NCT03456778 · Emory University
Assessing the Tendons With Shear Wave Elastography
What this study is about
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 the usual treatment treatment.
View original scientific description
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.
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
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.
Change in Tendon Healing
Time frame: Baseline, Month 3, Month 6, Month 12
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.
Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score
Time frame: Month 6, Month 9, Month 12
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.
Change in Victorian Institute of Sport Assessment - Patellar Tendon (VISA-P) Score
Time frame: Month 6, Month 9, Month 12
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.
Change in The Foot & Ankle Disability Index (FADI) Score
Time frame: Month 6, Month 9, Month 12
The FADI is a self-report instrument assessing function related to the foot and ankle. The FADI has 26 items that are scored on a 5-point scale where 0 = unable to do and 4 = no difficulty at all. Total raw scores range from 0 to 104 and scores are converted to percentages, where 100% indicates no dysfunction. This instrument is administered to symptomatic patients receiving standard of care treatment.
Change in The Foot & Ankle Disability Index (FADI) Sport Score
Time frame: Month 6, Month 9, Month 12
The FADI Sport is a self-report instrument assessing function related to the foot and ankle in athletes. The FADI Sport has 8 items that are scored on a 5-point scale where 0 = unable to do and 4 = no difficulty at all. Total raw scores range from 0 to 32 and scores are converted to percentages, where 100% indicates no dysfunction. This instrument is administered to symptomatic patients receiving standard of care treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2025 · Source of record for eligibility and locations