Major Trauma
Conditions
Keywords
major trauma, acupuncture, laser acupuncture
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.
Interventions
PROCEDUREElectroacupuncture (EA)
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.
PROCEDURELaser acupuncture (LA)
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.
PROCEDURESham laser acupuncture (SLA)
The laser device without any laser output applies on the acupoints the same as those in the LA group.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | up to 24 weeks | Count the total days of hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| CRP | measured at 48 hours, 7 days and 14 days | Inflammatory mediator, CRP |
| 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. |
| 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 |
| IL-10 | measured at 48 hours, 7 days and 14 days | Inflammatory mediator, IL-10 |
Countries
Taiwan
Contacts
Primary ContactChun-Ting Liu, Dr.
Outcome results
None listed