Effectiveness of preformed foot orthoses in reducing lower limb pain, swollen and tender joints and in improving quality of life and gait parameters in children with juvenile idiopathic arthritis: a randomised controlled trial (Protocol)

摘要

Background Many children and adolescents withudjuvenile idiopathic arthritis experience lower limb problemsudwhich may lead to physical disabilities significantlyudimpacting on their quality of life and symptoms. Emergingudevidence has identified the effective role of podiatry in theudmanagement of juvenile idiopathic arthritis, suggesting theudclinical benefit of different orthotic therapies.udMethods This study will be a parallel-group designed,udmulticentre, randomised controlled trial, aiming to recruitud66 children and adolescents with juvenile idiopathic arthritisudaged between 5 and 18 years. Those recruited will needudto be diagnosed according to the International League ofudAssociations for Rheumatology criteria, and present withudlower limb joint pain, swelling and/or tenderness. Participantsudwill be recruited from three outpatient hospital clinics in NewudSouth Wales, Australia. Participants will be randomly allocatedudto receive a trial or control intervention. The trial group will beudprescribed a customised preformed foot orthoses; instead,udthe control group will receive a flat 1 mm insole with noudcorrective modifications. Primary outcome measure recordedudwill be pain. Secondary outcomes will be quality of life, footuddisability, swollen and tender joint count and gait parametersud(such as plantar pressures, walking speed, stance and swingudtime). The allocated foot orthoses will be worn for 12 months,udwith data collected at baseline, 4 weeks, 3, 6 and 12 monthsudintervals. Group allocation will be concealed and all analysesudwill be carried out on an intention to treat.udDiscussion The purpose of this trial is to exploreudthe efficacy of a cost-effective, non-invasive podiatricudintervention that will be prescribed at the initialudbiomechanical consultation. This approach will promoteudearly clinical intervention, which is the gold standard inudpaediatric rheumatology. Furthermore, this study has theudpotential to provide new evidence for the effectivenessudof a mechanical intervention alone to reduce swollen andudtender joints in juvenile idiopathic arthritis.