Recruiting

Shear Wave Elastography

Sponsor:

Emory University

Code:

NCT03456778

Conditions

Tendinopathy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Shear Wave Elastography

Study Details

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.

Conditions

Tendinopathy

Study ID

NCT03456778

Start date

Feb 27, 2018

Status verified date

Jul, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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 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.

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.

Primary outcome measure

  • Viscoelastic Tendon Property [ Time Frame: Baseline ]
  • Change in Tendon Healing [ Time Frame: Baseline, Month 3, Month 6, Month 12 ]
  • Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score [ Time Frame: Month 6, Month 9, Month 12 ]
  • Change in Victorian Institute of Sport Assessment - Patellar Tendon (VISA-P) Score [ Time Frame: Month 6, Month 9, Month 12 ]
  • Change in The Foot & Ankle Disability Index (FADI) Score [ Time Frame: Month 6, Month 9, Month 12 ]
  • Change in The Foot & Ankle Disability Index (FADI) Sport Score [ Time Frame: Month 6, Month 9, Month 12 ]

Central Contacts and Locations

Central contacts

David Reiter, PhD

404-778-6098dareite@emory.edu

Locations

Emory Orthopaedics and Spine Center

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Aug 14, 2025

Last verified

Jul, 2025

Keywords

  • Sonographic imaging
  • Shear Wave Elastography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-08-14.