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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Injection of autologous platelet rich plasma (PRP)
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.
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.
University of Wisconsin, Madison
Madison, Wisconsin, United States
Change in Measure of Pain Level: VISA-P Score
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.
Time frame: baseline, 16 weeks, 32 weeks, 52 weeks
Change in Measure of Activity Level: Tegner Activity Level Score
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.
Time frame: baseline, 16 weeks, 32 weeks, 52 weeks
Change in Visual Analogue Scale (VAS) Pain Score
Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).
Time frame: baseline, 16 weeks, 32 weeks, 52 weeks
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Time frame: baseline, 16 weeks, 52 weeks
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Time frame: baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.
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Time frame: baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
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.
Time frame: baseline, 16 weeks, 52 weeks
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline
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.
Time frame: baseline, 16 weeks, 52 weeks