Study protocol for a double-blind, randomised placebo-controlled trial evaluating clinical effects of platelet-rich plasma injection for acute grade-2 hamstring tear among high performance athletes

Abstract

IntroductionHamstring injury among athletes often results in significant morbidity. Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.Methods and analysisThis study is a single-centre double-blind randomised placebo-controlled trial. Sixty-eight patients will be randomised to receive under ultrasound guidance either a single injection of leucocyte-rich PRP (LR-PRP) or normal saline. All patients will undergo a standardised hamstring rehabilitation programme under the supervision of a sports physiotherapist. Outcome data will be collected before intervention (baseline), and thereafter on a weekly basis. The primary outcome measure is the duration to return-to-play. It is defined as the duration (in days) from the date on which the injury occurred until the patients were pain-free, able to perform the active knee extension test and have regained hamstring muscle strength. Secondary outcome measures include assessment of pain intensity and the effect of pain on to day-to-day functions using the self-reported Brief Pain Inventory—Short Form questionnaire. Both the primary and secondary outcomes were assessed at baseline and thereafter once a week until return to play. Also, hamstring injury recurrence within the first 6 months after recovery will be monitored via telephone. The results of this study will provide insights into the effect of LR-PRP in muscle and may help to identify the best PRP application protocol for muscle injuries.Ethics and disseminationEthics approval were obtained from the Medical Research Ethics Committee of the University of Malaya Medical Centre. Results of this trial will be submitted for publication in a peer-reviewed journal.Trial registration numberISRCTN76844299.