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Assessing the Tendons With Shear Wave Elastography

StatusCompleted
PhaseNot specified
Started2018-02-27
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Identification, Study Status, Oversight, Study Design, Contacts/Locations v7
Trial completed
Final enrollment: 56 participants (planned 150)
Primary completion confirmed: May 2024 (last estimated July 2026)
Primary completion dateestimated 2026-07→confirmed 2024-05-20
Completion dateestimated 2026-07→confirmed 2024-05-20
Enrollment targetestimated 150→confirmed 56
Study sitesdetails revised at 1 of 1 site
2025-08-11
Study Status, Sponsor/Collaborators, Oversight v6
Primary completion date2025-03→2026-07
Completion date2025-03→2026-07
2024-05-17
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v5
PhaseNot applicable→Not specified
Primary completion date2023-11→2025-03
Completion date2023-11→2025-03
Enrollment target75→150
Study arms1→2
InterventionsUltrasound-guided Percutaneous Tenotomy with Platelet-Rich Plasma (PRP) (Procedure)→Shear Wave Elastography (Device)
Primary endpoints6 entries, revised
Change in tendinopathyTendon assessedHealing Viscoelastic byTendon B mode sonographic imaging Change in tendinopathy assessed by SWEProperty
Study description-186 characters
[...] se has not been clarified scientifically. The first part of thethis study aims to establish the difference between asymptomatic and symptomatic tendons by correlating elastography measurements (axial and sagittal mean velocity and relative anisotropic coefficient) with more standard clinically based outcome measures. Shear Wave Elastography (SWE) will be used with a small group ofamong patients affected by moderate-to-severe, chronic (>6 months [...] son to asymptomatic patients. After establishing a range of elastography normal to severe pathologic elastography measurements the researchers will cond [...] [...]
2022-12-15
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v4
Primary completion date2022-12→2023-11
Completion date2022-12→2023-11
Enrollment target15→75
InterventionsPlatelet-Rich Plasma Injection (Procedure)→Ultrasound-guided Percutaneous Tenotomy with Platelet-Rich Plasma (PRP) (Procedure)
Eligibility criteria-86 characters
Part One Inclusion Criteria for Asymptomatic Volunteers: Patients pre [...] ing at the study location with lower extremity pain without Achilles tendon involvement Inclusion Criteria for Symptomatic Volunt [...] esenting at the study location with a clinical diagnosis of achillodyniatenalgia Diagnosis of tendinopathy confirmed by ultrasound Exclusion Criteria: Pregnancy History of Achilles tendinopathy or surgery and morphologic abnormalities (high grade tears) at US (B-mode and/or power Doppler) History of systemic, metabolic, endocrine diseases, or psor [...]
Primary endpoints3 to 6 entries
Change in The Foot & Ankle Disability Index (FADI) Score Change in The Foot & Ankle Disability Index (FADI) Sport Score Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) scaleScore Change scorein Victorian Institute of Sport Assessment - Patellar Tendon (VISA-P) Score
Study description+344 characters
Achilles tendinopathyTendinopathy is a common affliction in athletes, recreational exercisers [...] nting clinically is most commonly seen in the chronic state related to tendon degeneration manifested as intra-tendinous mucoid degeneration and thechondroid metaplasia, which in many cases is accompanied by superimposed small intrasubstance/interstitial tears. Then a vicious cycle of attempted inadequate healing with superimposed acute pathology ensues leading to significant pain and discomfort over time significantly limiting physical activit [...] exact pathogenesis of this disease has not been clarified [...] [...]
Study sitescontacts updated at 1 of 1 site
Study title-1 characters
AchillesAssessing Tendinopathythe Tendons With Shear Wave Elastography Study
2021-10-21
Suspended→Recruiting Study Status, Contacts/Locations v3
Trial statusSuspended→Recruiting
Reason stoppedThe study activities are suspended due to COVID-19 pandemic→not stated
Study sitesdetails revised at 1 of 1 site
Show 2 earlier versions
2020-05-01
Recruiting→Suspended Study Status, Contacts/Locations v2
Trial statusRecruiting→Suspended
Reason stoppednot stated→The study activities are suspended due to COVID-19 pandemic
Primary completion date2019-12→2022-12
Completion date2019-12→2022-12
Study sitesdetails revised at 1 of 1 site
2019-04-03
Study Status v1
Re-verified, no change to tracked fields
2018-03-02
Original filing
The purpose of this study is to utilize Shear Wave Elastography (SWE) to study the viscoelastic properties of tendons to understand the functional differences between normal/asymptomatic and symptomatic tendon states. The study will also assess the degree of tendon healing following standard of care treatment.
Trial Details
NCT Number NCT03456778
Lead Sponsor Emory University
Conditions Tendinopathy
Enrollment 56 participants
Start Date 2018-02-27
Primary Completion 2024-05-20 (estimated)
Study Completion 2024-05-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-11