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Authors; Angela M. Barbara, and Jennifer Horton.
In patients with systemic diseases such as pronated foot, plantar heel pain, rheumatoid arthritis, juvenile idiopathic arthritis, diabetic plantar ulceration, or hallux valgus, the morbidity of the lower limb is compromised. As a result, patients will experience pain, impairment, disability, and reduction in foot function and quality of life.1,2 The complications associated with these conditions place the lower limb at risk of infection, deformity, and amputation.2 Foot orthotics (also referred to as orthoses) are shoe inserts that are designed to provide proper cushioning, ach support, and corrective biomechanics in people with these conditions.3 Although foot orthotics are sometimes referred to as insoles, these are specialized insoles with a treatment effect for specific foot disorders, as opposed to standard insoles.4
Foot orthotics fall under the broader category of conservative, nonsurgical offloading interventions.5,6 These are external devices specifically designed to offload local stress, thus relieving mechanical pressure from specific regions of the foot. Foot orthotics vary across different parameters, including materials, design and construction, and customization.3 The most common types are custom-made and prefabricated.7 Customized-foot orthotics are uniquely manufactured for the individual from a plaster cast or 3-dimensional laser scan of the foot. These contrast with prefabricated foot orthotics (also referred as “over-the-counter”), which are mass-produced based on foot sizes.7 Other conservative interventions for foot conditions are available, such as magnetized insoles (cushioned insoles with magnetic foil embedded in the foam under the proximal arch),8 prefabricated heel lifts,9 and resting night splints (braces that hold the foot in place, with the toes pointed up).1
Custom-made orthotics improve plantar pressure redistribution and gait mechanics8,10,11 However, a 2020 CADTH report12 found inconsistencies regarding the effectiveness of customized or prefabricated foot orthotics compared to control interventions (standard insole, placebo, or none) in alleviating pain and improving foot function in patients with chronic foot pain. Another CADTH13 report from 2019 found no difference between custom-made and prefabricated foot orthotics for pain reduction or functional improvement, based on a limited amount of evidence. Neither CADTH report included evidence of cost-effectiveness.
Health insurance plans may cover custom-made foot orthotics to treat diagnosed medical conditions. To ensure that these policies are evidence-based, the objective of this report is to summarize the evidence on the clinical effectiveness of custom-made orthotics for the treatment of people with lower-limb conditions. As custom-made orthotics can be more costly than other conservative options, another objective is to summarize the evidence on their cost-effectiveness. Additionally, evidence-based guidelines regarding the use of custom-made foot orthotics were sought.
A limited literature search was conducted by an information specialist on key resources including MEDLINE, the Cochrane Database of Systematic Reviews, the International HTA Database, the websites of Canadian and major international health technology agencies, as well as a focused internet search. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concept was custom-made foot orthoses. No filters were applied to limit the retrieval by study type. A separate search was conducted for guidelines, health technology assessments, systematic reviews, meta-analyses, or network meta-analyses on foot orthoses. Comments, newspaper articles, editorials, and letters were excluded. Where possible, retrieval was limited to the human population. The search was also limited to English-language documents published between January 1, 2017, and January 6, 2022.
One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.
Selection Criteria.
Articles were excluded if they did not meet the selection criteria outlined in Table 1, or if they were duplicate publications. Economic evaluations or evidence-based guidelines published before 2017 were excluded. Systematic reviews and randomized controlled trials (RCTs) that were published before 2020 were excluded. Systematic reviews in which all relevant studies were captured in other, more recent or more comprehensive, systematic reviews were excluded.14-20 Primary studies retrieved by the search were excluded if they were captured in 1 or more included systematic reviews.21
The included publications were critically appraised by 1 reviewer using the following tools as a guide: A MeaSurement Tool to Assess Systematic Reviews 222 for systematic reviews, the Downs and Black checklist23 for randomized studies, the Drummond checklist24 for economic evaluations, and the Appraisal of Guidelines for Research and Evaluation II instrument25 for guidelines. Summary scores were not calculated for the included studies; rather, the strengths and limitations of each included publication were described narratively.
