- Start date: 1 May 2021
- End date: 30 April 2027
- Funder: National Institute for Health and Care Research (NIHR)
- Value: £2,487,412.00
- Primary investigator: Professor Philip Conaghan
- Co-investigators: Professor Gretl McHugh Associate Professor Ian Kellar Associate Professor Sarah Kingsbury Miss Sarah Brown Dr Ruben Mujica-Mota Ms Claire Davies Professor Deborah Stocken
- External co-investigators: Professor Gary Macfarlane, Professor Krysia Dziedzic, Professor Jo Adams, Professor Karen Walker-Bone, Dr Claire Burton, Mrs Valerie Thurlow
Musculoskeletal diseases (MSDs) are common, chronic and disabling. Given their strong association with age, their burden is rapidly increasing with changing population demographics. They cause more disability than either heart disease or cancer and in fact, now constitute the second biggest cause of years lived with disability. MSDs cause substantial social and economic costs and consequences for the individual, healthcare providers and society
The focus of our study is musculoskeletal diseases affecting the elbow, forearm, wrist and hand (distal upper limb (DUL)). DUL-MSDs include: hand and wrist osteoarthritis (OA), epicondylitis, tendinitis and tenosynovitis and carpal tunnel syndrome. This is an area of research that has been comparatively neglected, despite the prevalence of the diseases.
Symptomatic hand osteoarthritis (OA) is more common in older ages, affecting an estimated 3-15% of adults over 60 years, making up one in six of all people with OA who seek treatment. Other distal upper limb musculoskeletal diseases are common across all ages, with carpal tunnel syndrome affecting 7-16%, and tendinitis and epicondylitis affecting around 1-2% of the population.
Many DUL-MSDs are defined by the UK Health & Safety Executive (HSE) as caused or made worse by work, and lead to absenteeism and presenteeism (being less productive) in the workforce. During 2017/18, HSE reported that DUL-MSDs accounted for 42% (197,000 people) of all work-related MSK disorders, with an estimated 2.6 million days lost from work.
In addition, less than 50% of people will return to work after 6 months of sickness absence with an MSD. According to one UK population survey, 11% and 21% of working aged adults reported elbow and wrist/hand pain respectively. The healthcare impacts are substantial: an estimated 15% of 2600 working-age patients consulted their GP about DUL-MSDs within the previous 12 months.
NHS musculoskeletal services have been recognised as massively overburdened with widespread variation (a postcode lottery) in terms of musculoskeletal rehabilitation service provision. Clinicians and patients express frustration with the resultant long waiting lists and lack of a consistent approach to care.
There is good evidence that delays in healthcare provision can lead to prolonged episodes of sickness absence from work and that, as duration of absence increases, likelihood of return to work reduces. Therefore, provision of early and effective interventions is essential, not only to reduce pain and disability, but to also have a positive effect on return to work for affected individuals.
There is evidently a clearly-defined need for a new way to promptly deliver an intervention that can reduce pain and disability affecting a significant proportion of the population and which is threatening livelihoods. Our plans to meet the unmet need involve making best use of important NHS priorities: providing supported self-management and personalised treatments provided remotely and using digital technology.
The study is made up of four separate but highly related stages called “workpackages”. In workpackage 1 we identify participants to assist us with designing the study. These participants will be both clinicians who have experience and knowledge of DUl-MSDs, as well as patients who live with such conditions and can speak to their experience. We want to work together with them to get a consensus on what the intervention should contain, and how it should work, as well as what barriers and facilitators may be present for patients.
In addition we will thoroughly review the relevant literature to give us a thorough understanding of the background to both DUL-MSDs and other interventions that have been developed.
In workpackage 2 we will work on designing the intervention with the clinician and patient stakeholders identified in workpackage 1. We will also explore “usability, adoption and adherence”; that is factors which will make the intervention more user-friendly and likely to be used consistently by patients, and those that make it less user-friendly and less likely to be used.
In workpackage 3 we roll out a randomised clinical trial; this will involve recruiting patients to trial the intervention itself to allow us to thoroughly analyse its effectiveness, in a rigorous scientific manner.
Workpackage 4 will run throughout the study and will involve continued involvement and feedback from community groups. DUL-MSDs affect people from all walks of life and we want to reach a diverse population of people so we can better understand how we can help them through our intervention.
Professor Philip Conaghan is a world-leading researcher and highly experienced clinical trialist who has led multiple large research programmes. His major interests are in understanding the causes and improving treatments for common painful musculoskeletal conditions like osteoarthritis. He is a NIHR Senior Investigator Emeritus and was Chair of NICE OA clinical guidance (2008, 2014). He is co-editor of the Oxford Textbook of Rheumatology and has authored over 600 PubMed publications.
Professor Gretl McHugh is a Professor of Applied Health Research, School of Healthcare, University of Leeds. Gretl has a clinical background in community and public health nursing. She has methodological expertise in reviews, intervention development, mixed methods research, feasibility and clinical trials. Gretl has an interest in self-management of chronic conditions and has expertise in digital interventions. Her research aims to improve care for people with bone, joint and muscle conditions.
