Abstract
BackgroundThere 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 resourcesMethods/DesignParticipants 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.DiscussionThe findings will improve the cost-effective evidence based management of hand OA.Trial registrationidentifier: ISRCTN33870549
Highlights
There is limited evidence for the clinical and cost effectiveness of occupational therapy (OT) approaches in the management of hand osteoarthritis (OA)
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?
The majority of people with hand OA are managed in primary care but often core treatments recommended by European and UK guidelines are not given [5] and patients report dissatisfaction with management [6]; ‘I went to the general practitioner (GP) gave me a form... with osteoarthritis or something, whatever they call it
Summary
Osteoarthritis (OA) is the commonest form of arthritis in the UK. It is the source of most of the musculoskeletal pain and disability in adults aged 50 years and over [1] and the hand is one of the most common sites of pain and osteoarthritic change in this age-group [2,3]. Secondary and tertiary outcome measures Self-reported questionnaire at baseline, 3, 6 and 12 months Individual subscales of the AUSCAN (pain, stiffness and function), hand pain manikin [43], average pain severity over the past 3 days (0-10 numerical rating scale), severity rating of participant nominated main functional problem over the past 3 days (0-10 numerical rating scale) [44], satisfaction with hand function over the past 3 days (0-10 numerical rating scale), side effects of treatment and adverse events, co-interventions (from the medical record download: follow-up visits to the GP, prescription of medication including NSAIDs and referral for other treatment such as surgery and from selfreported questionnaires: self-help remedies, contacts with private healthcare, over the counter medicines, use of hand splints), frustration related to hand disability [45], pain elsewhere (pain manikin), participation restriction [46], health-related quality of life using the EuroQol EQ-5D [47,48] and SF12v2 [49], satisfaction with care (3 and 6 months), Arthritis Self Efficacy pain subscale [50], Illness Perceptions Questionnaire-Revised (IPQR) modified for hand OA [45,51] and self-reported behaviour change using selected questions [52]. Any subsequent amendments will be reported in the DMC reports
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
