Platelet-Rich Plasma Therapy for Patellar Tendinopathy

Phase 2

Completed

Conditions: Patellar Tendinitis

Interventions: Biological: PRP
Procedure: Dry Needling
Procedure: Dry Needling - Sham

Registration Number: NCT03136965

Lead Sponsor: University of Wisconsin, Madison

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet-Rich Plasma (PRP)	PRP	Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
Dry Needling Procedure	Dry Needling	Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Sham Procedure	Dry Needling - Sham	Group 3 (sham) will undergo US-guided sham dry needling procedure.

Primary Outcome Measures

Name	Time	Method
Change in Measure of Pain Level: VISA-P Score	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.
Change in Measure of Activity Level: Tegner Activity Level Score	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.
Change in Visual Analogue Scale (VAS) Pain Score	baseline, 16 weeks, 32 weeks, 52 weeks	Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).

Secondary Outcome Measures

Name	Time	Method
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)	baseline, 16 weeks, 52 weeks	To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)	baseline, 16 weeks, 52 weeks	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)	baseline, 16 weeks, 52 weeks	To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline	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.
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline	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.