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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
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.
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGLength 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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