Clinical trial NCT03456778: Assessing the Tendons With Shear Wave Elastography
Official title: Assessing the Efficacy of the Treatment of Tendinopathy With Shear Wave Elastography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tendinopathy
Keywords: Sonographic imaging
Shear Wave Elastography
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the Emory Orthopaedics and Spine Center who are asymptomatic or symptomatic for tendinopathy.

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.

Eligibility 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

Primary outcomes:
measure: Viscoelastic Tendon Property
timeFrame: Baseline
measure: Change in Tendon Healing
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score
timeFrame: Month 6, Month 9, Month 12
measure: Change in Victorian Institute of Sport Assessment - Patellar Tendon (VISA-P) Score
timeFrame: Month 6, Month 9, Month 12
measure: Change in The Foot & Ankle Disability Index (FADI) Score
timeFrame: Month 6, Month 9, Month 12
measure: Change in The Foot & Ankle Disability Index (FADI) Sport Score
timeFrame: Month 6, Month 9, Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Orthopaedics and Spine Center
state: Georgia
Study officials:
affiliation: Emory University
name: David Reiter, PhD
role: PRINCIPAL_INVESTIGATOR
References: