Title: ACCorD: Adhesive Capsulitis Corticosteroid or Dilation in Primary Care: A Feasibility Study.
Funder: Department of Health and Social Care

Abstract: Research Question Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injection with hydrodilation (CSI & HD) compared to CSI (standard of care) for people with frozen shoulder? Background Shoulder pain accounts for 3% of all visits to a GP, with frozen shoulder being the most common cause of pain. Prevalence of frozen shoulder is estimated to be 10% of working age adults, having a significant impact on function and the ability to work. NICE advocate early treatment of frozen shoulder however there is significant variation in treatment offered with many people referred to secondary care. The steady rise in orthopaedic outpatient referrals, and the impact of COVID-19, has led to a 20% increase in waiting times for an appointment. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral. Aims and Objectives An adequately powered definitive randomised controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation (HD) is a clinically and cost-effective intervention. In this study, prior to a full RCT we propose a feasibility trial to evaluate: Clinician willingness to randomise a participant. Patients' acceptance of randomisation. Rates of withdrawal, crossover and attrition. Outcome data collection systems using routinely collected primary and secondary care data. Methods We will conduct a multicentre RCT comparing corticosteroid injection (CSI) and HD with CSI alone. People aged 18 and over with a clinical diagnosis of frozen shoulder will be randomised and blinded to receive either CSI and HD, or CSI. Feasibility outcomes include the rate of randomisation as a proportion of eligible patients and the ability to use routinely collected data for outcome evaluation. In a future definitive trial, the primary outcome will be shoulder function measured using the Oxford Shoulder Score at 6 months post randomisation. Secondary outcomes will include health-related quality-of-life, measured using the EuroQol EQ-5D-5L questionnaire, complications and resource use. This study has involved patients and the public in the trial design, dissemination methods and how to include groups who are underserved by research. Timelines for Delivery We will deliver this trial over 22 months: 6 months set up 6 months recruitment 6 months follow up 4 months analysis & reporting Anticipated Impact and Dissemination Results will be disseminated to clinicians and patients. We will disseminate findings amongst musculoskeletal clinicians via the British Orthopaedic Association, The Chartered Society of Physiotherapy, The Royal College of Radiologists and the Royal College of GPs. To ensure wide reach we will communicate findings through our established network of charities and organisations in addition to preparing dissemination findings in Bangla and Urdu (commonly spoken languages in NE London). If a full trial is shown to be feasible, we will seek additional NIHR funding for a definitive RCT. This definitive study will inform NICE guidelines for the management of frozen shoulder.

Lay abstract: &ldquo;Frozen shoulder&rdquo; is a painful condition that affects the shoulder. The joint becomes inflamed, tightening and shrinking the tissues leading to pain and stiffness. This combined pain and stiffness makes day-to-day activities difficult and stops many people from working. Most people recover, but for some symptoms continue for up to 3 years. Current guidelines recommend frozen shoulder treatment should start with physiotherapy. If physiotherapy fails, people are then sent for further assessment at a hospital, where an injection into the shoulder may be recommended. Two types of injection can be used, a steroid to reduce inflammation, or a small amount of fluid called hydrodilation which stretches out the shrunken tissues. Both treatments can be given in the community. We asked patients with frozen shoulder their views about treatment. They said research should focus upon prompt treatments avoiding operations where possible. Currently, there is a lot of variation in how this condition is treated. If an effective treatment can be given in the community it will mean people wait less time for treatment, with no need for a hospital visit and/or an operation; better outcomes and reduced cost to the NHS. We want to find out which one of these injections helps to reduce peoples shoulder pain, stiffness, and improves the use of their arm. We will need to carry out a large study to look at which treatment offers most benefit to people. Before we do this, we need to carry out a smaller study to find out if: &middot; GPs and physiotherapists with expertise in frozen shoulder will agree to be involved in the research. &middot; People with frozen shoulder will be willing to take part in the study. &middot; Whether the questions we ask patients about the effect of their treatment are important and relevant to them. We will ask patients with frozen shoulder at three boroughs in London and one borough in Cambridge to have either: &middot; a steroid injection and physiotherapy. &middot; an injection of steroid plus a small amount of fluid, and physiotherapy. We will record people s progress after their treatment, and while they follow their rehabilitation. Patients and members of the public have helped us to design this study. They will continue to be involved as it is carried out. Patients will help us to communicate the findings of this study to the public in the most effective way including sharing findings in different languages. We will also publish our findings for colleagues.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: MUSCULOSKELETAL