Assessing the Tendons With Shear Wave Elastography

NCT03456778 | Recruiting

• 1 other identifier: IRB00096405
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Sonographic imaging; Shear Wave Elastography

Outcome Measures

Primary Outcomes (6)

• Viscoelastic Tendon Property

  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.

  Baseline

• Change in Tendon Healing

  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.

  Baseline, Month 3, Month 6, Month 12

• Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score

  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.

  Month 6, Month 9, Month 12

• Change in Victorian Institute of Sport Assessment - Patellar Tendon (VISA-P) Score

  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.

  Month 6, Month 9, Month 12

• Change in The Foot & Ankle Disability Index (FADI) Score

  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.

  Month 6, Month 9, Month 12

• Change in The Foot & Ankle Disability Index (FADI) Sport Score

  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.

  Month 6, Month 9, Month 12

Study Arms (2)

Shear Wave Elastography for Asymptomatic Volunteers

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

Device: 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.

Device: Shear Wave Elastography

Interventions

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.

Shear Wave Elastography Symptomatic Volunteers; Shear Wave Elastography for Asymptomatic Volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at the Emory Orthopaedics and Spine Center who are asymptomatic or symptomatic for tendinopathy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• David Reiter, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Reiter, PhD

CONTACT

404-778-6098; dareite@emory.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 7, 2018
• Study Start: February 27, 2018
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)