OP0207-HPR EFFECT OF FOOT ORTHOSES IN REDUCING PAIN IN CHILDREN WITH JUVENILE IDIOPATHIC ARTHRITIS: A 12-MONTH RANDOMISED CLINICAL TRIAL

Abstract

Background: Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children and adolescents [1]. The manifestation of JIA may include joint swelling, tenderness, and painful limitation with joint movement. Only few studies have explored the effect of foot orthoses (FOs) alone in children with JIA [2,3]. These studies showed FOs can reduce pain in children with JIA, however, further research with larger sample sizes and longer follow‐ups are needed [4]. Prescribing FOs on the same day of the initial assessment may promote early clinical and targeted intervention, which is the gold standard approach in paediatric rheumatology. Objectives: This single blinded multicentre randomised clinical trial (RCT) aims to investigate the effect of customised prefabricated FOs in reducing pain amongst children and adolescents with JIA. Methods: Overall, 66 children and adolescents with JIA presenting with foot symptoms were recruited from the Sydney Children's Hospitals Network (Westmead and Randwick) and John Hunter Children's Hospital (Newcastle). The primary outcome measure was pain with a minimal clinical signifcance of 8mm on the visual analogue scale (VAS). Participants were randomly allocated to receive either customised prefabricated or sham FOs. The trial intervention was a low‐density Slimfex Simple device that was customised at chair‐side. The control (sham) device was made of 2mm fat leather board with no corrective modifcations. Standardised tests such as the Foot Posture Index, navicular drift and drop were used to identify biomechanical abnormalities. The FOs were worn for a total of 12 months, with data collected at baseline, 4 weeks, 3, 6 months and 12 months. Results: Reduction in self‐reported pain was statistically and clinically significant at 4‐weeks (p=0.018,‐14.92 [‐27.30,‐2.55]) and 3 months (p=<0.001,‐28.93 [‐40.90,‐16.96]) post intervention in favour of the trial group. The 6‐and 12‐month follow‐ups were not statistically or clinically signifcant. Parent reported pain was statistically and clinically signifcant at the 3‐month (p=<0.001,‐21.92 [‐33.16,‐10.67]) in the reduction of pain in favour of the trial group. However, parent reported pain was not statistically signifcant at the 4‐week, 6‐and 12‐month follow‐ups. These results are similar to child reported pain with a p‐value of less than 0.001 and average coefficients twice that of the clinical signifcance cut‐off for VAS pain in paediatric rheumatology. The trial intervention was safe and tolerated well by participants with high compliance and adherence rates. Conclusion: Results of this clinical trial indicate customised preformed FOs can be effective in reducing pain and in children with JIA experiencing foot and ankle symptoms. Signifcant clinical effects appear to be within the frst 3‐months of intervention prescription and reduce beyond 6 months. Overall, this podiatric intervention was safe, inexpensive, well tolerated and it can be easily implemented as part of the multidisciplinary paediatric rheumatology care.