A total of 622 citations were identified in the literature search. Following screening of titles and abstracts, 543 citations were excluded and 79 potentially relevant reports from the electronic search were retrieved for full-text review. Ten potentially relevant publications were retrieved from the grey literature search for full-text review. Of these potentially 89 relevant articles, 74 publications were excluded for various reasons, and 14 publications met the inclusion criteria and were included in this report. These comprised 6 systematic reviews, 5 RCTs, 1 economic evaluation, and 2 evidence-based guidelines. Appendix 1 presents the PRISMA26 flow chart of the study selection.
Additional references of potential interest are provided in Appendix 6.
Six systematic reviews,1,5,7,8,27,28 5 RCTs,9,29-32 1 economic evaluation,33 and 2 evidence-based guidelines34,35 were included in this report.
The 6 systematic reviews1,5,7,8,27,28 had broader inclusion criteria considered than the present review. Specifically, the systematic reviews investigated other types of mechanical or offloading devices (e.g., orthopedic footwear, shoes with heel lifts, taping, ankle-foot orthoses, fibreglass heel cast)1,7,8,27,28 or other interventions (e.g., dermal infrared thermometry, education, extracorporeal shockwave therapy, physiotherapy, stretching).5,7,8 Two systematic reviews also included non-randomized studies.1,7 Only the subset of primary RCTs meeting the inclusion criteria is presented in this report. There was some overlap in the studies included in the systematic reviews and the degree of overlap is summarized in Appendix 5.
The 2 guidelines also addressed a broader group of interventions than this report. The interventions were offloading devices35 and footwear.34 Only the recommendations on custom-made orthotics are presented within this report. The guideline by Bus et al.35 reported its methodology in a separate publication,36 which was used to supplement the information summarized in this report.
Additional details regarding the characteristics of the included publications are provided in Appendix 2.
Of the 6 systematic reviews,1,5,7,8,27,28 1 included meta-analyses.8 The number of relevant primary studies included in the systematic reviews ranged between 1 and 8 RCTs. The latest literature search dates were between March 2018 and August 2020.
Of the 5 included RCTs,9,29-32 2 trials were doubled blinded (participants, investigators, and assessors were blinded),31,32 2 trials were single blinded (participants or investigators and assessors were blinded)9,29 and 1 trial was unblinded.30 Two RCTs were conducted at multiple centres,29,32 and 3 were conducted at a single clinic.9,30,31
The systematic review by Clarke et al.28 included 2 relevant health economic evaluations: 1 cost-effectiveness analysis and 1 cost-effectiveness analysis plus a cost-utility analysis. Both economic evaluations conducted parallel clinical trials, with time horizons of 8 weeks and 16 weeks. One took the perspective of the health care payer, and the other took the perspectives of the health care payer and patient.
The included economic evaluation33 was conducted as cost-utility analyses, with a time horizon of 16 weeks. The study used a imputation model; and clinical, cost, and utility inputs were derived from a published RCT (included in this report)32 of custom-made foot orthotics compared to usual care (i.e., no foot orthosis), and the perspectives of health care payers and society were taken. Model parameters included patient characteristics, activity level, and bilateralism of pain. Assumptions were made about absenteeism from paid work and lost productivity.
The 2 evidence-based guidelines34,35 were informed by systematic reviews of the literature and included recommendations that were drafted using various consensus-generating methods. Both guidelines34,35 were updates to previously published versions and included updated evidence and recommendations.
The guideline by van Netten et al.,34 which was developed by Diabetic Foot Australia, used a systematic approach but did not follow a specific guideline development methodology or assess the quality of the evidence. The authors commented that many recommendations were predominantly based on expert opinion and standard of practice due to limited available evidence and might be seen as “good practice statements.”
