Keele Research Repository

<jats:title>Abstract</jats:title> <jats:p>BackgroundPhysiotherapy is recommended for people with Tennis Elbow, but whilst a wide array of treatments is available, the optimal approach remains uncertain. We have therefore recently developed an optimised physiotherapy treatment package for Tennis Elbow based on a synthesis of the evidence, patient input, and clinical consensus. It consists of detailed advice and education, a structured progressive exercise programme and provision of a counter-force elbow brace. Here we report the protocol for our multi-centre pilot and feasibility randomised controlled trial (RCT) designed to a) examine the feasibility of our optimised physiotherapy treatment package, and b) to pilot trial processes for a future fully-powered RCT to test clinical and cost-effectiveness compared with usual physiotherapy treatment.MethodsA multi-centre pilot and feasibility RCT will be conducted across three sites in England, recruiting up to 50 patients (or for a maximum of 12 months). Participants with Tennis Elbow, identified from physiotherapy clinic waiting lists and general practice surgeries, will be randomly allocated to receive the optimised physiotherapy treatment package or usual physiotherapy care. Analysis will focus on feasibility measures including; consent rate, intervention fidelity, follow-up rate, and outcome completion rate. A nested qualitative study will explore the acceptability of the study processes and patient and physiotherapist experiences of the new optimised intervention.DiscussionThis study will determine the feasibility of a new optimised physiotherapy treatment package for people with Tennis Elbow and pilot the processes for a future fully-powered RCT. In the longer term, this treatment package may improve pain and quality of life outcomes for people with Tennis Elbow and help to guide a more clinically and economically efficient treatment pathway design.Trial RegistrationRegistered with the ISRCTN database 19/7/2021. https://www.isrctn.com/ISRCTN64444585</jats:p>