Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Shoulder Tightness Score on Pain and Discomfort Assessment Questionnaire
研究概览
简要总结
The primary purpose of this study is to evaluate changes in shoulder tightness, chest tightness, and general pain related to post-mastectomy reconstructive surgery with tissue expansion in women who are randomized to receive acupuncture treatment immediately after surgery (twice a week for 6 weeks) compared to those who are randomized to no acupuncture treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are newly diagnosed with breast cancer, enrolled in the The Breast Cancer Database of NYU Cancer Center (BCD) and who are having breast cancer surgery involving a mastectomy procedure with insertion of a tissue expander for reconstructive purposes
- •Women who are newly diagnosed with breast cancer
- •Women who are enrolled in the Breast Cancer Database (BCD)
- •Women who are having breast cancer surgery involving a mastectomy procedure with insertion of a tissue expander for reconstructive purposes
排除标准
- •Women who had neoadjuvant chemotherapy and/or radiation therapy, women who are currently on anticoagulant therapy, women who are having breast reconstruction with Alloderm, women who have chronic pre-operative pain, and/or women who have had a history of previous implants or prior augmentations
- •Women who had neoadjuvant chemotherapy and/or radiation therapy
- •Women who are currently on anticoagulant therapy
- •Women who are having breast reconstruction with Alloderm
- •Women who have chronic pre-operative pain
- •Women who have had a history of previous implants or prior augmentations
- •Women who are currently on anticoagulant therapy
- •Women who are having breast reconstruction with Alloderm
- •Women who have chronic pre-operative pain
- •Women who have had a history of previous implants or prior augmentations
研究组 & 干预措施
Immediate Post Operative Acupuncture Treatment
干预措施: Immediate Post Operative Acupuncture Treatment (Other)
Acupuncture Treatment After 6 Weeks of Recovery
干预措施: No Acupuncture Treatment (Other)
结局指标
主要结局
Shoulder Tightness Score on Pain and Discomfort Assessment Questionnaire
时间窗: 6 Weeks
Chest Tightness Score on Pain and Discomfort Assessment Questionnaire
时间窗: 6 Weeks
General Pain Score on Pain and Discomfort Assessment Questionnaire
时间窗: 6 Weeks
次要结局
未报告次要终点