The Effects of Acupuncture for Major Trauma

March 15, 2022 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Procedure: 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 Comparator: 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.
Procedure: Sham laser acupuncture (SLA)
The laser device without any laser output applies on the acupoints the same as those in the LA group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: up to 24 weeks
Count the total days of hospitalization
up to 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chun-Ting Liu, Dr., Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRPG8L6041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

For patient privacy and research confidentiality, temporarily not open.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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