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临床试验/NCT00058851
NCT00058851已完成2 期

Massage Therapy for Breast Cancer-Related Lymphedema

National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2003年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
88
试验地点
2
主要终点
volume change

研究概览

简要总结

The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs.

详细描述

Massage therapy (in the form of manual lymph drainage [MLD]) and compression bandaging (CB) are integral components of combined physical therapy (CPT), the recommended treatment for peripheral lymphedema (LE). According to the World Health Organization, LE afflicts hundreds of millions worldwide and probably millions in the United States. Effects of various forms of massage on lymph circulation have been postulated for more than a century, but the efficacy of MLD alone without CB has not been demonstrated. New data suggest that MLD alone reduces established LE volume as effectively as CB in combination with CPT and minimizes LE development.

Patients will be randomly assigned to either treatment with MLD alone or a combination of MLD and CB. Patients will be treated in 10 one-hour sessions over 2 weeks. They will also undergo lymphangioscintigraphy (a nuclear medicine test) to depict the function of their lymphatic system. Patients will continue self treatment at home and will be followed for 6 months.

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
Single

入排标准

性别
All
接受健康志愿者

入选标准

  • Lymphedema (5% to 20% increase in volume) after breast cancer treatment

排除标准

  • Physically unable to perform massage or bandaging during home program

结局指标

主要结局

volume change

次要结局

未报告次要终点

研究者

研究点 (2)

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