Acupuncture Efficacy in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease During Hospitalization: a Randomized Controlled 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
- Dyspnea Intensity
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a major health problem. Acute exacerbations are a health-care burden involving frequent hospitalizations and elevated costs. They have effective therapies with significant side effects. Acupuncture has been shown to reduce dyspnea and other COPD-related symptoms. The investigators will compare the efficacy and safety of the addition of true acupuncture to usual care with both sham-acupressure added to usual care and usual care only for the treatment of acute exacerbations of COPD among inpatients.
详细描述
This is an assessor-blinded randomized controlled trial in the setting of a tertiary academic medical center in Israel. Patients with clinical diagnosis of acute exacerbation of COPD will be randomized to either usual care only, usual care with true acupuncture or usual care with sham-acupressure. The primary outcome will be clinical improvement of dyspnea as measured by mBorg scale. Secondary outcomes included improvement of other patient-reported outcomes and physiologic features, as well as duration of hospitalization and treatment failure. Acupuncture-related side effects will be evaluated by the validated Acupuncture Adverse Events (AcupAE) questionnaire.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous diagnosis of COPD
- •Clinical diagnosis of acute exacerbation of COPD
- •Informed consent
排除标准
- •Hemodynamic instability
- •Platelet count < 20 x 10^9/L
- •Expected respiratory deterioration requiring mechanical ventilation in the next 24 hours
结局指标
主要结局
Dyspnea Intensity
时间窗: At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment
modified Borg (mBorg) scale, which is a validated scale that has been used to evaluate the degree of dyspnea (0- no dyspnea, to 10- worse dyspnea)
次要结局
- Duration of Hospitalization(Through study completion, an average of 1 week)
- Respiratory Rate(At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment)
- Power of Hydrogen (pH)(Day 1, day 2, day 3, and day 4 of the study)
- Cough Intensity(Day 1, day 2, day 3, and day 4 of the study)
- Sputum Intensity(Day 1, day 2, day 3, and day 4 of the study)
- Oxygen Saturation(Day 1, day 2, day 3, and day 4 of the study)
- Carbon Dioxide Partial Pressure (pCO2)(Day 1, day 2, day 3, and day 4 of the study)