Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Limb volume measurement
研究概览
简要总结
Statement of the problem:
The problem will be stated in a questionary form:
"Which will be more effective endermologie or negative pressure therapy in reducing limb circumference and volume in postmastectomy lymphedema?".
Hypothesis:
It will be hypothesized that:
There is no significant difference between endermologie and negative pressure therapy in reducing circumference and limb volume in post mastectomy lymphedema.
详细描述
Subject:
Sixty- eight women treated for unilateral breast cancer with secondary upper limb lymphedema post mastectomy will participate in this study. Their ages will be ranged from 40 to 60 years, they will be free from any other diseases that will affect or influence the results and the participants will be selected from National Cancer Institute and randomly distributed into two equal groups in number.
Study design:
In this study the patients will be randomly assigned into two groups equal in number (34 patients for each group).
Inclusion Criteria:
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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Only females will participate in the study.
- •Patients' age was ranged between 40-60 years.
- •All patients will suffer from post mastectomy lymphedema.
- •All patients have a modified radical mastectomy.
- •All patients suffer from grade II lymphedema without skin changes one year post mastectomy(as defined by the International Society of Lymphology).
- •All patients are right-dominant hand.
- •All patients enrolled to the study will have their informed consent.
排除标准
- •The potential participants will be excluded if they meet one of the following criteria:
- •primary lymphedema.
- •Diabetes mellitus.
- •Pregnancy.
- •Recurrent cancer.
- •Current or recent cellulitis.
- •Current metastases.
- •Venous thrombosis.
- •Photosensitivity.
- •Phlebitis in development stage.
- •Infection.
- •Receiving anti-coagulant treatment.
研究组 & 干预措施
Group A (endermologie group)
This group includes 34 patients who will receive 30 min Endermologie 3 times per week in addition to their physical therapy program (active range of motion and elevation); hygiene and skin care for 6 weeks.
干预措施: Endermologie (Device)
Group B (Negative pressure therapy group)
This group includes34 patients who will receive 30min negative pressure therapy 3 times per week in addition to their physical therapy program (active range of motion and elevation); hygiene and skin care for 6 weeks
干预措施: Negative pressure therapy (Device)
结局指标
主要结局
Limb volume measurement
时间窗: Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb volume and decrease of lymph-edema
Limb volume measurement will be carried out by by measuring the circumference of each segment of the limb between two consecutive circumferences as a truncated zone. The volume of the segment was calculated as: V=h (c1+c1c2+c2 )/12π
Measuring Disability of the arm, shoulder and hand
时间窗: Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb function before and after treatment
Measuring Disability of the arm, shoulder and hand will be carried out by using Quick-DASH questionnaire
次要结局
未报告次要终点
研究者
Rayda Maher Mohamed Abdelkhalek
assistant lecturer
Cairo University