The Effects of Acupuncture for Major Trauma

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Major Trauma

Treatments: Procedure: Sham laser acupuncture (SLA); Procedure: Laser acupuncture (LA); Procedure: Electroacupuncture (EA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04970433

NMRPG8L6041

Details and patient eligibility

About

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.

Full description

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

Enrollment: 180 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

180 participants in 3 patient groups

Electroacupuncture (EA)

Experimental group

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.

Treatment:

Procedure: Electroacupuncture (EA)

Laser acupuncture (LA)

Active Comparator group

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.

Treatment:

Procedure: Laser acupuncture (LA)

Sham laser acupuncture (SLA)

Sham Comparator group

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.

Treatment:

Procedure: Sham laser acupuncture (SLA)