The Effects of Acupuncture for Major Trauma

Major Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970433
• Other study ID #: NMRPG8L6041
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: July 2024

Study information

• Verified date: July 2021
• Source: Chang Gung Memorial Hospital
• Contact: Chun-Ting Liu, Dr.
• Phone: 0773171232334
• Email: juntin0214[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Major Trauma
• Wounds and Injuries

Intervention

Procedure:
• Electroacupuncture (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.
• Laser 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.
• Sham laser acupuncture (SLA)
The laser device without any laser output applies on the acupoints the same as those in the LA group.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	Count the total days of hospitalization	up to 24 weeks
Secondary	CRP	Inflammatory mediator, CRP	measured at 48 hours, 7 days and 14 days
Secondary	IL-6	Inflammatory mediator, IL-6	measured at 48 hours, 7 days and 14 days
Secondary	TNF-a	Inflammatory mediator, TNF-a	measured at 48 hours, 7 days and 14 days
Secondary	IL-1ß	Inflammatory mediator, IL-1ß	measured at 48 hours, 7 days and 14 days
Secondary	IL-10	Inflammatory mediator, IL-10	measured at 48 hours, 7 days and 14 days
Secondary	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
Secondary	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
Secondary	Peripheral Blood Mononuclear Cell (PBMC) analysis	PBMC analysis by flow cytometry	measured at 48 hours, 7 days and 14 days