Kinesio Taping Versus Compression Garments in the Treatment of 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
- 30
- 试验地点
- 2
- 主要终点
- Estimated volumen of the upper limb.
研究概览
简要总结
Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.
详细描述
Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG.
Research design:
Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of "Breast Pathology Rehabilitation" at Hospital Universitario 12 de Octubre . The planned sample size was 30.
Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability.
Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the "Clinique Investigation Unit (i+12)" of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.
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
- •Suffering from clinically significant breast cancer-related lymphedema at least since three months ago.
- •Having a Compression Garment suitable for the lymphedema arm
排除标准
- •Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase).
- •Metastasis breast cancer or other tumour.
- •Treated with systemic chemotherapy and /or radiotherapy at that time
- •Heart Failure or Renal Failure.
- •Using Diuretics.
- •Bilateral axillary lymphadenectomy.
- •Cognitive impairment or delay that impedes understanding the study's instructions.
研究组 & 干预措施
Kinesio Taping
It was done a four week phase with Kinesio Taping in the arm affected with lymphedema.
干预措施: Kinesio Taping (Other)
Compression garment
It was done a four week phase with Compression garment in the arm affected with lymphedema.
干预措施: Compression Garment (Other)
结局指标
主要结局
Estimated volumen of the upper limb.
时间窗: Four weeks during each treatment phase
Truncated Cone Formula.
次要结局
- Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).(Four weeks during each treatment phase)
- Goniometry of Upper Limb.(Four weeks during each treatment phase)
研究者
Violeta Pajero Otero
Physiotherapist at the Mammary Pathology Unit
Hospital Universitario 12 de Octubre