Assessing the Tendons With Shear Wave Elastography

Emory University

Status: Enrolling

Conditions: Tendinopathy

Treatments: Device: Shear Wave Elastography

Study type: Observational

Funder types: Other

Identifiers

NCT03456778

IRB00096405

Details and patient eligibility

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 standard of care treatment.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

150 participants in 2 patient groups

Shear Wave Elastography for Asymptomatic Volunteers

Description:

Patients with extremity pain but without tendon involvement will have tendon imagining using shear wave elastography.

Treatment:

Device: Shear Wave Elastography

Shear Wave Elastography Symptomatic Volunteers

Description:

Patients diagnosed with tendinopathy will have tendon imagining using shear wave elastography. Participants may have the option to have repeated imaging to examine tendon healing for up to a year after receiving standard of care treatment.

Treatment:

Device: Shear Wave Elastography