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Protocol
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
  1. Mohamad Shariff A Hamid1,2,
  2. Kamarul Hashimy Hussein2,
  3. Ahmad Munawwar Helmi Salim2,
  4. Arshad Puji3,
  5. Rosnah Mat Yatim2,
  6. Chin Chee Yong2,
  7. Thomas Wong Yong Sheng2
  1. 1Sports Medicine, Universiti Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia
  2. 2Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia
  3. 3Department of Orthopaedic and Traumatology, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia
  1. Correspondence to Dr Mohamad Shariff A Hamid; ayip{at}um.edu.my

Abstract

Introduction Hamstring 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 analysis This 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 dissemination Ethics 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 number ISRCTN76844299.

  • sports medicine
  • rehabilitation medicine
  • musculoskeletal disorders
  • clinical trials
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors MSAH, KHH and AP conceived the trial and led the development of intervention design, data management, statistical analysis and drafted the first version of the manuscript. RMY, CCY and TWYS designed the rehabilitation program for the trial. KHH, RMY, CCY, TWYS and AMHS, involved in patient recruitment and data collection. All authors provided valuable feedback in preparing the manuscript. All authors have read and accepted the final version of the manuscript and are accountable for all aspects of the work.

  • Funding This study is funded by the National Sports Institute of Malaysia (ISNRP-002-2017).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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