Around 80 adults with persistent tennis elbow will be randomly assigned to either surgery or physiotherapy to test whether a full-scale trial comparing the two treatments is possible. Tennis elbow causes pain on the outer side of the elbow and can limit work and daily activities. While many people recover on their own, others suffer symptoms for months or years. There is no UK consensus on the best treatment. The British Elbow & Shoulder Society recommends physiotherapy but notes a lack of evidence for surgery, and patients have identified this as a high-priority research topic. If this feasibility trial shows that recruitment and retention are achievable, and that patients and clinicians accept randomisation, it will pave the way for a larger randomised controlled trial. That future trial could determine whether surgery or physiotherapy is more clinically effective and cost-effective for persistent tennis elbow. The results would directly inform NHS treatment pathways, potentially ending years of uncertainty for patients and clinicians alike. For now, this study will not change clinical practice—it will test whether a definitive answer can be found.
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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. 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. We will explore if it is feasible to conduct a randomised controlled trial (RCT) 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 1. Determine the recruitment rate and retention at 3, 6 and 12 months. 2. Explore acceptability of randomisation to surgery or physiotherapy to patients and healthcare professionals. 3. Identify barriers and facilitators to recruitment and retention. 4. Estimate the number of people in the physiotherapy group receiving surgery if needed. 5. Calculate key parameters to inform the sample size for a future trial. 6. Understand variation in surgery and post-operative rehabilitation protocols. 7. Determine the feasibility of conducting a full trial and recommendations on design and delivery. Methods 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. After informed consent, 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. Timelines Duration: 28 months; months 1-6 study set up, months 7-18 trial recruitment, months 10-24 follow-up, months 25-28 data analysis, write-up and dissemination. Anticipated impact and dissemination As this is a feasibility study we expect to influence future research rather than clinical practice. Findings will be presented at conferences, meetings, journal publications and through social media. The patient and public involvement group will input into dissemination and feedback to study participants. The aim will be to build engagement with key stakeholders who may become Principal Investigators of a full RCT that can impact clinical practice, if feasibility is established.
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