A double blind randomised control trial investigating the efficacy of platelet rich plasma versus placebo for the treatment of greater trochanteric pain syndrome

Abstract

Introduction: Greater trochanteric pain syndrome (GTPS) is a painful condition that significantly impairs patients’ quality of life. The purpose of this clinical trial was to evaluate the effectiveness of ultrasound-guided Leukocyte-rich platelet-rich plasma (LR-PRP) injections in the treatment of GTPS. Materials and Methods: An ethically approved, adequately powered, double-blinded RCT was conducted to evaluate the clinical outcomes in randomised LR-PRP and Placebo groups using the International Hip Outcome Tool-12 (iHOT12), Visual Analogue Scale (VAS), the modified Harris Hip Score (mHHS), the three-level version of the EuroQol five-dimensional (EQ5D-3L), Minimal Clinically Important Difference (MCID) and the presence or absence of complications. Results: The final analysis included 78 patients (39 in each group). The iHOT12 and mHHS scores improved significantly from respective baselines in both groups at three-and sixmonths follow-ups (P <0.05). At the same time, no statistically significant difference was observed between the two groups at both follow-ups (P >0.05). Fourteen patients achieved scores over the iHOT12-MCID in the PRP group and 18 in the placebo group at three months. At six months, fifteen patients achieved over the iHOT12-MCID in the PRP group and 17 in the placebo group. The differences between the groups were not statistically significant at three- and six-months (P 0.482 and P 0.808, respectively). The VAS and EQ5D-3L scores improved from baselines at three and six months in both groups, with no statistically significant difference observed between the two groups (P >0.05). A two-way ANOVA revealed BMI, age and gender had no effect on outcomes. No complications were reported in the two groups. Conclusions: This superiority trial concluded that both groups achieved statistically significant improvement from baseline; however, there was no significant difference between the two groups. The results did not reject the null hypothesis that LR-PRP is not superior to placebo; hence the routine use of PRP is not justified.