The Effects of Acupuncture for Major Trauma

NCT ID: NCT04970433

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-12

Study Completion Date

2024-07-31

Brief Summary

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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

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

Conditions

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Major Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Electroacupuncture (EA)

Intervention Type PROCEDURE

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)

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.

Group Type ACTIVE_COMPARATOR

Laser acupuncture (LA)

Intervention Type PROCEDURE

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)

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.

Group Type SHAM_COMPARATOR

Sham laser acupuncture (SLA)

Intervention Type PROCEDURE

The laser device without any laser output applies on the acupoints the same as those in the LA group.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Sham laser acupuncture (SLA)

The laser device without any laser output applies on the acupoints the same as those in the LA group.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun-Ting Liu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chun-Ting Liu, Dr.

Role: CONTACT

0773171232334

Facility Contacts

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Chun-Ting Liu, MD

Role: primary

+886-7-7317123 ext. 2334

References

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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.

Reference Type DERIVED
PMID: 34967368 (View on PubMed)

Other Identifiers

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NMRPG8L6041

Identifier Type: -

Identifier Source: org_study_id

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