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A Pilot Study: Treatment of Achilles Tendinopathy With Platelet-Rich Plasma Therapy

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ClinicalTrials.gov Identifier: NCT01911650
Recruitment Status : Recruiting
First Posted : July 30, 2013
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The overall goal of this proposal is to correlate ultrasound elastography technique with more standard clinically based outcome measures within the setting of a small sample sized group of patients affected by moderate-to- severe, chronic (>6months) midsubstance Achilles tendinopathy (AT).

Condition or disease Intervention/treatment
Achilles Tendinitis Other: Autologous Platelet Rich Plasma Other: Ultrasound Imaging Other: Quality of Life Questionnaires

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study Correlating Novel Ultrasound Elastography Techniques to Standard Clinical Outcomes in the Treatment of Achilles Tendinopathy With Platelet-Rich Plasma Therapy
Study Start Date : June 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2019

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Autologous Platlet Rich Plasma
This subject arm will receive one injection of autologous platelet rich plasma for the treatment of Achilles tendinopathy. In addition, they will be asked to undergo a palpatory exam of the Achilles tendon; complete Quality of Life Questionnaires at three different time points; and complete a 30 minute ultrasound imaging exam of the Achilles tendon.
Other: Autologous Platelet Rich Plasma
This procedure will include a single collection of 35 mL of peripheral blood. A two-stage spinning protocol will be used: the 1st separates red blood cells from platelets, and the 2nd concentrates the platelets to yield approximately 4 mL of concentrated autologous platelet. This layer of platelet rich plasma will be placed in the syringe by the centrifuge machine.
Other: Ultrasound Imaging
A conventional ultrasound in addition to AE and shear wave imaging (SWI) will be administered.
Other: Quality of Life Questionnaires
This questionnaire is a self-report of pain and function associated with the Achilles tendon.
Other Name: Victorian Institute of Sports Assessment - Achilles (VISA-A)
Waitlist
Subjects in this arm will have already received standard of care interventions for Achilles tendinopathy with unsatisfactory outcomes. For this research they will be asked to undergo a palpatory exam of the Achilles tendon; complete Quality of Life Questionnaires at three different time points; and complete a 30 minute ultrasound imaging exam of the Achilles tendon.
Other: Ultrasound Imaging
A conventional ultrasound in addition to AE and shear wave imaging (SWI) will be administered.
Other: Quality of Life Questionnaires
This questionnaire is a self-report of pain and function associated with the Achilles tendon.
Other Name: Victorian Institute of Sports Assessment - Achilles (VISA-A)


Outcome Measures

Primary Outcome Measures :
  1. Structure and Biomechanical function [ Time Frame: 12 weeks ]

    Primary outcome measure: Estimate ultrasound based changes consistent with disease modification in two ways:

    1. conventional ultrasound to assess Achilles tendon thickness, neovascularity, and hypoechogenicity.
    2. estimate AE and SWI variability and the correlations of AE and SWI with conventional ultrasound measures to plan future research.


Secondary Outcome Measures :
  1. Quality of Life Assessment [ Time Frame: 12 weeks ]
    Secondary outcome measure: Quality of life will be assessed with the VISA-A validated questionnaire of pain and function of the Achilles tendon. This measure will be administered at three time points.


Eligibility Criteria

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

Inclusion Criteria:

  1. age 18-65 years, inclusive
  2. diagnosis of moderate to severe AT, confirmed by Dr. Wilson using clinical symptoms and exam findings consistent with chronic AT (>6 month duration) - which includes pain while palpating the intratendinous swelling part of the Achilles tendon and relief of pain when tendon placed under tension - and pre-procedure US
  3. self-reported AT-related pain for at least 6 months and VAS (Visual Analog Scale) pain >5 (0-10 scale)
  4. self-reported failure of eccentric exercise protocol (at least 75% completion)
  5. self-reported failure of at least 2 of the 3 most common treatments for AT (NSAIDS, rest/ice or taping)
  6. patient considered surgery but decided to wait and/or refused surgery -

Exclusion Criteria:

  1. bilateral AT
  2. insertional AT
  3. local steroid injection within 6 weeks or physical therapy within 4 weeks
  4. inability to comply with follow-up criteria
  5. history of surgery on the Achilles tendon or systemic diseases (general inflammatory diseases such as rheumatologic disorders and diabetes)
  6. daily use of opioids for pain
  7. anticoagulation or immunosuppressive therapy
  8. intent to use NSAIDs or steroids
  9. self-reported pregnancy
Contacts and Locations

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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): NCT01911650


Contacts
Contact: Janice Yakey, RN 608-265-3018 jyakey@uwhealth.org
Contact: Jenny Swartz, RN 608-262-0770 jswartz@uwhealth.org

Locations
United States, Wisconsin
University of Wisconsin, Madison Recruiting
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Kenneth Lee, MD UW Madison
More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01911650     History of Changes
Other Study ID Numbers: 2012-0908
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by University of Wisconsin, Madison:
Achilles
tendinopathy

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