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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Platelet-Rich Plasma (PRP)
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
Biological: 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.
Procedure: Dry Needling
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.
Procedure: Dry Needling - Sham
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
General Electric

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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