Inflammatory foot disease in juvenile idiopathic arthritis Musculoskeletal Diseases Juvenile rheumatoid arthritis
Conditions
Interventions
Usual care
Participants randomised to usual care (standard podiatry) will receive normal outpatient medical care. Those in current receipt of foot care via (either adult or paediatric)
these will be delivered on the same day where possible. Customised orthoses will be manufactured via an external laboratory (Firefly Orthoses, Sligo, Ireland) according to the standardised order form,
Sponsors
Glasgow Caledonian University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All participants must have JIA diagnosed by their consultant rheumatologist, according to the International League of Associations for Rheumatology (ILAR) 2004 criteria. In addition, participants are to be included if they satisfy one of the following: 2. Lower limb arthritis of two or more large joints (hips, knees, ankles and subtalar joints). 3. Widespread polyarthritis involving large and small joints
Exclusion criteria
Exclusion criteria: Patients with only upper limb, jaw, or neck involvement only will be excluded, along with those unable to cooperate with the study. Participants may also be excluded from the study (prior to randomisation) on the basis that: - 1. Any lesion detected during the ultrasound foot scan is not typical of synovitis (for example tumour, septic arthritis) 2. The lesion may require biopsy 3. The lesion requires referral for a second opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Juvenile Arthritis Foot Disability Index (JAFI) (Andre et al, 2004). This questionnaire is organised by three dimensions related to impairment (9 items), activity limitation (14 items) and participation restriction (4 items) with a 5-point Likert scale for each item. Each point on the 5-point likert scale represents the frequency of the foot problem stated for that particular item during the past week (0 = Never, 1 = Occasionally/Less than once a week, 2 = Sometimes/Once a week, 3 = Frequently/Two to three times a week, and 4 = Always). Median scores are computed for each dimension. The JAFI is completed by parents of children <10 years and self-completed by adolescent children = 10 years of age. It has been shown to be to be valid and reliable for assessing foot-related impairment and disability among children/adolescents with JIA. This questionnaire will be administered at baseline, then 6 (by post) and 12 months from baseline. The exploratory nature of the trial will permit in-depth examination of the suitability of the JAFI as a primary outcome measure for use in definitive multicentre trials. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional impairment using the childhood health assessment questionnaire (CHAQ), a valid and reliable instrument for measuring global functional status in children with JIA 2. Self- and proxy-reported health-related quality of life (HRQoL) using the EQ-5D-Y (patients) and EQ-5D-3L (parents/guardians) questionnaires, which are both comparable, valid and reliable generic measures of HRQoL in children/adolescents and adults 3. Disease activity using the American College of Rheumatology (ACR) core variables for JIA (minus erythrocyte sedimentation rate) 4. Localised foot disease activity using summated clinical examination indices of tenderness and swelling 5. Foot deformity score using the structural index 6. Localised foot disease activity using summated musculoskeletal ultrasound examination indices of effusion, synovial hypertrophy, erosion, and power Doppler signal | — |
Countries
United Kingdom
Outcome results
None listed