Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment.
研究概览
简要总结
This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.
- Kinesio Taping.
详细描述
Breast Cancer-Related Lymphedema (BCRL) tends to progress in stage and grade if it is not treated.
Complex Physical Therapy (CPT), that includes Manual Lymph Drainage + Multilayer Bandage + Self-care, is the most used technique in order to join the benefits of each technique by the lack of great results with only one technique. The most volume reduction found in a study was achieved combining CPT and Pressotherapy(P). On the other hand, the use of Kinesio Taping (KT) for BCRL has been spreading lately although its clinical efficacy has not been determined by high quality studies.
GOALS:
Main objective: To analyze the effectiveness in the reduction of BCRL volume with KT versus CPT+P in patients attended at the rehabilitation service at HU12Octubre.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Submit BCRL
- •Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre.
- •Signing the informed consent.
排除标准
- •Breast Cancer metastasis or other active tumor. 2) Intravenous chemotherapy or radiotherapy actually. 3) Heart or kidney failure. 4) Use diuretics. 5) active infection (erysipelas) or any cutaneous disease in UL or back. 5) Bilateral lymphadenectomy. 6) present deterioration or cognitive delay that would prevent understanding instructions and purpose of the study.
- •Have performed treatment for BCRL during the 3 months prior to the start of the study (previous washing phase).
研究组 & 干预措施
Kinesio Taping
Kinesio Taping during three weeks
干预措施: Kinesio Taping (Other)
CPT+P
Complex Physical Therapy plus Pressotherapy during three weeks
干预措施: Complex Physical Therapy plus Pressotherapy (Other)
结局指标
主要结局
Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment.
时间窗: Four weeks during each treatment phase
Truncated Cone Formula for Volume from upper limb circumference.
次要结局
- Score of the TTDL questionnaire.(Four weeks during each treatment phase)
- Goniometry of Upper Limb.(Four weeks during each treatment phase)
- Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).(Four weeks during each treatment phase)
- Body Mass Index.(Four weeks during each treatment phase)
- Score on the DASH Outcome Measure.(Four weeks during each treatment phase)
- Stage of the lymphedema.(Four weeks during each treatment phase)
研究者
Violeta Pajero Otero
Physiotherapist at the Mammary Pathology Unit
Hospital Universitario 12 de Octubre