NCT03014739已完成不适用
Evaluation of the Reproducibility of Young's Modulus and Shear Wave Velocity Measurements With SWE™ in Achilles Tendons and Plantar Fascia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,165
- 试验地点
- 2
- 主要终点
- Intra- and inter-operator reproducibility
研究概览
简要总结
Achilles tendon plays a significant role in walking and sporting activities, particularly through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line examination of choice for patients suspected of having Achilles tendon injury, which is more and more frequent. Nowadays, ultrasound elastography can be used to evaluate the viscoelasticity properties of Achilles tendon, however little is known about the reproducibility of the technique. This study aims to evaluate the reproducibility of supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in Achilles tendon and plantar fascia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers with normal Achilles tendon:
- •Normal adult aged over 18 years old;
- •Without lower limb malformation;
- •With no symptoms of Achilles tendon lesion and no negative results of routine ultrasound examination for a possible tendinopathy.
排除标准
- •Subjects who failed to meet all inclusion criteria were will be automatically excluded;
- •Subjects who did will not wish or could will not sign the informed consent in person.
- •Volunteers with abnormal Achilles tendon for any of these reasons:
- •Lower limb malformation;
- •Achilles tendon pain, Achilles tendon disease, surgical history of Achilles tendon surgery, morphologic abnormalities of Achilles tendon ( gray-scale/color Doppler/MRI/plain film);
- •Suffer from systemic, metabolic and endocrine diseases, including but not limited to, diabetes, familial hyperlipidemia (FH), systemic lupus erythematosus (SLE), gout, ankylosing spondylitis, hyperthyroidism, chronic renal failure, etc.
- •Pregnant women;
- •Apply Ongoing hormone hormonal therapy;
结局指标
主要结局
Intra- and inter-operator reproducibility
时间窗: Baseline
Intraclass Correlation Coefficient
次要结局
未报告次要终点
研究者
研究点 (2)
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