Trial record 5 of 49 for:    Open Studies | "Tendinopathy"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01911650
First received: July 23, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention
Achilles Tendinopathy
Other: Autologous Platelet Rich Plasma
Other: Ultrasound Imaging
Other: Quality of Life Questionnaires

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Structure and Biomechanical function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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:
  • Quality of Life Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911650

Contacts
Contact: Janice Yakey, RN 608-265-3018 jyakey@uwhealth.org
Contact: Deborah Gawin, RN 608-265-8580 dgawin@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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01911650     History of Changes
Other Study ID Numbers: 2012-0908
Study First Received: July 23, 2013
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration
United States: University of Wisconsin Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Achilles
tendinopathy

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

ClinicalTrials.gov processed this record on July 31, 2014