The guideline by Bus et al.35 was developed by the International Working Group on the Diabetic Foot (IWGDF), using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for guideline development. The strength of the recommendations was scored as either strong or weak, based on the quality of evidence, balance between desirable and undesirable effects, values and preferences, resources, and costs, according to the GRADE framework. The quality of the evidence informing the recommendations was graded on study design (classified using the Scottish Intercollegiate Grouping Network criteria), risk of bias, inconsistency of results, publication bias, and presence of a large effect size and/or dose-response relationship.
The first authors of the systematic reviews were from Australia,28 Brazil,7 Spain,27 the Netherlands,1 and the UK.5,8
The RCTs were conducted in and enrolled patients from Australia,29 Brazil,30 Spain,9,31 and the Netherlands.32
The economic evaluation33 was conducted in and used data collect from the Netherlands.
The guidelines were intended for use in Australia34 and worldwide.35 The members of the IWGDF guideline group were from 40 countries and 5 continents, and recruited representatives from more than 100 countries around the world to help implement the recommendations.35
Two systematic reviews1,8 included patients with plantar fasciitis; 1 review reported on patients with type 1 or type 2 diabetes at risk of foot ulceration;5 1 review reported on people with posterior tibial tendon dysfunction (flatfoot);27 and 2 systematic reviews7,28 included patients with various lower limb conditions,7 such as rheumatoid arthritis,28 cavus foot,7 and flatfoot.7 The number of participants in the relevant RCTs included in these systematic reviews ranged from 15 to 400.
Four systematic reviews1,5,7,8,27 reported the mean ages in the included RCTs, which ranged from 22 years to 69 years. Two systematic reviews7,28 did not report the age of participants in the included studies. The proportion of females varied across studies, ranging from 23% to 89%.
Adult populations were investigated in 3 RCTs, and included people with plantar fasciitis31 and rheumatoid arthritis.30,32 The number of enrolled participants ranged from 83 to 185, the mean ages varied between 37 and 57 years, and the proportion of females ranged between 54% and 89%. The mean duration of the pain or condition was 6 months in 1 RCT,32 17 months in the second RCT,31 and 11 years in the third RCT.30
Two RCTs investigated pediatric populations, and enrolled children with calcaneal apophysitis (Sever disease)9 or with juvenile idiopathic arthritis.29 The number of enrolled children was 66 and 208; the mean ages were 11 and 12 years; and the proportion of females was 17% and 68%. The mean disease duration was 6.5 years in 1 RCT29 and not reported in the other RCT.9
Participants in the economic evaluation33 were the same study population (adults with plantar fasciitis) in the RCT by Rasenberg et al.32
The target population of the 2 guidelines34,35 was people with diabetes at various risk levels of foot ulceration, and the intended users were the clinicians and/or other health care providers who care for these patients.
In the systematic reviews, the relevant interventions were described as custom-made foot orthotics,28 custom orthoses,8 custom or customized insoles,1,5,7 customized inserts,5 and computer-aided design/computer-aided manufactured insoles (in which computer software was used for designing and producing these custom-made insoles).27 In the RCTs, the interventions were customized preformed foot orthoses,29,31 custom-made foot orthoses,9,30 and custom insoles.32 For consistency, this report uses the term “custom-made foot orthotics” to refer to these interventions.
Two systematic review5,7 provided details about the custom-made orthotics in the included RCTs (e.g., individually moulded ethylene-vinyl acetate insoles with a longitudinal medial arch and heel support7; full contact insoles made in ethylene-vinyl acetate and moulded in a negative cast plaster7; bespoke orthoses with offloading properties5; and customized medium-density cork inserts with a neoprene closed-cell cover).5
The comparators in the included systematic reviews and RCTs were prefabricated foot orthotics,1,8,27,28 prefabricated heel lifts,9 no orthoses (i.e., own footwear1,5,30,32 or standard/usual care),5,7,32,anterior night splints,1 and placebo intervention.1,5,7,8,27-29,31,32 The placebo intervention consisted of sham insoles (i.e., flat, thin, simple insoles), and its purpose is not to provide no effect, as a true placebo does, but to not provide the main therapeutic element of the custom-made orthotics so as to have minimal impact on the lower limb condition.4
In the systematic reviews, the length of time that participants were assigned to the intervention or comparator varied widely, and ranged from a single laboratory visit1 to 2 years.5 In the RCTs, the duration for wearing the intervention or comparator ranged from 4 weeks30 to 1 year.29 In this report, short-term duration is defined as up to 3 months, medium-term duration is between 3 months and 6 months, and long-term duration is more than 6 months.
The economic evaluation33 examined the cost-effectiveness of custom-made foot orthotics versus usual care led by a general practitioner (GP) after 16 weeks.
Recommendations regarding custom-made orthotics were included in the 2 guidelines.34,35
The clinical effectiveness outcomes reported in the selected systematic reviews included pain,1,7,8,27,28 foot function,1,7,8 disability,28 health-related quality of life,1,28 recurrence of diabetic foot ulcer (DFU).5 The RCTs also reported pain,9,29-32 foot function,30,31 disability,29,30 and quality of life.29,32
Pain, foot function, disability, and quality of life were measured in the primary studies of the systematic reviews and RCTs by scores on various patient-reported assessment tools. A frequently used measure of pain severity was the visual analogue scale, a numerical scale with marked points along a 10 cm long horizontal line where 0 equalled no pain and 10 equalled unbearable pain.1,8,9,27,29,31 Functionality was measured by the Foot Function Index, a questionnaire divided into different domains for pain, disability, and functional limitation; with higher values corresponding to higher pain, disability, and limitation.1,8,28,30,32 The Foot Health Status Questionnaire was used to measure foot pain and quality of life.7,8 One study also used the Numeric Rating Scale to measure foot pain on an 11-point scale from 0 to 10, where higher values indicated better outcomes.32 The Foot and Ankle Outcome score was used to measured function and quality of life, where higher scores indicated optimal foot health.1 One RCT31 used the Roles and Maudsley scale to assess functional valuation. The scale classified the patients into 4 categories, where a score of 1 corresponded to a patient with an excellent quality of life (no symptoms, unlimited walking ability without pain, patient satisfied with the treatment outcome); a score of 2 corresponded to good quality of life; a score of 3 to acceptable quality of life; and a score of 4 to a patient with the worst quality of life possible. The questionnaire contained 8 questions that cover 3 domains of pain, function, and activity, and scores were summated to give a total score out of 100, where higher scores indicated less severe Achilles tendinopathy. The RCT by Fellas29 assessed foot and ankle disability in children with idiopathic rheumatoid arthritis using the Juvenile Arthritis Foot ankle disability index. The 27-item questionnaire is divided into 3 main components: physical impairment, activity limitation, and participation restriction. This study also assessed quality of life using the Pediatric Quality of Life Inventory- Rheumatology Module.29 The Mental Health Component of the Short Form-12 questionnaire was used to collect data about quality of life, with higher values corresponding to lower quality of life.32 The systematic review by Mendes et al.7 did not report how pain and function were assessed.
The economic evaluations in the systematic review by Clarke et al.28 and by Rasenberg et al.33 calculated the benefits and costs of custom-made foot orthotics compared to an alternative intervention. The economic evaluation by Rome et al.28 used the generic preference-based outcome measure EQ-5D to produce utility values that were used to calculated quality-adjusted life-years (QALYs) for each intervention. The economic evaluation by Rasenberg et al.33 calculated the incremental cost-effectiveness ratio (ICER), expressed as ratios of incremental cost incurred per QALY gained, to compare custom-made orthotics versus standard care.
For the 2 guidelines, the outcomes considered by the guideline panels were DFU prevention and recurrence,34,35 harms (adverse events),35 and costs.35
An overview of the critical appraisal of the included publications is summarized in the following text. Additional details regarding the strengths and limitations of the included publications are provided in Appendix 3.
