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临床试验/NCT00155220
NCT00155220Unknown2 期

Treatment of Lymphedema- Application of the Kinesio Taping

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年8月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
60
试验地点
1
主要终点
The severity of swelling, such as arm circumference, volume of water displacement

研究概览

简要总结

There are 2 parts to this study.

First part:

  • Reliability of water displacement, circumference, tonometer.
  • Effect of taping: lifting effect measured with sonography
  • Effect of taping: peripheral circulation measured with DRT4

Second part:

  • Effects of different intervention models including decongestive lymphatic therapy (DLT) and modified DLT

详细描述

First part:

To investigate the reliability study of water displacement and circumference measurement and the change in thickness of subcutaneous space measured by sonography and blood flow measured by DRT4 in normal subjects after applying K-tape.

Second part:

The incidence of breast carcinoma is in the second place in women in Taiwan. Lymphedema is a common complication after treatment of breast carcinoma; it will lead not only to cosmetic problems but is also uncomfortable, and causes functional limitation for patients. The common management for lymphedema is decongestive lymphatic therapy (DLT) including skin care, manual lymph drainage, remedial exercises and compression therapies. At present, all possible compression therapies for lymphedema have limitations. Patients have poor compliance in using short-stretch bandage and compression garments due to the climate in Taiwan. Applying kinesio tape (K-tape) became a new treatment method in physical therapy; the inventor Dr. Kase claimed that the K-tape can improve circulation and remove congestion. Besides, it demonstrated good therapeutic effects in clinical application. However, there are few studies to show the clinical effects of K-tape. This restricts the further application of K-tape. Following the previous study, the purpose is to compare the effects among traditional DLT, modified DLT which replaces bandage with K-tape, and DLT combined K-tape in patients with lymphedema.

A randomized control study will be executed. Sixty patients with post-mastectomy lymphedema will be randomly grouped into taping, bandage and mixed groups. Each subject will go through 4 weeks of a control period, 4 weeks of an intervention period, and followed by 3 months of an observation period. The evaluation items include physical therapy assessment, the severity of swelling, such as arm circumference, volume of water displacement, related symptoms, the upper extremity function and quality of life. The evaluation will be executed 4 weeks before the interventions (start of control period), before the intervention (start of intervention period), after a 4 week intervention and 3 months after the intervention to compare the effects among 3 kinds of treatment. Subjects in each group will receive treatments including skin care, manual lymphatic drainage, pneumatic compression therapy and exercise during the intervention period; the taping group's patients will receive additional K-tape treatment; the mixed group's patients will receive K-tape combined bandage treatment. Each group will be treated 2 hours/time, 5 times/week; the entire course will take 4 weeks.

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

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female breast cancer lymphedema
  • •Unilateral lymphedema
  • •Lymphedema onset 3 months ago
  • •Moderate to severe lymphedema
  • •At least one measurement point greater than 2 cm
  • •Good compliance

排除标准

  • •Port-a-cath on affected side of chest with adhesion
  • •Skin disease
  • •Restriction of active range of motion
  • •Affected upper extremity (UE)
  • •Other diseases or medication might lead to swelling
  • •Irremovable bracelet or ring

结局指标

主要结局

The severity of swelling, such as arm circumference, volume of water displacement

The evaluation will be executed 4 weeks before the interventions, before the intervention, after 4 week intervention and 3 months after intervention.

次要结局

  • Related symptoms, the upper extremity function and quality of life
  • The evaluation time the same as primary outcomes

研究者

申办方类型
Other

研究点 (1)

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