title: IMpact of Platelet Rich plasma OVer alternative therapies in patients with lateral Epicondylitis (IMPROVE): protocol for a multicenter randomized controlled study: a multicenter, randomized trial comparing autologous platelet-rich plasma, autologous whole blood, dry needle tendon fenestration, and physical therapy exercises alone on pain and quality of life in patients with lateral epicondylitis.
abstract: BACKGROUND
  Lateral epicondylitis, commonly known as tennis elbow, is the most common cause of lateral elbow pain and the second most frequently diagnosed musculoskeletal disorder in the neck and upper limb in a primary care setting. Many therapeutic options, including conservative, surgical, and minimally invasive procedures, have been advocated for the treatment of lateral epicondylitis. Although numerous small studies have been performed to assess the efficacy of various treatments, there are conflicting results with no clear consensus on the optimal treatment. In an economic environment with limited health care resources, it is paramount that optimal cost-effective therapies with favorable patient-important outcomes be identified.
  
  
  METHODS
  This is a protocol paper which outlines a multicenter, multidisciplinary, single-blinded, four-arm randomized controlled trial, comparing platelet-rich plasma (PRP), whole blood injection, dry needle tendon fenestration, and sham injection with physical therapy alone for the treatment of lateral epicondylitis. Patients are screened based on pre-established eligibility criteria and randomized to one of the four study groups using an Internet-based system. The patients are followed at 6-week, 12-week, 24-week, and 52-week time points to assess the primary and secondary outcomes of the study. The primary outcome is pain. Secondary outcomes include health-related quality of life and ultrasound appearance of the common extensor tendon. Two university centers (McMaster University and the University of Michigan) are currently recruiting patients. We have planned a sample size of 100 patients (25 patients per arm) to ensure over 80% power to detect a three-point difference in pain scores at 52 weeks of follow-up.
  
  
  BACKGROUND
  This study has ethics approval from the McMaster University Research Ethics Board (REB# 12-146) and the University of Michigan Institutional Review Board (IRB# HUM00067750). Successful completion of this proposed study will significantly impact clinical practice and enhance patients' lives. More broadly, this trial will develop a network of collaboration from which further high-quality trials in ultrasound-guided interventions will follow.
authors.affiliation: Department of Diagnostic Imaging, Hamilton General Hospital and McMaster University, 237 Barton St East, Hamilton, Ontario, Canada L8L 2X2. Electronic address: chiavamm@mcmaster.ca.
authors.forename: Mary M
authors.initials: MM
authors.lastname: Chiavaras
authors.affiliation: Department of Radiology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Jon A
authors.initials: JA
authors.lastname: Jacobson
authors.affiliation: Department of Radiology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Ruth
authors.initials: R
authors.lastname: Carlos
authors.affiliation: Department of Physical Medicine and Rehabilitation, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Eugene
authors.initials: E
authors.lastname: Maida
authors.affiliation: Department of Physical Medicine and Rehabilitation, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Todd
authors.initials: T
authors.lastname: Bentley
authors.affiliation: Department of Orthopaedic Surgery, Hamilton General Hospital, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Nicole
authors.initials: N
authors.lastname: Simunovic
authors.affiliation: Department of Orthopaedic Surgery, Hamilton General Hospital, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Marilyn
authors.initials: M
authors.lastname: Swinton
authors.affiliation: Department of Orthopaedic Surgery, Hamilton General Hospital, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Mohit
authors.initials: M
authors.lastname: Bhandari
mesh_terms: D000293:Adolescent; D000328:Adult; D001804:Blood Transfusion, Autologous / Q000379:methods; D000529:Complementary Therapies / Q000379:methods; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009339:Needles; D010146:Pain / Q000209:etiology; D059408:Pain Management / Q000379:methods*; D017713:Platelet Transfusion / Q000379:methods*; D053657:Platelet-Rich Plasma; D011788:Quality of Life; D016037:Single-Blind Method; D013710:Tendons; D013716:Tennis Elbow / Q000150:complications / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Lateral epicondylitis; dry needle tendon fenestration; platelet-rich protein; randomized controlled trial; whole blood injection