Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT03860259
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2019-01-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Auriculotherapy for Surgical Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chelje@anes.upmc.edu', 'phone': '412-623-6382', 'title': 'Jacques E. Chelly, MD, PhD, MBA', 'organization': 'University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).", 'description': "Adverse event data was collected for the duration of the subject's 90-day study participation using the electronic medical record and via patient report at day 5, 14, 30, 60, and 90 follow-ups.", 'eventGroups': [{'id': 'EG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 25, 'otherNumAffected': 4, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 25, 'otherNumAffected': 10, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Postoperative Constipation', 'notes': 'Constipation is infrequent bowel movements or difficult passage of stools that persists for several days to weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Opioid Consumption Following Rotator Cuff Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'title': '24 Hours', 'categories': [{'measurements': [{'value': '31', 'spread': '20', 'groupId': 'OG000'}, {'value': '25', 'spread': '20', 'groupId': 'OG001'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '25', 'spread': '17', 'groupId': 'OG000'}, {'value': '21', 'spread': '17', 'groupId': 'OG001'}]}]}, {'title': '72 Hours', 'categories': [{'measurements': [{'value': '19', 'spread': '19', 'groupId': 'OG000'}, {'value': '12', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': '96 Hours', 'categories': [{'measurements': [{'value': '12', 'spread': '15', 'groupId': 'OG000'}, {'value': '9', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': '120 Hours', 'categories': [{'measurements': [{'value': '10', 'spread': '13', 'groupId': 'OG000'}, {'value': '5', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '96', 'spread': '67', 'groupId': 'OG000'}, {'value': '62', 'spread': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1771', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '24 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2833', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '48 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0909', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '72 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2310', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '96 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0801', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '120 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0307', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Total', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative', 'description': 'Investigate the efficacy of auriculotherapy in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective rotator cuff surgery. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative as well as the total sum of these intervals', 'unitOfMeasure': 'oral morphine mg equivalents (OME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Post-Operative Pain With Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'title': '24 Hours', 'categories': [{'measurements': [{'value': '8.11', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '7.42', 'spread': '2.67', 'groupId': 'OG001'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '6.83', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '6.21', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': '72 Hours', 'categories': [{'measurements': [{'value': '6.28', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '2.22', 'groupId': 'OG001'}]}]}, {'title': '96 Hours', 'categories': [{'measurements': [{'value': '5.44', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '4.65', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': '120 Hours', 'categories': [{'measurements': [{'value': '4.72', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '3.80', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '5.84', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '4.47', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '5.00', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '5.27', 'spread': '2.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '4.15', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '3.64', 'spread': '2.90', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '2.21', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '2.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1956', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '24 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2274', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '48 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1090', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '72 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1618', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '96 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1264', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '120 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0394', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 14', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3968', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 30', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3407', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 60', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4033', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 90', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hrs through 90-days post-operative', 'description': 'Numerical Rating Scale (NRS) Pain with movement on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Post-Operative Pain at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '0.89', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': '24 Hours', 'categories': [{'measurements': [{'value': '6.17', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '3.32', 'groupId': 'OG001'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '4.67', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '4.50', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': '72 Hours', 'categories': [{'measurements': [{'value': '3.89', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': '96 Hours', 'categories': [{'measurements': [{'value': '3.50', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '2.44', 'groupId': 'OG001'}]}]}, {'title': '120 Hours', 