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Biological
PRP for Patellar Tendinitis (PRP Trial)
Phase 2
Waitlist Available
Led By Kenneth Lee, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 16 weeks, 32 weeks, 52 weeks
Summary
This trial is testing three treatments for knee pain caused by patellar tendinopathy. One group will get a platelet-rich plasma injection, another will have dry needling, and the last will have a needle procedure. The goal is to see which treatment helps reduce pain and improve knee function. Platelet-rich plasma (PRP) injections have been shown to enhance functional capacity and alleviate pain in knee osteoarthritis, and dry needling is used for pain management in various knee pain syndromes.
Eligible Conditions
- Patellar Tendinitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 16 weeks, 32 weeks, 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 16 weeks, 32 weeks, 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Measure of Activity Level: Tegner Activity Level Score
Change in Measure of Pain Level: VISA-P Score
Change in Visual Analogue Scale (VAS) Pain Score
Secondary study objectives
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
+2 moreOther study objectives
Isokinetic Dynamometer Measure of Flexor and Extensor Muscle Strength Before and After the Intervention
Relationship Between Changes in Novel Quantitative MRI and US Parameters of PT and Clinical and Biomechanical Improvement Following Treatment.
Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Platelet-Rich Plasma (PRP)Experimental Treatment1 Intervention
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
Group II: Dry Needling ProcedurePlacebo Group1 Intervention
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Group III: Sham ProcedurePlacebo Group1 Intervention
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRP
2014
Completed Phase 4
~1860
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,217 Previous Clinical Trials
3,163,326 Total Patients Enrolled
General ElectricIndustry Sponsor
46 Previous Clinical Trials
12,367 Total Patients Enrolled
Kenneth Lee, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
20 Total Patients Enrolled
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