David J Keene1, Hessam Soutakbar2, Sally Hopewell2, Peter Heine2, Anju Jaggi3, Chris Littlewood4, Zara Hansen2, Karen Barker5, Willie Hamilton6, Andrew J Carr2, Sarah E Lamb2. 1. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Electronic address: david.keene@ndorms.ox.ac.uk. 2. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. 3. Royal National Orthopaedic Hospital NHS Trust, Stanmore, Middlesex, UK. 4. Primary Care and Health Sciences, Keele University, Keele, UK. 5. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK. 6. Institute of Health Research, University of Exeter, Exeter, UK.
Abstract
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.
RCT Entities:
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.
Authors: Sally Hopewell; David J Keene; Peter Heine; Ioana R Marian; Melina Dritsaki; Lucy Cureton; Susan J Dutton; Helen Dakin; Andrew Carr; Willie Hamilton; Zara Hansen; Anju Jaggi; Chris Littlewood; Karen Barker; Alastair Gray; Sarah E Lamb Journal: Health Technol Assess Date: 2021-08 Impact factor: 4.106
Authors: Sally Hopewell; David J Keene; Ioana R Marian; Melina Dritsaki; Peter Heine; Lucy Cureton; Susan J Dutton; Helen Dakin; Andrew Carr; Willie Hamilton; Zara Hansen; Anju Jaggi; Chris Littlewood; Karen L Barker; Alastair Gray; Sarah E Lamb Journal: Lancet Date: 2021-07-12 Impact factor: 79.321