title: A Double-Blinded Placebo Randomized Controlled Trial Evaluating Short-term Efficacy of Platelet-Rich Plasma in Reducing Postoperative Pain After Arthroscopic Rotator Cuff Repair: A Pilot Study.
abstract: BACKGROUND
  We aimed to determine whether patients with arthroscopically repaired rotator cuff (RC) tears would have reduced pain and improved function after ultrasound-guided platelet-rich plasma (PRP) injections compared with placebo injection.
  
  
  OBJECTIVE
  PRP compared with placebo (saline) was more effective in reducing pain at the site of an RC injury that has undergone arthroscopic repair.
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  Level 2.
  
  
  METHODS
  We conducted a 2-centered, blinded, randomized controlled trial comparing the level of pain in patients undergoing arthroscopic repair. Patients were randomized to either PRP or saline (placebo). They received 2 ultrasound-guided injections of the randomized product: 1 intraoperatively and 1 at 4 weeks postoperatively. The primary outcome measure was shoulder pain demonstrated using a visual analog scale (VAS) at 6 weeks postoperatively. Secondary outcomes included the EuroQol-5 Dimensions (EQ-5D); the Western Ontario Rotator Cuff Index (WORC); and the Disabilities of the Arm, Shoulder, and Hand Score (DASH), as well as adverse events and revision surgeries. Patients were assessed clinically preoperatively and at 2, 4, and 6 weeks postsurgery. A prespecified interim analysis was conducted after 50% of patients were recruited and followed.
  
  
  RESULTS
  We recruited 25 patients when interim power analysis led to an early trial termination. Follow-up was 96%. The mean difference between groups was not statistically significant (-1.81; 95% CI, -4.3 to 1.2; P = 0.16). The EQ-5D, WORC, and DASH scores also did not show significant differences between groups at week 6 (P = 0.5, 0.99, and 0.9, respectively). There were no revision surgeries, and 4 adverse events (3 PRP, 1 saline).
  
  
  CONCLUSIONS
  There was no statistical difference in outcome measures when augmenting arthroscopically repaired RC tears with PRP.
  
  
  CONCLUSIONS
  Identifying therapies that improve outcomes in patients with RC tears remains a challenge and deserves ongoing investigation.
authors.affiliation: Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Alisha
authors.initials: A
authors.lastname: Hak
authors.affiliation: Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Krishan
authors.initials: K
authors.lastname: Rajaratnam
authors.affiliation: Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Olufemi R
authors.initials: OR
authors.lastname: Ayeni
authors.affiliation: Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Jaydeep
authors.initials: J
authors.lastname: Moro
authors.affiliation: Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Devin
authors.initials: D
authors.lastname: Peterson
authors.affiliation: Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada ; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Sheila
authors.initials: S
authors.lastname: Sprague
authors.affiliation: Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada ; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Mohit
authors.initials: M
authors.lastname: Bhandari
keywords: arthroscopy; pain; platelet-rich plasma; rotator cuff