TY - JOUR
T1 - Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the ‘Getting it Right
T2 - Addressing Shoulder Pain’ (GRASP) trial
AU - Keene, David J.
AU - Soutakbar, Hessam
AU - Hopewell, Sally
AU - Heine, Peter
AU - Jaggi, Anju
AU - Littlewood, Chris
AU - Hansen, Zara
AU - Barker, Karen
AU - Hamilton, Willie
AU - Carr, Andrew J.
AU - Lamb, Sarah E.
N1 - Funding Information:
Funding: This research is funded by the National Institute of Health Research Health Technology Assessment Programme (15/26/06). The report was supported by the NIHR Biomedical Research Centre, Oxford. Professor Lamb receives funding from the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust and Dr Keene is supported by an NIHR Post Doctoral Fellowship (PDF-2016-09-056). Professor Carr receives funding from the NIHR , the Wellcome Trust , the Engineering and Physical Sciences Research Council , and the Medical Research Council .
Funding Information:
We acknowledge English language editing by Dr Jennifer A de Beyer of the Centre for Statistics in Medicine (University of Oxford), Deborah Brown (University of Oxford) for contributing to the development of the intervention materials, and Iveta Simera, Richard Goodier and Jean Millar (Patient and Public Involvement representatives) for reviewing the GRASP trial patient-facing materials. GRASP intervention development stakeholder meeting delegates:, Marcus Bateman (Derby Teaching Hospitals NHS Foundation Trust), Graham Boniface (University of Oxford), Debbie Brown (University of Oxford), Suzanne Folley (East Lancashire Hospitals NHS Trust), Beth Fordham (University of Oxford), Jo Gibson (Royal Liverpool and Broadgreen University Hospitals NHS Trust), Richard Goodier (Patient and Public Involvement representative), Sean Gove (Bristol Community Health), Zara Hansen (University of Oxford), Peter Heine (University of Oxford), Sally Hopewell (University of Oxford), Richard Husselbee (Birmingham Community Healthcare NHS Trust), Anju Jaggi (Royal National Orthopaedic Hospital NHS Trust), Gill Jones (Oxford Health NHS Foundation Trust), Harry Kardamilas (Bucks Musculoskeletal Intergrated Care Service, Care UK), David Keene (University of Oxford), Chris Littlewood (Keele University), Caroline Miller (University Hospitals Birmingham NHS Foundation Trust), Michelle Moynihan (Oxford University Hospitals NHS Foundation Trust), Peter O'Hara (Patient and Public Involvement representative), Iveta Simera (Patient and Public Involvement representative), Yogita Stokes (Sandwell and West Birmingham Hospitals NHS Trust), Georgina Taylor (Oxford University Hospitals NHS Foundation Trust), Helen Thompson (East Lancashire Hospitals NHS Trust), Esther Williamson (University of Oxford), Elaine Willmore (Gloucestershire Hospitals NHS Foundation Trust). Special thanks to Katie Chegwin (University of Oxford) for helping co-ordinate this meeting. GRASP Internal Pilot Sites (Principal Investigator, organisation), Marcus Bateman (Derby Teaching Hospitals NHS Foundation Trust); Helen Thompson (East Lancashire Hospitals NHS Trust); Elaine Willmore (Gloucestershire Hospitals NHS Foundation Trust). Funding: This research is funded by the National Institute of Health Research Health Technology Assessment Programme (15/26/06). The report was supported by the NIHR Biomedical Research Centre, Oxford. Professor Lamb receives funding from the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust and Dr Keene is supported by an NIHR Post Doctoral Fellowship (PDF-2016-09-056). Professor Carr receives funding from the NIHR, the Wellcome Trust, the Engineering and Physical Sciences Research Council, and the Medical Research Council. Ethical approval: Berkshire B Research Ethics Committee (REC: 16/SC/0508). Conflict of interest: None declared.
Publisher Copyright:
© 2019 The Authors
PY - 2020/6
Y1 - 2020/6
N2 - Objectives: The Getting it Right: Addressing Shoulder Pain (GRASP) trial is a large-scale, multicentre, 2 × 2 factorial randomised controlled trial investigating clinical and cost-effectiveness of a progressive exercise programme versus best-practice advice, with or without corticosteroid injection, for treating people with rotator cuff disorders. Here we describe the development, implementation and details of the physiotherapy-led interventions. Methods: Medical Research Council guidance for developing complex interventions were used, taking into account clinical guidelines, expert and patient opinion, research evidence, current practice variation, and deliverability. A stakeholder meeting of 26 experts, clinicians, researchers, and patient representatives was used to design key components of the interventions. Stakeholders prioritised strengthening posterior rotator cuff muscles and using practical, easy-to-do exercises. The interventions were designed to be deliverable across the UK National Health Service. Results: Progressive exercise consists of up to six sessions with a physiotherapist over 16 weeks. The best-practice advice consists of one face-to-face session with a physiotherapist with substantially greater reliance on self-management. Both interventions include self-management advice, home-exercise instruction, and behaviour-change strategies to target exercise adherence. All participants receive a Participant Information Booklet. The best-practice advice intervention is a self-guided system of progressively challenging exercises, with demonstration videos and written materials. The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback. Conclusion: GRASP has recruited 708 participants and will provide high quality evidence to inform management of people with shoulder pain due to a rotator cuff disorder. Results are anticipated in 2020. Trial registration number: ISRCTN16539266; EudraCT number:2016-002991-28.
AB - Objectives: The Getting it Right: Addressing Shoulder Pain (GRASP) trial is a large-scale, multicentre, 2 × 2 factorial randomised controlled trial investigating clinical and cost-effectiveness of a progressive exercise programme versus best-practice advice, with or without corticosteroid injection, for treating people with rotator cuff disorders. Here we describe the development, implementation and details of the physiotherapy-led interventions. Methods: Medical Research Council guidance for developing complex interventions were used, taking into account clinical guidelines, expert and patient opinion, research evidence, current practice variation, and deliverability. A stakeholder meeting of 26 experts, clinicians, researchers, and patient representatives was used to design key components of the interventions. Stakeholders prioritised strengthening posterior rotator cuff muscles and using practical, easy-to-do exercises. The interventions were designed to be deliverable across the UK National Health Service. Results: Progressive exercise consists of up to six sessions with a physiotherapist over 16 weeks. The best-practice advice consists of one face-to-face session with a physiotherapist with substantially greater reliance on self-management. Both interventions include self-management advice, home-exercise instruction, and behaviour-change strategies to target exercise adherence. All participants receive a Participant Information Booklet. The best-practice advice intervention is a self-guided system of progressively challenging exercises, with demonstration videos and written materials. The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback. Conclusion: GRASP has recruited 708 participants and will provide high quality evidence to inform management of people with shoulder pain due to a rotator cuff disorder. Results are anticipated in 2020. Trial registration number: ISRCTN16539266; EudraCT number:2016-002991-28.
KW - Clinical Trial
KW - Exercise
KW - Shoulder Pain
UR - http://www.scopus.com/inward/record.url?scp=85078449039&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85078449039&partnerID=8YFLogxK
U2 - 10.1016/j.physio.2019.07.002
DO - 10.1016/j.physio.2019.07.002
M3 - Article (journal)
C2 - 32026827
AN - SCOPUS:85078449039
SN - 0031-9406
VL - 107
SP - 252
EP - 266
JO - Physiotherapy (United Kingdom)
JF - Physiotherapy (United Kingdom)
ER -