Acupuncture for Blunt Chest Trauma

China Medical University

Status: Completed

Conditions: Chest Trauma; Rib Fractures

Treatments: Other: Press Tack Acupuncture; Other: Press Tack Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04318496

CMUH109-REC1-002

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Acupuncture with press tack needle group (Acu)

Experimental group

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.

Treatment:

Other: Press Tack Acupuncture

Placebo group (Con)

Placebo Comparator group

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.

Treatment:

Other: Press Tack Placebo