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临床试验/NCT06196619
NCT06196619已完成不适用

The Relationship of Shear Wave Elastography Findings With Pain Threshold and Quality of Life in Patients With Lipedema

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年4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
70
试验地点
1
主要终点
Subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs

研究概览

简要总结

The aim of this study is to evaluate the relationship between disease severity and subcutaneous tissue shearwave elastography findings with pain threshold and quality of life in patients diagnosed with lipedema.

详细描述

Patients diagnosed with lipedema were divided into 3 stages according to disease severity. Pain level was evaluated with visual analogue scale, pain threshold with algometric measurement, and quality of life with EQ-5D general quality of life scale. All patients underwent measurements using B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs at three anatomical levels.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients diagnosed with lipedema

排除标准

  • under 18 years of age,
  • Patients with edema of cardiac or nephrogenic origin, diabetes mellitus, thyroid dysfunction, patients with lymphedema or chronic venous insufficiency, oncology patients,
  • individuals with polyneuropathy, radiculopathy, or advanced degenerative diseases affecting the extremities within the last 6 months, based on clinical findings and medical history.
  • patients using antiepileptics and antidepressants,
  • individuals unable to cognitively tolerate participation in the study were also excluded.

结局指标

主要结局

Subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs

时间窗: 1 day

Measurements using B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs at three anatomical levels.

Visual analog scale(VAS)

时间窗: 1 day

Pain levels were assessed using the visual analog scale(VAS)

Algometric measurement

时间窗: 1 day

Pain threshold through algometric measurement

EQ-5D general quality of life scale.

时间窗: 1 day

quality of life using the EQ-5D general quality of life scale.

次要结局

未报告次要终点

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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