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  5. Adhesive Capsulitis Corticosteroid and Dilation randomized controlled trial

Adhesive Capsulitis Corticosteroid and Dilation randomized controlled trial

Overview

This study asked whether it was possible to run a large clinical trial comparing two common treatments for frozen shoulder in community care settings. The treatments were corticosteroid injections alone, or combined with hydrodilatation (a fluid injection to stretch the joint). 

Frozen shoulder affects up to 10% of working-age adults and can cause long-lasting pain and reduced movement. The study focused on adults receiving care through community musculoskeletal (MSK) hubs. 

The ACCorD study was a feasibility trial involving 52 participants recruited across four MSK hubs in London and Norfolk. It aimed to test whether patients and clinicians would take part, and whether the study processes would work in practice.

What we found

The study showed that running a larger trial in this setting was feasible. Key findings included: 

  • High eligibility and recruitment rates 
    • 72 patients screened; 63 (88%) eligible 
    • 52/63 (83%) of eligible patients agreed to take part  
  • Strong participation and adherence 
    • Most participants received their allocated treatment 
    • Very low crossover or withdrawal (2 participants did not follow allocation) 
  • Data collection was largely successful 
    • Primary outcome data available for 81% of participants 
  • No safety concerns identified 
    • No unexpected adverse events reported  
  • Limitations identified 
    • Remote measurement of shoulder movement was not feasible 
    • Linking routinely collected data in primary care (GP practices) did not work well with data missing

The study did not test effectiveness but showed that a full trial could be delivered.

Why it matters

The study provided important groundwork for improving care for frozen shoulder. It showed that community-based MSK hubs could successfully deliver a clinical trial, which could help reduce pressure on hospitals and improve access to care. 

In the short term, the study supported plans for a larger definitive trial, with a funding application planned to the NIHR Health Technology Assessment programme.  

In the longer term, if hydrodilatation proved effective, it could: 

  • Improve recovery and reduce long-term pain 
  • Help patients return to work sooner
  • Reduce demand on NHS services 

The study also improved understanding of how to design future trials, including how to recruit participants, collect data, and use routine NHS data to reduce burden.

Outputs and reach

One academic manuscript from the study was published (PMCID: PMC10909438), with further publication in preparation.  

A NIHR funding application for a definitive trial is in development.

Who was involved

The study was led by Chief Investigator Mr Livio Di Mascio (Barts Health NHS Trust), with Professor Xavier Griffin as Joint Lead Applicant at Queen Mary University of London.  

The team included researchers, clinicians, statisticians and health economists from Barts Health NHS Trust and Queen Mary University of London. 

The study was supported by the NIHR Clinical Research Network, the Pragmatic Clinical Trials Unit, and the NIHR Barts Biomedical Research Centre.  

Patient and public contributors were actively involved in study design and delivery.

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