A Double-Blinded Placebo Randomized Controlled Trial Evaluating Short-term Efficacy of Platelet-Rich Plasma in Reducing Postoperative Pain After Arthroscopic Rotator Cuff Repair

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.

Regenerative Sports Medicine: Past, Present, and Future (Adapted From the PASSOR Legacy Award Presentation; AAPMR; October 2016)

“…Published data are mixed with fewer robust studies for Achilles and patella tendinopathy, limiting our ability to draw conclusions about efficacy. Table 2 presents a list of studies [49‐89] and levels of evidence.…”

“…Reported no significant benefit from PRP but also suggested potential negative effects on rotator cuff healing. Hak et al (2015) [89] II 25 6 wk P: 10-12 mL (Â2 injections), NR; L: NR; R: NR; A: NR Reported early, underpowered studies demonstrating no significant benefit to pain or function of PRP augmentation during arthroscopic rotator cuff repair. The precise factors within BMAC responsible for its clinical effects are not clear.…”

Biological Treatments for Tendon and Ligament Abnormalities

“…We identified seventeen studies investigating the use of PRP as an adjunct for surgical repair of rotator cuff tears [2][3][4][19][20][21][22][23][24][25][26][27][28][29][30][31][32] , including thirteen randomized controlled trials (RCTs); one prospective cohort study; two casecontrol studies; and one cohort study involving a retrospective control group. The number of patients ranged from twenty to eighty-eight.…”

“…All patients were managed with arthroscopic rotator cuff repair; the studies varied as to whether concomitant procedures such as acromioplasty and/or biceps tenodesis were always performed, were performed if indicated, or resulted in exclusion of patients from the study. The most common outcome measures were (1) magnetic resonance imaging (MRI) assessment for the evaluation of retears and (2) clinical outcome scores, most commonly visual analog scale (VAS) scores [2][3][4]19,21,22,27,29,30,32 , the Disabilities of the Arm, Shoulder and Hand (DASH) score 3,21,22,30,32 , and the University of California at Los Angeles (UCLA) shoulder-rating scale 4,[19][20][21][22]24,27,31 .…”

“…Studies investigating pain and function in the immediate postoperative period also failed to show that PRP had a significant benefit with regard to reducing postoperative pain or accelerating the return of function 2,32 .…”