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

NCT01911650 | Completed

• 1 other identifier: 2012-0908
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Achilles Tendinitis

Keywords

Achilles; tendinopathy

Outcome Measures

Primary Outcomes (1)

• Structure and Biomechanical function

  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.

  12 weeks

Secondary Outcomes (1)

• Quality of Life Assessment

  12 weeks

Study Arms (2)

Autologous Platlet Rich Plasma

EXPERIMENTAL

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; Other: Ultrasound Imaging; Other: Quality of Life Questionnaires

Waitlist

OTHER

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; Other: Quality of Life Questionnaires

Interventions

Autologous Platelet Rich Plasma OTHER

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.

Autologous Platlet Rich Plasma

Ultrasound Imaging OTHER

A conventional ultrasound in addition to AE and shear wave imaging (SWI) will be administered.

Autologous Platlet Rich Plasma; Waitlist

Quality of Life Questionnaires OTHER

This questionnaire is a self-report of pain and function associated with the Achilles tendon.

Also known as: Victorian Institute of Sports Assessment - Achilles (VISA-A)

Autologous Platlet Rich Plasma; Waitlist

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 years, inclusive
• 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
• self-reported AT-related pain for at least 6 months and VAS (Visual Analog Scale) pain \>5 (0-10 scale)
• self-reported failure of eccentric exercise protocol (at least 75% completion)
• self-reported failure of at least 2 of the 3 most common treatments for AT (NSAIDS, rest/ice or taping)
• patient considered surgery but decided to wait and/or refused surgery -

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Tendinopathy

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Kenneth Lee, MD

  UW Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 30, 2013
• Study Start: June 1, 2013
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

US (1)