Assessing the Tendons With Shear Wave Elastography

Tendinopathy Clinical Trial

Official title: Assessing the Efficacy of Ultrasound-Guided Needle Tenotomy/PRP Injection in the Treatment of Tendinopathy With Real Time Shear Wave Elastography

Status Recruiting

Clinical Trial 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 tendons, such as the Achilles, patellar, quadriceps, epicondylar, and rotator cuff, 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 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 tendon healing.

Clinical Trial 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 the study aims to establish the difference between asymptomatic and symptomatic 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) 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. ;

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

• NCT number: NCT03456778
• Study type: Interventional
• Source: Emory University
• Contact: David Reiter, PhD
• Phone: 404-778-6098
• Email: dareite@emory.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2018
• Completion date: November 2023