A single blinded randomised controlled trial, to investigate the clinical effectiveness of pre-formed semi-rigid foot orthoses, on pain, quality of life and the dynamics of gait of patients diagnosed with juvenile idiopathic arthritis (JIA)”.
Coda, A. (2013) A single blinded randomised controlled trial, to investigate the clinical effectiveness of pre-formed semi-rigid foot orthoses, on pain, quality of life and the dynamics of gait of patients diagnosed with juvenile idiopathic arthritis (JIA)___., no. 442.
Introduction - Currently there is limited evidence supporting podiatric treatment of children with JIA. The foot orthoses (FOs) prescribed to JIA children so far appeared to be very expensive and required long time to manufacture before the fitting. This randomised controlled trial (RCT) aimed to determine whether pre-formed FOs that can be prescribed at chair side, impacted on pain, quality of life (primary outcomes) and/or gait-parameters (secondary outcomes) in children affected by JIA. Methods - 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 were diagnosed according to the ILAR criteria. Intervention was blinded to the patients. The trial group received Slimflex-plus FOs, with the addition of chair side corrections and the control FOs supplied were made with leather board (1mm thick) only. Both FOs had the same black EVA top cover. Primary outcomes were investigated using validated questionnaires (VAS, CHAQ and PedsQL). Tekscan™ equipment (F-Scan™ and HR Walkway®) measured secondary outcomes in-shoe pressure and force data with and without FOs intervention. Multiple foot strikes and repetitive gait patterns were compared pre and post-treatment. Primary and secondary outcome measures were recorded at baseline, 3rd and 6th month’s period. Results - 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, median age for the control group was 11 (range=12.90) and for the trial group were 11.50 (range=12.11). 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. In the control group 65.5% (n=19) were considered to be prescribed with stable medications. Similarly, amongst children receiving active treatment 74.2% (n=23) were deemed to be taking stable medications. Overall, 99.4% (n=179/180) appointments were completed, only one subject did not attend the 6 month session. Significant improvement was identified in the primary outcomes favouring active treatment with regards to pain and quality of life measures: VAS (p<0.05); CHAQ (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 where p<0.05, 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. Discussion - The results strongly suggest that FOs are effective in improving pain, quality of life and most gait parameters in JIA children. FOs can be customised at chair-side so JIA children can receive immediate podiatric benefit from the same day of the biomechanical assessment. Compliancy rate proved to be extremely high confirming that the podiatric treatment is well accepted by JIA children. Conclusion - Primary and secondary outcome’s results, strongly support the use of FOs in the treatment of JIA children, which highlights the important role of the podiatrists within the multidisciplinary team in paediatric rheumatology.