Title: Chronic pain after total knee replacement: better post-operative prevention and management
Funder: Department of Health and Social Care

Abstract: Background and rationale Chronic pain after knee replacement is not well understood and places considerable burden on individuals, society and the NHS. With 75,000 patients undergoing total knee replacement in the NHS annually, around 15,000 patients will have chronic pain afterwards. Referral for assessment and care is patchy, and people do not necessary receive or seek care. It is hard to predict pre-operatively who will have chronic pain afterwards. The Programme will address these issues and provide evidence-based recommendations about improvements in care. Aims and objectives The Programme aims to improve outcome for patients with chronic pain three months or more after total knee replacement. The Programme will: Synthesise evidence about the effectiveness of interventions for chronic pain after knee replacement and other surgeries and identify post-surgical predictors of chronic pain after knee replacement. Characterise the long-term trajectory of chronic pain including pain characteristics, disability and resource use up to five years after knee replacement. Finalise an assessment process and a care pathway for patients with chronic pain after knee replacement. Evaluate the clinical and cost-effectiveness of a new care pathway for patients with chronic pain after knee replacement. Identify reasons for non-use of services and provide recommendations. Make recommendations about best-practice care for patients with chronic pain after knee replacement and evaluate implementation of these. Research Plan To meet the objectives we will conduct six work packages (WPs). WP1 (months 1-24): Systematic reviews and analysis of national databases 1.1: A systematic review of effectiveness of interventions for chronic post-surgical pain after diverse types of surgery. 1.2: A systematic review of post-surgical predictors of chronic pain after total knee replacement and overview of peri- and early post-operative interventions. 1.3: Analysis of data from the UK National Joint Registry linked to Hospital Episode Statistics and Patient Reported Outcomes databases to identify any post-operative predictors of chronic pain. WP2 (months 1-48): Long-term follow-up and analysis of databases 2.1: Annual follow-up of an existing cohort of total knee replacement patients (n=1581), including collection of pain, disability and resource use data for five years after surgery. 2.2: Analysis of the Clinical Practice Research Datalink linked to the Hospital Episode Statistics database to characterise the natural history of chronic pain after knee replacement, including resource use. WP3 (months 1-12): Finalisation of an assessment protocol and care pathway Nominal Group Technique with professionals (n=33) and assessment of acceptability with professionals and patients (n=30-40) will finalise an assessment protocol and care pathway. This will underpin WP4. WP4 (months 13-57): Randomised Controlled Trial A fully-powered randomised controlled trial will evaluate a new care pathway for patients with chronic pain after total knee replacement. The trial will be a multi-centre (four centres) pragmatic trial with 12 months follow-up. Pain severity and interference will be co-primary outcomes. We will recruit 380 participants. Two embedded qualitative studies will explore trial processes and acceptability of the intervention. WP5 (months 4-48): Qualitative study A qualitative interview study with people with chronic pain after knee replacement but who make little or no use of formal healthcare services (n=40) will explore reasons for non-use of services. This will provide recommendations for individuals with pain and health professionals. WP6 (months 49-60): Implementation and dissemination 6.1: Using local structures we will implement study findings with 15-20 health professionals. We will explore use of the care pathway (WP4), comparing results in WP6 with those from WP3. 6.2: A range of dissemination activities will engage health professionals, researchers, policy makers, patients and the public. Dissemination, outputs and impact We will host a workshop, present at professional meetings, develop a web-based resource and work with patients, the public and Arthritis Care to ensure maximum reach of the Programme s findings. We aim to impact on practice within one to three years of completion. Patient and public involvement Patient and public involvement (PPI) was integral to the Programme s design and remains at its core. We work with an existing PPI group and will develop a complementary group focusing exclusively on chronic pain after knee replacement. PPI collaboration will include design of study materials and processes, research management and dissemination strategies. Management and governance A Programme Steering Committee will meet every six months to oversee all activities. WP4 will be overseen by Trial Steering and Monitoring Committees meeting every six then twelve months. Programme staff will meet monthly. Each WP team will meet weekly. The PIs will have responsibility for milestones and delivery, with co-applicants assuming key roles within WPs. Research will seek ethical and R&D approval and good practice will be adhered to. Benefit to Patients and the NHS The Programme aims to provide better care for people with chronic pain after total knee replacement within one to three years of Programme completion. Analysis of cost-effectiveness and resource use is key to the Programme.

Lay abstract: Osteoarthritis is a leading cause of pain and disability. Many people with severe knee pain because of osteoarthritis have an operation called total knee replacement. Total knee replacement involves replacing the painful knee joint with an artificial joint. It is a major operation and people often experience some pain in the first three months after surgery. However, around one in five patients report moderate or severe pain after this initial three month recovery period. We call this long-term , or chronic , pain. Over 75,000 total knee replacements take place every year in the NHS. This means that approximately 15,000 people have long-term pain afterwards. People with long-term pain say that pain stops them from doing things they value, including taking part in work, family and social activities. Pain can also change a person s mood, sometimes leading to anxiety and depression. We know that many people do not receive or seek care for long-term pain. Improving care and support for people with long-term pain after knee replacement will benefit patients, the NHS and society. Despite efforts to prevent long-term pain, we believe that there will always be some people who need care and support after surgery. Our proposed Programme is called STAR (Support and Treatment After Replacement). It will look at long-term pain after knee replacement and ways of helping people. This builds on work from our Programme Development Grant. In that work we identified current practice in assessment and treatment, found out how to collect information about people s use of services, identified issues that are important to people and reviewed published literature about pain management. Our earlier work provides the basis for six work packages in the STAR Programme, which will: Review the treatments that work for long-term pain after surgery, and identify any obvious issues after surgery that might affect long-term pain Describe the impact of long-term pain and use of healthcare services Describe the different types of long-term pain problems and match them to different treatments in what the NHS calls a care pathway Run a trial of a new, best care pathway that will benefit patients Find out why people cannot or do not want to use services, and provide recommendations to improve access to care Look at use of the Programme s findings in practice, and work with patients, professionals and researchers to make sure that findings reach the people who need them We are confident that the STAR Programme will succeed, that the questions we are asking are the right ones, and make sense to patients. Patients voices are at the heart of the Programme, from the original idea, to the design, planning, and successful delivery.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;7.1 INDIVIDUAL CARE NEEDS
Health categories: MUSCULOSKELETAL