Clinical trial NCT03136965: Platelet-Rich Plasma Therapy for Patellar Tendinopathy
Official title: Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patellar Tendinitis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2017-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Measure of Pain Level: VISA-P Score
timeFrame: baseline, 16 weeks, 32 weeks, 52 weeks
measure: Change in Measure of Activity Level: Tegner Activity Level Score
timeFrame: baseline, 16 weeks, 32 weeks, 52 weeks
measure: Change in Visual Analogue Scale (VAS) Pain Score
timeFrame: baseline, 16 weeks, 32 weeks, 52 weeks
Secondary outcomes:
measure: MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)
timeFrame: baseline, 16 weeks, 52 weeks
measure: MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
timeFrame: baseline, 16 weeks, 52 weeks
measure: Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
timeFrame: baseline, 16 weeks, 52 weeks
measure: Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
timeFrame: baseline, 16 weeks, 52 weeks
measure: Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline
timeFrame: baseline, 16 weeks, 52 weeks
Other outcomes:
measure: Isokinetic Dynamometer Measure of Flexor and Extensor Muscle Strength Before and After the Intervention
timeFrame: baseline, 16 weeks, 52 weeks
measure: Relationship Between Changes in Novel Quantitative MRI and US Parameters of PT and Clinical and Biomechanical Improvement Following Treatment.
timeFrame: 52 weeks
measure: Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single)
timeFrame: baseline, 16 weeks, 52 weeks
measure: T2* Fraction of Fast-relaxing Macromolecular-bound Water (FF)
timeFrame: baseline, 16 weeks, 52 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kenneth Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: