NCT04970433

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 12, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 31, 2022

Status Verified

July 1, 2021

Enrollment Period

2.6 years

First QC Date

July 12, 2021

Last Update Submit

March 15, 2022

Conditions

Major Trauma

Keywords

major traumaacupuncturelaser acupuncture

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Count the total days of hospitalization

    up to 24 weeks

Secondary Outcomes (8)

  • CRP

    measured at 48 hours, 7 days and 14 days

  • IL-6

    measured at 48 hours, 7 days and 14 days

  • TNF-α

    measured at 48 hours, 7 days and 14 days

  • IL-1β

    measured at 48 hours, 7 days and 14 days

  • IL-10

    measured at 48 hours, 7 days and 14 days

  • +3 more secondary outcomes

Study Arms (3)

Electroacupuncture (EA)

EXPERIMENTAL

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)

Laser acupuncture (LA)

ACTIVE COMPARATOR

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)

Sham laser acupuncture (SLA)

SHAM COMPARATOR

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)

Interventions

Electroacupuncture (EA)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.

Electroacupuncture (EA)
Laser acupuncture (LA)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.

Laser acupuncture (LA)
Sham laser acupuncture (SLA)PROCEDURE

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

Sham laser acupuncture (SLA)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 20 years or older
  • Confirmed diagnosis of major trauma with ISS ≥ 16

You may not qualify if:

  • Pregnancy
  • Malignancy
  • Pacemaker
  • Status epilepticus
  • Severe medical disease
  • Life threatening
  • Prior history of drug or alcohol dependence
  • Immunodeficiency
  • Vagotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34967368DERIVED

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Chun-Ting Liu, Dr.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Ting Liu, Dr.

CONTACT

0773171232334juntin0214@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 21, 2021

Study Start

October 12, 2021

Primary Completion

May 1, 2024

Study Completion

July 1, 2024

Last Updated

March 31, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

For patient privacy and research confidentiality, temporarily not open.

Locations

TW(1)