ACCorD: Adhesive Capsulitis Corticosteroid or Dilation in Primary Care: A Feasibility Study.

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.