A Randomized, Intent to Treat, Controlled Study of the Efficacy of Verum Acupuncture Compared to Sham Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Subjects That Have Undergone Axillary Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine the difference in pain and range of motion
研究概览
简要总结
This study is for the woman who will have axillary (armpit) surgery as part of their breast cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to control pain and improve range of motion (arm movement). Another goal is to find out if women have an improvement in their quality of life. This study is being done in collaboration with the Oregon College of Oriental Medicine (OCOM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects
- •Expected survival at least 6 months or greater
- •Has had surgery with axillary dissection
- •Greater than 6 nodes removed during surgery
- •Greater than 21 years of age
排除标准
- •Previous mastectomy
- •Double mastectomy at the time of current axillary surgery
- •Any diagnoses of autoimmune disease
- •Pregnant or lactating women
- •Unable to provide written informed consent
- •Suspected or diagnosed fibromyalgia
- •Previous shoulder injuries for the specific arm that will undergo axillary dissection
- •Known or suspected drug or alcohol abuse as determined by the investigator
- •Decreased range of motion (ROM) as evidenced on standard preoperative exam
- •Previous acupuncture (lifetime)
研究组 & 干预措施
Acupuncture
干预措施: Acupuncture (Procedure)
Sham Acupuncture
干预措施: Sham Acupuncture (Procedure)
Standard of Care
干预措施: Patient to receive standard care without Acupuncture or Sham Acupuncture. (Other)
结局指标
主要结局
Determine the difference in pain and range of motion
时间窗: 3 months after surgery
Determine the difference in function
时间窗: 3 months after surgery
Determine the difference in quality of life
时间窗: 3 months after surgery
次要结局
未报告次要终点