit with at least one previous treatment trial. Previous treatment could include a migraine prophylactic medication, a neuropathic pain medication, a physical intervention, or a cognitive-behavioral intervention.\n\nExclusion Criteria:\n\n* Significant underlying psychological concerns, as determined by study psychologist up on review of standardized assessment\n* Lack of parental consent and child assent (if patient age \\<18 years) or lack of consent (if patient age \\>18 years). Unable to complete the questionnaire, based on parental or patient estimation of cognitive or language limitations'}, 'identificationModule': {'nctId': 'NCT03007420', 'briefTitle': 'A Prospective Controlled Treatment Trial for Post-Traumatic Headaches', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'A Prospective Controlled Treatment Trial for Post-Traumatic Headaches', 'orgStudyIdInfo': {'id': 'IRB-P00025021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Occipital Nerve Block', 'description': "After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.\n\nIf patients exhibit \\< 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.", 'interventionNames': ['Drug: Occipital Nerve Block (ONB) using lidocaine and dexamethosone']}, {'type': 'EXPERIMENTAL', 'label': 'Cervical Medial Branch Block', 'description': "After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \\> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.\n\nIf patients exhibit \\< 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.", 'interventionNames': ['Drug: Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone']}], 'interventions': [{'name': 'Occipital Nerve Block (ONB) using lidocaine and dexamethosone', 'type': 'DRUG', 'description': 'Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites.', 'armGroupLabels': ['Occipital Nerve Block']}, {'name': 'Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone', 'type': 'DRUG', 'description': 'Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side.', 'armGroupLabels': ['Cervical Medial Branch Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators do not plan to share any IPD collected during the study with other researchers not included in the protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'Harvard University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Assistant Professor of Anesthesiology, Harvard Medical School; Staff Physician, Boston Children's Hospital", 'investigatorFullName': 'Pradeep Dinakar, MD, MS, FAAP', 'investigatorAffiliation': "Boston Children's Hospital"}}}}