Assessing the Tendons With Shear Wave Elastography

NCT ID: NCT03456778

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2026-07-31

Brief 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.

Detailed 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.

Conditions

Tendinopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Shear Wave Elastography for Asymptomatic Volunteers

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

Shear Wave Elastography

Intervention Type: 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.

Shear Wave Elastography Symptomatic Volunteers

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.

Shear Wave Elastography

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

David Reiter

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Reiter, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Orthopaedics and Spine Center

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Reiter, PhD

Role: CONTACT

dareite@emory.edu

404-778-6098

Other Identifiers

IRB00096405

Identifier Type: -

Identifier Source: org_study_id