Acupuncture for Blunt Chest Trauma: A Protocol for a Double-Blind Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale (NRS) - rest
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Numerical Rating Scale (NRS) - rest
时间窗: 3 months
pain scale form 1-10 when 10 is the most painful
Numerical Rating Scale (NRS) - mobile
时间窗: 3 months
pain scale form 1-10 when 10 is the most painful
次要结局
- Face Rating Scale (FRS)(4 days)
- Visual Analogue Pain Scale (VAS)(4 days)
- Flow meter(4 days)
- Verran and Snyder-Halpern sleep scale(4 days)
- Chest plain film(4 days)
- Pain killer or muscle relaxant medication does used(4 days)
研究者
Peiyu Kao
Principal Investigator
China Medical University Hospital