Title: BEhaviour change to reduce Pain in Knee Osteoarthritis (BEPKO-2): A feasibility study
Funder: Department of Health and Social Care

Abstract: Background: Current exercise-based management of knee osteoarthritis (KOA) is widely delivered on the NHS, yet approximately 40% of patients experience no benefit. This may be due to current strategies which focus on muscle strengthening. In contrast, research has demonstrated that individuals with KOA over contract their knee muscle during functional tasks, potentially exacerbating pain. Research has also demonstrated associations between psychosocial factors and clinical pain/disability in KOA. Therefore, there is a need to investigate interventions that integrate psychological pain management with muscle retraining rather than strengthening. Such interventions may be effective for those who do not respond to current exercise approaches. Through a previous RfPB project (PB-PG-0816-10105) we developed a new physiotherapy intervention, which guides patients through a process in which they develop awareness of muscular and emotional responses to pain and learn to normalise functional muscle patterns. The intervention uses EMG biofeedback to enable patients to visualise how thought processes and pain beliefs impact on muscle function. This is supported with animated instructional videos to explain biomechanical and pain concepts. Aims and objectives: In a proof of concept project, we delivered a fully formed version of our intervention to 11 patients with KOA and observed reductions in pain of between 38-100% (mean(SD) 69(19)%) using the WOMAC pain measure. Building on these promising results, we propose a study in which we will first refine our existing training package for NHS physiotherapists. We will then run a feasibility study to inform planning of a future RCT. This would seek to understand the clinical and cost effectiveness of our intervention for people with KOA who do not respond to current strengthening-based approaches. Methods: Our training package will combine online modules with face-to-face training to enable physiotherapists to learn new biomechanical, psychological and treatment skills. For the feasibility trial, we will recruit 90 patients who have previously received, but not benefited from, the NHS standard ESCAPE-pain intervention. Participants will be randomised equally into two groups: BEPKO (BEhaviour change to reduce Pain in Knee Osteoarthritis); and standard care. We will collect data on KOA pain, quality of life and patients capacity to self-manage pain at baseline, 3 months and 6 months, which will inform our future trial. In addition, we will test the feasibility of collecting health economic data and perform a qualitative investigation to understand physiotherapist s and patient s perspectives. Timelines for delivery: We plan to refine our training package within the first 6 months, with a 20-month period to deliver the feasibility trial. We will ensure that the application for a follow-on RCT will be ready by the end of this 24-month project. Anticipated impact and dissemination: If data from this feasibility trial support progression to a definitive RCT, then we will apply to the HTA programme. Robust evidence from such a study would lead to a new two-stage conservative pathway on the NHS for people with KOA, in which the BEPKO intervention could become an accepted physiotherapy treatment for people who do not respond to muscle strengthening, potentially reducing costly orthopaedic referral.

Lay abstract: People with knee osteoarthritis (KOA) often have physiotherapy which focuses on ways to strengthen the muscles in the leg. Unfortunately, for about 40% of people, this type of physiotherapy does not reduce their pain. This may be because people with KOA often over- tense their knee muscles during daily activities. In this situation, traditional exercise will not help to reduce their pain. We have developed a new physiotherapy treatment that may help people who do not experience benefit from muscle strengthening physiotherapy. This new treatment teaches patients how they can stop over-tightening their muscles when they walk or do other daily movements. It also teaches them to change the way they react to pain. Sensors are attached to the skin which enable patients to see their muscle patterns, both during movement and in response to pain. This muscle visualisation is supported with animated instructional videos to explain muscle and pain concepts. In our previous study, knee pain was reduced by an average of 69% following our treatment. We are therefore confident that it could reduce pain in patients who do not respond to traditional muscle-strengthening. We will ask 90 patients to take part, who have received muscle strengthening for KOA but who have not seen an improvement. Patients will be put into two groups by chance, like tossing a coin: half will get our new behavioural treatment, and the other half will get their usual care from their physiotherapist and other healthcare professionals. We will ask participants to tell us about their pain, quality of life and how they manage their own pain before they start the study and again three and six months later. We will also interview patients and physiotherapists to understand their experiences of receiving/delivering the new treatment. We have already worked with patients and physiotherapists to develop our new treatment. We will continue to do so in this study by asking their views on our training materials, how they experience our new treatment, and the best ways of letting people know about the results of our study. The information we get from this study will help us to understand if our new treatment is acceptable for people who do not respond to muscle strengthening. If so, we hope in the future to do a larger study which will tell us how helpful the intervention is at improving pain. This could change the way KOA is managed within the NHS, providing an alternative treatment for people who do not respond to muscle strengthening. This could help patients and also save the NHS money as it could stop patients needing to be referred for consideration of a knee replacement.

Research activity codes: 5.7 PHYSICAL;6.7 PHYSICAL
Health categories: MUSCULOSKELETAL