Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Limb volume change 1
研究概览
简要总结
This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.
详细描述
This is a double blind, randomized, clinical trial. 30 patients with lower limb lymphedema will be randomized in 2 groups. One group will receive the habitual complex decongestive therapy (lymphatic manual drainage and compression) plus extracorporeal shock waves therapy. The other group will receive complex decongestive therapy (lymphatic manual drainage and compression) plus placebo extracorporeal shock waves.
Patients in the 2 groups will be instructed on skin care measures and kinesitherapy. The usual manual lymphatic drainage and compression will be applied to the 2 groups. The 2 groups will receive 10 treatment sessions, 2 weekly for 5 weeks.
Group complex decongestive therapy + shock waves. Patients will receive treatment with manual lymphatic drainage, compression, and shock waves.
Group complex decongestant therapy + placebo. Patients will receive treatment with manual lymphatic drainage, compression, and placebo shock waves.
Tolerance and possible adverse effects will be recorded by physiotherapist. Any adverse effect detected will be evaluated by the rehabilitation medical doctor.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients, outcome assessors and investigators will not know if received treatment was placebo or therapeutic. The physiotherapist will apply the treatment according to a list of random numbers generated to make 2 treatment groups
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
- •Patients with lower limb lymphedema
- •Lymphedema of at least 6 months of evolution
- •The lymphedema must affect at least the knee to the foot
- •Moderate or severe lymphedema (grades 2 or 3)
- •Sign the informed consent
排除标准
- •Under 18 years of age
- •Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.)
- •Current or previous deep vein thrombosis of the lower extremity
- •Pregnancy
- •Electronic implantable medical devices as pacemaker implants, medication pumps, etc
- •Having received treatment with complex decongestive therapy or shock waves during the last 6 months
- •Treatment with corticosteroids or radiotherapy in the area to be treated in the last 6 weeks
- •Active oncological disease in the area to be treated
- •Active infectious-inflammatory process in the area to be treated
- •Cognitive or sensory deficits that prevent collaboration
- •Inability to walk independently or inability to attend therapy
结局指标
主要结局
Limb volume change 1
时间窗: 5 weeks
The difference between limb volume previous of treatment and at the end of treatment
次要结局
- Limb volume change 2(9 weeks)
- VAS Pain(9 weeks)
- VAS Heaviness(9 weeks)
- VAS Hardness(9 weeks)
研究者
Roser Belmonte
Rehabilitation specialist, MD, PhD
Parc de Salut Mar