Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Pain severity is measured by VAS
研究概览
简要总结
To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema
详细描述
Sixty women diagnosed clinically by physician as post-mastectomy lymphedema, suffered from grade 2 and 3 lymphedema based on clinical investigations and their ages between 40 and 60 years were randomly assigned in single pre - post measurement study. They divided randomly into three groups of equal size (A, B & C). The three groups received CDT program, group (A) (n=20) received CDT only, group (B) (n=20) received cryotherapy and group (C) (n=20) received KT
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 40 to 60 years. They were grade 2 and 3 lymphedema. They had more than 2 cm difference at circumference measurement. They had unilateral arm lymphedema post-mastectomy. They had completed chemotherapy and radiotherapy.
排除标准
- •Skin infection. Current ischemia. Systemic edema due to impaired heart, kidney and liver function. Current metastases. Venous thrombosis.
研究组 & 干预措施
Group (C)
(n=20) received kinesio taping and complex decongestive therapy
干预措施: Kinesio taping (Other)
Group (A)
(n=20) received complex decongestive therapy only
干预措施: Complex decongestive therapy (Other)
Group (B)
(n=20) received cryotherapy and complex decongestive therapy
干预措施: Complex decongestive therapy (Other)
Group (B)
(n=20) received cryotherapy and complex decongestive therapy
干预措施: Cryotherapy (Device)
Group (C)
(n=20) received kinesio taping and complex decongestive therapy
干预措施: Complex decongestive therapy (Other)
结局指标
主要结局
Pain severity is measured by VAS
时间窗: 12 consecutive weeks
It consisted of a line, often 10 cm long (100 mm); its ends are generally labelled with verbal pain anchors (e.g., "no pain" and "pain as bad as it could be")
Arm girth measurement is measured by Circumferential measurements
时间窗: 12 consecutive weeks
It is a valid and reliable method, its protocol was used throughout, with measures performed on both arms at the axilla, halfway from the axilla to the cubital fossa, cubital fossa, halfway from the cubital fossa to the wrist, and at the wrist.
次要结局
- The QOL is measured by SF-36(12 consecutive weeks)
- Range of motion (ROM) is measured by UG(12 consecutive weeks)
研究者
Ragaee Saeed Mahmoud
Lecturer
National Cancer Institute (NCI)