The Effects of Acupuncture for Major Trauma

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigators design a prospective clinical trial to investigate the efficacy of acupuncture for major trauma.

Official Title
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The Effects of Electroacupuncture and Laser Acupuncture Therapy for Patients With Major Trauma

Conditions
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Major Trauma

Intervention / Treatment
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* Procedure: Electroacupuncture (EA)
* Procedure: Laser acupuncture (LA)
* Procedure: Sham laser acupuncture (SLA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 20 years or older Confirmed diagnosis of major trauma with ISS ≥ 16 Exclusion Criteria: Pregnancy Malignancy Pacemaker Status epilepticus Severe medical disease Life threatening Prior history of drug or alcohol dependence Immunodeficiency Vagotomy

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture (EA)<br>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)<br>* 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.<br>|
| Active Comparator: Laser acupuncture (LA)<br>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)<br>* 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.<br>|
| Sham Comparator: Sham laser acupuncture (SLA)<br>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)<br>* The laser device without any laser output applies on the acupoints the same as those in the LA group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Count the total days of hospitalization | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP | Inflammatory mediator, CRP | measured at 48 hours, 7 days and 14 days | 
| IL-6 | Inflammatory mediator, IL-6 | measured at 48 hours, 7 days and 14 days | 
| TNF-α | Inflammatory mediator, TNF-α | measured at 48 hours, 7 days and 14 days | 
| IL-1β | Inflammatory mediator, IL-1β | measured at 48 hours, 7 days and 14 days | 
| IL-10 | Inflammatory mediator, IL-10 | 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. | 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. | measured at 3 and 6 months | 
| Peripheral Blood Mononuclear Cell (PBMC) analysis | PBMC analysis by flow cytometry | measured at 48 hours, 7 days and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major trauma, acupuncture, laser acupuncture