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Efficacy of Custom Foot Orthotics in Improving Pain and Functional Status in Children with Juvenile Idiopathic Arthritis: A Randomized Trial
MARY POWELL, MICHAEL SEID, and ILONA S. SZER
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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. (J Rheumatol 2005;32:943-50)
I am grateful to Karl Landorf for allowing me to reproduce this commentary:
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It's good to see a randomised trial evaluating the effectiveness of foot orthoses. Obviously a lot of hard work and a difficult population to assess. Positives include use of appropriate validated outcomes and the study attempts to answer a clinically worthwhile question.
At risk of being a party pooper though, I see there is a major limitation of this trial, on top of the low sample size and potential number of inferential tests they have run. The problem I see lies in the difference of severity of symptoms and number of joints involved between the three groups. I don't know the ins and outs of the 'MD global disease activity score' but if we look at the number of joints: the customized group has far more participants with polyarthritis (73%) compared to the shoe group (50%), which in turn has more than the prefab. group (31%). Therefore, the results may simply be due to regression towards the mean (i.e. the customised group started off worse, so have more 'room' to improve). An ANCOVA model would to some degree adjust for these baseline differences. Having said that, the graphs on page 946 appear to demonstrate the customised group consistently improves, where the others don't. However, it would be nice to have the estimates of the effect size between the interventions, rather than just p-values.
The baseline differences have largely occurred due to having small numbers in each group. The difference would have evened out if the investigators had continued recruitment and increased the numbers of participants. Although they do report 'Observed power' for the significant differences (some of which are good), they didn't report power for the non-significant differences. Of course the power would be sufficient for a significant difference. My impression is that this is really a form of bias because it creates the illusion of having a sufficiently large sample size. What do you think? All of this aside, though, the study would have been better if they had performed a prospective sample size calculation.
Further to the issue of power, and probably more importantly, there is no mention of whether these statistically significant results are clinically worthwhile (although they do, rather oddly, discuss this for the Peds QL 4.0 outcome - bottom of page 946). While the raw data indicates a moderate level of improvement for some variables, it's the estimate of the difference between groups (and the CIs) that would be the interesting result...something we are not provided with (only the p-value, which is no indication of the size of the difference).
I'm also confused as to this comment in the 'Statistical analysis' section: "Because of the relatively small sample size, no correction was made for family-wise error rate". Surely a small sample size has little to do with whether they performed this or not; it should be the number of inferential tests they performed...which appears to be a lot (creating a high Type 1 Error rate). Can anyone illuminate me on this...I'm confused?
A couple of other comments: the prefab. device appears to be a flat Spenco insole (with no arch contour), so it may not have been a good comparison for this population. It's also interesting that, although they state the primary outcomes were the sub-scales for the FFI, they have reported all results with equal importance. Finally, there was also an 18% drop-out rate, which is high for a three month trial.
In conclusion, although the results look promising, I think the only definitive conclusion that can be made is that the trial needs to be run again with more participants to find out if the differences are real and clinically worthwhile!
Just some thoughts. Would be interested in anyone's comments.
Medscape (free registration) have a story on this paper.
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The researchers conclude that custom-made orthotics "should become a standard part of the overall medical treatment for children with foot and/or ankle arthritis." It should also be covered by insurance, they add.
Background: Evidence suggests that foot problems are common in juvenile idiopathic arthritis (JIA), with prevalence estimates over 90%. The aim of this survey was to describe foot-related impairment and disability associated with JIA and foot-care provision in patients managed under modern treatment paradigms, including disease-modifying anti-rheumatic drugs (DMARDs) and biologic therapies.
Methods: The Juvenile Arthritis Foot Disability Index (JAFI), Child Health Assessment Questionnaire (CHAQ), and pain visual analogue scale (VAS) were recorded in 30 consecutive established JIA patients attending routine outpatient clinics. Foot deformity score, active/limited joint counts, walking speed, double-support time (s) (DS) and step length symmetry index % (SI) were also measured. Foot-care provision in the preceding 12 months was determined from medical records.
Results: Sixty-three per cent of children reported some foot impairment, with a median (range) JAFI subscale score of 1 (0-3); 53% reported foot-related activity limitation, with a JAFI subscale score of 1 (0-4); and 60% reported participation restriction, with a JAFI subscale score of 1 (0-3). Other reported variables were CHAQ 0.38 (0-2), VAS pain 22 (0-79), foot deformity 6 (0-20), active joints 0 (0-7), limited joints 0 (0-31), walking speed 1.09 m/s (0.84-1.38 m/s), DS 0.22 s (0.08-0.26 s) and SI ±4.0% (±0.2-±31.0%). A total of 23/30 medical records were reviewed and 15/23 children had received DMARDS, 8/23 biologic agents and 20/23 multiple intra-articular corticosteroid injections. Ten children received specialist podiatry care comprising footwear advice, orthotic therapy and silicone digital splints together with intrinsic muscle strengthening exercises.
Conclusion: Despite frequent use of DMARD/biologic therapy and specialist podiatry-led foot care, foot-related impairment and disability persists in some children with JIA.
Custom made orthoses better than prefab in kids with JCA
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