'categories': [{'measurements': [{'value': '2.88', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '2.26', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '2.13', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '1.23', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1707', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Time of discharge', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3446', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '24 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4310', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '48 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3143', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '72 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4749', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '96 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3728', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '120 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1628', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Day 14', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0731', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 30', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4909', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 60', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4411', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 90', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Time of discharge through 90-days post-operative', 'description': 'Numerical Rating Scale (NRS) pain at rest on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Non-narcotic Analgesic Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '4438.16', 'spread': '4066.01', 'groupId': 'OG000'}, {'value': '5955.63', 'spread': '5882.27', 'groupId': 'OG001'}]}]}, {'title': 'Ibuprofen', 'categories': [{'measurements': [{'value': '785.26', 'spread': '1576.68', 'groupId': 'OG000'}, {'value': '1370.00', 'spread': '2386.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1786', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Acetaminophen', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1876', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Ibuprofen', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day of surgery through 5-days post-operative', 'description': 'Investigate the efficacy of auriculotherapy in reducing total perioperative consumption of non-narcotic analgesics.', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'title': 'Baseline PCS', 'categories': [{'measurements': [{'value': '38.9', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '38.0', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 PCS', 'categories': [{'measurements': [{'value': '37.1', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 30 PCS', 'categories': [{'measurements': [{'value': '36.1', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 60 PCS', 'categories': [{'measurements': [{'value': '40.5', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '39.0', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 90 PCS', 'categories': [{'measurements': [{'value': '44.1', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline MCS', 'categories': [{'measurements': [{'value': '60.5', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '59.4', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 MCS', 'categories': [{'measurements': [{'value': '57.4', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '60.3', 'spread': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 30 MCS', 'categories': [{'measurements': [{'value': '61.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '59.6', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 60 MCS', 'categories': [{'measurements': [{'value': '59.9', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '58.6', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 90 MCS', 'categories': [{'measurements': [{'value': '60.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3638', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Baseline PCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0856', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 14 PCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4428', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 30 PCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3378', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 60 PCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3942', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 90 PCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2190', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Baseline MCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1112', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 14 MCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1737', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 30 MCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2408', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 60 MCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0380', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 90 MCS', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day of surgery through 90 days post-operative', 'description': "Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. The highest possible PCS-12 score is 56.57706 and the lowest possible score is 23.99938. The highest possible MCS-12 score is 67.37178 and the lowest possible score is 17.57825. Higher scores for both represent better functioning.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Length of Recovery Room Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '67.2', 'spread': '34.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2220', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day of surgery through recovery room discharge, up to 142 min post-operative', 'description': 'Evaluate time to readiness for discharge from post-anesthesia care unit (PACU) from out of OR time in minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '140.1', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '148.0', 'spread': '47.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2856', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day of surgery through time of discharge, up to 270 min post-operative', 'description': 'Evaluate time to hospital discharge from out of OR time in minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Post-operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of surgery through 90-days post-operative', 'description': 'The number of participants who experienced complications and received the standard protocol versus subjects who received the standard protocol + Auriculotherapy. Post-operative complications can be defined as unexpected problems that arise following surgery including increased bleeding, infection, recurrent rotator cuff tear, and displacement of suture anchor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Subjects Requiring Readmission Due to Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery through 90-days post-operative', 'description': 'Evaluate the number of subjects readmitted because of pain or pain-related issues during the 90 day study duration', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Overall Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2241', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day of surgery through time of discharge, up to 270 min post-operative', 'description': 'Participants are asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Pain Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '5.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': '24 Hours', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': '72 Hours', 'categories': [{'measurements': [{'value': '5.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '96 Hours', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '120 Hours', 'categories': [{'measurements': [{'value': '4.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '5.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2714', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Time of discharge', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3749', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '24 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3862', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '48 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1735', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '72 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4304', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '96 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4902', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': '120 hrs', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4371', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 14', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1950', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 30', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4124', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Day 60', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0268', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value less than 0.1 will be considered significant', 'groupDescription': 'Day 90', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day of surgery through 90-days post-operative', 'description': 'Participants are asked to assess their satisfaction with pain management at discharge, 24 hrs, 48 hrs, 72 hrs, 96, hours, 120 hrs and 14 days, 30 days, 60 days and 90 days post-operative on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}, {'type': 'SECONDARY', 'title': 'Subjects Requiring Hospital Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'OG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of surgery through 90-days post-operative', 'description': 'Evaluate the number of subjects readmitted to the hospital for post-operative complications other than pain-related issues.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'FG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited in the pre-operative holding area of UPMC Shadyside or UPMC Montefiore Hospitals on the day of their scheduled rotator cuff surgery. Recruitment began on January 24, 2020 and concluded on July 1, 2021. During this time, recruitment was on hold due to COVID-19 protocol from February to July of 2020.', 'preAssignmentDetails': 'A total of 50 subjects signed an informed consent and all subjects were randomized to either the placebo or intervention group. No subjects were excluded prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Auriculotherapy Without Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'BG001', 'title': 'Auriculotherapy With Nitrogen Gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.\n\nAuriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', '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': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.2', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '169.1', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '169.6', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'spread': '17.8', 'groupId': 'BG000'}, {'value': '94.7', 'spread': '27.2', 'groupId': 'BG001'}, {'value': '90.3', 'spread': '23.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '32.8', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '31.2', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients undergoing elective rotator cuff repair with an interscalene block and general anesthesia'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-20', 'size': 239890, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-06T08:59', 'hasProtocol': True}, {'date': '2020-08-04', 'size': 271570, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-22T12:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The only person unblinded to treatment allocation will be the Principal investigator or designee -- the individual performing cryopuncture'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2019-01-22', 'resultsFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-06', 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Consumption Following Rotator Cuff Surgery', 'timeFrame': '24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative', 'description': 'Investigate the efficacy of auriculotherapy in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective rotator cuff surgery. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative as well as the total sum of these intervals'}], 'secondaryOutcomes': [{'measure': 'Post-Operative Pain With Movement', 'timeFrame': '24 hrs through 90-days post-operative', 'description': 'Numerical Rating Scale (NRS) Pain with movement on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.'}, {'measure': 'Post-Operative Pain at Rest', 'timeFrame': 'Time of discharge through 90-days post-operative', 'description': 'Numerical Rating Scale (NRS) pain at rest on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.'}, {'measure': 'Non-narcotic Analgesic Consumption', 'timeFrame': 'Day of surgery through 5-days post-operative', 'description': 'Investigate the efficacy of auriculotherapy in reducing total perioperative consumption of non-narcotic analgesics.'