Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 6:23 AM
Study NCT ID:
NCT01302769
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2011-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ear Acupuncture for Acute Sore Throat.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020831', 'term': 'Acupuncture, Ear'}], 'ancestors': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055097', 'term': 'Auriculotherapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amanda.j.crawford.ctr@health.mil', 'phone': '7026533583', 'title': 'Amanda Crawford', 'organization': '99MDG Regional Clinical Investigation Program'}, 'certainAgreement': {'otherDetails': 'Study takes place at military hospital with DoD active duty, veterans, and beneficiaries. Publishing of aggregate or simply deidentified data is prohibited.', 'restrictionType': 'OTHER', 'piSponsorEmployee': True, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Small sample size, no sham acupuncture, subjects not blinded to treatment.'}}, 'adverseEventsModule': {'timeFrame': '48 hours (per subject)', 'description': 'No difference.', 'eventGroups': [{'id': 'EG000', 'title': 'Battlefield Auricular Acupuncture', 'description': 'battlefield auricular acupuncture\n\nStandard treatment plus ear acupuncture: Standard treatment plus ear acupuncture', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'standard of care', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Battlefield Auricular Acupuncture', 'description': 'battlefield auricular acupuncture\n\nStandard treatment plus ear acupuncture: Standard treatment plus ear acupuncture'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'standard of care'}], 'classes': [{'title': 'Pain scores (0-10) [0 minutes]', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '6.8'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '6.7'}]}]}, {'title': 'Pain scores (0-10) [15 minutes]', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '3.5'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '6.6'}]}]}, {'title': 'Pain scores (0-10) [6 hours]', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '3.4'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '5.6'}]}]}, {'title': 'Pain scores (0-10) [24 hours]]', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.8'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '4.9'}]}]}, {'title': 'Pain scores (0-10) [48 hours]]', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '2.0'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours per subject', 'description': 'Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture.\n\nSubjects will be asked 15 minutes after their treatment to assess their pain on a likert scale of 0-10. After the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to assess their pain level.\n\nScale: 11-point scale of 0-10 with 10 being the worst pain.\n\nSubjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ibuprofen Doses Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Battlefield Auricular Acupuncture', 'description': 'battlefield auricular acupuncture\n\nStandard treatment plus ear acupuncture: Standard treatment plus ear acupuncture'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'standard of care'}], 'classes': [{'title': 'ibuprofen doses taken (6 hours)', 'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.58'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '1.45'}]}]}, {'title': 'ibuprofen doses taken (24 hours)', 'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.82'}, {'value': '2.63', 'groupId': 'OG001', 'lowerLimit': '1.95', 'upperLimit': '3.31'}]}]}, {'title': 'ibuprofen doses taken (48 hours)', 'categories': [{'measurements': [{'value': '2.19', 'groupId': 'OG000', 'lowerLimit': '1.44', 'upperLimit': '2.94'}, {'value': '4.07', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours per subject', 'description': 'Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture.\n\nAfter the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to ask the number of doses of ibuprofen taken.', 'unitOfMeasure': 'number ibuprofen doses taken', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Missed Work Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Battlefield Auricular Acupuncture', 'description': 'battlefield auricular acupuncture\n\nStandard treatment plus ear acupuncture: Standard treatment plus ear acupuncture'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'standard of care'}], 'classes': [{'title': 'Missed work hours [15 minutes]', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.25'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '1.77'}]}]}, {'title': 'Missed work hours [6 hours]', 'categories': [{'measurements': [{'value': '1.57', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '2.48'}, {'value': '3.19', 'groupId': 'OG001', 'lowerLimit': '1.91', 'upperLimit': '4.47'}]}]}, {'title': 'Missed work hours [24 hours]', 'categories': [{'measurements': [{'value': '3.04', 'groupId': 'OG000', 'lowerLimit': '1.34', 'upperLimit': '4.74'}, {'value': '5.48', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '7.71'}]}]}, {'title': 'Missed work hours [48 hours]', 'categories': [{'measurements': [{'value': '3.78', 'groupId': 'OG000', 'lowerLimit': '1.63', 'upperLimit': '5.93'}, {'value': '6.48', 