The Effects of Acupuncture for Major Trauma

Not Applicable

• Conditions: Major Trauma
• Interventions: Procedure: Electroacupuncture (EA); Procedure: Laser acupuncture (LA); Procedure: Sham laser acupuncture (SLA)

• Registration Number: NCT04970433
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-21
• Study Start: 2021-10-12
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31
• Primary Completion: 2024-05
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture (EA)	Electroacupuncture (EA)	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.
Laser acupuncture (LA)	Laser acupuncture (LA)	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.
Sham laser acupuncture (SLA)	Sham laser acupuncture (SLA)	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.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 24 weeks	Count the total days of hospitalization

Secondary Outcome Measures

Name	Time	Method
IL-10	measured at 48 hours, 7 days and 14 days	Inflammatory mediator, IL-10
Sequential organ failure assessment (SOFA) score	measured at 48 hours, 7 days and 14 days	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.
CRP	measured at 48 hours, 7 days and 14 days	Inflammatory mediator, CRP
IL-6	measured at 48 hours, 7 days and 14 days	Inflammatory mediator, IL-6
TNF-α	measured at 48 hours, 7 days and 14 days	Inflammatory mediator, TNF-α
IL-1β	measured at 48 hours, 7 days and 14 days	Inflammatory mediator, IL-1β
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version	measured at 3 and 6 months	WHODAS 2.0 is used to measure of disability after major trauma.
Peripheral Blood Mononuclear Cell (PBMC) analysis	measured at 48 hours, 7 days and 14 days	PBMC analysis by flow cytometry

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan