Title: A randomised controlled feasibility study of TRAK musculoskeletal digital self-management physiotherapy intervention for individuals with musculoskeletal pain
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background Musculoskeletal pain (MSK pain) is common affecting 18.8 million people in the UK with estimated healthcare costs of £10.2 billion for treating the two most common joint conditions (1). In Wales, 29.3% of the population (887,000 people), have a MSK condition, which is associated with pain, loss of function and reduced levels of physical activity (2). Current self-management and exercise interventions for MSK pain have limited effectiveness so there is a need for new approaches. TRAK- MSK is a new digital intervention that combines up to 5 online consultations with physiotherapists trained in self-management and web-based support optimised to promote self-management. TRAK- MSK has been developed to help people be more confident to self-manage their condition so that they are more physically active and experience less pain. Aims The aim is to evaluate the feasibility of conducting a pragmatic, multi-centre randomised controlled trial of TRAK-MSK physiotherapy self-management intervention for people with MSK pain compared to usual care. Methods Research design: Two-arm randomised feasibility study with embedded process evaluation comparing TRAK-MSK intervention to usual care. Setting: Participant homes and physiotherapy services across 2 NHS health boards in Wales which encompass a spread of population density and deprivation levels. Sample: 80 adults attending physiotherapy clinics with MSK pain will be randomised to TRAK-MSK or usual care. We will have some devices for loan to people that do not have access to technology and we will provide Interpreters and/ or translation for non-English speaking participants. Inclusion criteria: adults age 18 and over with self-reported activity related joint pain on most days for the past 3 months. The 6 month TRAK-MSK intervention has 3 components: • Physiotherapists trained to deliver self-management support. • Access to TRAK-MSK website with functionality optimised to support self-management from home. • up to 5 online consultations over 4 months with specially trained physiotherapists who integrate self-management principles alongside use of the TRAK-MSK website The comparator will be usual care physiotherapy which could be an online or telephone consultation or face to face physiotherapy but the physiotherapist will not be trained in self-management. The primary outcome will be to evaluate feasibility of delivering the intervention. Secondary outcomes will be to estimate the effect size and variance of the patient rated outcome measures across both arms and cost the intervention. Timeline Study set up, approvals, protocol development (0-5 mths), develop/ validate TRAK-MSK database (0- 5 mths), train site staff (4-5 mths), recruitment (6-9 mths), intervention phase (6-13 mths), 6 mth post randomisation follow-up (12-15 mths), statistical analysis and write-up (16-17 mths), dissemination workshop (month 18). Anticipated impact If feasibility is successfully demonstrated this will lead to a fully powered randomised controlled trial. If the randomised controlled trial demonstrates that TRAK-MSK is more effective than usual care, then TRAK-MSK users will develop the skills and confidence required to manage their condition independently from their physiotherapist. Success will see those individuals experiencing less pain and being more physically active, leading to healthier lives and less healthcare resource use.

Lay abstract: Pain of the muscles, joints, bones and soft tissues (musculoskeletal (MSK) pain) affects 18.8 million people in the UK. In Wales approximately 1 in 3 people have a MSK condition, with back pain and knee osteoarthritis being the most common conditions. Conservative treatments such as exercise and physiotherapy are recommended but they appear to have limited benefit in helping people manage their condition at home, as they often struggle to keep going with regular exercise. Technology like TRAK-MSK has the potential to make a difference. TRAK-MSK is a new digital physiotherapy intervention for people with MSK pain, that helps people to manage their exercise and pain at home. In this intervention individuals can have up to five online consultations with a specially physiotherapist trained in self-management. The timing and number of appointments will be decided by the participant. Individuals will have immediate access to the TRAK-MSK website throughout, which provides information, personalised video based exercise plans, progress tracker, individual set challenges and remote access to a physiotherapist. The combination of online consultations with a specially trained physiotherapist and access to the TRAK-MSK website will support individuals to practice and gain the skills to manage their condition themselves at home. The aim of this study is to find out if TRAK-MSK intervention can be delivered and if people find it acceptable. This study will ask whether people with MSK pain can be recruited and retained to clinical studies of TRAK-MSK and what it costs to deliver the TRAK-MSK intervention. We will see if TRAKMSK increases people’s confidence to independently manage their pain and help them remain physically active. TRAK-MSK will be tested using a randomized study design in 2 different locations across Wales that represent a spread in wealth and population density. By randomized, we mean that people who agree to take part will receive either usual physiotherapy appointment (which involve exercises and advice) or the new TRAK-MSK intervention based on chance. We will have some devices for loan to people that do not have access to a mobile device and we will provide interpretation and translation for individuals that do not speak English. A series of patient, public and clinician involvement workshops have informed the development of this research proposal. Individuals have given feedback on the content of TRAK-MSK website, the recruitment strategy, the use of online methods for registering and consenting to take part and the dissemination strategy. A public member is a co-applicant on this application and will attend project meetings, contribute to developing and reviewing information resources, and ensure clarity of key messages from the study. The findings will be circulated to a variety of audiences and tailored accordingly. We will hold a feedback event for key stakeholders. Findings will be distributed publicly via NHS and university websites, social media accounts and press releases in collaboration with Cardiff and Vale and Cardiff University press offices. Our findings will be presented to the academic community via publication in open access peer reviewed academic journals and at an international conference.

Research activity codes: 6.3 MEDICAL DEVICES;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MUSCULOSKELETAL