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临床试验/NCT06230913
NCT06230913已完成不适用

Comparative Effects of Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema Following Microsurgical Breast Reconstruction After Severe Chest Burns.

Prince Sattam Bin Abdulaziz University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Arm circumference:

研究概览

简要总结

The goal of this randomised control study is to compare kinesiotaping and pressue garments in secondary upper extremity lymphedema following microsurgical breast reconstruction after severe chest burns.

The primary objective of this study was to compare the effects of kinesiotaping and pressure garments on limb circumference, handgrip strength, shoulder pain and disability index (SPADI), and limb circumference in patients with lymphedema following breast reconstruction due to chest burns.

The participants were randomly assigned to one of two groups: the kinesiotaping group (n = 28) and the pressure garments group (n = 28).

To perform taping of the chest in the kinesiotaping group, the patient was asked to stand upright with the affected shoulder rotated externally. Five straps of the fan-shaped tape were extended to the chest toward the affected axilla with 15% to 20% tension, and the anchor was positioned without tension in the anterior axilla on the sound side.

In the pressure garment group, the participant's skin was washed and dried before applying the PG. The Premium Lymphedema Gradient Garment (Jobskin, Long Eaton, England) was used to apply PGs. This garment has a pressure gradient built into it, applying between 20 and 60 mm Hg for at least 15 to 18 hours each day for three weeks.

详细描述

The participants were randomly assigned to one of two groups: the kinesiotaping group (n = 28) and the pressure garments group (n = 28).

To perform taping of the chest in the kinesiotaping group, the patient was asked to stand upright with the affected shoulder rotated externally. Five straps of the fan-shaped tape were extended to the chest toward the affected axilla with 15% to 20% tension, and the anchor was positioned without tension in the anterior axilla on the sound side.

In the pressure garment group, the participant's skin was washed and dried before applying the PG. The Premium Lymphedema Gradient Garment (Jobskin, Long Eaton, England) was used to apply PGs. This garment has a pressure gradient built into it, applying between 20 and 60 mm Hg for at least 15 to 18 hours each day for three 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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Microsurgical breast reconstruction after severe chest burns.
  • the patient's arm circumference should be at least more than 2cm but not greater than 8 cm when compared to the same site on the opposite arm.

排除标准

  • Conditions that resulted in oedema or swelling,
  • medication like diuretics,
  • infections,
  • allergies,
  • other systemic diseases,
  • pregnancy,
  • bilateral lymphadenitis

结局指标

主要结局

Arm circumference:

时间窗: 12 months

To measure the arm circumference, the patient lays in a prone position with their arms relaxed by the side of the body. A measuring tape is used to take the measurement. It was measured starting with 3 cm on the ulnar styloid process and proceeding with 45 cm proximal, and additionally at the metacarpal bones and midhand. For an accurate reading, the tape was snugly wrapped around the arm. The measurements were recorded for both the affected and unaffected arms, and the difference between the two measurements was then recorded under the title "circumference difference"

次要结局

  • Functional disability - SPADI(12 months)
  • Handgrip strength(12 months)
  • QOL(12 months)

研究者

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

Gopal Nambi

Professor

Prince Sattam Bin Abdulaziz University

研究点 (2)

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