Assessing the Tendons With Shear Wave Elastography
ConditionTendinopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients presenting at the study location with lower extremity pain without tendon involvement
Patients presenting at the study location with a clinical diagnosis of tenalgia
Diagnosis of tendinopathy confirmed by ultrasound
Disqualifiers
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
Trial population
Patients at the Emory Orthopaedics and Spine Center who are asymptomatic or symptomatic for tendinopathy.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Shear Wave Elastography
DeviceAn 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Shear Wave Elastography for Asymptomatic Volunteers1 intervention
Group B: Shear Wave Elastography Symptomatic Volunteers1 intervention
Trial outcomes
Primary outcomes
1
Viscoelastic Tendon Property
Shear wave elastography imaging will be used to establish baseline measurements of viscoelastic properties of tendons, such as the Achilles, patellar, quadriceps, epicondylar, and rotator cuff, among asymptomatic and symptomatic patients.
Time frame
Baseline2
Change in Tendon Healing
The degree of tendon healing among symptomatic patients receiving standard of care treatment will be assessed by examining stiffness changes measured by shear wave imaging.
Time frame
Baseline, Month 3, Month 6, Month 123
Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score
Participants symptomatic for Achilles tendinopathy who received standard of care treatment will be asked to complete the VISA-A scale. The VISA-A scale assesses the severity of chronic Achilles tendinopathy. This 8-item, self-administered questionnaire asks about Achilles tendon pain, daily living function, and sporting activity. Total scores can range from 0 to 100, with 0 representing worst pain and function and 100 signifying no pain or limitations to function. Scores below 70 indicate the presence of Achilles tendinopathy.
Time frame
Month 6, Month 9, Month 124
Change in Victorian Institute of Sport Assessment - Patellar Tendon (VISA-P) Score
Participants symptomatic for patellar tendinopathy who received standard of care treatment will be asked to complete the VISA-A scale. The VISA-P scale assesses patellar tendinosis. This 8-item, self-administered questionnaire asks about symptoms, pain, function, and sporting activity. Total scores can range from 0 to 100, with 0 representing worst pain and function and 100 signifying no pain or limitations to function.
Time frame
Month 6, Month 9, Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov