Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT04880733
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-26
First Post:
2021-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Acupuncture in the Emergency Department for Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D059408', 'term': 'Pain Management'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019468', 'term': 'Disease Management'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdusek@hs.uci.edu', 'phone': '617-519-8082', 'title': 'Jeffery Dusek', 'organization': 'University California-Irvine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It should be noted that recruitment was conducted during the COVID-19 pandemic.'}}, 'adverseEventsModule': {'timeFrame': 'Any adverse event from baseline to 4 weeks for the Acupuncture and Usual Care Arms, approximately 6 months for the ED Staff/Providers Arm', 'eventGroups': [{'id': 'EG000', 'title': 'Acupuncture', 'description': "This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.\n\nAcupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.\n\nUsual care for pain management: Patient will receive usual care for pain management.", 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 0, 'seriousNumAtRisk': 83, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'This arm will receive usual care for pain management.\n\nUsual care for pain management: Patient will receive usual care for pain management.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 0, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'ED Staff/Providers', 'description': 'ED Staff and Providers were asked complete 2 questions about their perceptions of acupuncture in the ED.\n\nIf the ED staff or providers had direct contact with the ACUITY study in their ED, then they were asked to complete 2 additional questions inquiring about how ACUITY may have impacted the ED.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death', 'notes': 'Death due to retroperitoneal hemorrhage (preliminary cause of death) and cirrhosis (secondary) at Site 2 about 7 days after their ED discharge and subsequent inpatient admission . It was unanticipated, fatal and not study related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for Suspected Stroke', 'notes': 'Hospitalization included diagnosis of new cerebral mass lesion concerning for metastasis and likely culprit of the patients symptoms. Patient also diagnosed with Left low extremity DVT. It was unexpected, severe and not study related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Successful Recruitment of Participants Into the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Approached', 'description': 'Total approached across all 3 sites'}, {'id': 'OG001', 'title': 'University Hospitals/Case Western', 'description': 'Patients approached at University Hospitals/Case Western'}, {'id': 'OG002', 'title': 'VUMC', 'description': 'Patients approached at VUMC'}, {'id': 'OG003', 'title': 'UCSD', 'description': 'Patients approached at UCSD'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '27.7', 'groupId': 'OG001'}, {'value': '16.3', 'groupId': 'OG002'}, {'value': '49.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Enrollment', 'description': 'The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.', 'unitOfMeasure': 'Percentage of participants enrolled', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were eligible AND approached.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Retained in the Study at Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Enrolled', 'description': 'Total Enrolled across all 3 sites'}, {'id': 'OG001', 'title': 'University Hospitals/Case Western', 'description': 'Enrolled at University Hospitals/Case Western'}, {'id': 'OG002', 'title': 'VUMC', 'description': 'Enrolled at VUMC'}, {'id': 'OG003', 'title': 'UCSD', 'description': 'Enrolled at UCSD'}], 'classes': [{'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}, {'value': '98.4', 'groupId': 'OG001'}, {'value': '95.5', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At post treatment (45-60 minutes)', 'description': 'Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.', 'unitOfMeasure': 'percentage of patients retained at post', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who enrolled'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Retained at 1-week Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Enrolled', 'description': 'Enrolled across all 3 sites'}, {'id': 'OG001', 'title': 'University Hospitals/Case Western', 'description': 'Enrolled at University Hospitals/Case Western'}, {'id': 'OG002', 'title': 'VUMC', 'description': 'Enrolled at VUMC'}, {'id': 'OG003', 'title': 'UCSD', 'description': 'Enrolled at UCSD'}], 'classes': [{'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000'}, {'value': '82.0', 'groupId': 'OG001'}, {'value': '81.6', 'groupId': 'OG002'}, {'value': '69.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One-week after the participant was discharged from the ED', 'description': 'Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.', 'unitOfMeasure': 'percentage of patients retained at 1-wk', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who enrolled'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Question 1 at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Satisfaction', 'description': 'Total Satisfaction across all 3 sites'}, {'id': 'OG001', 'title': 'Acupuncture', 'description': 'Satisfaction for those randomized to acupuncture in the ED and who answered the question'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Satisfaction for those randomized to the Usual Care arm and who answered the question'}], 'classes': [{'categories': [{'measurements': [{'value': '3.91', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '4.36', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '3.46', 'spread': '1.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At post-treatment (45-60 minutes after baseline)', 'description': 'Question 1: "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who has Post-treatment scores and answered satisfaction question 1 at post-treatment'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Question 2 at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Satisfaction', 'description': 'Satisfaction across all sites'}, {'id': 'OG001', 'title': 'Acupuncture', 'description': 'Satisfaction for those randomized to the Acupuncture Arm'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Satisfaction for those randomized to the Usual Care Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '4.13', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '4.57', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '3.70', 'spread': '1.