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Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial)

Ceri Battle, Amy Charnock, Sara Davies, Susan Davies, Thomas Dawson, Timothy Driscoll Orcid Logo, Phillip A Evans, Deborah Fitzsimmons Orcid Logo, Shaun Harris Orcid Logo, Kate Jones, Fiona Elizabeth Lecky, Claire O'Neill Orcid Logo, Joanne Prosser, Hannah Toghill, Alan Watkins Orcid Logo, Hayley Hutchings Orcid Logo

BMJ Open, Volume: 12, Issue: 4, Start page: e060055

Swansea University Authors: Ceri Battle, Timothy Driscoll Orcid Logo, Deborah Fitzsimmons Orcid Logo, Shaun Harris Orcid Logo, Claire O'Neill Orcid Logo, Alan Watkins Orcid Logo, Hayley Hutchings Orcid Logo

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DOI (Published version): 10.1136/bmjopen-2021-060055

Abstract

Introduction Chronic pain and disability are now well-recognised long-term complications of blunt chest wall trauma. Limited research exists regarding therapeutic interventions that can be used to address these complications. A recent feasibility study was completed testing the methods of a definiti...

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Published in: BMJ Open
ISSN: 2044-6055 2044-6055
Published: BMJ 2022
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Limited research exists regarding therapeutic interventions that can be used to address these complications. A recent feasibility study was completed testing the methods of a definitive trial. This protocol describes the proposed definitive trial, the aim of which is to investigate the impact of an early exercise programme on chronic pain and disability in patients with blunt chest wall trauma.Methods/analysis This mixed-methods, multicentre, parallel randomised controlled trial will run in four hospitals in Wales and one in England over 12-month recruitment period. Patients will be randomised to either the control group (routine physiotherapy input) or the intervention group (routine physiotherapy input plus a simple exercise programme completed individually by the patient). Baseline measurements including completion of two surveys (Brief Pain Inventory and EuroQol 5-dimensions, 5-Levels) will be obtained on initial assessment. These measures and a client services receipt inventory will be repeated at 3-month postinjury. Analysis of outcomes will focus on rate and severity of chronic pain and disability, cost-effectiveness and acceptability of the programme by patients and clinicians. Qualitative feedback regarding acceptability will be obtained through patient and clinician focus groups.Ethics/dissemination London Riverside Research Ethics Committee (Reference number: 21/LO/0782) and the Health Research Authority granted approval for the trial in December 2021. Patient recruitment will commence in February 2022. 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spelling 2022-05-13T11:32:39.0537763 v2 59781 2022-04-08 Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial) 9ae21f1afb903db3c39684cd47b94760 Ceri Battle Ceri Battle true false 2be5c329c44d14550ceac4934fcb409e 0000-0001-9879-2509 Timothy Driscoll Timothy Driscoll true false e900d99a0977beccf607233b10c66b43 0000-0002-7286-8410 Deborah Fitzsimmons Deborah Fitzsimmons true false 10b1bd08dbad1f2681ff1e527af9f9a3 0000-0001-7724-6621 Shaun Harris Shaun Harris true false b6ee9140bc0cf54b94165f477a530f9e 0000-0003-3497-0235 Claire O'Neill Claire O'Neill true false 81fc05c9333d9df41b041157437bcc2f 0000-0003-3804-1943 Alan Watkins Alan Watkins true false bdf5d5f154d339dd92bb25884b7c3652 0000-0003-4155-1741 Hayley Hutchings Hayley Hutchings true false 2022-04-08 FGMHL Introduction Chronic pain and disability are now well-recognised long-term complications of blunt chest wall trauma. Limited research exists regarding therapeutic interventions that can be used to address these complications. A recent feasibility study was completed testing the methods of a definitive trial. This protocol describes the proposed definitive trial, the aim of which is to investigate the impact of an early exercise programme on chronic pain and disability in patients with blunt chest wall trauma.Methods/analysis This mixed-methods, multicentre, parallel randomised controlled trial will run in four hospitals in Wales and one in England over 12-month recruitment period. Patients will be randomised to either the control group (routine physiotherapy input) or the intervention group (routine physiotherapy input plus a simple exercise programme completed individually by the patient). Baseline measurements including completion of two surveys (Brief Pain Inventory and EuroQol 5-dimensions, 5-Levels) will be obtained on initial assessment. These measures and a client services receipt inventory will be repeated at 3-month postinjury. Analysis of outcomes will focus on rate and severity of chronic pain and disability, cost-effectiveness and acceptability of the programme by patients and clinicians. Qualitative feedback regarding acceptability will be obtained through patient and clinician focus groups.Ethics/dissemination London Riverside Research Ethics Committee (Reference number: 21/LO/0782) and the Health Research Authority granted approval for the trial in December 2021. Patient recruitment will commence in February 2022. