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Achilles Tendinopathy Shear Wave Elastography Study

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ClinicalTrials.gov Identifier: NCT03456778
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Felix Gonzalez, Emory University

Brief 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.

Condition or disease Intervention/treatment Phase
Achilles Tendinopathy Procedure: Platelet-Rich Plasma Injection Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Efficacy of Ultrasound-Guided Needle Tenotomy-PRP Injection in the Treatment of Achilles Tendinopathy With Real Time Shear Wave Elastography (SWE)
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: Platelet-Rich Plasma Injection
Participants will receive a Platelet-Rich Plasma (PRP) injection to treat chronic tendinopathy
Procedure: Platelet-Rich Plasma Injection
7 cubic centimeters (cc) of blood will be collected and processed for the PRP injection. The site to be injected will be prepared with isopropyl alcohol and then sprayed with ethyl chloride to achieve cutaneous anesthesia. Next, with continuous sonographic visualization, the skin and subcutaneous tissues overlying the posterior mid-Achilles tendon will be infiltrated with 0.5% bupivacaine and 1% sodium bicarbonate (50 milliequivalents (mEq)/50 mL) via a 25-gauge hypodermic needle. Once adequate anesthesia is achieved, a 20-gauge needle will be used to repeatedly fenestrate the tendinotic portion of the tendon along the long plane. Any calcifications within the substance of the tendon will be mechanically fragmented. When the region of interest has been treated, a PRP injection (5 cc) will be delivered. Each patient will then be provided a post-procedure care form with specific information regarding initial physical activity limitation and return to normal activity.
Other Name: PRP




Primary Outcome Measures :
  1. Change in tendinopathy assessed by SWE [ Time Frame: Baseline, Month 3, Month 6 ]
    Shear wave elastography imaging will be used to assess the degree of tendon healing after percutaneous tenotomy and PRP injection. Markers for healing assessed by SWE will be determined in Part 1 of this study.

  2. Change in tendinopathy assessed by B mode sonographic imaging [ Time Frame: Baseline, Month 3, Month 6 ]
    Qualitative measures to assess the degree of tendon healing after percutaneous tenotomy and PRP injection will be measured by B mode sonographic imaging.

  3. Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) scale score [ Time Frame: Month 6, Month 9, Month 12 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456778


Contacts
Contact: Felix Gonzalez, MD 404-778-5834 felix.m.gonzalez@emory.edu

Locations
United States, Georgia
Emory Orthopaedics and Spine Center Recruiting
Atlanta, Georgia, United States, 30329
Contact: Felix Gonzalez, MD    404-778-5834    felix.m.gonzalez@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Felix Gonzalez, MD Emory University

Responsible Party: Felix Gonzalez, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03456778     History of Changes
Other Study ID Numbers: IRB00096405
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felix Gonzalez, Emory University:
Sonographic imaging
Platelet-rich plasma (PRP) injection
Shear Wave Elastography

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries