An interventional study of Electroacupuncture (EA) and Laser acupuncture (LA) in Major Trauma, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
The investigators design a prospective clinical trial to investigate the efficacy of acupuncture for major trauma.
Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 237 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Electroacupuncture (EA)
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.
Procedure: Laser acupuncture (LA)
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.
Procedure: Sham laser acupuncture (SLA)
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.
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.
The laser device without any laser output applies on the acupoints the same as those in the LA group.
Length of hospital stay
Count the total days of hospitalization
Time frame: up to 24 weeks
CRP
Inflammatory mediator, CRP
Time frame: measured at 48 hours, 7 days and 14 days
IL-6
Inflammatory mediator, IL-6
Time frame: measured at 48 hours, 7 days and 14 days
TNF-α
Inflammatory mediator, TNF-α
Time frame: measured at 48 hours, 7 days and 14 days
IL-1β
Inflammatory mediator, IL-1β
Time frame: measured at 48 hours, 7 days and 14 days
IL-10
Inflammatory mediator, IL-10
Time frame: measured at 48 hours, 7 days and 14 days
Sequential organ failure assessment (SOFA) score
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.
Time frame: measured at 48 hours, 7 days and 14 days
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version
WHODAS 2.0 is used to measure of disability after major trauma.
Time frame: measured at 3 and 6 months
Peripheral Blood Mononuclear Cell (PBMC) analysis
PBMC analysis by flow cytometry
Time frame: measured at 48 hours, 7 days and 14 days
Plan to share: No — For patient privacy and research confidentiality, temporarily not open.
Started Oct 2021 (actual). Primary completion is estimated for May 2024, 31 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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