Platelet Rich Plasma (PRP) in Chronic Epicondylitis
Condition: Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 3

Summary: 
      Background Tendinopathy is a difficult problem to manage and can result in significant
      patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but
      its efficacy remains controversial. Current experimental research postulates different
      efficiency among PRP formulations.Recent reviews showed that most clinical studies in
      tendinopathies have been performed with L-PRP. The investigators aim to examine the efficacy
      of pure-PRP in the management of epicondylitis.

      The investigators hypothesized that pure PRP associated to needling intervention can enhance
      tendon healing in epicondylitis, improve function and reduce pain.

      Methods and design Randomized double blind controlled trial, a total of 80 patients will be
      randomly allocated into one of two groups: PRP or control. Interventions: PRP group,
      ultrasound (US)guided needling associated to delivery of multiple PRP depots each alternate
      week for a total of two interventions. Control Group: US-guided needling with lidocaine each
      alternate week for a total of two interventions. Main outcome measure: Changes in pain and
      activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH)outcome
      measure score, before and six months after intervention.The primary end-point is 25%
      reduction in DASH. The investigators will compare the percentage of patients, in each group,
      that achieve a successful treatment defined as a reduction of at least 25% in the DASH score.

      Secondary outcome measures:Changes in pain and function as assessed by DASH and changes in
      pain as assessed by the visual analogue scale (VAS)at the 3, 6 and 12 month follow-up.
      Changes in sonographic features and neovascularity at 3, 6 and 12 months.
    


Intervention name(s): US-guided tenotomy with PRP; US-guided tenotomy with lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): Blood will be drawn from the patient from the patient's unaffected arm. the anti-coagulated blood will be centrifuged and pure-PRP (without leukocytes) collected.
Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; PRP will be delivered in multiple depots during the procedure; Blood will be drawn from the patient from the patient's unaffected arm. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; lidocaine will be delivered in multiple depots during the procedure
Other intervention name(s): pure-PRP (without leukocytes); local anesthetic
Intervention MeSH terms: Lidocaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet Rich Plasma; tendinopathy; epicondylitis; ultrasound; injection therapy; needle tenotomy