Evaluation of Shear Wave Elastography Reproducibility in Achilles Tendons and Plantar Fascia

Achilles Tendon Clinical Trial

— ME1  

Official title:

Evaluation of the Reproducibility of Young's Modulus and Shear Wave Velocity Measurements With SWE™ in Achilles Tendons and Plantar Fascia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014739
• Other study ID #: ME1
• Status: Completed
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: December 2018
• Source: SuperSonic Imagine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1165
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• Athletes

Related Conditions & MeSH terms

• Achilles Tendon
• Plantar Fascia

Intervention

Other:
• Supersonic ShearWave Elastography
ShearWave Elastography (SWE) is part of routine ultrasound examination

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Beijing
China	The third Affiliated Hospital of Peking University	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
SuperSonic Imagine	Beijing Chao Yang Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Cao W, Sun Y, Liu L, Wang Z, Wu JY, Qiu L, Wang YX, Yuan Y, Shen SF, Chen Q, Chen T, Zhang W, Wu CJ, Liu FX, Zhong SG, Chen L, Tong MH, Cui LG, Guo RJ. A Multicenter Large-Sample Shear Wave Ultrasound Elastographic Study of the Achilles Tendon in Chinese — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of limb dominance	Variability of ICC as a function of dominant versus non-dominant leg	Baseline
Primary	Intra- and inter-operator reproducibility	Intraclass Correlation Coefficient	Baseline