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Acupuncture for Blunt Chest Trauma

Primary Purpose

Chest Trauma, Rib Fractures

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Press Tack Acupuncture
Press Tack Placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Trauma focused on measuring Blunt chest trauma, Acupuncture, Press tack needle, Rib fracture

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Out-Patient Clinic of China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupuncture with press tack needle group (Acu)

Placebo group (Con)

Arm Description

the 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.

The 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.

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS) - rest
pain scale form 1-10 when 10 is the most painful
Numerical Rating Scale (NRS) - mobile
pain scale form 1-10 when 10 is the most painful

Secondary Outcome Measures

Visual Analogue Pain Scale (VAS)
Pain scale form 1-10 when 10 is the most painful
Face Rating Scale (FRS)
Face expression pain scale. scores form 0-5 when 5 is the most painful
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
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
Chest plain film
Chest X-ray, will help examine the number of rib fractures, the incidence of hemothorax and pneumothorax
Pain killer or muscle relaxant medication does used
We will measure the amount of analgesic or muscle relaxant medication each patient used

Full Information

First Posted
March 20, 2020
Last Updated
November 15, 2021
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04318496
Brief Title
Acupuncture for Blunt Chest Trauma
Official Title
Acupuncture for Blunt Chest Trauma: A Protocol for a Double-Blind Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University 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
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Trauma, Rib Fractures
Keywords
Blunt chest trauma, Acupuncture, Press tack needle, Rib fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double Blinded Randomized Control Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study nurse 1 will be responsible to randomize and prepare the needles in the envelopes. Outside the envelopes, there will be a number belonged to one patient, and inside the envelopes, there will 14 separate sterile needle which can be either placebo or true press tack needles. The envelopes and the pouches of needle will look the same. The acupuncturist will be asked not to check the needles when they insert them. At the time of acupuncture, a nurse will accompany the acupuncturist and will verify that he is not examining the needles closely. Study nurse 2 will do the measurement. The acupuncturist, patients and study nurse 2 will be blinded.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture with press tack needle group (Acu)
Arm Type
Experimental
Arm Description
the 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.
Arm Title
Placebo group (Con)
Arm Type
Placebo Comparator
Arm Description
The 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.
Intervention Type
Other
Intervention Name(s)
Press Tack Acupuncture
Other Intervention Name(s)
Press Tack Needle/ sticker needle/ PYONEX
Intervention Description
PYONEX Φ0.20×0.6 mm made by Seirin Corporation
Intervention Type
Other
Intervention Name(s)
Press Tack Placebo
Other Intervention Name(s)
PYONEX placebo
Intervention Description
PYONEX placebo sticker made by Seirin Corporation
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) - rest
Description
pain scale form 1-10 when 10 is the most painful
Time Frame
3 months
Title
Numerical Rating Scale (NRS) - mobile
Description
pain scale form 1-10 when 10 is the most painful
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual Analogue Pain Scale (VAS)
Description
Pain scale form 1-10 when 10 is the most painful
Time Frame
4 days
Title
Face Rating Scale (FRS)
Description
Face expression pain scale. scores form 0-5 when 5 is the most painful
Time Frame
4 days
Title
Flow meter
Description
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
Time Frame
4 days
Title
Verran and Snyder-Halpern sleep scale
Description
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
Time Frame
4 days
Title
Chest plain film
Description
Chest X-ray, will help examine the number of rib fractures, the incidence of hemothorax and pneumothorax
Time Frame
4 days
Title
Pain killer or muscle relaxant medication does used
Description
We will measure the amount of analgesic or muscle relaxant medication each patient used
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peiyu Kao, M.D.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Out-Patient Clinic of China Medical University Hospital
City
Taichung
ZIP/Postal Code
404472
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35670748
Citation
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.
Results Reference
derived
PubMed Identifier
33950945
Citation
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.
Results Reference
derived

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Acupuncture for Blunt Chest Trauma

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