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NCT Number: NCT03456778

Assessing the Tendons With Shear Wave Elastography

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.

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Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shear Wave Elastography

Device

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Reiter, PhD

CONTACT

[email protected]

404-778-6098

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Assessing the Efficacy of the Treatment of Tendinopathy With Shear Wave Elastography

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2018
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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