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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03014739

Acronym

ME1

Enrollment

1165

Registered

2017-01-09

Start date

2016-06-30

Completion date

2018-06-30

Last updated

2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendon, Plantar Fascia

Keywords

Elastography, Musculoskeletal System

Brief 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.

Interventions

OTHERSupersonic ShearWave Elastography

ShearWave Elastography (SWE) is part of routine ultrasound examination

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Intra- and inter-operator reproducibility	Baseline	Intraclass Correlation Coefficient

Other

Measure	Time frame	Description
Effect of limb dominance	Baseline	Variability of ICC as a function of dominant versus non-dominant leg

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026