Abstract
BackgroundFoot and ankle problems are a common but relatively neglected manifestation of juvenile idiopathic arthritis. Studies of medical and non-medical interventions have shown that clinical outcome measures can be improved. However existing data has been drawn from small non-randomised clinical studies of single interventions that appear to under-represent the adult population suffering from juvenile idiopathic arthritis. To date, no evidence of combined therapies or integrated care for juvenile idiopathic arthritis patients with foot and ankle problems exists.Methods/designAn exploratory phase II non-pharmacological randomised controlled trial where patients including young children, adolescents and adults with juvenile idiopathic arthritis and associated foot/ankle problems will be randomised to receive integrated podiatric care via a new foot care programme, or to receive standard podiatry care. Sixty patients (30 in each arm) including children, adolescents and adults diagnosed with juvenile idiopathic arthritis who satisfy the inclusion and exclusion criteria will be recruited from 2 outpatient centres of paediatric and adult rheumatology respectively. Participants will be randomised by process of minimisation using the Minim software package. The primary outcome measure is the foot related impairment measured by the Juvenile Arthritis Disability Index questionnaire's impairment domain at 6 and 12 months, with secondary outcomes including disease activity score, foot deformity score, active/limited foot joint counts, spatio-temporal and plantar-pressure gait parameters, health related quality of life and semi-quantitative ultrasonography score for inflammatory foot lesions. The new foot care programme will comprise rapid assessment and investigation, targeted treatment, with detailed outcome assessment and follow-up at minimum intervals of 3 months. Data will be collected at baseline, 6 months and 12 months from baseline. Intention to treat data analysis will be conducted.A full health economic evaluation will be conducted alongside the trial and will evaluate the cost effectiveness of the intervention. This will consider the cost per improvement in Juvenile Arthritis Disability Index, and cost per quality adjusted life year gained. In addition, a discrete choice experiment will elicit willingness to pay values and a cost benefit analysis will also be undertaken.Trial RegistrationTrial registration number: UKCRN5045
Highlights
Foot and ankle problems are a common but relatively neglected manifestation of juvenile idiopathic arthritis
Foot problems have been reported as being common in Juvenile Idiopathic Arthritis (JIA) with 90% of children in a cross-sectional survey presenting with at least one foot problem associated with the disease process [4]
Significant advances in the pharmacological management of JIA have taken place with the advocated earlier use of intra-articular cortico-steroid injections (ICIs), disease modifying anti-rheumatic drugs (DMARDs) and biologic therapies
Summary
Juvenile Idiopathic Arthritis (JIA) is the commonest rheumatic disease in childhood with a variable worldwide prevalence ranging from 0.07 to 4.01 per 1000 children [1], while in the UK the prevalence is estimated at between 0.65 and 2.0 per 1000 children [1,2,3]. Significant advances in the pharmacological management of JIA have taken place with the advocated earlier use of intra-articular cortico-steroid injections (ICIs), disease modifying anti-rheumatic drugs (DMARDs) and biologic therapies These drugs have greatly improved the treatment options for paediatric rheumatologists, and functional outcomes appear to have improved as a result [14,15]. Podiatry care included provision of customised functional foot orthoses, intrinsic muscle stretching and strengthening exercises, footwear advice and silicone digital splinting appliances These podiatric treatment methods appeared to be in line with current recommendations [17]. Treatment for foot and ankle disease in JIA has focused on the use of intra-articular cortico-steroid injections (ICIs), physiotherapy, orthoses and orthopaedic surgery as an adjunct to medical care to both resolve synovitis and to correct or maintain foot posture and function. The secondary aim of the study will be to determine what the optimum timing for intervention is in these patients by comparing the outcomes of pre-determined groups at different stages of the disease (children, adolescents and adults)
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