search
Back to results

The Effects of Acupuncture for Major Trauma

Primary Purpose

Major Trauma

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Electroacupuncture (EA)
Laser acupuncture (LA)
Sham laser acupuncture (SLA)
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Trauma focused on measuring major trauma, acupuncture, laser acupuncture

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Electroacupuncture (EA)

Laser acupuncture (LA)

Sham laser acupuncture (SLA)

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Length of hospital stay
Count the total days of hospitalization

Secondary Outcome Measures

CRP
Inflammatory mediator, CRP
IL-6
Inflammatory mediator, IL-6
TNF-α
Inflammatory mediator, TNF-α
IL-1β
Inflammatory mediator, IL-1β
IL-10
Inflammatory mediator, IL-10
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.
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version
WHODAS 2.0 is used to measure of disability after major trauma.
Peripheral Blood Mononuclear Cell (PBMC) analysis
PBMC analysis by flow cytometry

Full Information

First Posted
July 12, 2021
Last Updated
March 15, 2022
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04970433
Brief Title
The Effects of Acupuncture for Major Trauma
Official Title
The Effects of Electroacupuncture and Laser Acupuncture Therapy for Patients With Major Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Trauma
Keywords
major trauma, acupuncture, laser acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture (EA)
Arm Type
Experimental
Arm 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.
Arm Title
Laser acupuncture (LA)
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham laser acupuncture (SLA)
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture (EA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laser acupuncture (LA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham laser acupuncture (SLA)
Intervention Description
The laser device without any laser output applies on the acupoints the same as those in the LA group.
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Count the total days of hospitalization
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
CRP
Description
Inflammatory mediator, CRP
Time Frame
measured at 48 hours, 7 days and 14 days
Title
IL-6
Description
Inflammatory mediator, IL-6
Time Frame
measured at 48 hours, 7 days and 14 days
Title
TNF-α
Description
Inflammatory mediator, TNF-α
Time Frame
measured at 48 hours, 7 days and 14 days
Title
IL-1β
Description
Inflammatory mediator, IL-1β
Time Frame
measured at 48 hours, 7 days and 14 days
Title
IL-10
Description
Inflammatory mediator, IL-10
Time Frame
measured at 48 hours, 7 days and 14 days
Title
Sequential organ failure assessment (SOFA) score
Description
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
Title
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version
Description
WHODAS 2.0 is used to measure of disability after major trauma.
Time Frame
measured at 3 and 6 months
Title
Peripheral Blood Mononuclear Cell (PBMC) analysis
Description
PBMC analysis by flow cytometry
Time Frame
measured at 48 hours, 7 days and 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Ting Liu, Dr.
Phone
0773171232334
Email
juntin0214@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu, Dr.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu, MD
Phone
+886-7-7317123
Ext
2334
Email
juntin0214@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
For patient privacy and research confidentiality, temporarily not open.
Citations:
PubMed Identifier
34967368
Citation
Liu CT, Hsieh TM, Shih FY, Lai WH, Hsieh CH, Wu BY, Chen YH. The effects of electroacupuncture and laser acupuncture therapy for patients with major trauma: A study protocol. Medicine (Baltimore). 2021 Dec 30;100(52):e28367. doi: 10.1097/MD.0000000000028367.
Results Reference
derived

Learn more about this trial

The Effects of Acupuncture for Major Trauma

We'll reach out to this number within 24 hrs