Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT04970433
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2021-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Acupuncture for Major Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-20', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'up to 24 weeks', 'description': 'Count the total days of hospitalization'}], 'secondaryOutcomes': [{'measure': 'CRP', 'timeFrame': 'measured at 48 hours, 7 days and 14 days', 'description': 'Inflammatory mediator, CRP'}, {'measure': 'IL-6', 'timeFrame': 'measured at 48 hours, 7 days and 14 days', 'description': 'Inflammatory mediator, IL-6'}, {'measure': 'TNF-α', 'timeFrame': 'measured at 48 hours, 7 days and 14 days', 'description': 'Inflammatory mediator, TNF-α'}, {'measure': 'IL-1β', 'timeFrame': 'measured at 48 hours, 7 days and 14 days', 'description': 'Inflammatory mediator, IL-1β'}, {'measure': 'IL-10', 'timeFrame': 'measured at 48 hours, 7 days and 14 days', 'description': 'Inflammatory mediator, IL-10'}, {'measure': 'Sequential organ failure assessment (SOFA) score', 'timeFrame': 'measured at 48 hours, 7 days and 14 days', 'description': 'The SOFA score is a simple and objective score that allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic), and the score can measure individual or aggregate organ dysfunction.The SOFA score ranges from 0 to 24; higher scores mean a worse outcome.'}, {'measure': 'WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version', 'timeFrame': 'measured at 3 and 6 months', 'description': 'WHODAS 2.0 is used to measure of disability after major trauma.'}, {'measure': 'Peripheral Blood Mononuclear Cell (PBMC) analysis', 'timeFrame': 'measured at 48 hours, 7 days and 14 days', 'description': 'PBMC analysis by flow cytometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['major trauma', 'acupuncture', 'laser acupuncture'], 'conditions': ['Major Trauma']}, 'referencesModule': {'references': [{'pmid': '34967368', 'type': 'DERIVED', 'citation': 'Liu CT, Hsieh TM, Shih FY, Lai WH, Hsieh CH, Wu BY, Chen YH. The effects of electroacupuncture and laser acupuncture therapy for patients with major trauma: A study protocol. Medicine (Baltimore). 2021 Dec 30;100(52):e28367. doi: 10.1097/MD.0000000000028367.'}]}, 'descriptionModule': {'briefSummary': 'Major trauma is a significant cause for morbidity and mortality in the world. After traumatic injury, the damage tissue could induce systemic inflammatory response (SIRS) and activate autonomic nervous system in response to stress, followed by compensatory anti-inflammatory response (CARS). Imbalance of SIRS and CARS may lead to organ failures, sepsis and death.', 'detailedDescription': 'The investigators design a prospective clinical trial to investigate the efficacy of acupuncture for major trauma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 20 years or older\n* Confirmed diagnosis of major trauma with ISS ≥ 16\n\nExclusion Criteria:\n\n* Pregnancy\n* Malignancy\n* Pacemaker\n* Status epilepticus\n* Severe medical disease\n* Life threatening\n* Prior history of drug or alcohol dependence\n* Immunodeficiency\n* Vagotomy'}, 'identificationModule': {'nctId': 'NCT04970433', 'briefTitle': 'The Effects of Acupuncture for Major Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Effects of Electroacupuncture and Laser Acupuncture Therapy for Patients With Major Trauma', 'orgStudyIdInfo': {'id': 'NMRPG8L6041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electroacupuncture (EA)', 'description': 'Acupoint regimen: Hegu (LI4), Neiguan (PC6), Zusanli (ST36), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electrical stimulation using an EA apparatus, with a pair of electrodes connecting acupoints LI4 with PC6, and another pair of electrodes connecting ST36 with SP6. EA stimulation will last for 15 min with a continuous wave of 2 Hz and a current intensity of 0.1-1 mA.', 'interventionNames': ['Procedure: Electroacupuncture (EA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laser acupuncture (LA)', 'description': 'Participants allocated to the LA group will receive LA therapy at the same acupoints used in EA group. The laser will be applied to each point for 40 seconds, which delivered 3 J of energy at each of the acupoints.', 'interventionNames': ['Procedure: Laser acupuncture (LA)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham laser acupuncture (SLA)', 'description': 'Participants in the control group will receive sham LA treatment without any laser output. The acupuncture points, application duration, and total number of treatments are the same as those in the LA group.', 'interventionNames': ['Procedure: Sham laser acupuncture (SLA)']}], 'interventions': [{'name': 'Electroacupuncture (EA)', 'type': 'PROCEDURE', 'description': 'Acupuncture at Hegu (LI4), Neiguan (PC6), Zusanli (ST36), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electrical stimulation with a pair of electrodes connecting on LI4/PC6 and ST36/SP6.', 'armGroupLabels': ['Electroacupuncture (EA)']}, {'name': 'Laser acupuncture (LA)', 'type': 'PROCEDURE', 'description': 'The laser applies to each point for 40 seconds, which delivers 3 J of energy at each of the acupoints as those in electroacupuncture group.', 'armGroupLabels': ['Laser acupuncture (LA)']}, {'name': 'Sham laser acupuncture (SLA)', 'type': 'PROCEDURE', 'description': 'The laser device without any laser output applies on the acupoints the same as those in the LA group.', 'armGroupLabels': ['Sham laser acupuncture (SLA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chun-Ting Liu, MD', 'role': 'CONTACT', 'email': 'juntin0214@gmail.com', 'phone': '+886-7-7317123', 'phoneExt': '2334'}], 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Chun-Ting Liu, Dr.', 'role': 'CONTACT', 'email': 'juntin0214@gmail.com', 'phone': '0773171232334'}], 'overallOfficials': [{'name': 'Chun-Ting Liu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'For patient privacy and research confidentiality, temporarily not open.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}