Physical Therapies in the Decongestive Treatment of Lymphedema: A Multicenter, Randomized, Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Percentage reduction in Excess Volume (PREV)
研究概览
简要总结
The purpose of this multicenter randomised controlled study is to determine whether manual lymphatic drainage (MLD) brings any benefit when added to intermittent pneumatic compression (IPC) plus multilayer, multicomponent bandages (MB) in the decongestive lymphatic therapy (DLT) in patients with lymphedema
详细描述
Study Design: the study was a multicenter, randomized controlled study conducted at three university hospitals in Spain. Potential subjects were identified at Rehabilitation Department where physicians were responsible for screening subjects for eligibility and enrolling into the study.
Patients that fulfilled the inclusion criteria and signed up the informed consent were stratified within 2 stratums, upper and lower limb lymphedema, and then were randomized to one of the three treatment groups.
The type of randomization was a total randomization with ratio 1:1:1 and the method used to generate the random allocation sequence was a computer-generated random numbers table. Adequate randomization includes calling a central office once eligibility has been determined.
The physicians that assessed the outcome and the statistic who analyzed de data were blinded to the subjects' treatment assignment.
The study was approved by the Research Ethics Committee of the University Hospital La Fe. It was conducted according to the ethical principles laid down in the declaration of Helsinki (52nd World Medical Association General Assembly, Edinburgh, Scotland, October 2000) and the rules of best clinical practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary or secondary lymphedema,
- •lymphedema stages II or III
- •affecting unilateral upper or lower limb
- •Excess volume (EV) > 10%
排除标准
- •malignancy or active neoplasm disease or lack of information about it.
- •active lymphangitis
- •known contraindications for Decongestive Lymphatic Therapy (DLT): renal insufficiency, uncontrolled hypertension, cardiac disease and venous thrombosis.
- •a course of DLT during last year.
- •anything that could alter the patient's capability to consent truly to participate in this study
结局指标
主要结局
Percentage reduction in Excess Volume (PREV)
时间窗: at 10 sessions of DLT (2 weeks), at 20 sessions of DLT (4 weeks) and at 1, 6 and 12 months after the end of DLT
It is obtained with the following formula: \[(Initial EV - Final EV)/ Initial EV\] x 100; where Excess Volume (EV) is the difference between Lymphedematous (VL) and Healthy limb volume (VH). Volumes were calculated with tape perimeter measurements (C) taken from the dorsum of the hand (C1) and repeated for every 4 cm proximally until the axilla (Cn), using Kuhnke formula, as the disk model is considered the method of choice in clinical practice. We assessed the change from baseline in PREV during Decongestive Lymphedema Treatment (DLT)and during 12 months of follow-up after DLT.
次要结局
- the Percentage of Volume reduction (PRV)(at 10 sessions of DLT (2 weeks), at 20 sessions of DLT (4 weeks) and at 1, 6 and 12 months after the end of DLT)
研究者
Isabel Forner-Cordero, MD, PhD.
Consultant in Physical Medicine and Rehabilitation at the Lymphedema Unit
Hospital Universitario La Fe