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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial

Authors: Stephen Brealey, Alison L. Armstrong, Andrew Brooksbank, Andrew Jonathan Carr, Charalambos P. Charalambous, Cushla Cooper, Belen Corbacho, Joseph Dias, Iona Donnelly, Lorna Goodchild, Catherine Hewitt, Ada Keding, Lucksy Kottam, Sarah E. Lamb, Catriona McDaid, Matthew Northgraves, Gerry Richardson, Sara Rodgers, Sarwat Shah, Emma Sharp, Sally Spencer, David Torgerson, Francine Toye, Amar Rangan

Published in: Trials | Issue 1/2017

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Abstract

Background

Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy.

Methods

We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods.

Discussion

The three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults.

Trial registration

International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508. Registered on 25 July 2014.
Appendix
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Metadata
Title
United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial
Authors
Stephen Brealey
Alison L. Armstrong
Andrew Brooksbank
Andrew Jonathan Carr
Charalambos P. Charalambous
Cushla Cooper
Belen Corbacho
Joseph Dias
Iona Donnelly
Lorna Goodchild
Catherine Hewitt
Ada Keding
Lucksy Kottam
Sarah E. Lamb
Catriona McDaid
Matthew Northgraves
Gerry Richardson
Sara Rodgers
Sarwat Shah
Emma Sharp
Sally Spencer
David Torgerson
Francine Toye
Amar Rangan
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2352-2

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