}, {'measure': 'Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12)', 'timeFrame': 'Day of surgery through 90 days post-operative', 'description': "Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. The highest possible PCS-12 score is 56.57706 and the lowest possible score is 23.99938. The highest possible MCS-12 score is 67.37178 and the lowest possible score is 17.57825. Higher scores for both represent better functioning."}, {'measure': 'Length of Recovery Room Stay', 'timeFrame': 'Day of surgery through recovery room discharge, up to 142 min post-operative', 'description': 'Evaluate time to readiness for discharge from post-anesthesia care unit (PACU) from out of OR time in minutes'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Day of surgery through time of discharge, up to 270 min post-operative', 'description': 'Evaluate time to hospital discharge from out of OR time in minutes'}, {'measure': 'Number of Participants Who Experienced Post-operative Complications', 'timeFrame': 'Day of surgery through 90-days post-operative', 'description': 'The number of participants who experienced complications and received the standard protocol versus subjects who received the standard protocol + Auriculotherapy. Post-operative complications can be defined as unexpected problems that arise following surgery including increased bleeding, infection, recurrent rotator cuff tear, and displacement of suture anchor.'}, {'measure': 'Subjects Requiring Readmission Due to Pain', 'timeFrame': 'Day of surgery through 90-days post-operative', 'description': 'Evaluate the number of subjects readmitted because of pain or pain-related issues during the 90 day study duration'}, {'measure': 'Overall Patient Satisfaction', 'timeFrame': 'Day of surgery through time of discharge, up to 270 min post-operative', 'description': 'Participants are asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.'}, {'measure': 'Satisfaction With Pain Management', 'timeFrame': 'Day of surgery through 90-days post-operative', 'description': 'Participants are asked to assess their satisfaction with pain management at discharge, 24 hrs, 48 hrs, 72 hrs, 96, hours, 120 hrs and 14 days, 30 days, 60 days and 90 days post-operative on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.'}, {'measure': 'Subjects Requiring Hospital Readmission', 'timeFrame': 'Day of surgery through 90-days post-operative', 'description': 'Evaluate the number of subjects readmitted to the hospital for post-operative complications other than pain-related issues.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['opioids', 'auriculotherapy', 'acute pain', 'shoulder surgery'], 'conditions': ['Acute Pain', 'Surgery', 'Shoulder Pain']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Alimi D., Geissmann A., Gardeur D., Bahr F. Study in fMRI of the stimulation of the auricular areas of the knee as the French -German and Chinese localizations. The Journal of Radiology. 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French"}, {'pmid': '31297168', 'type': 'BACKGROUND', 'citation': 'Wirz-Ridolfi A. The History of Ear Acupuncture and Ear Cartography: Why Precise Mapping of Auricular Points Is Important. Med Acupunct. 2019 Jun 1;31(3):145-156. doi: 10.1089/acu.2019.1349. Epub 2019 Jun 17.'}, {'type': 'BACKGROUND', 'citation': "Alimi, D. L'Auriculotherapie Medicale: Bases Scientifiques, Principles, Indications et Strategies Therapeutiques. Chapitre 10. Neurophysiologie des perceptions. Elsevier Masson"}, {'type': 'BACKGROUND', 'citation': "Felten DL, Shetty AN. Second edition of the Netter's Atlas of Neuroscience Chapter 9. Peripheral nervous system. Publisher Saunders, Elsevier;2010. pp 135-172"}, {'pmid': '11835542', 'type': 'BACKGROUND', 'citation': 'Peuker ET, Filler TJ. The nerve supply of the human auricle. Clin Anat. 2002 Jan;15(1):35-7. doi: 10.1002/ca.1089.'}, {'pmid': '26227955', 'type': 'BACKGROUND', 'citation': 'Anthwal N, Thompson H. The development of the mammalian outer and middle ear. J Anat. 2016 Feb;228(2):217-32. doi: 10.1111/joa.12344. Epub 2015 Jul 30.'}, {'pmid': '22337528', 'type': 'BACKGROUND', 'citation': 'Rouwette T, Vanelderen P, Roubos EW, Kozicz T, Vissers K. The amygdala, a relay station for switching on and off pain. Eur J Pain. 2012 Jul;16(6):782-92. doi: 10.1002/j.1532-2149.2011.00071.x. Epub 2011 Dec 19.'}, {'pmid': '28526575', 'type': 'BACKGROUND', 'citation': 'Babygirija R, Sood M, Kannampalli P, Sengupta JN, Miranda A. Percutaneous electrical nerve field stimulation modulates central pain pathways and attenuates post-inflammatory visceral and somatic hyperalgesia in rats. Neuroscience. 2017 Jul 25;356:11-21. doi: 10.1016/j.neuroscience.2017.05.012. Epub 2017 May 17.'}]}, 'descriptionModule': {'briefSummary': 'The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. In the United States, over $600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood.\n\nTo date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. The interscalene block is the gold standard for postoperative pain management following shoulder surgery. However, the duration of the block does not cover rehabilitation, and in most cases, patients are discharged from the hospital with an opioid prescription. Therefore, there is a growing need to investigate complementary pain-management methods that offer a non-pharmacological solution to managing post-operative pain. Auriculotherapy is such a technique that has been shown in previous studies to provide significant analgesia without the adverse effects of opioids or other pain-relieving medications. Auriculotherapy has been shown to reduce the need for opioid immediately after surgery. However, everyone agrees that more research is needed, especially due to the concern of the placebo effect when using a needle and electro-stimulation. This study is purposely based on the use of a cryopuntor device, which has been shown to produce the same effect as needles. This is a novel complementary approach to reducing the persistence of opioid prescription following rotator cuff surgery, which is considered a model of severe functional pain. Data obtained from this study will support a future NIDA proposal to expand the use of auriculotherapy for perioperative management of pain and functional recovery associated with surgery. The use of an auriculotherapy approach has the potential of providing effective non-opioid analgesia to patients not only undergoing rotator cuff surgery, but also other surgical models.', 'detailedDescription': 'Once patient has signed the Informed Consent to participate in this trial, demographic information and medical history will be collected from each participant on the day of surgery. Research staff will record this information from the medical chart. The Medical Outcomes Study Questionnaire 12-Item Short Form Health Survey (SF-12) will also be administered at this time to obtain baseline value. Randomization will occur by assigning the participant a subject ID number, and this ID number will correspond to a treatment allocation based on a pre-designed randomization schema. This treatment allocation (intervention/control) will be contained in a sealed, opaque, envelope with the subject ID number that is designated on envelope. The master randomization list will be created and held by an independent data monitor who will both create and hold the master randomization list.