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings.Trial registration number ISRCTN65829737; Pre-results. Journal Article BMJ Open 12 4 e060055 BMJ 2044-6055 2044-6055 7 4 2022 2022-04-07 10.1136/bmjopen-2021-060055 COLLEGE NANME Medicine, Health and Life Science - Faculty COLLEGE CODE FGMHL Swansea University Another institution paid the OA fee Health and Care Research Wales 2022-05-13T11:32:39.0537763 2022-04-08T11:27:14.2860983 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Ceri Battle 1 Amy Charnock 2 Sara Davies 3 Susan Davies 4 Thomas Dawson 5 Timothy Driscoll 0000-0001-9879-2509 6 Phillip A Evans 7 Deborah Fitzsimmons 0000-0002-7286-8410 8 Shaun Harris 0000-0001-7724-6621 9 Kate Jones 10 Fiona Elizabeth Lecky 11 Claire O'Neill 0000-0003-3497-0235 12 Joanne Prosser 13 Hannah Toghill 14 Alan Watkins 0000-0003-3804-1943 15 Hayley Hutchings 0000-0003-4155-1741 16 59781__23796__15fa7a30c71e489591f54d2018609168.pdf ELECT protocol paper.pdf 2022-04-08T11:42:08.7305590 Output 1428135 application/pdf Version of Record true © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. true eng http://creativecommons.org/licenses/by-nc/4.0/
title Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial)
spellingShingle Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial)
Ceri Battle
Timothy Driscoll
Deborah Fitzsimmons
Shaun Harris
Claire O'Neill
Alan Watkins
Hayley Hutchings
title_short Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial)
title_full Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial)
title_fullStr Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial)
title_full_unstemmed Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial)
title_sort Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial)
author_id_str_mv 9ae21f1afb903db3c39684cd47b94760
2be5c329c44d14550ceac4934fcb409e
e900d99a0977beccf607233b10c66b43
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b6ee9140bc0cf54b94165f477a530f9e
81fc05c9333d9df41b041157437bcc2f
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author_id_fullname_str_mv 9ae21f1afb903db3c39684cd47b94760_***_Ceri Battle
2be5c329c44d14550ceac4934fcb409e_***_Timothy Driscoll
e900d99a0977beccf607233b10c66b43_***_Deborah Fitzsimmons
10b1bd08dbad1f2681ff1e527af9f9a3_***_Shaun Harris
b6ee9140bc0cf54b94165f477a530f9e_***_Claire O'Neill
81fc05c9333d9df41b041157437bcc2f_***_Alan Watkins
bdf5d5f154d339dd92bb25884b7c3652_***_Hayley Hutchings
author Ceri Battle
Timothy Driscoll
Deborah Fitzsimmons
Shaun Harris
Claire O'Neill
Alan Watkins
Hayley Hutchings
author2 Ceri Battle
Amy Charnock
Sara Davies
Susan Davies
Thomas Dawson
Timothy Driscoll
Phillip A Evans
Deborah Fitzsimmons
Shaun Harris
Kate Jones
Fiona Elizabeth Lecky
Claire O'Neill
Joanne Prosser
Hannah Toghill
Alan Watkins
Hayley Hutchings
format Journal article
container_title BMJ Open
container_volume 12
container_issue 4
container_start_page e060055
publishDate 2022
institution Swansea University
issn 2044-6055
2044-6055
doi_str_mv 10.1136/bmjopen-2021-060055
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description Introduction Chronic pain and disability are now well-recognised long-term complications of blunt chest wall trauma. Limited research exists regarding therapeutic interventions that can be used to address these complications. A recent feasibility study was completed testing the methods of a definitive trial. This protocol describes the proposed definitive trial, the aim of which is to investigate the impact of an early exercise programme on chronic pain and disability in patients with blunt chest wall trauma.Methods/analysis This mixed-methods, multicentre, parallel randomised controlled trial will run in four hospitals in Wales and one in England over 12-month recruitment period. Patients will be randomised to either the control group (routine physiotherapy input) or the intervention group (routine physiotherapy input plus a simple exercise programme completed individually by the patient). Baseline measurements including completion of two surveys (Brief Pain Inventory and EuroQol 5-dimensions, 5-Levels) will be obtained on initial assessment. These measures and a client services receipt inventory will be repeated at 3-month postinjury. Analysis of outcomes will focus on rate and severity of chronic pain and disability, cost-effectiveness and acceptability of the programme by patients and clinicians. Qualitative feedback regarding acceptability will be obtained through patient and clinician focus groups.Ethics/dissemination London Riverside Research Ethics Committee (Reference number: 21/LO/0782) and the Health Research Authority granted approval for the trial in December 2021. Patient recruitment will commence in February 2022. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings.Trial registration number ISRCTN65829737; Pre-results.
published_date 2022-04-07T04:17:20Z
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