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At post-treatment (45-60 minutes after baseline)', 'description': '"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who has Post-treatment scores and answered satisfaction question 2 at post-treatment'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Question 1 at 1-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Satisfaction', 'description': 'Satisfaction for all participants'}, {'id': 'OG001', 'title': 'Acupuncture', 'description': 'Satisfaction for those randomized to the Acupuncture Arm'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Satisfaction for those randomized to the Usual Care Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '3.95', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '3.73', 'spread': '1.30', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week after participant was discharged from the ED', 'description': '"How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who has Post-treatment scores and answered satisfaction question 1 at 1-week FU'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Question 2 at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Satisfaction', 'description': 'Satisfaction across sites'}, {'id': 'OG001', 'title': 'Acupuncture', 'description': 'Satisfaction for those randomized to the Acupuncture Arm'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Satisfaction for those randomized to the Usual Care Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '3.98', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '4.19', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '3.75', 'spread': '1.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week after participant was discharged from the ED', 'description': '"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who has Post-treatment scores and answered satisfaction question 2 at 1-week FU'}, {'type': 'SECONDARY', 'title': 'Provider Satisfaction Question1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Appropriateness', 'description': "Average score of providers' perception of appropriateness of acupuncture in the ED"}], 'classes': [{'categories': [{'measurements': [{'value': '2.19', 'spread': '1.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': "After enrollment at the provider's site completed (~6 months after first enrollee).", 'description': '"Do you view acupuncture in general as an appropriate intervention for the ED setting?" on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Providers who responded to the survey after their site completed enrollment.'}, {'type': 'SECONDARY', 'title': 'Provider Satisfaction Question 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Helpful', 'description': "Average score of providers' perception of helpfulness of acupuncture in the ED"}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'spread': '1.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': "After enrollment at the provider's site completed (~6 months after first enrollee).", 'description': '"Do you view acupuncture in general as helpful in managing patient pain in the ED?" on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Providers who responded to the survey.'}, {'type': 'SECONDARY', 'title': 'Provider Satisfaction Question 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Satisfied', 'description': 'Of those ED providers who were exposed to ACUITY, how satisfied were they with acupuncture as delivered in the study?'}], 'classes': [{'categories': [{'measurements': [{'value': '3.03', 'spread': '0.90', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': "After enrollment at the provider's site completed (~6 months after first enrollee).", 'description': '"How satisfied are you with the way that the acupuncture intervention was implemented in your setting" on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Providers who responded to the survey and were exposed to ACUITY'}, {'type': 'SECONDARY', 'title': 'Provider Satisfaction Que4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Burden', 'description': 'Of those ED providers who were exposed to ACUITY, what was their perception of how much burden did the study impose in your setting?'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '0.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': "After enrollment at the provider's site completed (~6 months after first enrollee).", 'description': '"Did the ACUITY project impose a burden on ED staff in your setting?" on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Providers who responded to the survey and were exposed to ACUITY'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acupuncture', 'description': "This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.\n\nAcupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.\n\nUsual care for pain management: Patient will receive usual care for pain management."}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'This arm will receive usual care for pain management.\n\nUsual care for pain management: Patient will receive usual care for pain management.'}, {'id': 'FG002', 'title': 'ED Staff/Providers', 'description': 'These were ED staff or providers who answered questions after their site had finished study recruitment.'}], 'periods': [{'title': 'Participants in the RCT (Overall Study)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received Acupuncture', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received Usual Care', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Data collection issue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Delay due to ED imaging', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Early discharge', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'ED Staff/Providers 6 Month Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'Completed Question 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'Completed Question 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'Completed Question 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'Completed Question 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Skipped question 2', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment period: May 3, 2021 - September 24, 2022 from three Emergency Departments', 'preAssignmentDetails': 'At the moment of consent,165 patients were randomized to group. However, 14 (7 per group) did not provide outcomes as detailed below. Complete participants were 151 at Post-Treatment.