Acupuncture for Blunt Chest Trauma

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.

Study Overview

• Status: Completed
• Conditions: Chest Trauma; Rib Fractures
• Intervention / Treatment: Other: Press Tack Acupuncture; Other: Press Tack Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404472
    • Out-Patient Clinic of China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acupuncture with press tack needle group (Acu); 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.	Other: Press Tack Acupuncture; PYONEX Φ0.20×0.6 mm made by Seirin Corporation; Other Names: Press Tack Needle/ sticker needle/ PYONEX
PLACEBO_COMPARATOR: Placebo group (Con); 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.	Other: Press Tack Placebo; PYONEX placebo sticker made by Seirin Corporation; Other Names: PYONEX placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) - rest	pain scale form 1-10 when 10 is the most painful	3 months
Numerical Rating Scale (NRS) - mobile	pain scale form 1-10 when 10 is the most painful	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Pain Scale (VAS)	Pain scale form 1-10 when 10 is the most painful	4 days
Face Rating Scale (FRS)	Face expression pain scale. scores form 0-5 when 5 is the most painful	4 days
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	4 days
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	4 days
Chest plain film	Chest X-ray, will help examine the number of rib fractures, the incidence of hemothorax and pneumothorax	4 days
Pain killer or muscle relaxant medication does used	We will measure the amount of analgesic or muscle relaxant medication each patient used	4 days

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Peiyu Kao, M.D., China Medical University Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2020
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Acupuncture; Rib fracture; Blunt chest trauma; Press tack needle
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Rib Fractures
• Other Study ID Numbers: CMUH109-REC1-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No