Acupuncture for Blunt Chest Trauma

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Chest Trauma, Rib Fractures

Intervention / Treatment
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* Other: Press Tack Acupuncture
* Other: Press Tack Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blinded Randomized Control Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture with press tack needle group (Acu)<br>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<br>* PYONEX Φ0.20×0.6 mm made by Seirin Corporation<br>* Other names: Press Tack Needle/ sticker needle/ PYONEX;|
| Placebo Comparator: Placebo group (Con)<br>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<br>* PYONEX placebo sticker made by Seirin Corporation<br>* Other names: PYONEX placebo;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rib fracture, Blunt chest trauma, Acupuncture, Press tack needle