Tennis Elbow Platelet-rich plasma Injection Study
Platelet-Rich Plasma (PRP) versus Autologous Whole Blood versus Saline Injection in the Treatment of Resistant Tennis Elbow: A Pilot Randomised Controlled Trial
Cormac Kelly, Johanna Wales, Jan Herman Kuiper, Megan Hyne, Leighann Sharp, Julie Lloyd Evans, Charlotte Perkins, Jean Denton, Tessa Rowlands, Claire Nicholas and Deepak Menon
Funded by the Orthopaedic Institute and the British Elbow and Shoulder Society. Consumables and equipment are being provided free of charge by Lavender Medical.
Tennis Elbow is a common overuse syndrome that causes lateral elbow pain. It is associated with repetitive activity at work and play and is thought to be caused by micro-tears in the tendons of the elbow. Although many cases resolve over a period of 3 months either with or without non-surgical treatments such as rest, exercises and bracing, other treatments such as steroid injections or surgery may be necessary.
In an autologous blood injection, blood is taken from the patient and re-injected around the affected tendon. Autologous blood injection is thought to promote healing through the action of growth factors on the affected tendon. The injection is given using a technique called needle barbotage that disrupts tendon fibres and is also thought to promote the healing process.
Either whole blood can be injected, or a fragment known as platelet-rich plasma (PRP) can be separated from the red blood cells and then injected. PRP may have a more effective tendon repair potential compared to whole blood, however there is a lack of well-designed studies to support this and there remains variable evidence on whether whole blood or PRP is beneficial to patients with Tennis Elbow.
We chose to carry out a pilot trial to assess the feasibility of designing a larger multi-centre randomised controlled trial to investigate the clinical and cost-effectiveness of autologous whole blood and PRP in the treatment of Tennis Elbow. Patients were allocated to either receiving an injection of autologous whole blood, PRP or saline (placebo).
A target of 10 patients per group (total sample size of 30) was selected in order to inform the number of participants needed in future studies, assess acceptability of study design, and investigate measures that are both clinically relevant and important to patients. Assessments of pain and elbow function were carried out at 6 weeks, 12 weeks, 6 months and 1 year following injection. We also collected information on side effects experienced during the study period.
Patient recruitment and data collection included follow-up data has now completed. 132 patients were screened for eligibility. 29 underwent randomisation, and 25 total patients underwent intervention (7 whole blood, 9 PRP and 8 saline). There were no serious adverse events suggesting treatment is safe. However, recruitment was slower than anticipated, with a large number of patients declining study participation due to PRP injection being available outside of the trial. Collated data is currently in the process of analysis.
