Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
72 participants
INTERVENTIONAL
2020-03-23
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acupuncture with press tack needle group (Acu)
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.
Press Tack Acupuncture
PYONEX Φ0.20×0.6 mm made by Seirin Corporation
Placebo group (Con)
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.
Press Tack Placebo
PYONEX placebo sticker made by Seirin Corporation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Press Tack Acupuncture
PYONEX Φ0.20×0.6 mm made by Seirin Corporation
Press Tack Placebo
PYONEX placebo sticker made by Seirin Corporation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
China Medical University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peiyu Kao
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peiyu Kao, M.D.
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Out-Patient Clinic of China Medical University Hospital
Taichung, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CMUH109-REC1-002
Identifier Type: -
Identifier Source: org_study_id