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The Osteoarthritis Thumb Therapy Trial (OTTER II): 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

The Osteoarthritis Thumb Therapy Trial (OTTER II): 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
The Osteoarthritis Thumb Therapy Trial (OTTER II): 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
splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectivenss. 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 AUSCAN hand pain scale. The study end point 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 eissemination: 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 patientorganisations. The research will contribute to improving the management of thumb base OA andhelp clinicians and patients make informed decisions about the value of different interventions.
2044-6055
Adams, Joanna
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Barratt, Paula
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Arden, Nigel
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Barbosa Boucas, Sofia
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Bradley, Sarah
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Doherty, Michael
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Dutton, Susan
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Dziedzic, Krysia
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Gooberman-Hill, Rachael
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Hislop Lennie, Kelly
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Hutt Greenyer, Corinne
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Jansen, Victoria
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Luengo-Fernandez, Ramon
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Meagher, Claire
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White, Peter J
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Williams, Mark
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Adams, Joanna
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Barratt, Paula
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Arden, Nigel
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Barbosa Boucas, Sofia
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Bradley, Sarah
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Doherty, Michael
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Dutton, Susan
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Dziedzic, Krysia
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Gooberman-Hill, Rachael
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Hislop Lennie, Kelly
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Hutt Greenyer, Corinne
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Jansen, Victoria
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Luengo-Fernandez, Ramon
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Meagher, Claire
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White, Peter J
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Williams, Mark
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Adams, Joanna, Barratt, Paula, Arden, Nigel, Barbosa Boucas, Sofia, Bradley, Sarah, Doherty, Michael, Dutton, Susan, Dziedzic, Krysia, Gooberman-Hill, Rachael, Hislop Lennie, Kelly, Hutt Greenyer, Corinne, Jansen, Victoria, Luengo-Fernandez, Ramon, Meagher, Claire, White, Peter J and Williams, Mark (2019) The Osteoarthritis Thumb Therapy Trial (OTTER II): 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, 9, [e028342]. (doi:10.1136/bmjopen-2018-028342).

Record type: Article

Abstract

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 effectivenss. 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 AUSCAN hand pain scale. The study end point 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 eissemination: 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 patientorganisations. The research will contribute to improving the management of thumb base OA andhelp clinicians and patients make informed decisions about the value of different interventions.

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The Osteoarthritis Thumb Therapy Trial OTTER II A study protocol for a three arm multi centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost effectiveness - Accepted Manuscript
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Accepted/In Press date: 19 July 2019
e-pub ahead of print date: 22 October 2019

Identifiers

Local EPrints ID: 432894
URI: http://eprints.soton.ac.uk/id/eprint/432894
ISSN: 2044-6055
PURE UUID: 128b1948-731b-4d6e-8839-556532edc71b
ORCID for Joanna Adams: ORCID iD orcid.org/0000-0003-1765-7060
ORCID for Kelly Hislop Lennie: ORCID iD orcid.org/0000-0001-8242-8665

Catalogue record

Date deposited: 31 Jul 2019 16:30
Last modified: 26 Nov 2021 02:58

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Contributors

Author: Joanna Adams ORCID iD
Author: Paula Barratt
Author: Nigel Arden
Author: Sofia Barbosa Boucas
Author: Sarah Bradley
Author: Michael Doherty
Author: Susan Dutton
Author: Krysia Dziedzic
Author: Rachael Gooberman-Hill
Author: Kelly Hislop Lennie ORCID iD
Author: Corinne Hutt Greenyer
Author: Victoria Jansen
Author: Ramon Luengo-Fernandez
Author: Claire Meagher
Author: Peter J White
Author: Mark Williams

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