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

NCT ID: NCT03014739

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Achilles Tendon Plantar Fascia

Keywords

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Elastography Musculoskeletal System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Supersonic ShearWave Elastography

ShearWave Elastography (SWE) is part of routine ultrasound examination

Intervention Type OTHER

Eligibility Criteria

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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.

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

SuperSonic Imagine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Chao-Yang Hospital

Beijing, , China

Site Status

The third Affiliated Hospital of Peking University

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 30208234 (View on PubMed)

Other Identifiers

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ME1

Identifier Type: -

Identifier Source: org_study_id