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

Completed

• Conditions: Plantar Fascia; Achilles Tendon

• Registration Number: NCT03014739
• Lead Sponsor: SuperSonic Imagine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-09
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1165

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra- and inter-operator reproducibility	Baseline	Intraclass Correlation Coefficient

Trial Locations

Locations (2)

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, China

The third Affiliated Hospital of Peking University; 🇨🇳 Beijing, China