\n\nA sample of ED providers at the sites answered 2 questions on the appropriateness and helpfulness of acupuncture being provided in the Emergency Department.\n\nIndividuals with direct exposure to ACUITY answered 2 more questions on satisfaction and burden of conducting ACUITY in their ED.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Acupuncture', 'description': "This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.\n\nAcupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.\n\nUsual care for pain management: Patient will receive usual care for pain management."}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'This arm will receive usual care for pain management.\n\nUsual care for pain management: Patient will receive usual care for pain management.'}, {'id': 'BG002', 'title': 'ED Staff/Providers', 'description': 'ED Staff and Providers were asked complete 2 questions about their perceptions of acupuncture in the ED.\n\nIf the ED staff or providers had direct contact with the ACUITY study in their ED, then they were asked to complete 2 additional questions inquiring about how ACUITY may have impacted the ED.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '44.9', 'spread': '16.9', 'groupId': 'BG000'}, {'value': '43.9', 'spread': '17.4', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '9.35', 'groupId': 'BG002'}, {'value': '44.4', 'spread': '17.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity data not collected for the ED Staff/Providers Arm'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG003'}]}]}, {'title': 'Black/AA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'individuals', 'populationDescription': 'Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'title': 'No high school diploma', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'High school or equivalent', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Some college', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'College degree', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'Graduate or professional degree', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Education data not collected for the ED Staff/Providers Arm'}, {'title': 'Income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Less than $20,000', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': '$20,000 - $50,000', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': '$50,001 to $100,000', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': '$100,001 to $150,000', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'More than $150,000', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Income data not collected for the ED Staff/Providers Arm'}, {'title': 'Insurance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Medicare', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'Medicaid', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Private insurance', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'No insurance', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Decline to answer', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Insurance data not collected for the ED Staff/Providers Arm'}, {'title': 'Location of Pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Abdomen', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Head', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Flank', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Chest', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Back', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG003'}]}, {'title': 'Extremity', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'Neck', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Multiple', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Location of Pain data not collected for the ED Staff/Providers Arm'}, {'title': 'Prior Acupuncture', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Prior Acupuncture data not collected for the ED Staff/Providers Arm'}, {'title': 'Pain Intensity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '7.1', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '7.3', 'spread': '2.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '0-10 Numeric Rating Scale of Pain Intensity (where "0" is No pain and "10" is maximal Pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Pain Intensity data not collected for the ED Staff/Providers Arm'}, {'title': 'Anxiety- acute', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '4.1', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '4.3', 'spread': '3.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '0-10 Numeric Rating Scale of acute anxiety (where "0" is No anxiety and "10" is maximal anxiety)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Anxiety- acute data not collected for the ED Staff/Providers Arm'}], 'populationDescription': 'Demographics and initial conditions of participants providing pre and post pain scores in part of the RCT.\n\nOr the demographics of the ED Staff/Providers who answered several questions at the 6 month point after recruitment in their ED was complete.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-09', 'size': 2670021, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_003.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-12-14T12:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data collector will be masked to study outcomes via electronic data collection'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2021-04-30', 'resultsFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-29', 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Recruitment of Participants Into the Study.', 'timeFrame': 'At Enrollment', 'description': 'The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Retained in the Study at Post Treatment', 'timeFrame': 'At post treatment (45-60 minutes)', 'description': 'Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.'}, {'measure': 'Percentage of Patients Retained at 1-week Follow up', 'timeFrame': 'One-week after the participant was discharged from the ED', 'description': 'Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.'}, {'measure': 'Patient Satisfaction Question 1 at Post-treatment', 'timeFrame': 'At post-treatment (45-60 minutes after baseline)', 'description': 'Question 1: "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).'}, {'measure': 'Patient Satisfaction Question 2 at Post-treatment', 'timeFrame': 'At post-treatment (45-60 minutes after baseline)', 'description': '"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).'