Assessing the Tendons With Shear Wave Elastography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shear Wave Elastography.
- Who it may be relevant to
- Registry conditions: Tendinopathy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing the Efficacy of the Treatment of Tendinopathy With Shear Wave Elastography
Overview
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.
Detailed description
Tendinopathy is a common affliction in athletes, recreational exercisers, the general population and even inactive people. Tendon pathology presenting clinically is most commonly seen in the chronic state related to tendon degeneration manifested as intra-tendinous mucoid degeneration and chondroid 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 activity. The exact pathogenesis of this disease has not been clarified scientifically.
The first part of this study aims to establish the difference between asymptomatic and symptomatic tendons among patients affected by moderate-to-severe, chronic (\>6 months of symptoms) tendinopathy in comparison to asymptomatic patients. After establishing a range of elastography normal to severe pathologic measurements, a second part of the study will focus on utilizing ultrasound elastography imaging follow up to assess degree of tendon healing after various standard of care treatments.
The purpose of this prospective observational study is to utilize a ultrasound modality known as real-time Shear Wave Elastography (SWE) to study the viscoelastic properties of tendons, such as the Achilles, patellar, quadriceps, epicondylar, and rotator cuff, to understand the functional differences between normal/asymptomatic (n=75) vs symptomatic (n=75) tendon states (total n=150). The secondary aim will be to assess the degree of tendon healing after standard of care treatment. The clinical implications are very significant because it will provide insights into the mechanism of tendon healing.
Interventions
- Device Shear Wave Elastography
An ultrasound (US) technique, known as shear wave elastography (SWE), is used to examine structure and biomechanical function. The examination takes place in the ultrasound room at the study site and lasts for approximately 20 minutes.
Primary outcome measures
- Viscoelastic Tendon Property [Time frame: Baseline]
- Change in Tendon Healing [Time frame: Baseline, Month 3, Month 6, Month 12]
- Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score [Time frame: Month 6, Month 9, Month 12]
- Change in Victorian Institute of Sport Assessment - Patellar Tendon (VISA-P) Score [Time frame: Month 6, Month 9, Month 12]
- Change in The Foot & Ankle Disability Index (FADI) Score [Time frame: Month 6, Month 9, Month 12]
- Change in The Foot & Ankle Disability Index (FADI) Sport Score [Time frame: Month 6, Month 9, Month 12]
Eligibility criteria
Inclusion Criteria for Asymptomatic Volunteers:
- Patients presenting at the study location with lower extremity pain without tendon involvement
Inclusion Criteria for Symptomatic Volunteers:
- Patients presenting at the study location with a clinical diagnosis of tenalgia
- Diagnosis of tendinopathy confirmed by ultrasound
Exclusion criteria
- Pregnancy
- History of tendinopathy or surgery and morphologic abnormalities
- History of systemic, metabolic, endocrine diseases, or psoriasis
- History of treatment with corticosteroids, estrogens, long term quinolone antibiotics, and cholesterol drugs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Emory Orthopaedics and Spine Center — Atlanta
Identifiers
NCT: NCT03456778 · IRB00096405