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临床试验/NCT03401086
NCT03401086已完成不适用

Comparison of Kinesiotaping and Pressure Garment on Old Adult Women With Secondary Upper Extremity Lymphedema Following Mastectomy: A Randomized Controlled Trial

Ahlia University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Limb circumference

研究概览

简要总结

Breast cancer is a standout amongst the most widely recognized cancer among women. It is observed that upper extremity lymphedema is one of the most dangerous and prevalent complication following breast cancer surgery which prompts functional impairment, psychological disaster and social problems

This study aimed to compare the effects of Kinesio taping and the pressure garment application on secondary lymphedema of the upper extremity and quality of life following mastectomy after breast cancer.

Material and Methods: In this experimental study with pre and post-tests, 66 women with lymphedema following mastectomy were randomly allocated to Kinesio taping (KT) group (n=33) and pressure garment (PG) group (n=33). The KT group received Kinesio taping application, while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day through the study. All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life at baseline and end of intervention.

详细描述

66 women with unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side. The participants were randomly assigned to 2 groups. Kinesio taping group included 33 patients receiving Kinesio taping (KT) and pressure garment (PG) included 33 patients.

The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.

All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life

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
Double (Participant, Outcomes Assessor)

盲法说明

The KT group received Kinesio taping application, while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day through the study.

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side.

排除标准

  • The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.

研究组 & 干预措施

Study group

Active Comparator

Kinesio Taping

干预措施: Kinesio Taping (Other)

Control group

No Intervention

No intervention

结局指标

主要结局

Limb circumference

时间窗: 1 month

The upper Limbs circumferences were measured by using a tape measure with the patient in prone lying position.

次要结局

  • Quality of life(1 month)
  • Shoulder Pain and Disability Index(1 month)
  • Hand grip strength(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Sayed Tantawy

Associate Professor

Ahlia University

研究点 (2)

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