Dr Ian Kellar is an experienced behavioural scientist with expertise in theory-based evidence synthesis and co-production activities to support the development and evaluation of complex behaviour change interventions. Among other responsibilities, he led the intervention adaptation workstream lead on an NIHR programme grant to develop and evaluate a behavioural activation intervention for people with co-morbid depression and diabetes in South Asia
Dr Sarah Kingsbury is an applied health researcher with expertise in intervention development and testing, including large randomised controlled trials, and in expert stakeholder processes and systematic reviews. She is co-applicant on an NIHR-funded project to improve self-management of osteoarthritis and a funded digital electronic-health project for chronic knee pain both involving developing and testing new interventions.
Sarah Brown is a Principal statistician at the Clinical Trials Research Unit at Leeds, with expertise in statistics, study design, implementation and analysis on the evaluation of health technology interventions. She has a track record in national collaboration and delivery of complex NIHR programmes.
Professor Gary Macfarlane leads a programme of research in musculoskeletal health, focussing on chronic pain. He has experience leading major epidemiological studies, randomised controlled trials and health services research. He has been an investigator in a large trial which demonstrated the benefit of continued activities for persons with distal arm pain and no benefit for “fast-track” over normal-timed physiotherapy. In addition, he co-directs the MRC Versus Arthritis Centre for Musculoskeletal Health and Work.
Professor Krysia Dziedzic is a senior member of the research programme team integrating methods for impact (NIHR Senior Investigator), offers a rheumatology physiotherapy perspective on quality of care, NICE recommendations and pathways of primary care for Musculoskeletal Pain.
Emeritus Professor Jo Adams is an occupational therapist and Emeritus Professor of Musculoskeletal (MSK) Health at Southampton University. Her collaborative research projects focus on working alongside patient partners living with musculoskeletal disease and clinicians to develop, design and run randomised controlled trials examining the effectiveness and efficacy of rehabilitation self-management approaches. She also has experience in integrating strategies to widen participation into trials and to make trials more accessible for all types of NHS patients.
Professor Karen Walker-Bone studied the epidemiology of upper limb disorders for her PhD in 2002 and developed and validated the Southampton examination schedule. She is currently the Director of the Monash Centre for Occupational and Environmental Health and Professor of Occupational Rheumatology in Melbourne, Australia. Her research interests are in work and health, with a particular focus on work participation and return to work. She has vast expertise in work and musculoskeletal health, epidemiology, and occupational rheumatology, and was Director of the MRC Versus Arthritis Centre for Musculoskeletal Health and Work at MRC Lifecourse Epidemiology Unit. She has been a member of the UK Fit for Work Coalition and sits on the Industrial Injuries Advisory Council.
Dr Ruben Mujica-Mota is an applied econometrician and health economics decision modeller. He has led teams of mathematical modellers, clinical experts and health services researchers reviewing the clinical and cost-effectiveness evidence and developing cost-effectiveness models to inform NICE technology appraisals. He is an expert user of causal inference methods of observational data analysis for evaluating treatments used in routine practice in orthopaedics, cardiovascular disease, oncology and neonatal care. He will lead the health economics work package.
Dr Claire Burton is a practicing GP and NIHR Clinical Lecturer in Primary Care at Keele University, with a research interest in musculoskeletal disorders of the upper limb. Her PhD included defining the prognosis and improving the management of carpal tunnel syndrome in primary care. She also has experience in recruiting patients from primary care to randomised controlled trials. Claire will be able to offer recommendations on the development and implementation of the D-MAPP from a primary care perspective.
Claire Davies is a Senior Trial Manager at the CTRU in Leeds with expertise in trial design, set-up and trial management. She currently has a leading role in the delivery of the NIHR PROMPT programme grant in psoriatic arthritis and further musculoskeletal studies with alternative funders.
Professor Deborah Stocken is Professor of Clinical Trials Research, Head of Statistics, Director of the Surgical Interventions, Diagnostics and Devices Division, Leeds CTRU. She has expertise in design and analysis of early and late phase NIHR and MRC funded trials. She will be responsible for scientific and statistical oversight of the trial design, conduct, analysis, and reporting.
Dr Laura Swaithes is a Knowledge Mobilisation Research Fellow at Keele University. After working as a Physiotherapist for 15 years, Laura completed the NIHR Masters in Research Methods and went on to complete a PhD which investigated the implementation of musculoskeletal innovations in primary care. Laura has a keen interest in knowledge mobilisation strategies and the role that patients and the public play in implementation.
Amy Rebane MA is the Patient and Public Involvement/Engagement (PPIE) Manager at the NIHR Leeds Biomedical Research Centre – University of Leeds/Leeds Teaching Hospitals NHS Trust. Amy is an experienced PPIE manager and brings a diverse portfolio of PPIE expertise to the research team. She currently provides specific PPIE support for cancer research at the NIHR Leeds Clinical Research Facility, as well as PPIE support for musculoskeletal research at the NIHR Leeds Biomedical Research Centre. Prior to this she worked in the voluntary sector managing and carrying out inclusive PPIE practices on behalf of the Leeds Clinical Commissioning Group, so also brings a wealth of experience of engaging with groups that are often under-represented in health research.
