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
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 wor...
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| Format: | Article |
| Language: | English |
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BMC
2017-12-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2352-2 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Stephen Brealey |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-10T09:26:32Z |
| format | Article |
| id | doaj.art-8e8835a438a8407eb1a8ee32e8a89f8a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T09:26:32Z |
| publishDate | 2017-12-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-8e8835a438a8407eb1a8ee32e8a89f8a2022-12-22T01:54:31ZengBMCTrials1745-62152017-12-0118111510.1186/s13063-017-2352-2United 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 trialStephen Brealey0Alison L. Armstrong1Andrew Brooksbank2Andrew Jonathan Carr3Charalambos P. Charalambous4Cushla Cooper5Belen Corbacho6Joseph Dias7Iona Donnelly8Lorna Goodchild9Catherine Hewitt10Ada Keding11Lucksy Kottam12Sarah E. Lamb13Catriona McDaid14Matthew Northgraves15Gerry Richardson16Sara Rodgers17Sarwat Shah18Emma Sharp19Sally Spencer20David Torgerson21Francine Toye22Amar Rangan23York Trials Unit, Department of Health Sciences, Faculty of Sciences, University of YorkUniversity Hospitals of Leicester NHS Trust, Leicester General HospitalGlasgow Royal InfirmaryNuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research CentreBlackpool Victoria Hospital and Blackpool and School of Medicine University of Central LancashireNuffield Department of Orthopaedics, University of Oxford, Botnar Research CentreYork Trials Unit, Department of Health Sciences, Faculty of Sciences, University of YorkUniversity Hospitals of Leicester NHS TrustUniversity of Glasgow, Glasgow Royal Infirmary Orthopaedic Research UnitJames Cook University Hospital, South Tees Hospitals NHS TrustYork Trials Unit, Department of Health Sciences, Faculty of Sciences, University of YorkYork Trials Unit, Department of Health Sciences, Faculty of Sciences, University of YorkDepartment of Trauma and Orthopaedics, South Tees Institute of Learning Research and Innovation, The James Cook University Hospital, South Tees Hospitals NHS Foundation TrustNuffield Department of Orthopaedics, Rheumatology and Musculo-skeletal Sciences, University of Oxford, Botnar Research CentreYork Trials Unit, Department of Health Sciences, Faculty of Sciences, University of YorkYork Trials Unit, Department of Health Sciences, Faculty of Sciences, University of YorkCentre for Health Economics, University of YorkYork Trials Unit, Department of Health Sciences, Faculty of Sciences, University of YorkDepartment of Health Sciences, Faculty of Sciences, University of YorkOrthopaedic Department, Glasgow Royal InfirmaryEdge Hill UniversityYork Trials Unit, Department of Health Sciences, Faculty of Sciences, University of YorkNuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation TrustDepartment of Health Sciences, University of YorkAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2352-2Frozen shoulderPhysiotherapyManipulation under anaesthesiaArthroscopic capsular releaseRandomised controlled trial |
| spellingShingle | 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 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 Trials Frozen shoulder Physiotherapy Manipulation under anaesthesia Arthroscopic capsular release Randomised controlled trial |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Frozen shoulder Physiotherapy Manipulation under anaesthesia Arthroscopic capsular release Randomised controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-017-2352-2 |
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