\n\nStudy coordinators, Co-Is and subjects will be blinded. Only the research staff completing the treatment will be unblinded. Once the patient is randomized to a treatment group by research staff, Auriculotherapy will be performed by certified research staff using a cryoauriculopuncture in the post-anesthesia recovery room, either with nitrogen gas (intervention group), or an empty cryoauriculopunture with no gas (control group).\n\nAfter proper disinfection of the designated ear, the treatment consists of the stimulation of 9 ear points on the ipsilateral ear. These points include:-Ω2 (the master point for the mesoderm), the shoulder point, 6 points involved with the pain pathway (the stellar ganglion, the sensory and motor C7 branches, the sensory master point (MSP), the reticular master point (RMP) and the point corresponding to the Thalamus). Finally, the stimulation of the ACTH point completes the treatment. The total time required to complete auriulotherapy treatment is approximately 10 minutes. The enrolled subject will also receive a pre-operative interscalene block as per standard of care. The patient will receive standard of care treatment for surgery, post-operative pain management, and physical therapy. After surgery, the subject will be assessed at time of hospital discharge to review how to complete the subject diary, administer pain satisfaction questionnaire (0-6) and obtain NRS pain at rest and with movement scores (0-10). When the patient is discharged from the hospital, the subject will be asked to take home and complete a subject diary where they will record their total narcotic/pain medication consumption, pain satisfaction score (0-6), and NRS pain score (0-10), and adverse events daily for first 5 days post-discharge. The subject will be instructed to complete the diary just before bedtime on these post-op days. The patient will be contacted via telephone on Day 5 post-operatively as a reminder to return pain diary. On post-operative Day 14, 30, 60 and 90 telephone calls, functional recovery will be measured using the Medical Outcomes Study Questionnaire 12-Item Short Form Health Survey (SF-12). The subject will also be asked to assess their overall patient satisfaction at the Day 90 call, on a scale of 0 (least satisfaction) to 10 (most satisfaction). Analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with oral morphine equivalent doses of analgesics used to provide pain relief). Secondary outcome measures will include pain at rest and with movement, total non-narcotic pain medication consumption for the first 5-days post-discharge, time to readiness for discharge from PACU, time to hospital discharge, readmission to the hospital because of pain related issues, incidence of postoperative complications, overall patient satisfaction, patient satisfaction relating to pain management and functional recovery. Functional recovery will be measured using the Medical Outcomes Study Questionnaire 12-Item Short Form Health Survey (SF-12).\n\nSince, starting the study, the secondary outcome measure of "Change in post-operative opioid consumption in opioid naïve subjects undergoing rotator cuff surgery" has been removed as this is repetitive of the data collected as part of the primary outcome measure and its analysis. Additionally the outcome of "Pain scores following rotator cuff surgery" was further specified to Post-operative pain at rest and Post-operative pain with movement for clarification and analysis of each individually. This was also altered from a primary to secondary outcome to match the current IRB approved protocol for this study in which pain scores were a secondary outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is greater than 18 years of age\n2. Subject is willing and able to provide informed consent\n3. Subject is scheduled to undergo elective rotator cuff surgery\n4. Subject has consented to an interscalene block\n\nExclusion Criteria:\n\n1. Opioid dependence\n2. Any subject diagnosed with a chronic pain condition which daily opioid use is needed\n3. Anatomical malformation, which in the investigator's opinion may interfere with the placement of the nerve block\n4. Raynaud's disease diagnosis\n5. Vasculopathy\n6. Patient refusal"}, 'identificationModule': {'nctId': 'NCT03860259', 'briefTitle': 'Auriculotherapy for Surgical Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'The Effect of Auriculotherapy for Post-Operative Pain Management Following Rotator Cuff Surgery: A Randomized, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': 'PRO18050099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Auriculotherapy without nitrogen gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.', 'interventionNames': ['Device: Auriculotherapy cryopuncture device without nitrogen gas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Auriculotherapy with nitrogen gas', 'description': 'Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.', 'interventionNames': ['Device: Auriculotherapy cryopuncture device with nitrogen gas']}], 'interventions': [{'name': 'Auriculotherapy cryopuncture device without nitrogen gas', 'type': 'DEVICE', 'description': 'Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy', 'armGroupLabels': ['Auriculotherapy without nitrogen gas']}, {'name': 'Auriculotherapy cryopuncture device with nitrogen gas', 'type': 'DEVICE', 'description': 'Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy', 'armGroupLabels': ['Auriculotherapy with nitrogen gas']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Shadyside Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Jacques E Chelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacques E. Chelly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology (with Tenure) and Orthopedic Surgery', 'investigatorFullName': 'Jacques E. Chelly', 'investigatorAffiliation': 'University of Pittsburgh'}}}}