PEAK Platelet Rich Plasma Injection Treatment for Chronic Lateral Epicondylosis
Condition: Chronic Lateral Epicondylosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed project will be the first to assess pain- and function-dependent, elbow-specific
      quality of life and in-vivo mechanical properties of common extensor tendons post-treatment
      with PRP in a Level 1, RCT with subject and assessor blinding. The valuable data gained will
      significantly add to the knowledge base of treatment effects of PRP for a chronic
      tendinopathy. Positive findings of PRP compared to control (corticosteroid injection) would
      suggest future larger scale studies to help establish an optimal protocol for the nonsurgical
      management of CLE. Correlating US and shear wave acoustoelastography imaging assessments with
      validated clinical outcomes will provide a powerful tool for future outcomes analyses using a
      non-invasive imaging modality to monitor tissue healing both morphologically as well as
      biomechanically, and may even be used to evaluate injury risk.
    

Detailed description: 
      Randomization procedures Subjects will be randomized to 1 of 2 study arms. Subjects in Group
      1 (PRP) will receive a single ultrasound-guided intratendinous (common extensor tendon
      origin) injection of up to 3 mL autologous PEAK platelet-rich plasma at week 0 (baseline).
      Subjects in Group 2 (corticosteroid control) will receive a single ultrasound-guided
      intratendinous injection approximately (may be limited by tendon/soft tissue limitations of
      the subject) of 2 mL 1% lidocaine + 1mL of him 40mg Kenalog (triamcinolone hexacetonide,
      40mg/mL) at week 0. If a subject has bilateral elbow common extensor tendon pain, both elbows
      will be treated in the same study arm.

      Blinding: Subjects and assessors will be blinded to the subject group allocation. Control
      subjects will also undergo phlebotomy to maintain blinding. Injection syringes will be
      cloaked using opaque adhesive tape in order to ensure the injector is unaware of subject
      treatment allocation. Subjects will be identified to study personnel using a unique study
      number only and results of the imaging studies will be blinded, batched and evaluated in a
      randomized manner.

      Ultrasound imaging analyses will be conducted at baseline, 26 weeks, and 52 weeks post
      treatment.

      The platelet concentration will be analyzed in both samples (whole blood compared to PRP) in
      order to record and verify the consistency of the concentration factor in PRP.

      Shear wave ultrasound imaging will be compared using comparison of average shear wave speed
      (SWS) between baseline and post treatment 52 week follow-up between the two randomized
      groups. Shear wave speed is a quantitative measure obtained by measuring speed of ultrasound
      in a selected region of interest (ROI). In prior studies, the study team has successfully
      blinded the investigator when selecting the ROI, and conducted inter-rater repeatability
      analysis showing that this was a valid, repeatable way of measuring SWS in a particular ROI.

      For patients:Total of 9 visits Initial Screen - Initial Eligibility Screening Baseline -
      Informational Meeting: Secondary eligibility screen, enrollment (informed consent),
      questionnaires; Grip Strength Test; Ultrasound and SWAE imaging Week 0 Intervention -
      Injection of PRP under ultrasound Weeks 4, 8, 12, 16 - Questionnaires: QUICK-DASH, SF-12,
      PRTEE, SANE-ELBOW, PRP Satisfaction; Grip Strength Test Week 26 - Questionnaires: QUICK-DASH,
      SF-12, PRTEE, SANE-ELBOW, PRP Satisfaction; Grip Strength Test; Ultrasound and SWAE imaging
      Week 52 - Questionnaires: QUICK-DASH, SF-12, PRTEE, SANE-ELBOW, PRP Satisfaction; Grip
      Strength Test; Ultrasound and SWAE imaging
    

Intervention name(s): Platelet Rich Plasma - Group 1; Corticosteroid Control - Group 2
Intervention type(s): Biological; Drug
Intervention description(s): Subjects in Group 1 (PRP) will receive a single ultrasound-guided intratendinous (common extensor tendon origin) injection of up to 3 mL autologous PEAK platelet-rich plasma at week 0 (baseline).; Subjects in Group 2 (corticosteroid control) will receive a single ultrasound-guided intratendinous injection approximately (may be limited by tendon/soft tissue limitations of the subject) of 2 mL 1% lidocaine + 1mL of him 40mg Kenalog (triamcinolone hexacetonide, 40mg/mL) at week 0.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CLE; epicondylosis; platelet rich plasma; PRP; ultrasound; shear wave ultrasound; tendinopathy; elbow; tenis elbow; plasma; plasma injection; tendinosis; tendinitis