Nicki Evans graduated from the University of Liverpool in 2001 with a degree in Nutrition. Following her graduation, she went on to work for over 10 years in the NHS within the public health arena in the areas of childhood obesity and the national Healthy Lifestyle Advisors programme. In 2015, Nicki brought her management skills to the Impact Accelerator Unit at Keele University, initially as a Project Manager for two major implementation projects, before moving into the role of Impact Accelerator Unit Manager in June 2020. Nicki has oversight of the day to day management of the unit, including Patient and Public Involvement and Engagement (PPIE).
Sam Mason is a full time research assistant with the D-MAPP team. Prior to joining D-MAPP, Sam’s background was in health and wellbeing research; she completed a BSc (Hons) in Psychology in 2008 followed by an MSc in Forensic Psychology in 2009, both completed at Sheffield Hallam University. Previously she worked at the University of Huddersfield contributing to a global project aiming to address Gender-based violence using immersive video games. Prior to this she worked at the University of Leeds contributing to health and wellbeing research in patient preferences and patient reported outcomes. Her research interests include psychosocial outcomes, wellbeing, patient preferences, big data and psychometrics.
Lucy Brading is a Research Fellow at the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds. After graduating from the University of Bristol with a BSc in Chemical Physics, Lucy undertook a PhD at the University of Liverpool. There she employed qualitative methodologies to explore patient and public involvement (PPI) in the development of core outcome sets (COS). Before joining the D-MAPP team, Lucy worked on a project developing a digital intervention for people with MND diseases.
Jo Rimmer is the D-MAPP Programme Manager and is based at the Leeds Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds. Jo graduated with a degree in Chemistry and has since worked at Universities including University of York, Imperial College London and University of Leeds managing world-leading research groups, delivering research programmes, and facilitating interdisciplinary research collaborations.
Dr Edward Webb is a Senior Research Fellow at the Academic Unit of Health Economics. He has worked there since graduating with a PhD in economics from the University of Copenhagen in 2016. His research focuses primarily on preferences and decision-making, both for patients as well as health professionals and other stakeholders, as well as how we value health. He has also conducted research on how having a long-term health condition, or caring for someone with a long-term health condition, can affect labour market outcomes, finances, and wellbeing.
Is it possible to develop a robust evidence-based, digitally delivered care package to address the deficiencies in treatment and healthcare support for people with distal upper limb (DUL) musculoskeletal disorders (MSDs) in order to optimise recovery; improve long-term functional use and reduce pain?
DUL-MSDs are highly prevalent and commonly include: hand, wrist and thumb osteoarthritis (OA), carpal tunnel syndrome, tendinitis and epicondylitis. DUL-MSDs cause distressing levels of pain, swelling, loss of function and disability. The effects of living with a DUL-MSD are considerable in terms of personal, social and economic consequences.
Primary care consultations for upper limb disorders are high: a UK population survey reported 15% had consulted a GP within the previous year with upper limb pain. There are difficulties in the treatment and management of DUL-MSDs and a lack of national guidelines. Current challenges in our NHS including increasing costs, overburdened musculoskeletal (MSK) services and an unwarranted variation in service provision, all call for innovative ways of delivering rehabilitation. Supporting self-management and personalising treatments, including the use of digital technology are NHS priority areas.
The overall aim of this research programme is to co-develop and evaluate a digital rehabilitation programme - Digital-My Arm Pain Programme (D-MAPP) to be prescribed by health professionals for improving DUL-MSDs.
- To develop consensus between patients and key clinician stakeholders on the required components of DMAPP;
- To explore potential barriers and facilitators to patient engagement;
- To iteratively co-design and refine D-MAPP with patients and clinical stakeholders, identifying key intervention attributes and specifications for optimising use;
- To identify the causal mechanisms underpinning D-MAPP, and develop a logic model of the intervention;
- To explore with patients and key clinical stakeholders the content and usability of D-MAPP and any barriers to usability, adoption and adherence;
- To examine the clinical and cost-effectiveness of D-MAPP to determine if it will provide clinical and cost-effective improvements in DUL regional pain and physical function and facilitate workability compared to usual care;
- To explore experience, perceptions, usability and adherence of the D-MAPP by people with DUL-MSDs;
- To assess the challenges of intervention implementation of D-MAPP with patients and key clinical stakeholders in primary and community care.
We will produce a novel digital intervention (D-MAPP) for people with DUL-MSDs which has the potential to reduce pain control, improve physical function and, if relevant, enhance work participation. The D-MAPP will also reduce burden on over-stretched GPs and musculoskeletal services and likely post-COVID changed working practices.
We will ensure that the D-MAPP is widely disseminated to GPs, other health professionals, charity based organisations and patient groups, including through social media, publications and conference presentations.