Acupuncture for Blunt Chest Trauma

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318496
• Other study ID #: CMUH109-REC1-002
• Status: Completed
• Phase: N/A
• Start date: March 23, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2021
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Trauma
• Rib Fractures
• Thoracic Injuries
• Wounds and Injuries

Intervention

Other:
• Press Tack Acupuncture
PYONEX F0.20×0.6 mm made by Seirin Corporation
• Press Tack Placebo
PYONEX placebo sticker made by Seirin Corporation

Locations

Country	Name	City	State
Taiwan	Out-Patient Clinic of China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS) - rest	pain scale form 1-10 when 10 is the most painful	3 months
Primary	Numerical Rating Scale (NRS) - mobile	pain scale form 1-10 when 10 is the most painful	3 months
Secondary	Visual Analogue Pain Scale (VAS)	Pain scale form 1-10 when 10 is the most painful	4 days
Secondary	Face Rating Scale (FRS)	Face expression pain scale. scores form 0-5 when 5 is the most painful	4 days
Secondary	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
Secondary	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
Secondary	Chest plain film	Chest X-ray, will help examine the number of rib fractures, the incidence of hemothorax and pneumothorax	4 days
Secondary	Pain killer or muscle relaxant medication does used	We will measure the amount of analgesic or muscle relaxant medication each patient used	4 days