Achilles Tendinopathy Shear Wave Elastography Study

  • STATUS
    Recruiting
  • End date
    Dec 3, 2022
  • participants needed
    15
  • sponsor
    Emory University
Updated on 27 February 2022

Summary

The purpose of this prospective study is to utilize a real-time ultrasound modality known as real-time Shear Wave Elastography (SWE) to first study the viscoelastic properties of the Achilles tendon to understand the functional differences between normal/asymptomatic vs tendinotic/symptomatic tendon states. The secondary aim will be to assess the degree of tendon healing after percutaneous tenotomy (a minimally invasive technique that can be used to treat tendinosis) and Platelet-Rich Plasma (PRP) targeting mid-substance Achilles tendinopathy. Utilizing a quantitative tool to assess healing response to percutaneous tendon fenestration and PRP injection may have significant clinical implications because it will provide insight into the mechanism of Achilles tendon healing.

Description

Achilles 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 and the exact pathogenesis of this disease has not been clarified scientifically.

The first part of the study aims to establish the difference between asymptomatic and symptomatic Achilles tendons by correlating elastography measurements (axial and sagittal mean velocity and relative anisotropic coefficient) with more standard clinically based outcome measures. Shear Wave Elastography (SWE) will be used with a small group of patients affected by moderate-to-severe, chronic (>6 months of symptoms) midsubstance Achilles tendinopathy in comparison to asymptomatic patients.

After establishing a range of normal to severe pathologic elastography measurements the researchers will conduct a 12-month clinical trial to determine whether percutaneous needling with PRP injection improves disease-specific clinical outcomes. PRP injection is commonly used in clinical practice to treat chronic tendinopathy. The pathophysiology is believed to be mediated through a variety of growth factors, including platelet-derived growth factor, transforming growth factor, and insulin-like growth factor, that promote a healing response. One of the main advantages is that PRP is autologous and is prepared at the time of treatment (point of care). It has an excellent safety profile with almost no side effects. SWE imaging will then be used to assess degree of tendon healing following tenotomy-PRP injection.

Details
Condition Achilles Tendinopathy
Treatment platelet-rich plasma injection
Clinical Study IdentifierNCT03456778
SponsorEmory University
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients presenting at the study location with lower extremity pain without Achilles tendon involvement
Inclusion Criteria for Symptomatic Volunteers
Patients presenting at the study location with a clinical diagnosis of achillodynia
Diagnosis of tendinopathy confirmed by ultrasound

Exclusion Criteria

Pregnancy
History of Achilles tendinopathy or surgery and morphologic abnormalities (high grade tears) at US (B-mode and/or power Doppler)
History of systemic, metabolic, endocrine diseases, or psoriasis
History of treatment with corticosteroids, estrogens, long term quinolone antibiotics, and cholesterol drugs
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