Clinical trial NCT03014739: Evaluation of Shear Wave Elastography Reproducibility in Achilles Tendons and Plantar Fascia
Official title: Evaluation of the Reproducibility of Young's Modulus and Shear Wave Velocity Measurements With SWE™ in Achilles Tendons and Plantar Fascia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendon
Plantar Fascia
Keywords: Elastography
Musculoskeletal System
Lead sponsor: SuperSonic Imagine
Sponsor class: INDUSTRY
Collaborators: name: Beijing Chao Yang Hospital
name: Peking University Third Hospital
First posted: 2017-01-09
Enrollment: 1165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers without any Achilles tendon disease

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intra- and inter-operator reproducibility
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Effect of limb dominance
timeFrame: Baseline
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: The third Affiliated Hospital of Peking University
Study officials:
References:
citation: 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.