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OpenTrials
Completed

NCT Number: NCT03014739

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

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.

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Key information

Conditions

Achilles Tendon Plantar Fascia

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao-Yang Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supersonic ShearWave Elastography

Other

ShearWave Elastography (SWE) is part of routine ultrasound examination

Primary outcomes

  1. Intra- and inter-operator reproducibility

    Time frame: Baseline

    Intraclass Correlation Coefficient

Other outcomes

  1. Effect of limb dominance

    Time frame: Baseline

    Variability of ICC as a function of dominant versus non-dominant leg

Sponsors and collaborators

Lead sponsor

SuperSonic Imagine

Industry

Collaborators

  • Beijing Chao Yang Hospital
  • Peking University Third Hospital

Registry information

Official study title

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

Acronym: ME1

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2017
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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