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

Alisha Hak, Krishan Rajaratnam, Olufemi R Ayeni, Jaydeep Moro, Devin Peterson, Sheila Sprague, Mohit Bhandari, Alisha Hak, Krishan Rajaratnam, Olufemi R Ayeni, Jaydeep Moro, Devin Peterson, Sheila Sprague, Mohit Bhandari

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.

Hypothesis: PRP compared with placebo (saline) was more effective in reducing pain at the site of an RC injury that has undergone arthroscopic repair.

Study design: Randomized controlled trial.

Level of evidence: 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).

Conclusion: There was no statistical difference in outcome measures when augmenting arthroscopically repaired RC tears with PRP.

Clinical relevance: Identifying therapies that improve outcomes in patients with RC tears remains a challenge and deserves ongoing investigation.

Keywords: arthroscopy; pain; platelet-rich plasma; rotator cuff.

Conflict of interest statement

The following authors declared potential conflicts of interest: Alisha Hak, BSc, and Sheila Sprague, PhD, received payment for writing or reviewing the manuscript from GRS Inc; Mohit Bhandari, MD, PhD, FRCSC, is a paid consultant for Smith & Nephew, Stryker, Amgen, Zimmer, Moximed, and Bioventus.<?release-delay 12|0>

Figures

Figure 1.
Figure 1.
Flow diagram of study methodology. PRP, platelet-rich plasma; VAS, visual analog scale.
Figure 2.
Figure 2.
Flow diagram of study participants. CAC, Central Adjudication Committee; PRP, platelet-rich plasma.
Figure 3.
Figure 3.
Mean VAS pain scores across follow-up time points for PRP and saline groups. PRP, platelet-rich plasma; VAS, visual analog scale.

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