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临床试验/NCT05037708
NCT05037708已完成不适用

Effects of Physiotherapy in the Maintenance Phase in the Treatment of Lymphedema After Breast Cancer

University of Vigo2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
circometry

研究概览

简要总结

Lymphedema related to breast cancer is one of the main complications after breast cancer treatment. Manual lymphatic drainage appears as a technique which could be applied in the treatment of lymphedema along with other techniques. The aim of this study is to analyze the effects of a physiotherapy program based on manual lymphatic drainage on the treatment of lymphedema after breast cancer, during the stabilization or maintenance phase of complex decongestant therapy. Therefore, a randomized, blinded, crossover clinical trial is suggested to assess the effect of an intensive physiotherapy intervention on the treatment of lymphedema in its maintenance phase, in comparison with a control group without physiotherapy treatment. The cytometry, displaced water volume, thickness of the lymphedema with ultrasound, dynamometry and sensation of heaviness, pain and tension of the upper limb will be evaluated.

详细描述

Complex decongestant therapy is a set of techniques which seek the treatment of lymphedema in a conservative way as described in the recent international consensus of the International Lymphology Society, published in 2020. Complex decongestant therapy in a first phase aims to reduce cutaneous edema and in a second phase it aims to preserve and optimize the results obtained.

The first phase consists of skin care, manual lymphatic drainage, muscle pumping exercises, and compression techniques, typically applied with multilayer bandages. The second phase consists of compression with low elasticity, skin care exercises, and repeated manual lymphatic drainage as needed.

The frequency and intensity of components of complex decongestant therapy in phase I and II should depend on the clinical findings of edema and the stage of lymphedema and could be adapted to clinical changes. Note that phase II or stabilization represents long-term therapy over many years and in the case of deterioration of edema, phase I of complex decongestant therapy may need to be repeated.

In recent years, there is debate about the efficacy of manual lymphatic drainage. Sometimes it is not prescribed, being replaced by the recommendation of a self-massage. Furthermore, complex decongestant therapy was suggested to be time consuming, expensive and difficult to tolerate, and does not improve lymphatic function.

In contrast, researchers such as Müller et al., in 2018, state that it is a well-tolerated and safe treatment technique, demonstrating benefits in reducing edema. Other research has also shown that manual lymphatic drainage is effective both on a preventive level and as a postoperative rehabilitation treatment, having optimal results when combined with the other elements of complex decongestant therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women included in the lymphedema treatment maintenance program through the Galician Lymphedema Association
  • Women with secondary unilateral lymphedema after breast cancer

排除标准

  • Women undergoing chemotherapy or radiotherapy treatment.
  • Severe systemic or neurological disease

结局指标

主要结局

circometry

时间窗: 4 month

measurement of upper limb perimeters

Volumetry by water displacement

时间窗: 4 month

weight of water extravasated when introducing the upper limb into a container with water

Measurement of edema thickness by ultrasound

时间窗: 4 month

measurement of subcutaneous tissue thickness

次要结局

  • Assessment of the sensation of heaviness(4 month)
  • Assessment of the sensation of pain(4 month)
  • Assessment of the sensation of tension in the upper limb(4 month)
  • dynamometry(4 month)

研究者

发起方
University of Vigo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva María Lantarón Caeiro

Principal Investigator

University of Vigo

研究点 (2)

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