Background:\ud Currently there is limited evidence supporting podiatric treatment of children with JIA. This trial aimed to determine whether pre-formed cost-effective orthoses impacted on pain, quality of life (primary outcomes) and/or gait-parameters (secondary outcomes) in children affected by JIA. The RCT aims to strengthen and add new knowledge to the podiatric management of children affected by this paediatric condition. \ud \ud Methods:\ud The study took place at the Gait Analysis laboratory at Queen Margaret University – Edinburgh and at the TORT Centre, Ninewells Hospital-Dundee. Children with JIA, as diagnosed by a consultant paediatric rheumatologist, were block randomised by a computer generator. Intervention was blinded to the patients. The trial group received Slimflex Plus insoles, with the addition of chair side corrections and the control insole supplied was made with leather board (1mm thick) without corrections. Both insoles had the same black EVA top cover. Primary outcome measures were recorded at each of the 3 data recording appointments over the 6 months period, using validated questionnaires such as VAS, CHAQ and PedsQL. Tekscan™ equipment (F-Scan™ and HR Walkway®) measured in-shoe pressure and force data with and without orthotic intervention, using same type of sensors of equal resolution. Multiple foot strikes and repetitive gait patterns were compared pre and post-treatment. In addition, the HR Walkway® captures multiple sequential footsteps during barefoot walking; allowing barefoot and in-shoe measurements to be compared. \ud \ud Results:\ud Sixty children were recruited; 48.3% (n=29) control and 51.7% (n=31) active treatment group. Within the control group 20.7% (n=6) of patients were male. Within the active treatment group, 29% (n=9) subjects were male. Age ranged between 5 to 18 years, mean age for the control group was 11.17(SD3.51) and for the trial group were 10.64 (SD3.84). In order to attribute any effect solely on the FOs intervention, details of changes of medication and/or new joint injections were recorded during the trial. 65.5% (n=19) of the control group were on stable medications. 74.2% (n=23) of the children receiving active treatment were on stable medication. Overall, 99.4% (n=179/180) appointments were completed and contributed to this preliminary data analysis. Significant improvement was identified in the primary outcomes favouring active treatment with regards to pain and quality of life measures: VAS (p<0.05); PedsQL paediatric-generic (p<0.05) Peds paediatric rheumatology (p<0.05); PedsQL parent generic (p<0.05); PedsQL parent rheumatology (p<0.05). In all these quality of life tools, clinical significance was also obtained. Significant differences were also identified between the groups for gait time, stance time, total plantar surface, heel contact, midfoot, 5th metatarsal head and distal phalanx.\ud \ud Conclusion:\ud The results show that pre-formed orthoses are effective in improving pain, quality of life and most gait parameters in JIA children. This research also provides new evidence to the role of podiatrists within the multidisciplinary team in paediatric rheumatology and hopes to raise the profile of podiatrists working within the paediatric hospitals and private practices
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