}, {'measure': 'Patient Satisfaction Question 1 at 1-Week', 'timeFrame': 'One week after participant was discharged from the ED', 'description': '"How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).'}, {'measure': 'Patient Satisfaction Question 2 at 1 Week', 'timeFrame': 'One week after participant was discharged from the ED', 'description': '"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).'}, {'measure': 'Provider Satisfaction Question1', 'timeFrame': "After enrollment at the provider's site completed (~6 months after first enrollee).", 'description': '"Do you view acupuncture in general as an appropriate intervention for the ED setting?" on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better.'}, {'measure': 'Provider Satisfaction Question 2', 'timeFrame': "After enrollment at the provider's site completed (~6 months after first enrollee).", 'description': '"Do you view acupuncture in general as helpful in managing patient pain in the ED?" on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better.'}, {'measure': 'Provider Satisfaction Question 3', 'timeFrame': "After enrollment at the provider's site completed (~6 months after first enrollee).", 'description': '"How satisfied are you with the way that the acupuncture intervention was implemented in your setting" on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better'}, {'measure': 'Provider Satisfaction Que4', 'timeFrame': "After enrollment at the provider's site completed (~6 months after first enrollee).", 'description': '"Did the ACUITY project impose a burden on ED staff in your setting?" on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acupuncture', 'Pain Management', 'Emergency Department', 'Acute Pain']}, 'referencesModule': {'references': [{'pmid': '39640074', 'type': 'DERIVED', 'citation': 'Dusek JA, Kallenberg GA, Storrow AB, Hughes RM, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, Faryar KA, Dyer NL, Barton BA, McKee MD. Acupuncture in the emergency department (ACUITY): Results from a BraveNet multi-center feasibility randomized controlled trial. Integr Med Res. 2024 Dec;13(4):101095. doi: 10.1016/j.imr.2024.101095. Epub 2024 Oct 21.'}, {'pmid': '38841077', 'type': 'DERIVED', 'citation': 'Nielsen A, Dyer NL, Lechuga C, McKee MD, Dusek JA. Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines. Integr Med Res. 2024 Jun;13(2):101048. doi: 10.1016/j.imr.2024.101048. Epub 2024 May 10.'}, {'pmid': '35244059', 'type': 'DERIVED', 'citation': 'Dusek JA, Kallenberg GA, Hughes RM, Storrow AB, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, McKee MD. Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study. Medicine (Baltimore). 2022 Mar 4;101(9):e28961. doi: 10.1097/MD.0000000000028961.'}, {'pmid': '35229658', 'type': 'DERIVED', 'citation': 'Nielsen A, Olson J, Quesada M, Zhu C, Raskin E, Vang B, Painovich J, Scott M, Xiong VJ, Dusek JA. Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process. Acupunct Med. 2022 Aug;40(4):339-346. doi: 10.1177/09645284221076507. Epub 2022 Mar 1.'}, {'pmid': '34009391', 'type': 'DERIVED', 'citation': 'Dyer NL, Surdam J, Dusek JA. A Systematic Review of Practiced-Based Research of Complementary and Integrative Health Therapies as Provided for Pain Management in Clinical Settings: Recommendations for the Future and a Call to Action. Pain Med. 2022 Jan 3;23(1):189-210. doi: 10.1093/pm/pnab151.'}]}, 'descriptionModule': {'briefSummary': 'Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a \\~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (\\~10 per site) and acupuncture patients (\\~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).', 'detailedDescription': 'The goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will include the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), the investigators will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. Prior to the start of the RCT at all sites, study investigator meetings will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), the investigators will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a \\~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Study outcomes include responsive manualization of acupuncture intervention, recruitment, retention, patient adoption, patient acceptability, and provider acceptability. Measures will be collected including pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (\\~10 per site) and acupuncture patients (\\~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years of age\n* Ability to communicate in English.\n* Level 3, 4, 5 on triage rate scale\n* Presentation with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac chest, abdominal, flank or head) pain ≥4 on a 0-10-point NRS due to non-penetrating injury.\n\nExclusion Criteria:\n\n* Fever exceeding 100° F\n* Presenting with a chief complaint of a psychological / psychiatric concern\n* Presenting with chief complaint of Migraine\n* Patient arriving via ambulance or skipping triage\n* Current Pregnancy\n* Self-reported opioid medication taken orally within 4 hours\n* Presenting with chief complaint of Joint Dislocation\n* Presenting with chief complaint of Bone Fracture\n* Confirmed or suspected COVID-19'}, 'identificationModule': {'nctId': 'NCT04880733', 'acronym': 'ACUITY', 'briefTitle': 'Acupuncture in the Emergency Department for Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study', 'orgStudyIdInfo': {'id': 'R01AT010598-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01AT010598-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.', 'interventionNames': ['Procedure: Acupuncture for pain management', 'Other: Usual care for pain management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'This arm will receive usual care for pain management.', 'interventionNames': ['Other: Usual care for pain management']}], 'interventions': [{'name': 'Acupuncture for pain management', 'type': 'PROCEDURE', 'description': "A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.", 'armGroupLabels': ['Acupuncture']}, {'name': 'Usual care for pain management', 'type': 'OTHER', 'description': 'Patient will receive usual care for pain management.', 'armGroupLabels': ['Acupuncture', 'Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Einstein School of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals/Case Western Reserve University- Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vandebilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Jeffery A Dusek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University California-Irvine'}, {'name': 'M. Diane McKee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeffery Dusek, PhD', 'investigatorAffiliation': 'University of California, Irvine'}}}}