Platelet-Rich Plasma Therapy for Patellar Tendinopathy (PRP)

October 4, 2023 updated by: University of Wisconsin, Madison

Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers

The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.

Study Overview

Detailed Description

Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different treatment options will be assessed by pain- and function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P) quality of life scores, activity level scores, knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin, Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 and 39 years
  2. Chronic (>3 months) PT
  3. Clinical examination consistent with PT
  4. MRI or US confirmation of PT
  5. Pain score of 3 or greater on a 10-point visual analogue scale
  6. Self-report failure of supervised physical therapy
  7. Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).

Exclusion Criteria:

  1. Inability to comply with study follow-up requirements
  2. History of bleeding disorders or other hematologic conditions
  3. Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction)
  4. Full or partial patellar tendon tear
  5. Current use of anticoagulation or immunosuppressive therapy
  6. Prior knee trauma requiring medical attention or surgery
  7. Worker's compensation injury
  8. Daily opioid use for pain
  9. Contraindication to MRI.
  10. Systemic diseases such as Diabetes and connective tissue diseases.
  11. Prior PRP or DN procedure.
  12. Women that are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet-Rich Plasma (PRP)
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
Injection of autologous platelet rich plasma (PRP)
Placebo Comparator: Dry Needling Procedure
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
Sham Comparator: Sham Procedure
Group 3 (sham) will undergo US-guided sham dry needling procedure.
This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Measure of Pain Level: VISA-P Score
Time Frame: baseline, 16 weeks, 32 weeks, 52 weeks
A quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain.
baseline, 16 weeks, 32 weeks, 52 weeks
Change in Measure of Activity Level: Tegner Activity Level Score
Time Frame: baseline, 16 weeks, 32 weeks, 52 weeks
The Tegner Activity Level Score will be used to evaluate activity level before and after the intervention. It is scored from 0-10 with 0 indicating disability and 10 competitive elite sport.
baseline, 16 weeks, 32 weeks, 52 weeks
Change in Visual Analogue Scale (VAS) Pain Score
Time Frame: baseline, 16 weeks, 32 weeks, 52 weeks
Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).
baseline, 16 weeks, 32 weeks, 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)
Time Frame: baseline, 16 weeks, 52 weeks
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
baseline, 16 weeks, 52 weeks
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
Time Frame: baseline, 16 weeks, 52 weeks
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
Time Frame: baseline, 16 weeks, 52 weeks
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.
baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
Time Frame: baseline, 16 weeks, 52 weeks
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Echogenicity is the grey scale images found on standard B-mode exams. The grey scale can change with pathology, therefore, the grading scale is implemented. The data reported are scores from a grading system, where 0 - normal; 1- mild; 2- moderate; 3- severe.
baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline
Time Frame: baseline, 16 weeks, 52 weeks
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Hyperemia means an increase in the number of blood vessels, it is scored on a semi-qualitative scale where 0 - normal; 1- mild; 2- moderate; 3- severe. If there's an improvement in hyperemia grading then the score decreases.
baseline, 16 weeks, 52 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isokinetic Dynamometer Measure of Flexor and Extensor Muscle Strength Before and After the Intervention
Time Frame: baseline, 16 weeks, 52 weeks
Flexor and extensor muscle strength will be measured with this device before and after the intervention.
baseline, 16 weeks, 52 weeks
Relationship Between Changes in Novel Quantitative MRI and US Parameters of PT and Clinical and Biomechanical Improvement Following Treatment.
Time Frame: 52 weeks
To investigate the relationship between changes in novel quantitative MRI techniques and US parameters of PT and clinical and biomechanical improvement following treatment.
52 weeks
Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single)
Time Frame: baseline, 16 weeks, 52 weeks
Exploratory MRI measure
baseline, 16 weeks, 52 weeks
T2* Fraction of Fast-relaxing Macromolecular-bound Water (FF)
Time Frame: baseline, 16 weeks, 52 weeks
baseline, 16 weeks, 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Kenneth Lee, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2017

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

August 15, 2022

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-0811
  • A539300 (Other Identifier: UW Madison)
  • SMPH/RADIOLOGY/RADIOLOGY* (Other Identifier: UW Madison)
  • Protocol Ver 0.15, 12/23/2021 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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