Title: A loaded self-managed exercise programme for patellofemoral pain: a mixed methods feasibility study
Funder: Health Education England

Abstract: Background Patellofemoral pain (PFP) is a common musculoskeletal (MSK) disorder with 1 in 6 young people suffering at any one time. The main symptoms include pain behind or around the patella. There is no consensus on the cause of PFP and it seems likely to be multifactorial. There exists some debate over the role of anatomical variations/dysfunction in the development of PFP and lack of association between pathology and pain and traditional pain models that describe tissue pathology as a source of pain have been insufficient in the assessment and treatment of PFP.Long term outcomes are poor with 91% of patients reporting pain and dysfunction at a minimum follow-up of 4 years post. PFP is an important problem to patients, clinicians and commissioners, and due to the paucity of high quality evidence upon which to base assessment and treatment further research is warranted incorporating contemporary pain models. It is hypothesised that a prescription of a self managed high load lower limb strengthening exercise, that are not directed at specific tissue pathology, but rather based upon neurophysiology, set within clearly defined boundaries, will have a positive impact upon PFP patients as with other musculoskeletal disorders. Aims The aim is to establish the feasibility of conducting a definitive RCT which will evaluate the clinical and cost-effectiveness of a loaded self-managed exercise programme for people with patellofemoral pain (PFP). Specifically the project will address the following objectives: Can the devised loaded self-managed exercise programme be delivered as planned in an NHS physiotherapy outpatient clinic? What are the most appropriate outcome measures to evaluate in the definitive trial? Can we collect valid and reliable data? To inform sample size calculation for an RCT Is the intervention acceptable and tolerable to participants and therapists? Is it feasible to recruit and randomise participants and what are the potential barriers? Evaluate the training package delivered to physiotherapists The future definitive RCT will answer the following research question: Does a loaded self-managed exercise programme improve pain and disability for people suffering from PFP better than usual physiotherapy management? Plan of Investigation There will be two components of this study: Component A: Systematic reviews to explore the effects of painful exercises upon musculoskeletal disorders; the epidemiology of PFP in the UK and a survey of current physiotherapy practice. Component B: A feasibility study with a controlled trial component will be undertaken to examine the acceptability, feasibility and tolerability of the intervention within an NHS outpatient setting. Impact Potential long term health benefits are engaging the patient with appropriate long term exercise and associated health benefits, staying within work and improving quality of life. This project has its background in the strong evidence towards the associated health benefits through exercise, such as a reduced risk of diabetes, cardiovascular disease and osteoarthritis; and self-management, such as reducing demand and encouraging personal responsibility. If the intervention is found to be unsuccessful then NHS resources can be used elsewhere to develop alternative strategies. Numerous papers will be prepared for dissemination through presentations via NHS professional networks and publication in peer-reviewed journals. The findings and promotion of the peer-reviewed articles will be disseminated via social media to achieve the full potential of engagement within the profession of physiotherapy and orthopaedics. Conferences will be informed, such as the Chartered Society of Physiotherapy and patients will be informed via charities, such as Arthritis Research UK.

Lay abstract: Knee pain is a common complaint, with 1 in 6 young people suffering from pain around the kneecap at any one time. The routine treatment is physiotherapy and painkillers, but current long-term outcomes are poor with 91% of patients reporting pain 4 years after starting treatment. This means that many patients are exposed to potential long-term disability and pain. Patients with this complaint will typically receive a course of physiotherapy which can include a variety of treatments. These may include strengthening exercises, taping, stretches and foot orthoses. The use of strengthening exercises has been shown to be most promising, but the best dose' remains unclear. Resistance exercises, which include painful movements, have been shown to be beneficial for the back and shoulders, but further investigation is warranted to evaluate these exercises for the knee and particularly in relation to home based exercise versus usual physiotherapy. The best research would be a trial of different treatments, with patients randomly assigned to each to see which is better. However, we are in the early stages, and do not know if this intervention is acceptable for this current patient group. We also do not know if we will be able to recruit a suitable number of patients into a study. The aim of this study is test the feasibility of running a large randomised controlled trial. The potential benefits are reducing pain and disability, and engaging the patients with appropriate long-term exercise, in order for them to stay in work and have an improved quality of life. The investigation will have two components. The first component will explore the background of painful exercises for musculoskeletal pain in general, look at how common this problem is in the UK, and identify current physiotherapy treatments. The second component will involve the feasibility study for a controlled trial. The aim of this will be to look at the acceptability, feasibility and tolerability of the intervention and the trial. The assessment will be in the form of patient recorded outcome measures and a number of interviews to understand patients' and therapists' perceptions and potential barriers. Patients and public (PPI) views and preferences have been sought, and these have been incorporated into the design of the study. The PPI member has also jointly written this plain English summary, and will review the study documentation and help with promoting the findings of the study. The study will promote the findings through papers in peer-reviewed journals, conferences, charities and through a newsletter to all participants.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL