East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol
Introduction Knee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementatio...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e037760.full |
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| author | Michael Doherty Roshan das Nair Ana Valdes Reuben Ogollah Paul Greenhaff Bonnie Millar Michelle Hall Amy Fuller Polykarpos Angelos Nomikos David A Walsh A Abhishek |
| author_facet | Michael Doherty Roshan das Nair Ana Valdes Reuben Ogollah Paul Greenhaff Bonnie Millar Michelle Hall Amy Fuller Polykarpos Angelos Nomikos David A Walsh A Abhishek |
| author_sort | Michael Doherty |
| collection | DOAJ |
| description | Introduction Knee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.Methods and analysis In phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared with video analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based on the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at three time points: baseline, 13 and 26 weeks after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms.Ethics and dissemination This protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at ClinicalTrials.gov (protocol v4.0, 10/02/2020). The study will be reported in accordance with the Consolidated Standards of Reporting Trials guidance and standards. The results will be submitted for publication in peer-reviewed academic journals.Trial registration number NCT03670706 |
| format | Article |
| id | doaj-art-d9b9b22f51da44b58e3df3376b6bc80d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-d9b9b22f51da44b58e3df3376b6bc80d2025-01-08T12:45:10ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-037760East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocolMichael Doherty0Roshan das Nair1Ana Valdes2Reuben Ogollah3Paul Greenhaff4Bonnie Millar5Michelle Hall6Amy Fuller7Polykarpos Angelos Nomikos8David A Walsh9A Abhishek10Academic Rheumatology, University of Nottingham, Nottingham, UKInstitute of Mental Health, Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK4 School of Medicine, University of Nottingham, Nottingham, UKNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UKSchool of Medical and Surgical Sciences, University of Nottingham, Nottingham, Nottinghamshire, UKNIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UKCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia3Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle UniversityAcademic Rheumatology, University of Nottingham, Nottingham, UKNIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK1Division of Rheumatology, Orthopedics and DermatologyIntroduction Knee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.Methods and analysis In phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared with video analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based on the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at three time points: baseline, 13 and 26 weeks after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms.Ethics and dissemination This protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at ClinicalTrials.gov (protocol v4.0, 10/02/2020). The study will be reported in accordance with the Consolidated Standards of Reporting Trials guidance and standards. The results will be submitted for publication in peer-reviewed academic journals.Trial registration number NCT03670706https://bmjopen.bmj.com/content/10/9/e037760.full |
| spellingShingle | Michael Doherty Roshan das Nair Ana Valdes Reuben Ogollah Paul Greenhaff Bonnie Millar Michelle Hall Amy Fuller Polykarpos Angelos Nomikos David A Walsh A Abhishek East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol BMJ Open |
| title | East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol |
| title_full | East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol |
| title_fullStr | East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol |
| title_full_unstemmed | East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol |
| title_short | East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol |
| title_sort | east midlands knee pain multiple randomised controlled trial cohort study cohort establishment and feasibility study protocol |
| url | https://bmjopen.bmj.com/content/10/9/e037760.full |
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