Chest Trauma, Rib Fractures
Conditions
Keywords
Blunt chest trauma, Acupuncture, Press tack needle, Rib fracture
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
Interventions
OTHERPress Tack Acupuncture
PYONEX Φ0.20×0.6 mm made by Seirin Corporation
OTHERPress Tack Placebo
PYONEX placebo sticker made by Seirin Corporation
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Intervention model description
Double Blinded Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) - rest | 3 months | pain scale form 1-10 when 10 is the most painful |
| Numerical Rating Scale (NRS) - mobile | 3 months | pain scale form 1-10 when 10 is the most painful |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow meter | 4 days | 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 | 4 days | 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 |
| Visual Analogue Pain Scale (VAS) | 4 days | Pain scale form 1-10 when 10 is the most painful |
| Pain killer or muscle relaxant medication does used | 4 days | We will measure the amount of analgesic or muscle relaxant medication each patient used |
| Chest plain film | 4 days | Chest X-ray, will help examine the number of rib fractures, the incidence of hemothorax and pneumothorax |
| Face Rating Scale (FRS) | 4 days | Face expression pain scale. scores form 0-5 when 5 is the most painful |
Countries
Taiwan
Outcome results
None listed