Review question
What are the benefits and harms of using foot orthoses (shoe inserts) to treat flat feet in children?
Background
Children with flat feet have a lower foot arch. When the child is standing, the foot arch looks flat against the floor, and may roll inwards, and even touch the floor. Sometimes, flat feet can cause pain, or change the way a child walks.
There are many types of non-surgical treatments for flat feet, but unless painful, most children do not need any treatment.
Foot orthoses (FOs) or shoe inserts, muscle stretching, footwear selection, physical activity modification, and reducing body weight, may be part of an overall foot and activity management. The short-term use of medication for pain and inflammation may be prescribed.
Study characteristics
This Cochrane Review is current to September 2021. There are 16 studies (1058 children, aged 11 months to 19 years) including three groups - healthy children with painless flat feet; children with arthritis and painful flat feet; others (developmental coordination disorder; painful flat feet). The studies were conducted across the USA, Australia, India, Iran, Turkey, UK, and Republic of Korea. We found information about footwear, exercises, and different types of foot orthoses.
Results:
Comparing custom foot orthoses (CFOs) to shoes in painless flat feet:
Proportion without pain (1 trial, 106 children) at 12 months:
12% fewer children with CFOs were without pain (ranging from 26% fewer to 5.5% more)
67 out of 100 children were without pain with CFOs compared to 79 children out of 100 with shoes.
Withdrawal due to side effects (3 trials, 211 children):
3% more children with CFOs withdrew from treatment due to side effects (ranging from 4% fewer to 13% more) .
72 out of 100 children withdrew from treatment with CFOs compared with 69 children out of 100 with shoes.
Comparing prefabricated foot orthoses (PFOs) to shoes in painless flat feet
Proportion without pain (1 trial, 106 children) at 12 months:
5% fewer children with PFOs were without pain (ranging from 18.9% fewer to 12.6% more)
74 out of 100 children were without pain with PFOs compared to 79 out of 100 children with shoes.
Withdrawal due to side effects (4 trials, 338 children):
0.7% fewer children with PFOs withdrew from treatment due to side effects (ranging from 15.2% fewer to 16.6% more).
71 out of 100 children withdrew from treatment with PFOs compared with 72 out of 100 children with shoes.
Comparing CFOs to PFOs in painless flat feet
Proportion without pain (1 trial, 106 children) at 12 months:
7% fewer children with CFOs were without pain (ranging from 22.2% fewer to 11.1% more)
68 out of 100 children were without pain with CFOs compared to 74 out of 100 children with PFOs.
Withdrawal due to side effects (1 trial, 118 children):
0% fewer children withdrew from treatment with CFOs due to side effects (ranging from 9.2% fewer to 11% more).
91 out of 100 children withdrew from treatment with CFOs compared with 91 out of 100 children with PFOs.
Function, quality of life, treatment success and side effects were not reported in these trials
Quality of the evidence
In healthy children with painless flat feet, low to very low-quality evidence shows that compared to shoes, CFOs and PFOs result in no difference in the proportion without pain or withdrawal due to side effects from treatment. The quality of the evidence is very low to low, weakening conclusions. We downgraded the certainty of the evidence because the trials were poorly conducted and there were not enough data.
Low to very low-certainty evidence shows that the effect of CFOs (high cost) or PFOs (low cost) versus shoes, and CFOs versus PFOs on pain, function and HRQoL is uncertain. This is pertinent for clinical practice, given the economic disparity between CFOs and PFOs. FOs may improve pain and function, versus shoes in children with JIA, with minimal delineation between costly CFOs and generic PFOs.
This review updates that from 2010, 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 about FOs for treating paediatric flat feet.
The availability of normative and prospective foot development data, dismisses most flat foot concerns, and negates continued attention to this topic. Attention should be re-directed to relevant paediatric foot conditions, which cause pain, limit function, or reduce quality of life. The agenda for researching asymptomatic flat feet in healthy children must be relegated to history, and replaced by a targeted research rationale, addressing children with indisputable foot pathology from discrete diagnoses, namely JIA, cerebral palsy, congenital talipes equino varus, trisomy 21 and Charcot Marie Tooth. Whether research resources should continue to be wasted on studying flat feet in healthy children that do not hurt, is questionable. Future updates of this review will address only relevant paediatric foot conditions.
