Plantar orthoses for the treatment of pediatric flat feet
Cochrane Database System Rev. 2022 Jan 26;1:CD006311. doi: 10.1002/14651858.CD006311.pub4.
BACKGROUND: Pediatric flat feet are a common presentation in primary care; the reported prevalence is about 15%. A minority of flat feet can hurt and limit gait. There is no optimal strategy, nor consensus, for the use of foot orthoses (POs) to treat pediatric flatfoot.
OBJECTIVES: To assess the advantages and disadvantages of foot orthoses for the treatment of pediatric flatfoot.
We searched CENTRAL, MEDLINE and Embase up to 1 September 2021, and two clinical trials registers on 7 August 2020.
SELECTION CRITERIA: We identified all randomized controlled trials ( RCTs ) investigating OPs as an intervention for pediatric flatfoot. The outcomes included in this review were pain, function, quality of life, treatment success and adverse events. The desired comparisons were: all FOs vs fake, all FOs vs shoes, custom FOs (CFOs) vs pre-made FOs (PFOs).
DATA COLLECTION AND ANALYSIS: We followed standard methods recommended by Cochrane.
MAIN RESULTS: We included 16 trials involving 1058 children, aged 11 months to 19 years, with flexible flat feet. Distinct presentations of flatfoot included asymptomatic juvenile idiopathic arthritis (JIA), symptomatic and developmental coordination disorders (DCD). The trial interventions were FOs, shoes, foot and rehabilitation exercises, and neuromuscular electrical stimulation (NMES). Due to heterogeneity, we did not pool the data. Most trials had potential for selective selection, performance, detection and reporting bias. No trial blinded participants. We present results separately for asymptomatic (healthy children) and symptomatic (children with JIA) flatfoot. The certainty of the evidence was very low to low, downgraded for bias, imprecision and indirectness. Three comparisons were assessed between trials: CFO versus footwear; FOP versus shoes; CFO versus PFO. Asymptomatic flat feet 1. CFO versus shoes (1 trial, 106 participants): low-quality evidence showed that CFO causes little or no difference in the proportion without pain (10-point visual analogue scale (VAS)) at one year (risk ratio (RR) 0.85, 95% confidence interval (CI) 0.67 to 1.07); absolute decrease (11.8%, 95% CI 4.7% less to 15.8% more); or on dropouts due to adverse events ( RR 1.05, 95% CI 0.94 to 1.19); absolute effect (3.4% more, 95% CI 4.1% less to 13.1% more). 2. FOP versus shoes (1 trial, 106 participants): Low to very low quality evidence showed that FOP results in little or no difference in the proportion pain free (10 point VAS) at one year (RR 0. 94, 95% CI 0.76 to 1.16); absolute effect (4.7% less, 95% CI 18.9% less to 12.6% more); or on dropouts due to adverse events ( RR 0.99, 95% CI 0.79 to 1.23). 3. CFO versus FOP (1 trial, 108 participants): low-quality evidence found no difference in the proportion pain-free at one year (RR 0.93, 95% CI 0.73 to 1.18) ; absolute effect (7.4% less, 95% CI 22.2% less to 11.1% more); or discontinued due to adverse events ( RR 1.00, 95% CI 0.90 to 1.12). Function and quality of life (QOL) were not assessed. Symptomatic flat feet (JIA) 1. CFO versus shoes (1 trial, 28 participants, 3 month follow-up): very low quality evidence showed little or no difference in pain (scale 0 to 10, 0 no pain) between groups ( MD -1.5, 95% CI -2.78 to -0.22). Low-quality evidence showed improvements in function with CFOs (Foot Function Index – FFI Disability, 0 to 100, 0 better function; MD -18.55, 95% CI -34.42 to -2.68 ), child-rated quality of life (PedsQL, 0 to 100 , 100 best quality; MD 12.1, 95% CI -1.6 to 25.8) and parent-rated quality of life (PedsQL MD 9, 95% CI -4.1 to 22.1) and little or no difference between groups in treatment success (timed walk; MD – 1.33 seconds, 95% CI -2.77 to 0.11), or discontinued due to adverse events ( RR 0.58, 95% CI 0.11 to 2.94); absolute difference (9.7% less, 20.5% less to 44.8% more). 2. FOP versus shoes (1 trial, 25 participants, 3 month follow-up): very low quality evidence showed little or no difference in pain between groups ( MD 0.02, 95% CI -1, 94 to 1.98). Low-quality evidence showed no difference between groups in function (FFI-disability MD -4.17, 95% CI -24.4 to 16.06), quality of life assessed by child (PedsQL MD -3.84, 95% CI -19 to 11.33) or parent-assessed quality of life (PedsQL MD -0.64, 95% CI -13.22 to 11.94). 3. CFO versus FOP (2 trials, 87 participants): low-quality evidence showed little or no difference between groups in terms of pain (scale 0 to 10, 0 no pain) at 3 months (MD – 1.48, 95% CI -3.23 to 0.26), function (FFI-disability MD -7.28, 95% CI -15.47 to 0.92), quality of life assessed by child (PedsQL MD 8.6, 95% CI -3.9 to 21.2) or parent-assessed quality of life (PedsQL MD 2.9, 95% CI -11 to 16.8).
AUTHORS’ CONCLUSIONS: Low to very low certainty evidence shows that the effect of CFOs (high cost) or FOPs (low cost) compared to shoes, and CFOs compared to FOPs on pain, function and HRQOL is uncertain. This is relevant to clinical practice, given the economic disparity between CFOs and PFOs. FOs can improve pain and function, compared to shoes in children with JIA, with minimal delineation between expensive CFOs and generic FOPs. This review updates the 2010 review, confirming that in the absence of pain, the use of high-cost CFOs for healthy children with flexible flat feet has no supporting evidence, and draws very limited conclusions on OF for the treatment of pediatric flatfoot. The availability of normative and prospective data on foot development discounts most flatfoot problems and negates any ongoing attention to this topic. Attention should be redirected to relevant pediatric foot conditions that cause pain, limit function, or reduce quality of life. The research agenda for asymptomatic flat feet in healthy children must be relegated to history, and replaced by a targeted research logic, addressing children with an indisputable pathology of the foot from discrete diagnoses , namely JIA, cerebral palsy, clubfoot equinus varus, trisomy 21 and Charcot Marie Dent. It’s debatable whether research resources should continue to be wasted studying flat feet in healthy children who don’t hurt. Future updates of this review will only address relevant pediatric conditions of the foot.