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Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial

Venateswaran, Balachandran; Motkur, Prabhakar; Garg, Sunil; Hawken, Richard; Kelly, Cormac; Kent, Matthew; Kumar, Kapil; Lawrence, Tom; Little, Christopher; Macleod, Iain; Malal, Jodi George; Matthews, Tim; McClelland, Damian; Millar, Neal; Nanda, Rajesh; Crowther, Mark; Peach, Chris Peach; Peckham, Tim; Rai, Jayanti; Ray, Ravi; Robinson, Douglas; Rosell, Philip; Ruman, Adam; Saithna, Adnan; Senior, Colin; Shanker, Harish; Sheridan, Barnaby; Theivendran, Kanthan; Thomas, Simon; Drew, Steve; Candal-Couto, Jamie; Butt, Asim; Bidwai, Amit; Baldwick, Cheryl; Ahrens, Philip; Rangan, Amar; Brealey, Stephen; Keding, Ada; Corbacho, Belen; Northgraves, Matthew; Kottam, Lucksy; Goodchild, Lorna; Srikesavan, Cynthia; Rex, Saleema; Charalambous, Charalambos; Hanchard, Nigel; Armstrong, Alison; Brooksbank, Andrew; Carr, Andrew; Cooper, Cushla; Dias, Joseph; Donnelly, Iona; Hewitt, Catherine; Lamb, Sarah; McDaid, Catriona; Richardson, Gerry; Rodgers, Sara; Sharp, Emma; Spencer, Sally; Torgerson, David; Toye, Francine

Authors

Balachandran Venateswaran

Prabhakar Motkur

Sunil Garg

Richard Hawken

Cormac Kelly

Matthew Kent

Kapil Kumar

Tom Lawrence

Christopher Little

Iain Macleod

Jodi George Malal

Tim Matthews

Damian McClelland

Neal Millar

Rajesh Nanda

Mark Crowther

Chris Peach Peach

Tim Peckham

Jayanti Rai

Ravi Ray

Douglas Robinson

Philip Rosell

Adam Ruman

Adnan Saithna

Colin Senior

Harish Shanker

Barnaby Sheridan

Kanthan Theivendran

Simon Thomas

Steve Drew

Jamie Candal-Couto

Asim Butt

Amit Bidwai

Cheryl Baldwick

Philip Ahrens

Amar Rangan

Stephen Brealey

Ada Keding

Belen Corbacho

Lucksy Kottam

Lorna Goodchild

Cynthia Srikesavan

Saleema Rex

Charalambos Charalambous

Nigel Hanchard

Alison Armstrong

Andrew Brooksbank

Andrew Carr

Cushla Cooper

Joseph Dias

Iona Donnelly

Catherine Hewitt

Sarah Lamb

Catriona McDaid

Gerry Richardson

Sara Rodgers

Emma Sharp

Sally Spencer

David Torgerson

Francine Toye



Abstract

© 2020 The Author(s). Publishedx by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Background: Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection. Methods: In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0–48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508. Findings: Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (–1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release). Interpretation: All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective. Funding: The National Institute for Health Research Health Technology Assessment programme.

Citation

Ahrens, P., Baldwick, C., Bidwai, A., Butt, A., Candal-Couto, J., Crowther, M., …Toye, F. (2020). Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial. Lancet, 396(10256), 977-989. https://doi.org/10.1016/S0140-6736%2820%2931965-6

Journal Article Type Article
Acceptance Date Jul 9, 2020
Online Publication Date Oct 3, 2020
Publication Date Oct 3, 2020
Deposit Date Aug 10, 2020
Publicly Available Date Apr 4, 2021
Journal The Lancet
Print ISSN 0140-6736
Electronic ISSN 1474-547X
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 396
Issue 10256
Pages 977-989
DOI https://doi.org/10.1016/S0140-6736%2820%2931965-6
Keywords Frozen shoulder; Adhesive capsulitis; Physiotherapy; Intra-articular injection; Manipulation under anaesthesia; Arthroscopic capsular release; Randomised controlled trial
Public URL https://hull-repository.worktribe.com/output/3556717
Publisher URL https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31965-6/fulltext
Related Public URLs https://www.sciencedirect.com/science/article/abs/pii/S0140673620319656

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