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This feasibility study assesses the effectiveness of corticosteroid injections (CSI) with hydrodilation (HD) versus CSI alone for frozen shoulder. Findings will guide a definitive randomized controlled trial (RCT) for optimal patient management.

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Area of Science:

  • Orthopedics
  • Musculoskeletal Health
  • Clinical Trials

Background:

  • Frozen shoulder management in the UK often involves primary care interventions like corticosteroid injections (CSI).
  • Current practice shows variation in injection types, including CSI alone versus CSI combined with hydrodilation (HD).
  • Musculoskeletal hubs offer infrastructure for early, effective frozen shoulder management, potentially reducing healthcare costs.

Purpose of the Study:

  • To determine the feasibility of a definitive multicentre randomized controlled trial (RCT) comparing CSI with HD versus CSI alone for frozen shoulder.
  • To evaluate patient and clinician willingness for randomization, recruitment and retention rates, and data collection feasibility.
  • To inform future definitive RCT design and potential NICE guideline updates for frozen shoulder treatment.

Main Methods:

  • A multicentre feasibility randomized controlled trial (RCT) comparing combined CSI and HD with CSI alone.
  • Patients aged 18+ with a clinical diagnosis of frozen shoulder will be randomized and blinded.
  • Feasibility outcomes include randomization rates and the use of routinely collected data for outcome evaluation.

Main Results:

  • The study will assess recruitment and retention rates, withdrawal, crossover, and attrition.
  • Feasibility of collecting outcome data from routine primary and secondary care will be evaluated.
  • Patient and public involvement has shaped the trial design and dissemination strategies.

Conclusions:

  • This feasibility study is crucial for planning a definitive RCT on CSI with HD for frozen shoulder.
  • Successful feasibility will lead to seeking funding for a definitive RCT to inform clinical practice.
  • Findings will contribute to evidence-based guidelines for frozen shoulder management, potentially impacting NICE recommendations.