Title: Is ultrasound stratification informative for shoulder pain management?
Funder: Department of Health and Social Care

Abstract: Background: Shoulder pain is common with a UK prevalence of 7%. The economic burden is substantial and it has a significant impact on quality of life. Importantly for our ageing society, shoulder pain increases with age, with prevalence of 21% in over 70 year olds. Management is challenging, often with poor outcomes: 50% of people have chronic pain. Although ultrasound scans offer accurate diagnosis and are increasingly used, there is no consensus on how to best use the information they provide. My preliminary work involved analysing retrospective data on 3000 ultrasound reports. I demonstrated 4 different groups according to clusters of ultrasound pathology: cuff tears, localised inflammation, diffuse inflammation, and minimal pathology (of which 55% have no ultrasound-reported pathology). Shoulder surgeons, radiologists and rheumatologists thought these categories made sense and represented groups with likely different outcomes and treatment needs. A prospective study is required to confirm these groups exist, understand their outcomes and responses to treatment. Hypothesis: People with shoulder pain can be grouped according to clusters of ultrasound-detected pathologies, and these groups will differ in their long-term outcomes and response to common therapies, informing potential new treatment pathways. Aims: Confirm preliminary findings that people with shoulder pain can be classified into distinct groups according to ultrasound pathology Determine 6 month outcomes for each group when taking into account other factors including co-morbidities, activity and treatments Explore response to steroid injection in different groups at 2 weeks Assess the group with no ultrasound pathology to explore causes of pain and if further investigations are required Use the above findings to inform an expert consensus on how an ultrasound-based classification should guide treatment of shoulder pain. Post-Fellowship, to further evaluate specific elements of the ultrasound-based pathway based on the expert group's recommendations Plan: Project 1 Prospective study on a community-based cohort (n=500) with shoulder pain presenting for their first routine ultrasound scan.1a: Confirmation of different groupsSystematic ultrasound reporting will be analysed and latent class analysis performed to identify clusters of pathologies. 1b Exploring long-term clinical outcomes in each group Participants will complete questionnaires at baseline and 6 months. I will use linear regression analysis including covariates (such as co-morbidities) to evaluate differences in outcomes at 6 months. 1c Exploring short-term response to steroid injections in each group All participants will also complete a pain and function questionnaire 2 weeks after their scan. 1d Exploring why the group with no ultrasound-detected pathology have symptoms If this group exists after systematic reporting of data is introduced, I will perform a clinical assessment to explore possible causes of pain and if further investigations are required. Project 2: Expert consensus process Project 1 will inform a meeting of 15 shoulder experts (including patients surgeons and rheumatologists), to develop preliminary recommendations on treatments for these different groups. Feasibility 60-70 primary care patients attend my Radiology Department weekly for shoulder scans. A prior feasibility survey of 200 people showed 60% were willing and suitable for study inclusion. I have conservatively allowed 18 months for recruitment. CHAR(13) + CHAR(10) Summary of the potential benefits to patients and the NHS: This Fellowship is very well suited to the needs of the NHS. It focuses on a growing long-term condition with huge patient and NHS burden. This Fellowship will provide the basis for a novel ultrasound-based classification of shoulder problems that guides therapy. It will deliver consensus-achieved preliminary recommendations on how to treat patients by the end of this Fellowship, while also providing the basis for post-Fellowship evaluation of the classification that would impact within 5 years of Fellowship completion.

Lay abstract: Shoulder pain is common, affecting 7 in every 100 adults. It worsens with age, and will become more common as the UK population ages. Shoulder pain has a negative impact on quality of life and is estimated to cost the UK 310 million per year. The best way to treat shoulder pain is unknown. Worryingly, half of those with shoulder pain still have pain after 18 months. Diagnosis of shoulder problems start with clinical assessment which is often inaccurate. Modern imaging, especially ultrasound, is increasingly used as it provides more accurate diagnosis. However, despite a large increase in the use of ultrasound, its role in improving shoulder pain and function is unclear. Currently, most people are treated in the same way. It is unclear whether certain ultrasound features tell us who will have poor long-term outcomes, and how these people should be treated. Shoulder problems are a key priority for research by a large number of groups, including the James Lind Alliance and the British Elbow and Shoulder Society. My research over the past 12 months has shown people who have ultrasound scans on their painful shoulder can be categorised into four groups based on ultrasound findings: those with tears; localised inflammation; generalised inflammation; minimal abnormalities (55% of this last group have no abnormalities). However, further work is needed to confirm the existence of these groups, and how they differ in symptoms and response to steroid injections. The aim of this Fellowship is to develop ultrasound-based groupings for shoulder pain that leads to specific treatments for each group. In particular I will: Confirm findings from my retrospective review by undertaking a study to show that people with shoulder pain can be categorised into distinct groups using ultrasound Explore if these groups differ in pain and function at 6 months, when taking into account other factors such as anxiety and depression Explore if the groups respond differently to shoulder steroid injections Explore the possible causes of symptoms in the group with no ultrasound abnormalities Use these findings to develop an expert agreement for the treatment of shoulder pain To achieve these aims I will: Invite people already referred by their General Practitioner (GP) and attending for an ultrasound scan of their shoulder as part of their routine NHS care to participate Analyse participants' ultrasound reports to confirm that different groups exist Ask participants to fill in questionnaires at presentation, 2 weeks and 6 months Explore if the groups differ in their response to steroid injections at 2 weeks After introducing a systematic way of reporting ultrasounds, see if a group with no ultrasound abnormalities exists, and explore why they may have shoulder pain. Present the results of this work to experts (including patients) and achieve agreement on the best way to treat each group Every week, GPs in the Leeds area refer 100 people with shoulder pain for ultrasound. I surveyed 200 such people and showed 60% of them are willing and suitable to participate in the proposed study. This supports my ability to recruit a large number of people. This research will improve the treatment of shoulder pain as for the first time it will classify people into distinct groups based on accurate ultrasound findings and make treatment relevant to an individual's problems. It will also provide expert agreement on how to treat these different groups. Throughout the development of this Fellowship, patients and the public have helped. I discussed and took their advice on what was important to them, including the study design and questionnaires. This patient and public group will continue to play an important role throughout. I will meet 6 monthly to update them and ask their advice on any problems. At the end of the study they will help to communicate the results. Once the study is complete, I will communicate my findings to the patients, the public and my colleagues in the following ways: Writing to participants Presenting at meetings for patients and the public and at scientific conferences Publishing in scientific journals Publishing results through online journals and our freely-accessible dedicated website

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: MUSCULOSKELETAL