Phase 2
N=29
Platelet-Rich Plasma Therapy for Patellar Tendinopathy
Patellar Tendinitis
Bottom Line
View on ClinicalTrials.gov: NCT03136965 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Change in Measure of Pain Level: VISA-P Score — 32.2; 46.3; 43.2; 52.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PRP (Biological); Dry Needling (Procedure); Dry Needling - Sham (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Measure of Pain Level: VISA-P Score |
32.2; 46.3; 43.2; 52.5; 56.9; 53.7 | — |
| PRIMARY Change in Measure of Activity Level: Tegner Activity Level Score |
2.8; 5; 5.3; 3.5; 4.5; 4.6 | — |
| PRIMARY Change in Visual Analogue Scale (VAS) Pain Score |
5.9; 5.5; 6.1; 2.5; 4.2; 2.9 | — |
| SECONDARY MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity) |
— | — |
| SECONDARY MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) |
— | — |
| SECONDARY Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) |
6.6; 5.2; 7; 6.5; 5.4; 7 | — |
| SECONDARY Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline |
1.3; 1.5; 1.4; 1.3; 1.3; 1.9 | — |
| SECONDARY Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline |
1.1; 0.6; 1.4; 0.7; 0.4; 1.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03136965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.