Clinical trial NCT04318496: Acupuncture for Blunt Chest Trauma
Official title: Acupuncture for Blunt Chest Trauma: A Protocol for a Double-Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Trauma
Rib Fractures
Keywords: Blunt chest trauma
Acupuncture
Press tack needle
Rib fracture
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blinded Randomized Control Trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Numerical Rating Scale (NRS) - rest
timeFrame: 3 months
measure: Numerical Rating Scale (NRS) - mobile
timeFrame: 3 months
Secondary outcomes:
measure: Visual Analogue Pain Scale (VAS)
timeFrame: 4 days
measure: Face Rating Scale (FRS)
timeFrame: 4 days
measure: Flow meter
timeFrame: 4 days
measure: Verran and Snyder-Halpern sleep scale
timeFrame: 4 days
measure: Chest plain film
timeFrame: 4 days
measure: Pain killer or muscle relaxant medication does used
timeFrame: 4 days
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Out-Patient Clinic of China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Peiyu Kao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.