Paediatric flat feet are a common presentation in primary care; reported prevalence approximates 15%. A minority of flat feet can hurt and limit gait. There is no optimal strategy, nor consensus, for using foot orthoses (FOs) to treat paediatric flat feet.
To assess the benefits and harms of foot orthoses for treating paediatric flat feet.
We searched CENTRAL, MEDLINE, and Embase to 01 September 2021, and two clinical trials registers on 07 August 2020.
We identified all randomised controlled trials (RCTs) of FOs as an intervention for paediatric flat feet. The outcomes included in this review were pain, function, quality of life, treatment success, and adverse events. Intended comparisons were: any FOs versus sham, any FOs versus shoes, customised FOs (CFOs) versus prefabricated FOs (PFOs).
We followed standard methods recommended by Cochrane.
We included 16 trials with 1058 children, aged 11 months to 19 years, with flexible flat feet. Distinct flat foot presentations included asymptomatic, juvenile idiopathic arthritis (JIA), symptomatic and developmental co-ordination disorder (DCD). The trial interventions were FOs, footwear, foot and rehabilitative exercises, and neuromuscular electrical stimulation (NMES). Due to heterogeneity, we did not pool the data. Most trials had potential for selection, performance, detection, and selective reporting bias. No trial blinded participants. We present the results separately for asymptomatic (healthy children) and symptomatic (children with JIA) flat feet.
The certainty of evidence was very low to low, downgraded for bias, imprecision, and indirectness.
Three comparisons were evaluated across trials: CFO versus shoes; PFO versus shoes; CFO versus PFO.
Asymptomatic flat feet
1. CFOs versus shoes (1 trial, 106 participants): low-quality evidence showed that CFOs result in 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% fewer to 15.8% more); or on withdrawals due to adverse events (RR 1.05, 95% CI 0.94 to 1.19); absolute effect (3.4% more, 95% CI 4.1% fewer to 13.1% more).
2. PFOs versus shoes (1 trial, 106 participants): low to very-low quality evidence showed that PFOs result in little or no difference in the proportion without pain (10-point VAS) at one year (RR 0.94, 95% CI 0.76 to 1.16); absolute effect (4.7% fewer, 95% CI 18.9% fewer to 12.6% more); or on withdrawals due to adverse events (RR 0.99, 95% CI 0.79 to 1.23).
3. CFOs versus PFOs (1 trial, 108 participants): low-quality evidence found no difference in the proportion without pain at one year (RR 0.93, 95% CI 0.73 to 1.18); absolute effect (7.4% fewer, 95% CI 22.2% fewer to 11.1% more); or on withdrawal due to adverse events (RR 1.00, 95% CI 0.90 to 1.12).
Function and quality of life (QoL) were not assessed.
Symptomatic (JIA) flat feet
1. CFOs versus shoes (1 trial, 28 participants, 3-month follow-up): very low-quality evidence showed little or no difference in pain (0 to 10 scale, 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 best function; MD -18.55, 95% CI -34.42 to -2.68), child-rated QoL (PedsQL, 0 to 100, 100 best quality; MD 12.1, 95% CI -1.6 to 25.8) and parent-rated QoL (PedsQL MD 9, 95% CI -4.1 to 22.1) and little or no difference between groups in treatment success (timed walking; MD -1.33 seconds, 95% CI -2.77 to 0.11), or withdrawals due to adverse events (RR 0.58, 95% CI 0.11 to 2.94); absolute difference (9.7% fewer, 20.5 % fewer to 44.8% more).
2. PFOs 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), child-rated QoL (PedsQL MD -3.84, 95% CI -19 to 11.33), or parent-rated QoL (PedsQL MD -0.64, 95% CI -13.22 to 11.94).
3. CFOs versus PFOs (2 trials, 87 participants): low-quality evidence showed little or no difference between groups in pain (0 to 10 scale, 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), child-rated QoL (PedsQL MD 8.6, 95% CI -3.9 to 21.2), or parent-rated QoL (PedsQL MD 2.9, 95% CI -11 to 16.8).