Compression Bandages in Upper Limb Lymphedema After Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in arm volume
研究概览
简要总结
Despite different types of bandages are using in the lymphedema treatment, numerous of them have not been directly compared. The aim of this study is to compare the efficacy of five different kinds of bandages on limb volume and lymphedema-related symptoms. It was also measured as secondary variables the comfort of the bandage related by the participants and the directly cost of each kind of bandage during the treatment.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women after breast cancer surgery undergoing upper limb lymphedema not previously treated
- •Having more than two centimeters between two adjacent measurements between the lymphedematous and the contralateral upper limb
- •The presence of heaviness, tension or fovea in the affected limb
- •More than six months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema
排除标准
- •Bilateral breast cancer surgery
- •Only hand lymphedema
- •Active cutaneous infection
- •A loco-regional cancer recurrence
- •The impossibility of complete all the physical therapy sessions
- •A primary lymphedema
- •Women with lymphedema symptoms like thickness and heaviness in the upper limb but without a difference of two centimeters in two adjacent points
- •Any contraindication to physiotherapy
结局指标
主要结局
Change in arm volume
时间窗: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
To assess the volume of the limb it will be used the circumference measurement. The assessment will be with the subject in upright position with the arm placed on a table, the forearm relaxed on the table, the shoulder in a neutral rotation, a flexion of 45º of the elbow, and forearms in supine position. The reference will be the elbow fold where was measure the circumference of the limb in 5cm intervals. The circumference measurements will be converted into volume values with the truncated cone formula in each 5 centimeters long.
Change in heath related quality of life lymphedema
时间窗: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version
次要结局
- Change in comfort of the bandage(3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention)
研究者
Maria Torres Lacomba
Professor
University of Alcala