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SORE Elbow Feasibility Trial - Surgery Or REhabilitation for persistent tennis elbow

Background

Tennis Elbow (TE) is a common condition, causing pain on the outer side of the elbow and affecting functional ability, including work. Although, in many cases, the condition is self-limiting, some individuals suffer persistent symptoms. It has a prevalence of 1 to 3% of the population and an incidence of 4 to 7 people per 1000 every year. It affects both men and women equally, usually occurring in people aged 30-60 years old but it can occur at any age, and it is the most common cause of persistent elbow pain.

There is currently no established consensus in the UK regarding the most appropriate treatment method. The recent British Elbow & Shoulder Society (BESS) guideline recommends that patients are offered physiotherapy but highlights the lack of evidence for surgery. The James Lind Alliance has identified the treatment of TE as a high priority research topic. 

Aim

To explore if it is feasible to conduct a randomised controlled trial of the clinical- and cost-effectiveness of surgery compared to physiotherapy for adult patients who have had persistent TE symptoms for more than 6 months.

Objectives

This feasibility study is designed to inform the successful execution of a future full-scale trial. Our primary aims are to determine the trial's feasibility by assessing patient recruitment and retention rates, and calculating key parameters necessary for sample size estimation. We will also actively explore the acceptability of the treatment arms (surgery vs. physiotherapy) among patients and healthcare professionals, identify crucial barriers and facilitators to participation, and document variations in current clinical care protocols. The final outcome will be a robust set of recommendations on the optimal design and delivery for a larger trial.

Trial Design

The trial objectives will be addressed using a multi-centre, randomised feasibility trial with a parallel qualitative study. We will recruit 80 adults with unilateral TE with symptoms for more than 6 months. There will be an active campaign of awareness in primary and intermediate care settings addressing the range of care pathways, to meet the sample size. Given the potentially small pool of participants at any one site the study will include 12 sites with Participant Identification Centres (PIC) sites utilised where appropriate to screen eligible participants from orthopaedic surgeon/physiotherapist referral lists.

Participants will be randomised, stratified by site, in a 1:1 allocation ratio to open or arthroscopic TE surgery (under local, regional or general anaesthesia) or a standardised physiotherapy intervention with minimum follow-up of 6 months. 

A nested qualitative study (10-15 participants from each intervention group and 10-15 trial clinicians) will explore acceptability of the interventions, randomisation and delivery of the trial. Qualitative interviews will also be undertaken with 10-15 key clinical stakeholders.

Qualitative and quantitative findings will be jointly displayed in a mixed method matrix to allow for assessment of feasibility of a full-scale RCT against the progression criteria and inform the design if feasible.

Duration: 28 months (Nov 2025 – August 2028)