The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis
Introduction The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend...
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BMJ Publishing Group
2019-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/10/e028342.full |
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| author | Michael Doherty Rachael Gooberman-Hill Susan Dutton Peter White Nigel K Arden Mark Williams Jo Adams Paula Barratt Sofia Barbosa Bouças Sarah Bradley Krysia Dziedzic Kelly Hislop Lennie Corinne Hutt Greenyer Victoria Jansen Ramon Luengo-Fernandez Claire Meagher |
| author_facet | Michael Doherty Rachael Gooberman-Hill Susan Dutton Peter White Nigel K Arden Mark Williams Jo Adams Paula Barratt Sofia Barbosa Bouças Sarah Bradley Krysia Dziedzic Kelly Hislop Lennie Corinne Hutt Greenyer Victoria Jansen Ramon Luengo-Fernandez Claire Meagher |
| author_sort | Michael Doherty |
| collection | DOAJ |
| description | Introduction The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectiveness. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints.Methods and analysis Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint. The primary outcome is the Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale. The study endpoint is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4, 8 and 12 weeks. Cost-effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise.Ethics and dissemination South Central—Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions.Trial registration number ISRCTN54744256. |
| format | Article |
| id | doaj-art-c8d2da69b1634722bb00f3ffa4267a46 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c8d2da69b1634722bb00f3ffa4267a462025-08-20T02:38:51ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2018-028342The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritisMichael Doherty0Rachael Gooberman-Hill1Susan Dutton2Peter White3Nigel K Arden4Mark Williams5Jo Adams6Paula Barratt7Sofia Barbosa Bouças8Sarah Bradley9Krysia Dziedzic10Kelly Hislop Lennie11Corinne Hutt Greenyer12Victoria Jansen13Ramon Luengo-Fernandez14Claire Meagher15Academic Rheumatology, University of Nottingham, Nottingham, UKMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK1 Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK1 Wolfson Institute for Population Health, Queen Mary University Barts and The London School of Medicine and Dentistry, London, UK3 Medicine, University of Southampton, Southampton, UKSchool of Business and Management, Queen Mary University of London, London, UK2University of Southampton, Health Sciences, Southampton, United Kingdom1 School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK4 Department of Life Sciences, Brunel University, Uxbridge, UK5 Occupational Therapy Department, Poole Hospital NHS Foundation Trust, Poole, Poole, UK4Keele University, Research Institute for Primary Care and Health Science, Keele, United Kingdom1 School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK1 School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK10 Pulvertaft Hand Centre, Royal Derby Hospital, Derby, UKOxford Respiratory Trials Unit, University of Oxford, Oxford, UK1 School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UKIntroduction The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectiveness. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints.Methods and analysis Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint. The primary outcome is the Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale. The study endpoint is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4, 8 and 12 weeks. Cost-effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise.Ethics and dissemination South Central—Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions.Trial registration number ISRCTN54744256.https://bmjopen.bmj.com/content/9/10/e028342.full |
| spellingShingle | Michael Doherty Rachael Gooberman-Hill Susan Dutton Peter White Nigel K Arden Mark Williams Jo Adams Paula Barratt Sofia Barbosa Bouças Sarah Bradley Krysia Dziedzic Kelly Hislop Lennie Corinne Hutt Greenyer Victoria Jansen Ramon Luengo-Fernandez Claire Meagher The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis BMJ Open |
| title | The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis |
| title_full | The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis |
| title_fullStr | The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis |
| title_full_unstemmed | The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis |
| title_short | The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis |
| title_sort | osteoarthritis thumb therapy otter ii trial a study protocol for a three arm multi centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost effectiveness of splints for symptomatic thumb base osteoarthritis |
| url | https://bmjopen.bmj.com/content/9/10/e028342.full |
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