The PhysioTouch, A Novel Treatment for Radiation Fibrosis Syndrome in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in self-reported pain
研究概览
简要总结
A quarter of a million women will develop breast cancer (BC) in this year alone. Many of these women will have side effects as a result of their breast cancer treatment. Radiation Fibrosis Syndrome (RFS) is a common complication from breast cancer treatment that progressively changes tissue and can cause decreased function, pain, and range of motion. The PhysioTouch is a hand held device that can be used to treat RFS and may improve the treatment of fibrotic tissue. This pilot randomized controlled trial aims to determine the efficacy of using the PhysioTouch in addition to current standard of care for treatment of BC-related RFS.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of radiation therapy for breast cancer
- •Clinical or suspected RFS
- •Reported functional impairments
排除标准
- •Metastatic disease of soft tissue
- •History of bilateral radiation therapy
- •Previously diagnosed shoulder impairments not related to RFS
- •Prior treatment with PhysioTouch
- •Current or recent pregnancy
- •Current breastfeeding
- •Other contraindications to safe and meaningful participation at discretion of study team
研究组 & 干预措施
PhysioTouch
干预措施: PhysioTouch (Behavioral)
Standard OT
干预措施: Standard OT (Behavioral)
结局指标
主要结局
Change in self-reported pain
时间窗: Baseline to 12 weeks
Self-reported upper extremity pain as measured by the BPI
Change in self-reported upper extremity function
时间窗: Baseline to 12 weeks
Self-reported upper extremity function as measured by QuickDash
次要结局
- Change in affected shoulder abduction(Baseline to 12 weeks)
- Change in affected shoulder flexion(Baseline to 12 weeks)
研究者
Katie Rogers
Occupational Therapist
University of Michigan