'groupId': 'OG001', 'lowerLimit': '3.99', 'upperLimit': '8.97'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours per subject', 'unitOfMeasure': 'number hours missed from work', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Battlefield Auricular Acupuncture', 'description': 'battlefield auricular acupuncture\n\nStandard treatment plus ear acupuncture: Standard treatment plus ear acupuncture'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'standard of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'analyzed', 'groupId': 'FG000', 'numSubjects': '27'}, {'comment': 'analyzed', 'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Battlefield Auricular Acupuncture', 'description': 'battlefield auricular acupuncture\n\nStandard treatment plus ear acupuncture: Standard treatment plus ear acupuncture'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'standard of care'}, {'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': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Control- 1 patient lost to follow up Intervention- 1 patient lost to follow up'}, {'title': 'throat culture', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'If throat culture is positive, patients will be notified and referred to their Primary Care Manager to be prescribed standard of care antibiotics', 'unitOfMeasure': 'Participants'}, {'title': 'urine pregnancy test', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'If there is a chance that the subject could be pregnant, they will be sent for a urine pregnancy test (15-20 mls or approximately 2-3 teaspoons of urine).', 'unitOfMeasure': 'Participants'}], 'populationDescription': '28 were initially in study. Each arm lost one subject to follow-up.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2011-02-18', 'resultsFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-08', 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Pain', 'timeFrame': '48 hours per subject', 'description': 'Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture.\n\nSubjects will be asked 15 minutes after their treatment to assess their pain on a likert scale of 0-10. After the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to assess their pain level.\n\nScale: 11-point scale of 0-10 with 10 being the worst pain.\n\nSubjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.'}, {'measure': 'Ibuprofen Doses Taken', 'timeFrame': '48 hours per subject', 'description': 'Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture.\n\nAfter the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to ask the number of doses of ibuprofen taken.'}, {'measure': 'Missed Work Hours', 'timeFrame': '48 hours per subject'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Sore Throat', 'Ear Acupuncture'], 'conditions': ['Acute Sore Throat']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare ear acupuncture plus standard of care versus standard therapy (anti-inflammatory medications) in the reduction of pain, reduction in oral anti inflammatory medication use, hours lost from work in acute sore throat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Male and female subjects (DoD beneficiaries), 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat.\n* Minimum pain score of 5 points on an 11 point scale (0-10 with 10 being the worst pain)\n\nExclusion:\n\n* History of significant gastrointestinal bleed\n* Previous documented history of stage 2 kidney disease or worse\n* Known Pregnancy\n* History of gastric bypass surgery\n* Known Peritonsillar abscess (PTA)\n* Throat, mouth or esophageal cancer\n* Chronic oral steroids use\n* Absence of one or more ears\n* Active cellulitis of ear\n* Ear anatomy precluding identification of acupuncture landmarks\n* Non-English speaking\n* Use of Hearing Aids that preclude the use of ear acupuncture\n* Allergy to Ibuprofen'}, 'identificationModule': {'nctId': 'NCT01302769', 'briefTitle': 'Ear Acupuncture for Acute Sore Throat.', 'organization': {'class': 'FED', 'fullName': "Mike O'Callaghan Military Hospital"}, 'officialTitle': 'Ear Acupuncture for Acute Sore Throat. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'FWH20110008H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'battlefield auricular acupuncture', 'description': 'battlefield auricular acupuncture', 'interventionNames': ['Device: Standard treatment plus ear acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'placebo'}], 'interventions': [{'name': 'Standard treatment plus ear acupuncture', 'type': 'DEVICE', 'otherNames': ['Sedatelec ASP Original Gold needles'], 'description': 'Standard treatment plus ear acupuncture', 'armGroupLabels': ['battlefield auricular acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89191', 'city': 'Nellis Air Force Base', 'state': 'Nevada', 'country': 'United States', 'facility': "Mike O'Callaghan Federal Hosptial", 'geoPoint': {'lat': 36.24607, 'lon': -115.05721}}], 'overallOfficials': [{'name': 'David Moss, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Mike O'Callaghan Federal Hospital/Nellis Air Force Base"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not permitted to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Mike O'Callaghan Military Hospital", 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}