ACCORD

• Research type

  Research Study

• Full title

  Adhesive Capsulitis Corticosteroid and Dilation Randomised Controlled Trial: A Feasibility Study in Primary Care

• IRAS ID

  314582

• Contact name

  Livio Dimasco

• Contact email

  livio.dimascio@nhs.net

• Sponsor organisation

  Barts Health NHS Trust

• ISRCTN Number

  ISRCTN00000000

• Duration of Study in the UK

  1 years, 9 months, 30 days

• Research summary

  “Frozen shoulder” 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:

  · GPs and physiotherapists with expertise in frozen shoulder will agree to be involved in the research.
  · People with frozen shoulder will be willing to take part in the study.
  · 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:

  · a steroid injection and physiotherapy.
  · 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. We will also publish our findings for colleagues.

  Summary of results
  ACCorD aimed to see if it would be possible to run a large study comparing these two treatments in bone and joint healthcare hubs. We wanted to check that patients and healthcare staff were willing to take part and that we could collect the right information.

  The study involved four of these hubs. Adults with frozen shoulder were given either steroid injections alone or along with hydrodilation using a process called randomisation. Randomisation means that at the end of the study the groups are similar and the comparison between treatments is fair. Patients were followed up for six months to see whether they improved. In the six months following patients were asked about how their shoulder felt and worked, their quality-of-life, their shoulder range of motion, whether they had attended their GP or hospital.

  Over six months in 2023 we reviewed 72 patients, 63 were suitable for the study and 52 agreed to take part. We were able to collect the most important information we needed from 42 of the 52 patients. We found that health information held by hospitals and GP surgeries could be used to check how often people used NHS services.

  Working with the public and patients was really important to make sure the study was patient-centred and included all different types of people – especially people who don’t usually take part in research.
  Overall, the study indicates that a larger trial in community care settings is possible.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  22/LO/0718

• Date of REC Opinion

  29 Nov 2022

• REC opinion

  Further Information Favourable Opinion