Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial
Introduction Persistent, knee pain is a common cause of disability. Education and exercise treatment are advocated in all clinical guidelines; however, the increasing prevalence of persistent knee pain presents challenges for health services regarding appropriate and scalable delivery of these treat...
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BMJ Publishing Group
2022-06-01
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author | Philip G Conaghan Kim L Bennell Mark Conner Rana S Hinman Sarah R Kingsbury Elizabeth M A Hensor Gretl A McHugh Christine Comer Dawn Groves-Williams Rachel K Nelligan |
author_facet | Philip G Conaghan Kim L Bennell Mark Conner Rana S Hinman Sarah R Kingsbury Elizabeth M A Hensor Gretl A McHugh Christine Comer Dawn Groves-Williams Rachel K Nelligan |
author_sort | Philip G Conaghan |
collection | DOAJ |
description | Introduction Persistent, knee pain is a common cause of disability. Education and exercise treatment are advocated in all clinical guidelines; however, the increasing prevalence of persistent knee pain presents challenges for health services regarding appropriate and scalable delivery of these treatments. Digital technologies may help address this, and this trial will evaluate the feasibility and acceptability of two electronic-rehabilitation interventions: ‘My Knee UK’ and ‘Group E-Rehab’.Methods and analysis This protocol describes a non-blinded, randomised feasibility trial with three parallel groups. The trial aims to recruit 90 participants (45 years or older) with a history of persistent knee pain consistent with a clinical diagnosis of knee osteoarthritis. Participants will be randomly assigned in a 1:1:1 allocation ratio. The ‘My Knee UK’ intervention arm will receive a self-directed unsupervised internet-based home exercise programme plus short message service support (targeting exercise behaviour change) for 12 weeks; the ‘Group E-Rehab’ intervention arm will receive group-based physiotherapist-prescribed home exercises delivered via videoconferencing accompanied by internet-interactive educational sessions for 12 weeks; the control arm will receive usual physiotherapy care or continue with their usual self-management (depending on their recruitment path). Feasibility variables, patient-reported outcomes and clinical findings measured at baseline, 3 and 9 months will be assessed and integrated with qualitative interview data from a subset of Group E-Rehab and My Knee UK participants. If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care.Ethics and dissemination The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). The results of the study will be disseminated to study participants, the study grant funder and will be submitted for publication in peer-reviewed journals.Trial registration number ISRCTN15564385. |
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institution | Kabale University |
issn | 2044-6055 |
language | English |
publishDate | 2022-06-01 |
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spelling | doaj-art-5409cf0268ea421680fcac64cea9cf522025-01-24T15:50:10ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-063608Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trialPhilip G Conaghan0Kim L Bennell1Mark Conner2Rana S Hinman3Sarah R Kingsbury4Elizabeth M A Hensor5Gretl A McHugh6Christine Comer7Dawn Groves-Williams8Rachel K Nelligan9NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK10 Department of Physiotherapy, Faculty of Medicine Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, AustraliaUniversity of Leeds School of Psychology, Leeds, Leeds, UKCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Melbourne, Victoria, AustraliaLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UKLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, West Yorkshire, UKSchool of Healthcare, University of Leeds, Leeds, UKMusculoskeletal and Rehabilitation Services, Leeds Community Healthcare NHS Trust, Leeds, UKClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UKDepartment of Physiotherapy, The University of Melbourne Centre for Health Exercise and Sports Medicine, Melbourne, Victoria, AustraliaIntroduction Persistent, knee pain is a common cause of disability. Education and exercise treatment are advocated in all clinical guidelines; however, the increasing prevalence of persistent knee pain presents challenges for health services regarding appropriate and scalable delivery of these treatments. Digital technologies may help address this, and this trial will evaluate the feasibility and acceptability of two electronic-rehabilitation interventions: ‘My Knee UK’ and ‘Group E-Rehab’.Methods and analysis This protocol describes a non-blinded, randomised feasibility trial with three parallel groups. The trial aims to recruit 90 participants (45 years or older) with a history of persistent knee pain consistent with a clinical diagnosis of knee osteoarthritis. Participants will be randomly assigned in a 1:1:1 allocation ratio. The ‘My Knee UK’ intervention arm will receive a self-directed unsupervised internet-based home exercise programme plus short message service support (targeting exercise behaviour change) for 12 weeks; the ‘Group E-Rehab’ intervention arm will receive group-based physiotherapist-prescribed home exercises delivered via videoconferencing accompanied by internet-interactive educational sessions for 12 weeks; the control arm will receive usual physiotherapy care or continue with their usual self-management (depending on their recruitment path). Feasibility variables, patient-reported outcomes and clinical findings measured at baseline, 3 and 9 months will be assessed and integrated with qualitative interview data from a subset of Group E-Rehab and My Knee UK participants. If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care.Ethics and dissemination The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). The results of the study will be disseminated to study participants, the study grant funder and will be submitted for publication in peer-reviewed journals.Trial registration number ISRCTN15564385.https://bmjopen.bmj.com/content/12/6/e063608.full |
spellingShingle | Philip G Conaghan Kim L Bennell Mark Conner Rana S Hinman Sarah R Kingsbury Elizabeth M A Hensor Gretl A McHugh Christine Comer Dawn Groves-Williams Rachel K Nelligan Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial BMJ Open |
title | Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial |
title_full | Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial |
title_fullStr | Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial |
title_full_unstemmed | Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial |
title_short | Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial |
title_sort | evaluation of two electronic rehabilitation programmes for persistent knee pain protocol for a randomised feasibility trial |
url | https://bmjopen.bmj.com/content/12/6/e063608.full |
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