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

NCT03014739 | Completed

• 1 other identifier: ME1
• Study Type: observational
• Target: 1,165
• Locations: 1 country
• Sites: 2

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.

Conditions

Achilles Tendon; Plantar Fascia

Keywords

Elastography; Musculoskeletal System

Outcome Measures

Primary Outcomes (1)

• Intra- and inter-operator reproducibility

  Intraclass Correlation Coefficient

  Baseline

Other Outcomes (1)

• Effect of limb dominance

  Baseline

Interventions

Supersonic ShearWave Elastography OTHER

ShearWave Elastography (SWE) is part of routine ultrasound examination

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers without any Achilles tendon disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SuperSonic Imagine: lead
• Beijing Chao Yang Hospital: collaborator
• Peking University Third Hospital: collaborator

Study Sites (2)

Beijing Chao-Yang Hospital

Beijing, 100020, China

Location

The third Affiliated Hospital of Peking University

Beijing, 100191, China

Location

Related 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 Adults. J Ultrasound Med. 2019 May;38(5):1191-1200. doi: 10.1002/jum.14797. Epub 2018 Sep 12.

  PMID: 30208234 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 9, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)