Assessing the Tendons With Shear Wave Elastography

Last updated: May 17, 2024
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tendon Injuries

Sprains

Treatment

Shear Wave Elastography

Clinical Study ID

NCT03456778
IRB00096405
  • Ages 18-65
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria for Asymptomatic Volunteers:

  • Patients presenting at the study location with lower extremity pain without tendoninvolvement

Inclusion Criteria for Symptomatic Volunteers:

  • Patients presenting at the study location with a clinical diagnosis of tenalgia

  • Diagnosis of tendinopathy confirmed by ultrasound

Exclusion

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 quinoloneantibiotics, and cholesterol drugs

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Shear Wave Elastography
Phase:
Study Start date:
February 27, 2018
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Emory Orthopaedics and Spine Center

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

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