Achilles Tendinopathy Shear Wave Elastography Study
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/6/2019 |
| Start Date: | February 27, 2018 |
| End Date: | December 2019 |
| Contact: | Felix Gonzalez, MD |
| Email: | felix.m.gonzalez@emory.edu |
| Phone: | 404-778-5834 |
Assessing the Efficacy of Ultrasound-Guided Needle Tenotomy-PRP Injection in the Treatment of Achilles Tendinopathy With Real Time Shear Wave Elastography (SWE)
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.
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.
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.
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.
Part One
Inclusion Criteria for Asymptomatic Volunteers:
- 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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