BEhaviour change for People with clinically diagnosed Knee Osteoarthritis: A pragmatic trial (BEPKO-3)

Background: Current NICE guidelines recommend therapeutic exercise as an initial management strategy for people living with knee osteoarthritis (KOA). However, a large proportion of patients do not experience meaningful reductions in pain and are dissatisfied with this approach. We have developed a new form of physiotherapy, known as "Cognitive Muscular Therapy (CMT)", that is now ready for testing. We propose that CMT could be implemented as a second line treatment for patients who are dissatisfied with NHS-provided therapeutic exercise for KOA. CMT is very different from existing physiotherapy techniques. Rather than prescribe strengthening exercises, biofeedback training is used to provide patients with the ability to reduce overactivity of the knee muscles during standing and functional tasks. As muscle overactivity reduces, mechanical loading through the joint changes and this is likely to reduce nociceptive input. CMT also integrates psychological techniques for pain management. In a previous NIHR-funded study (NIHR202203), we investigated the feasibility of a trial designed to compare CMT + usual care with usual care alone for people who had failed to benefit from therapeutic exercise. We recruited 82 patients, of which 42 were allocated to the CMT arm. Of this group, 32 patients completed the intervention, reporting 47% reductions in pain post-intervention, a change which was maintained at 8-month follow-up Aims and objectives: We propose a definitive RCT which will determine the clinical and cost-effectiveness of CMT + usual care versus usual care for people with KOA. Methods: We will recruit 252 participants who are dissatisfied with therapeutic exercise. Participants will be randomised on a 1:1 basis to: CMT + usual care or usual care alone. The intervention will be delivered by CMT-trained NHS physiotherapists. We will collect data on KOA pain, quality of life, and healthcare resource utilisation at baseline, 6 months, and 12 months. The primary outcome will be the WOMAC composite score, with secondary outcomes on pain self-efficacy and pain catastrophizing. We will also perform a process evaluation to map barriers and facilitators to future roll-out of CMT on the NHS. Assuming 80% retention, data from 200 participants will allow us to quantify clinical effectiveness and cost effectiveness of the CMT intervention. Timelines for delivery HRA approvals will be in place when the project starts, and research sites set up during the first three months. Recruitment will complete by month 21 and intervention delivery will be completed by Month 24. This will allow for a 12-month (from baseline) follow up and 3 months for data analysis. Anticipated impact and dissemination: If we can demonstrate that CMT delivers sustained reductions in KOA pain for people who have tried therapeutic exercise, then this should change the NHS pathway this condition. Once integrated into practice, this should lead to less pain and disability from KOA and a reduction in costly orthopaedic referral. With strong results, we will work with Health Innovation Manchester to roll out the intervention at NHS trusts once the project completes.