Title: Individualised progressive exercise versus supported self-management for people after acute patellar dislocation: a multicentre feasibility randomised controlled trial with an embedded qualitative study
Funder: Department of Health and Social Care

Abstract: BackgroundPatellar dislocations mainly affect adolescents and young adults. After this injury, non-surgical treatment provided by a physiotherapist is routine. The most effective physiotherapy approach is unknown because high-quality trials are lacking. Consequentially, physiotherapy treatment and patient outcomes vary widely. Common problems after this injury include recurrent dislocation, reduced activity levels, and later surgery. Previous trials that compared one physiotherapy session of advice versus intensive exercise-based physiotherapy programmes for people with other musculoskeletal injuries have shown conflicting findings. It is uncertain which of these approaches is most clinically and cost-effective after acute patellar dislocation. A definitive randomised controlled trial would clarify this uncertainty. Whether a definitive trial is feasible is unclear. AimTo assess the feasibility of a definitive trial comparing 'individualised progressive exercise' versus 'supported self-management' by conducting a multicentre feasibility randomised controlled trial with an embedded qualitative study. Feasibility objectives willingness to be randomised: proportion of eligible patients approached who provide informed consent recruitment rate: number of participants recruited per centre per month follow-up rate: proportion of participants that return nine-month Lysholm Knee Scoring Scale outcome data (definitive trial primary outcome) intervention adherence: proportion of participants attending intended number of physiotherapy sessions acceptability of the interventions, follow-up methods, and patient-reported outcomes measures to participants, assessed by qualitative interviewsMethodsProject 1: a multicentre feasibility randomised controlled trial with parallel group design. Fifty males or females aged 14 years, with an acute first-time or recurrent patellar dislocation will be recruited from three National Health Service hospitals. Participants will be randomly allocated 1:1 using a web-based service to 'individualised progressive exercise' (4-6, one-to-one, face-to-face/video physiotherapy sessions, over a maximum of six months, comprised of advice, intense individualised home exercise, and strategies to support exercise adherence) or 'supported self-management' (one, one-to-one, face-to-face physiotherapy session of advice and exercise. Participants will then self-manage their recovery, guided by a study website). Follow-up will be three and nine months after randomisation, using electronic questionnaires as recommended by patient and public partners. Project 2: embedded qualitative study. We will conduct semi-structured interviews with up to 12 participants, purposively sampled for variation, to understand acceptability of the interventions, follow-up methods, and patient-reported outcome measures to participants. Interviews will be audio-recorded and transcribed verbatim. AnalysisFollow-up will be expressed as a proportion with 95% confidence intervals. All other quantitative feasibility outcomes and all other quantitative data will be analysed using descriptive statistics. Framework analysis will be used for qualitative data. Anticipated impact I will apply for a definitive trial if results indicate this is feasible. This would provide much needed robust evidence to guide clinical practice and improve patient care. DisseminationThe feasibility study will be prospectively registered on the ISRCTN registry. The protocol, feasibility randomised controlled trial, and qualitative study will be published in open-access journals. Findings will be presented at academic conferences and shared on social media to reach a wide public and healthcare audience. Lay summaries of the results, co-produced with public partners, will be shared with participants and patient and public involvement groups.

Lay abstract: Background The kneecap is a round shaped bone at the front of the knee. It sits in a groove in the thigh bone. Kneecap dislocations occur when the kneecap moves out of this groove. This happens suddenly, mainly to young people during twisting activities. This is a painful injury that makes the knee swollen. Most people need to go to the Emergency Department. The kneecap is pushed back into place if it is stuck outside the groove, and the knee is put in a splint to support it. To help recovery, patients are normally given physiotherapy.Unfortunately, not everyone recovers fully. Sometimes the knee remains painful or the kneecap dislocates again. Occasionally, people need to have surgery.It is unclear what the best physiotherapy treatment is for this injury. Finding out the best physiotherapy treatment could improve patients' recovery.Research aimWe want to compare two physiotherapy treatments to find out which is better for people with a recent kneecap dislocation. This requires carrying out a large study. To decide if a large study would work, we will first compare the two physiotherapy treatments in a smaller feasibility study (described in the next section). This is necessary as we are unsure how many patients will agree to take part, and if participants will complete their physiotherapy treatments and study questionnaires.MethodsProject 1: we will recruit 50 patients, at least 14 years old, who have had a recent kneecap dislocation. These patients will receive one of two physiotherapy treatments: 'Supported self-management'. This involves one session with a physiotherapist who will give participants advice and exercises to help them recover. Participants will then manage their own recovery, assisted by a website with high-quality videos and guidance. 'Individualised progressive exercise'. This involves 4-6 physiotherapy sessions over a maximum of six months. Physiotherapists will give participants advice and exercises to perform at home. The exercises in this treatment are more challenging. Physiotherapists will also use strategies to help participants do their exercises, for example giving participants a diary to record when they do their exercises.To ensure the comparison between treatments is fair, the treatment participants receive will be randomly decided by a computer. We will measure recovery by asking participants to complete questionnaires on a smartphone/computer before the first physiotherapy session, then three and nine months later.Project 2: I will interview up to twelve participants to understand what they think about the treatment they received and the study questionnaires.We will decide if a large study would work by assessing: how many patients agree to take part how many participants return completed study questionnaires how many physiotherapy sessions participants attend what participants think of the study treatments and questionnairesPatient and public involvementPatients and the public helped design this study, for example, they recommended using questionnaires that can be completed on a smartphone/computer. We are working with them to ensure the information given to participants in the study is easily understandable. This help will include testing the study website so that it works well. A patient who had a kneecap dislocation will help to monitor how the study is conducted. Two members of the public helped write this explanation, so that it is easy to read by members of the public.DisseminationWe will publish our study plans and results in academic journals and present them at conferences. We will share the results with any study participants who want to receive them. Through social media and patient representative groups, we will provide updates about the study's progress and results, to reach a wide audience of healthcare professionals and the public.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL