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Open Access Highly Accessed Study protocol

Self management, joint protection and exercises in hand osteoarthritis: a randomised controlled trial with cost effectiveness analyses

Krysia S Dziedzic1*, Susan Hill1, Elaine Nicholls1, Alison Hammond2, Helen Myers1, Tracy Whitehurst1, Jo Bailey1, Charlotte Clements1, David GT Whitehurst13, Sue Jowett14, June Handy1, Rhian W Hughes1, Elaine Thomas1 and Elaine M Hay1

Author Affiliations

1 Arthritis Research UK Primary Care Centre, Keele University, Keele, Staffordshire, ST5 5BG, UK

2 Centre for Health, Sport & Rehabilitation Research, University of Salford, Frederick Road, Salford, Greater Manchester, M6 6PU, UK

3 School of Population and Public Health, University of British Columbia, Vancouver, BCV5ZIM9, Canada

4 School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

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BMC Musculoskeletal Disorders 2011, 12:156  doi:10.1186/1471-2474-12-156

Published: 11 July 2011

Abstract

Background

There is limited evidence for the clinical and cost effectiveness of occupational therapy (OT) approaches in the management of hand osteoarthritis (OA). Joint protection and hand exercises have been proposed by European guidelines, however the clinical and cost effectiveness of each intervention is unknown.

This multicentre two-by-two factorial randomised controlled trial aims to address the following questions:

• Is joint protection delivered by an OT more effective in reducing hand pain and disability than no joint protection in people with hand OA in primary care?

• Are hand exercises delivered by an OT more effective in reducing hand pain and disability than no hand exercises in people with hand OA in primary care?

• Which of the four management approaches explored within the study (leaflet and advice, joint protection, hand exercise, or joint protection and hand exercise combined) provides the most cost-effective use of health care resources

Methods/Design

Participants aged 50 years and over registered at three general practices in North Staffordshire and Cheshire will be mailed a health survey questionnaire (estimated mailing sample n = 9,500). Those fulfilling the eligibility criteria on the health survey questionnaire will be invited to attend a clinical assessment to assess for the presence of hand or thumb base OA using the ACR criteria. Eligible participants will be randomised to one of four groups: leaflet and advice; joint protection (looking after your joints); hand exercises; or joint protection and hand exercises combined (estimated n = 252). The primary outcome measure will be the OARSI/OMERACT responder criteria combining hand pain and disability (measured using the AUSCAN) and global improvement, 6 months post-randomisation. Secondary outcomes will also be collected for example pain, functional limitation and quality of life. Outcomes will be collected at baseline and 3, 6 and 12 months post-randomisation. The main analysis will be on an intention to treat basis and will assess the clinical and cost effectiveness of joint protection and hand exercises for managing hand OA.

Discussion

The findings will improve the cost-effective evidence based management of hand OA.

Trial registration

identifier: ISRCTN33870549