AzTrials
AzTrials

Chest TraumaNCT04318496

Acupuncture for Blunt Chest Trauma

A study testing Press Tack Acupuncture in people with Chest Trauma and Rib Fractures, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Introduction: Chest blunt trauma accounts in up to 65% of polytrauma patients. In patients with 0-2 rib fracture, the treatment is relatively limited to oral pain killer and breathing exercise. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Chest Trauma, Rib Fractures
What is being tested?
Press Tack Acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteTaiwan
Study dates
23 Mar 2020to 30 Jun 2021
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 20-80 year-old
  • Patients have chest trauma described by themselves or medical chart record within one week
  • Injury Severity Score (ISS) is less than 18 points
  • Body Mass Index(BMI)<30

Who cannot join

  • Sternal fracture
  • Injury Severity Score (ISS) is equal or more than 18 points
  • History of intercostal nerve injury
  • History of cardiovascular disease
  • History of chronic lung disease
  • Significant lung mass or chest deformity noted in the chest plain film

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Out-Patient Clinic of China Medical University Hospital

    Taichung, 404472

Other trials in Taiwan

About this study

Official title: Acupuncture for Blunt Chest Trauma: A Protocol for a Double-Blind Randomized Control Trial

Introduction:

Chest blunt trauma accounts in up to 65% of polytrauma patients. In patients with 0-2 rib fracture, the treatment is relatively limited to oral pain killer and breathing exercise. The patients will suffer two weeks of severe pain accompanied with poor sleep and inability to preform simple daily live activities. In this double blind randomized control study, the investigators offer acupuncture as an additional treatment option.

Methods:

The study is a double blind randomized control trial. the study will include the press needle acupuncture (Acu) and placebo (Con) group. Both groups will receive one treatment, following the first visit to the clinic after chest trauma accident.

Read the detailed description

Introduction:

Chest blunt trauma accounts in up to 65% of polytrauma patients. In patients with 0-2 rib fracture, the treatment is relatively limited to oral pain killer and breathing exercise. The patients will suffer two weeks of severe pain accompanied with poor sleep and inability to preform simple daily live activities. In this double blind randomized control study, the investigators offer acupuncture as an additional treatment option.

Methods:

The study is a double blind randomized control trial. the study goal is to examine the effect of acupuncture on patients with chest trauma. the study will include totally 72 patients and divide them to two group; the press needle acupuncture (Acu) and placebo (Con) group. Both groups will receive one treatment, following the first visit to the clinic after chest trauma accident. Follow up time will be 3 months.

Expected outcome:

The results of this study can potentially provide a simple and cost effective provide analgesic solution to blunt chest trauma patients. The study design can serve as supporting evidence for future double blind studies in acupuncture.

Other information:

The study will be conducted in thoracic surgical department and acupuncture department in China medical university hospital, Taichung, Taiwan. The study is conducted on blunt chest injury patients and is anticipated to have minimum risk for adverse events. Enrollment of the patients and data collection will start after March 2020. The study expected completion time will be March 2022.

Keywords: blunt chest trauma, acupuncture, press tack needle, rib fracture

Being tested
Press Tack Acupuncture, Press Tack Placebo
Keywords
Blunt chest trauma, Acupuncture, Press tack needle, Rib fracture
Medical subject headings
Thoracic Injuries, Rib Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Press Tack AcupunctureOther

    Also called Press Tack Needle/ sticker needle/ PYONEX

    PYONEX Φ0.20×0.6 mm made by Seirin Corporation

  • Press Tack PlaceboOther

    Also called PYONEX placebo

    PYONEX placebo sticker made by Seirin Corporation

Study groups in NCT04318496
Study groupRoleWhat they receive
Acupuncture with press tack needle group (Acu)Experimentalthe press tack needles (PYONEX Φ0.20×0.6 mm made by Seirin Corporation) has a diameter of 0.2 mm and length of 0.6 mm will be used on the following bilateral points; GB 36 (Waiqiu), GB 34 (YangLingQuan), ST 36 (Zusanli), LI 4 (HeGu), LU 7 (LieQue), TH 5 (Waiguan) press tack needles retention time will be 4 days.
Receives: Other: Press Tack Acupuncture
Placebo group (Con)Placebo comparatorThe pess tack placebo is PYONEX sticker and pack that is identical to the press needle, except that the needle part was removed. The acupuncturist will apply the stickers on the following bilateral acupoints: GB 36 (Waiqiu), GB 34 (YangLingQuan), ST 36 (Zusanli), LI 4 (HeGu), LU 7 (LieQue), TH 5 (Waiguan) press tack stickers retention time will be 4 days.
Receives: Other: Press Tack Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numerical Rating Scale (NRS) - rest

    pain scale form 1-10 when 10 is the most painful

    Measured: 3 months

  2. Numerical Rating Scale (NRS) - mobile

    pain scale form 1-10 when 10 is the most painful

    Measured: 3 months

Secondary outcomes (6)

  1. Visual Analogue Pain Scale (VAS)

    Pain scale form 1-10 when 10 is the most painful

    Measured: 4 days

  2. Face Rating Scale (FRS)

    Face expression pain scale. scores form 0-5 when 5 is the most painful

    Measured: 4 days

  3. Flow meter

    Measure the amount of air the patient can exhale, It has three chambers with their own balls that requires air pressures from 600-1200 cc per second. 1200cc is the highest score and indicates good exhalation

    Measured: 4 days

  4. Verran and Snyder-Halpern sleep scale

    includes 15 question on the patients sleep quality, each question has a 100mm line. Patients will raking each question 0-100 when 100 means no existing insomnia

    Measured: 4 days

  5. Chest plain film

    Chest X-ray, will help examine the number of rib fractures, the incidence of hemothorax and pneumothorax

    Measured: 4 days

  6. Pain killer or muscle relaxant medication does used

    We will measure the amount of analgesic or muscle relaxant medication each patient used

    Measured: 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2020
  2. Study start23 Mar 2020
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

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
Model description
Double Blinded Randomized Control Trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04318496
Sponsor's protocol ID
CMUH109-REC1-002
Status last verified
Nov 2021
First submitted
20 Mar 2020
Last updated
17 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kao PY, Lottering B, Lu TY, Ho WC, Lin YS, Huang TM, Chen CK, Chen JX, Lee YC, Chen FP, Ben-Arie E. Press tack needle stimulation for blunt chest trauma: a randomized double-blind control trial. Interact Cardiovasc Thorac Surg. 2022 Jun 15;35(1):ivac158. doi: 10.1093/icvts/ivac158.

    PubMed 35670748

  • Kao PY, Ben-Arie E, Lu TY, Ho WC, Lee YC, Lin YS, Chen CK, Chen JX, Huang TM, Chen FP. Acupuncture for blunt chest trauma: A protocol for a double-blind randomized control trial. Medicine (Baltimore). 2021 May 7;100(18):e25667. doi: 10.1097/MD.0000000000025667.

    PubMed 33950945

Questions about this trial

What is this clinical trial studying?

A study testing Press Tack Acupuncture in people with Chest Trauma and Rib Fractures, run by China Medical University 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 17 Nov 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numerical Rating Scale (NRS) - rest (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04318496, which also lists 2 linked publications.

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 17 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in