Tennis Elbow Platelet-rich Plasma Injection Study (TEPIS)
Research type
Research Study
Full title
A Pilot Study of Platelet-rich Plasma (PRP) versus autologous whole blood versus saline in the treatment of resistant tennis elbow
IRAS ID
150292
Contact name
Cormac Kelly
Contact email
Research summary
Tennis elbow is a common condition 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 may be necessary such as corticosteroid injections or surgery.
In an autologous blood injection, blood is taken from the patient and re-injected around the affected tendon. Either whole blood can be injected, or a fragment known as platelet-rich plasma (PRP) can be separated from the red blood cells and injected. PRP contains a high level of growth factors which are thought to stimulate the healing process.
The primary aim of this study is to assess feasibility and guide the planning of a large multi-centre study to investigate both the clinical and cost effectiveness of PRP as a treatment for tennis elbow. Three treatment options will be investigated; an injection of either whole blood, PRP or saline using a technique called needle barbotage that disrupts tendon fibres and promotes the healing process. Patients will be allocated to one of the treatment groups at random.
Patients attending Robert Jones and Agnes Hunt Orthopaedic Hospital with symptoms of Tennis Elbow, and meeting the eligibility criteria, will be given the chance to take part in this study, which will last for one year. Assessments of pain and elbow function will be carried out at 6 weeks, 12 weeks, 6 months and 1 year.Summary of results
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 study.Cormac Kelly, Johanna Wales, Jan Herman Kuiper, Megan Hyne, Leighann Sharp, Julie Lloyd Evans
[RPG138] Funders: Institute of Orthopaedics and the British Elbow and Shoulder Society. Consumables and equipment are being provided free of charge by Lavender Medical.
Study start date: Jan 2015 Expected completion date: June 2019
Study design
TEPIS is a pilot study of 30 patients, to inform the design of a large multi-centre randomised controlled trial to compare autologous whole blood injection with Platelet-rich plasma (PRP) or saline in established elbow lateral tendinopathy (Tennis elbow). The parameters that are being investigated are the ability to recruit the required number of patients in a reasonable timeframe, their compliance with the study protocol and the incidence of missing data and the most appropriate outcome measure tool for use in future studies.
All participants are be required to complete a standardised program of physiotherapy prior to enrolment in the study to ensure that their symptoms cannot be relieved by more conservative means. Participants are then allocated to one of three treatment groups at random, (an injection of whole blood, PRP or saline).The primary outcome measure is the Patient-rated Tennis Elbow Evaluation (PRTEE) score at 12 weeks following intervention. The one-sided 80% upper confidence level of the standard deviation of the PRTEE will allow determination of the within-group standard deviation to be used for sample size calculations of a future trial. Assessments of pain and elbow function are carried out at 6 weeks, 12 weeks, 6 months and 1 year. We are also collecting information on any side effects experienced, use of pain medications, quality of life and satisfaction with treatment.
Study progress
Recruitment has progressed more slowly than we anticipated. We revised the study timelines and now aim to complete recruitment into the study in May 2018 (see figure 1 below). Recruitment is currently a little behind target, with 21 of the 30 patients enrolled (84% of our pro-rata target).
The study team meet with the Trial Steering Committee on a quarterly basis to ensure that recruitment and follow-up are progressing.
A substantial amendment was approved by the ethics committee in July 2017. This allowed us to introduce two Patient Identification Centres (PICs), at Royal Shrewsbury Hospital and Princess Royal Telford Hospital. Posters are displayed in clinic waiting rooms and consultants are asked to refer any eligible patients to RJAH for entry into the trial.
We will monitor progress against recruitment targets carefully over the coming months and have implemented a strategy to improve referral into the trial. A monthly recruitment update is sent to all consultants at RJAH and the two PICs to encourage referrals. We will provide training to the new rotation of registrars, and display posters in RJAH clinic waiting rooms.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
14/WM/1063
Date of REC Opinion
22 Aug 2014
REC opinion
Favourable Opinion