- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03136965
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
Completed
Conditions
Intervention / Treatment
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
- Name: Suzanne Hanson, BS
- Phone Number: 608.263.7421
- Email: shanson@uwhealth.org
Study Locations
-
-
Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin, Madison
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-
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:
- Age between 18 and 39 years
- Chronic (>3 months) PT
- Clinical examination consistent with PT
- MRI or US confirmation of PT
- Pain score of 3 or greater on a 10-point visual analogue scale
- Self-report failure of supervised physical therapy
- 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:
- Inability to comply with study follow-up requirements
- History of bleeding disorders or other hematologic conditions
- Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction)
- Full or partial patellar tendon tear
- Current use of anticoagulation or immunosuppressive therapy
- Prior knee trauma requiring medical attention or surgery
- Worker's compensation injury
- Daily opioid use for pain
- Contraindication to MRI.
- Systemic diseases such as Diabetes and connective tissue diseases.
- Prior PRP or DN procedure.
- 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.
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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.
Sponsor
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
Additional Relevant MeSH Terms
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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