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NCT Number: NCT03136965

Platelet-Rich Plasma Therapy for Patellar Tendinopathy

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.

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Key information

Conditions

Patellar Tendinitis

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP

Biological

Injection of autologous platelet rich plasma (PRP)

dry needling

Procedure

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.

Dry Needling - Sham

Procedure

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.

Primary outcomes

  1. Change in Measure of Pain Level: VISA-P Score

    Time frame: 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.

  2. Change in Measure of Activity Level: Tegner Activity Level Score

    Time frame: 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.

  3. Change in Visual Analogue Scale (VAS) Pain Score

    Time frame: 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 outcomes

  1. MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)

    Time frame: baseline, 16 weeks, 52 weeks

    To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.

  2. MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)

    Time frame: baseline, 16 weeks, 52 weeks

    To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.

  3. Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)

    Time frame: baseline, 16 weeks, 52 weeks

    To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.

  4. Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline

    Time frame: 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.

  5. Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline

    Time frame: 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.

Other outcomes

  1. Isokinetic Dynamometer Measure of Flexor and Extensor Muscle Strength Before and After the Intervention

    Time frame: baseline, 16 weeks, 52 weeks

    Flexor and extensor muscle strength will be measured with this device before and after the intervention.

  2. Relationship Between Changes in Novel Quantitative MRI and US Parameters of PT and Clinical and Biomechanical Improvement Following Treatment.

    Time frame: 52 weeks

    To investigate the relationship between changes in novel quantitative MRI techniques and US parameters of PT and clinical and biomechanical improvement following treatment.

  3. Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single)

    Time frame: baseline, 16 weeks, 52 weeks

    Exploratory MRI measure

  4. T2* Fraction of Fast-relaxing Macromolecular-bound Water (FF)

    Time frame: baseline, 16 weeks, 52 weeks

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • General Electric

Registry information

Official study title

Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers

Acronym: PRP

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 2, 2017
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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