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)
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Date
2017-11-30Author
Fellas, Antoni
Singh-Grewal, Davinder
Chaitow, Jeffrey
Santos, Derek
Coda, Andrea
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Fellas, A., Singh-Grewal, D., Chaitow, J., Santos, D. & Coda, A. (2017) 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), BMJ Paediatrics Open, vol. 1, , pp. e000121,
Abstract
Background Many children and adolescents with
juvenile idiopathic arthritis experience lower limb problems
which may lead to physical disabilities significantly
impacting on their quality of life and symptoms. Emerging
evidence has identified the effective role of podiatry in the
management of juvenile idiopathic arthritis, suggesting the
clinical benefit of different orthotic therapies.
Methods This study will be a parallel-group designed,
multicentre, randomised controlled trial, aiming to recruit
66 children and adolescents with juvenile idiopathic arthritis
aged between 5 and 18 years. Those recruited will need
to be diagnosed according to the International League of
Associations for Rheumatology criteria, and present with
lower limb joint pain, swelling and/or tenderness. Participants
will be recruited from three outpatient hospital clinics in New
South Wales, Australia. Participants will be randomly allocated
to receive a trial or control intervention. The trial group will be
prescribed a customised preformed foot orthoses; instead,
the control group will receive a flat 1 mm insole with no
corrective modifications. Primary outcome measure recorded
will be pain. Secondary outcomes will be quality of life, foot
disability, swollen and tender joint count and gait parameters
(such as plantar pressures, walking speed, stance and swing
time). The allocated foot orthoses will be worn for 12 months,
with data collected at baseline, 4 weeks, 3, 6 and 12 months
intervals. Group allocation will be concealed and all analyses
will be carried out on an intention to treat.
Discussion The purpose of this trial is to explore
the efficacy of a cost-effective, non-invasive podiatric
intervention that will be prescribed at the initial
biomechanical consultation. This approach will promote
early clinical intervention, which is the gold standard in
paediatric rheumatology. Furthermore, this study has the
potential to provide new evidence for the effectiveness
of a mechanical intervention alone to reduce swollen and
tender joints in juvenile idiopathic arthritis.