Major TraumaNCT04970433
The Effects of Acupuncture for Major Trauma
A study testing Electroacupuncture (EA) and Laser acupuncture (LA) in people with Major Trauma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Major Trauma
- What is being tested?
- Electroacupuncture (EA) and Laser acupuncture (LA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Oct 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 20 years or older
- Confirmed diagnosis of major trauma with ISS ≥ 16
Who cannot join
- Pregnancy
- Malignancy
- Pacemaker
- Status epilepticus
- Severe medical disease
- Life threatening
Show all 9Show fewer
- Prior history of drug or alcohol dependence
- Immunodeficiency
- Vagotomy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Chun-Ting Liu, MD, +886-7-7317123 ext. 2334, juntin0214@gmail.com
About this study
Official title: 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.
Read the detailed description
The investigators design a prospective clinical trial to investigate the efficacy of acupuncture for major trauma.
- Conditions
- Major Trauma
- Being tested
- Electroacupuncture (EA), Laser acupuncture (LA), Sham laser acupuncture (SLA)
- Keywords
- major trauma, acupuncture, laser acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture (EA)Procedure or surgery
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)Procedure or surgery
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)Procedure or surgery
The laser device without any laser output applies on the acupoints the same as those in the LA group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Sham laser acupuncture (SLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Count the total days of hospitalization
Measured: up to 24 weeks
Secondary outcomes (8)
CRP
Inflammatory mediator, CRP
Measured: measured at 48 hours, 7 days and 14 days
IL-6
Inflammatory mediator, IL-6
Measured: measured at 48 hours, 7 days and 14 days
TNF-α
Inflammatory mediator, TNF-α
Measured: measured at 48 hours, 7 days and 14 days
IL-1β
Inflammatory mediator, IL-1β
Measured: measured at 48 hours, 7 days and 14 days
IL-10
Inflammatory mediator, IL-10
Measured: measured at 48 hours, 7 days and 14 days
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: measured at 48 hours, 7 days and 14 days
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: measured at 3 and 6 months
Peripheral Blood Mononuclear Cell (PBMC) analysis
PBMC analysis by flow cytometry
Measured: measured at 48 hours, 7 days and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start12 Oct 2021
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major TraumaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Ting Liu, Dr., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970433
- Sponsor's protocol ID
- NMRPG8L6041
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For patient privacy and research confidentiality, temporarily not open.
Publications
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.
PubMed 34967368
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Electroacupuncture and Laser Acupuncture Therapy for Patients With Major Trauma
- ClinicalTrials.gov ID
- NCT04970433
- Acronym / sponsor ID
- NMRPG8L6041
- Conditions
- Major Trauma
- Keywords
- major trauma, acupuncture, laser acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) | Experimental | Procedure: 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. |
| Laser acupuncture (LA) | Active comparator | Procedure: 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. |
| Sham laser acupuncture (SLA) | Sham comparator | Procedure: 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 20 years or older
- Confirmed diagnosis of major trauma with ISS ≥ 16
Key exclusion criteria (9 listed)
- Pregnancy
- Malignancy
- Pacemaker
- Status epilepticus
- Severe medical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Electroacupuncture (EA) |
| 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. | Procedure or surgery | Laser acupuncture (LA) |
| Sham laser acupuncture (SLA)The laser device without any laser output applies on the acupoints the same as those in the LA group. | Procedure or surgery | Sham laser acupuncture (SLA) |
Primary outcome
Length of hospital stay
Time frame: up to 24 weeks
Count the total days of hospitalization
8 secondary outcomes
CRP
Time frame: measured at 48 hours, 7 days and 14 days
IL-6
Time frame: measured at 48 hours, 7 days and 14 days
TNF-α
Time frame: measured at 48 hours, 7 days and 14 days
IL-1β
Time frame: measured at 48 hours, 7 days and 14 days
IL-10
Time frame: 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
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version
Time frame: measured at 3 and 6 months
Peripheral Blood Mononuclear Cell (PBMC) analysis
Time frame: measured at 48 hours, 7 days and 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 34967368Liu 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.
- Individual participant dataSharing planned: No. For patient privacy and research confidentiality, temporarily not open.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Ting Liu, Dr. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture (EA) and Laser acupuncture (LA) in people with Major Trauma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Ting Liu, Dr. (0773171232334, juntin0214@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04970433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.