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Efficacy of custom foot orthotics in improving pain and functional status in children with juvenile idiopathic arthritis: a randomized trial
Powell M, Seid M, Szer IS
The Journal of Rheumatology 2005 May;32(5):943-950
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE:. To compare the clinical efficacy of custom foot orthotics, prefabricated "off-the-shelf" shoe inserts, and supportive athletic shoes worn alone, on reducing pain and improving function for children with juvenile idiopathic arthritis (JIA). METHODS: Children with JIA and foot pain (n = 40) were randomized to one of 3 groups receiving: (1) custom-made semirigid foot orthotics with shock absorbing posts (n = 15), (2) off-the-shelf flat neoprene shoe inserts (n = 12), or (3) supportive athletic shoes with a medial longitudinal arch support and shock absorbing soles worn alone (n = 13). Foot pain and functional limitations were measured using the Pediatric Pain Questionnaire-visual analog scale (VAS), timed walking, Foot Function Index (FFI), and the Physical Functioning Subscale of the Pediatric Quality of Life Inventory (PedsQL). Measures were administered by personnel blinded to group status at baseline (before wearing the assigned intervention) and at 3 months' followup. RESULTS: Children in the orthotics group showed significantly greater improvements in overall pain (p = 0.009), speed of ambulation (p = 0.013), activity limitations (p = 0.002), foot pain (p = 0.019), and level of disability (p = 0.024) when compared with the other 2 groups. Both children and parents in the orthotics group reported clinically meaningful improvement in child health-related quality of life, although the group by time interaction did not show statistical significance. Except for a reduction in pain for supportive athletic shoes (paired t test, p = 0.011), neither the off-the-shelf shoe inserts nor the supportive athletic shoes worn alone showed significant effect on any of the evaluation measures. CONCLUSION: In children with JIA, custom-made semirigid foot orthotics with shock-absorbing posts significantly improve pain, speed of ambulation, and self-rated activity and functional ability levels compared with prefabricated off-the-shelf shoe inserts or supportive athletic shoes worn alone.

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