Back to resultsPlatelet-Rich Plasma Therapy for Patellar Tendinopathy (PRP)
Primary Purpose
Patellar Tendinitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRP
Dry Needling
Dry Needling - Sham
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Tendinitis
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin, Madison
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Sham Comparator
Arm Label
Platelet-Rich Plasma (PRP)
Dry Needling Procedure
Sham Procedure
Arm Description
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Outcomes
Primary Outcome Measures
Measure of pain level
A quality of life measure, the VISA-P will be used to evaluate pain before and after the intervention.
Measure of activity level
A quality of life measure, the VISA-P will be used to evaluate activity level before and after the intervention.
Secondary Outcome Measures
MRI Scan To demonstrate treatment-related changes in pathologic imaging features of PT (thickness and T2 signal intensity).
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Ultrasound Scan to demonstrate treatment-related changes in pathologic imaging features of PT (thickness, echogenicity, and hyperemia)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.
Isokinetic Dynamometer measure of flexor and extensor muscle strength before and after the intervention
Flexor and extensor muscle strength will be measured with this device before and after the intervention.
Full Information
NCT ID
NCT03136965
First Posted
April 6, 2017
Last Updated
January 19, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
General Electric
1. Study Identification
Unique Protocol Identification Number
NCT03136965
Brief Title
Platelet-Rich Plasma Therapy for Patellar Tendinopathy
Acronym
PRP
Official Title
Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
General Electric
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Subjects and assessors will be blinded to the subject group allocation. Subjects will be identified to study personnel using a unique study number only and results of the imaging studies will be blinded, batched, and evaluated in a randomized manner.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet-Rich Plasma (PRP)
Arm Type
Experimental
Arm Description
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
Arm Title
Dry Needling Procedure
Arm Type
Placebo Comparator
Arm Description
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Arm Title
Sham Procedure
Arm Type
Sham Comparator
Arm Description
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
Injection of autologous platelet rich plasma (PRP)
Intervention Type
Procedure
Intervention Name(s)
Dry Needling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dry Needling - Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure of pain level
Description
A quality of life measure, the VISA-P will be used to evaluate pain before and after the intervention.
Time Frame
52 weeks
Title
Measure of activity level
Description
A quality of life measure, the VISA-P will be used to evaluate activity level before and after the intervention.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
MRI Scan To demonstrate treatment-related changes in pathologic imaging features of PT (thickness and T2 signal intensity).
Description
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Time Frame
52 weeks
Title
Ultrasound Scan to demonstrate treatment-related changes in pathologic imaging features of PT (thickness, echogenicity, and hyperemia)
Description
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.
Time Frame
52 weeks
Title
Isokinetic Dynamometer measure of flexor and extensor muscle strength before and after the intervention
Description
Flexor and extensor muscle strength will be measured with this device before and after the intervention.
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Relationship between changes in novel quantitative MRI and US parameters of PT and clinical and biomechanical improvement following treatment.
Description
To investigate the relationship between changes in novel quantitative MRI techniques and US parameters of PT and clinical and biomechanical improvement following treatment.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Lee, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Platelet-Rich Plasma Therapy for Patellar Tendinopathy
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