Award Title: OPTimisE - Optimising Physiotherapy for Tennis Elbow
Funder: Department of Health and Social Care

Abstract: Background Tennis Elbow (TE) is a painful condition affecting an individual's ability to work. Physiotherapy is recommended but current NHS physiotherapy treatment varies widely and is sub-optimal. Agreeing and testing an optimal physiotherapy treatment could improve patients' outcomes, reduce the number of TE patients developing persistent symptoms and yield cost-savings to the NHS by reducing the need for more costly and invasive treatments, such as surgery. Objectives	Develop an optimised TE physiotherapy intervention for use in the NHS 	Determine feasibility of recruiting and retaining patients with TE 	Determine treatment fidelity of, and adherence to, the optimised physiotherapy intervention 	Estimate the number of patients and hospital sites required for a future main trial.Method Phase 1:A consensus exercise involving 10-15 specialist physiotherapists, patients and physiotherapy managers to agree an optimised physiotherapy intervention for TE based on best evidence for use in the NHS. This will use Nominal Group Technique - a method involving ranking of component parts, group discussion and re-ranking to form consensus. A package of care and physiotherapist education package will then be developed. Phase 2a: A multi-centre pilot and feasibility randomised controlled trial (RCT) to determine whether an optimised physiotherapy treatment programme can be delivered, whether patients engage with it and whether a future main RCT evaluating it is feasible. Participants: Adults with TE identified from primary care and physiotherapy clinics. Intervention/control: Participants randomly allocated on a 1:1 basis stratified by site and duration of symptoms to a) the optimised physiotherapy intervention or b) usual physiotherapy treatment. Feasibility outcomes: 1) Rate of recruitment; 2) Attendance; 3) Adherence to treatment; 4) Intervention fidelity; 5) Intervention contamination; 6) Rate of retention, including outcome measure completion. Clinical outcomes: Elbow pain and function (Patient Reported TE Evaluation, Oxford Elbow Score, Quick-DASH) and quality of life (EQ-5D-5L) measured at baseline, 6 weeks, 3 and 6 months. Sample size: 60 participants. Analysis: Descriptive analysis focusing on feasibility outcomes. Phase 2b:Qualitative research with patients and physiotherapists involved in the pilot and feasibility RCT.Participants: Up to 20 patients (purposively sampled for variation in site, age, gender, TE pain and function, treatment adherence) and 10 physiotherapists from different trial sites. Methods:Face-to-face interviews focussing on acceptability of the optimised physiotherapy treatment programme from both the perspectives of patients and physiotherapists that may lead to further refinement of the intervention for a future main trial. Analysis: Thematic analysis.Anticipated impact and dissemination Outputs from the project will be disseminated in open-access peer-reviewed journals, conference presentations, the lay press and social media. These include:	Pilot and feasibility RCT protocol 	Outcomes to assess whether delivery of the newly devised physiotherapy treatment programme is feasible, treatment fidelity acceptable and whether a future main RCT is feasible 	Evidence of acceptability of the intervention from the integrated qualitative element.Develop myself as a future NIHR research leader with skills and experience in leading a multi-centre RCT, qualitative research and consensus methods alongside leadership in research.

Lay Abstract: Background to the research: Tennis Elbow is a painful condition that makes it difficult to do work, hobbies and sports. Physiotherapy is recommended but at the moment physiotherapists use lots of different treatments. Research tells us that some treatments might work better than others but not all patients are getting the best treatment. If more patients got better physiotherapy treatment then outcomes could be improved and fewer patients would need injections or surgery. The NHS could also save money. Aim of the research: In this project we will decide what the best physiotherapy treatment package is for Tennis Elbow. We will then test whether it is fit to use it in the NHS. Design and methods used: Phase 1:We will use the best research evidence that mostly comes from Australia and adapt it for use in the NHS. We will ask specialist UK physiotherapists to help design this along with patients and NHS managers.Phase 2a: We will do a 'feasibility trial' to test this optimised treatment to see if physiotherapists working in the NHS can be taught to do it, that patients are willing to receive it and that the ways of measuring if it works are suitable. We will recruit 60 patients at physiotherapy clinics in three different cities. They will then be randomly given either the new optimised physiotherapy or the usual physiotherapy treatment that would have normally been given. Patients will then be asked to complete questionnaires before treatment, after 6 weeks, 3 months and 6 months to measure if their elbow pain is getting better. They will be given the option of doing this online using their smartphone/computer or on paper.Phase 2b:We will interview 20 patients and 10 physiotherapists involved in the feasibility trial to ask their opinions of how it went and how it could be improved. Analysis: We will decide whether it is possible to go ahead with a full research trial based upon: 1) The number of patients willing to participate 2) Whether patients actually attended their appointments 3) Whether patients did the exercises they were asked to do 4) Whether the physiotherapists gave the treatments that they were supposed to 5) Whether the optimised treatment was sufficiently different from usual treatment 6) Whether patients completed their questionnaires and whether they preferred the paper or online method 7) Whether the interviews suggested that the physiotherapists and patients were happy with what they were asked to do during the trial. Patient and public involvement: We already have a group of patients who have all had Tennis Elbow that have helped us design the project. These patients have expressed an interest in remaining involved and will help with design of all of the information given to patients to make sure that it makes sense and is easy to understand. They will also contribute to management of the study, help interpret the findings and report the results. Sharing the findings: At the end of the project we will share the results with participants, in medical magazines and in medical conferences. We hope that we will then be able to set up a full research trial to see if the optimised treatment is more effective than the current usual treatment.

Research Activity Codes: 6.7 PHYSICAL
Health Categories: MUSCULOSKELETAL