Achilles TendonME1NCT03014739
Evaluation of Shear Wave Elastography Reproducibility in Achilles Tendons and Plantar Fascia
An observational study of Achilles Tendon and Plantar Fascia, run by SuperSonic Imagine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendon, Plantar Fascia
- What is being tested?
- Supersonic ShearWave Elastography
- How many people
- 1,165 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers without any Achilles tendon disease
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnant women;
- Apply Ongoing hormone hormonal therapy;
- Athletes
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Chao-Yang Hospital
Beijing, 100020
The third Affiliated Hospital of Peking University
Beijing, 100191
About this study
Official title: Evaluation of the Reproducibility of Young's Modulus and Shear Wave Velocity Measurements With SWE™ 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.
- Conditions
- Achilles Tendon, Plantar Fascia
- Being tested
- Supersonic ShearWave Elastography
- Keywords
- Elastography, Musculoskeletal System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supersonic ShearWave ElastographyOther
ShearWave Elastography (SWE) is part of routine ultrasound examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra- and inter-operator reproducibility
Intraclass Correlation Coefficient
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achilles TendonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,165 participants (actual)
Sponsor and investigators
- Lead sponsor
- SuperSonic Imagine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Chao Yang Hospital, Peking University Third Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014739
- Sponsor's protocol ID
- ME1
- Acronym
- ME1
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2016
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30208234
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reproducibility of Young's Modulus and Shear Wave Velocity Measurements With SWE™ in Achilles Tendons and Plantar Fascia
- ClinicalTrials.gov ID
- NCT03014739
- Acronym / sponsor ID
- ME1 / ME1
- Conditions
- Achilles Tendon, Plantar Fascia
- Keywords
- Elastography, Musculoskeletal System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,165 participants (actual)
- Lead sponsor
- SuperSonic ImagineIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Chao Yang Hospital, Peking University Third Hospital
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers without any Achilles tendon disease
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supersonic ShearWave ElastographyShearWave Elastography (SWE) is part of routine ultrasound examination | Other | – |
Primary outcome
Intra- and inter-operator reproducibility
Time frame: Baseline
Intraclass Correlation Coefficient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Results publication: PubMed 30208234Cao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon and Plantar Fascia, run by SuperSonic Imagine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra- and inter-operator reproducibility (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.