In the 6 selected systematic reviews,1,5,7,8,27,28 the objective and inclusion criteria were clearly stated; a literature search was conducted using multiple databases; the selection of articles was described and a flow chart presented; a list of the included primary studies was presented; and the characteristics of the included studies were described. Providing details of the literature search strategy increases the reproducibility of the review. Five systematic reviews registered their study protocol in PROSPERO.5,7,8,27,28 One systematic review1 did not report whether a protocol had been published before the conduct of the review; therefore, it is unknown whether any significant protocol deviations occurred that may impact the interpretation of the findings of this systematic review.1
Study selection was done independently by 2 reviewers for 2 systematic reviews,5,27 and by 1 reviewer for 2 other systematic reviews.1,28 Two other 2 systematic reviews7,8 only reported on title and abstract screening, but did not report the approach for full-text screening. Data extraction was done by 2 reviewers in 2 systematic review,5,27 and 1 review in 1 systematic review.28 However, in 3 systematic reviews, it was unclear how data extraction was done.1,7,8 Therefore, the potential for errors in data extraction is unknown. A list of excluded studies was not presented in any of the reviews. In the absence of justifications for excluding studies, it is unclear if the selection process captured all the relevant studies.
The quality of the included studies was assessed in all 6 systematic reviews.1,5,7,8,27,28 Three systematic reviews1,5,27 used the Cochrane Risk of Bias tool to assess risk of bias. In the systematic review by Gomez-Juardo et al.,27 the included trial had 3 domains assessed as high risk of bias using the Cochrane tool. In the systematic review by Crawford et al.,5 3 included trials were judged to be high risk and 1 trial was judged to be low risk of bias on the Cochrane tool. In the systematic review by Schuitema et al., the included studies had 1 or more domains assessed as high risk of bias on the Cochrane Risk of Bias tool.1 One systematic review7 used the Physiotherapy Evidence Database (PEDro) scale, and the included trials were given a score of 7 out of 10 to 9 out of 10, where a higher score equalled greater quality. In the systematic review by Morrissey et al.,8 RCTs were evaluated using both the PEDro scale and the Cochrane Risk of Bias tool. The relevant RCTs scored 8 out of 10 or 9 out of 10 on the PEDRO scale. These same RCTs were assessed as low risk on the Cochrane tool, with the exception of 1 RCT, which had some concerns due to selective reporting.8 The PEDro scale and Cochrane tool have been shown to be valid, reliable, and frequently used tools for assessing methodological quality and risk of bias.
In the systematic review of health economic evaluations,28 the extended version of the Consensus on Health Economic Criteria was used to assess risk of bias in individual studies. The 2 included economic evaluations used appropriate designs, perspectives, and benefits; however, methodological issues were identified, such as, intervention groups that differed on clinical factors that would likely have influenced the benefit outcome, sample sizes that were too small, time horizons that were too short, limitations in the model input data, and the absence of sensitivity analyses to manage uncertainty.28
Meta-analyses were conducted in the systematic review by Morrissey et al.,8 and were appropriate. In the systematic review by Crawford et al.,5 meta-analyses were also conducted; however, data on custom-made foot orthotics was pooled with orthopedic footwear (i.e., shoes) and non–custom-made orthotics. Therefore, only data from the individual studies (and not the meta-analyses) has been included in this report.
In 5 systematic reviews,5,7,8,27,28 the authors reported that there were no conflicts of interest. In 1 systematic review,1 conflicts of interest were not reported.
In the 5 selected RCTs,9,29-32 the objective, selection criteria, patient characteristics, interventions, and outcomes were described. The method of randomization was described and was appropriate in 4 RCTs29-32 and was not described in 1 RCT.9 In 2 RCTs,31,32 both the investigator and the participants were blinded. In 1 RCT,29 the participants were blinded but the investigators were not; in anther RCT,9 the investigators and assessors were blinded but the participants were not; and in 1 RCT,30,37-40 there was no blinding. Lack of blinding has the potential of introducing detection and performances biases, as the outcomes were mainly subjective.
Sample size calculations were undertaken in all 5 RCTs,9,29-32 and the appropriate number of participants were recruited in 4 trials.9,29,31,32 In the fourth trial,30 the necessary sample size was not achieved, which reduced the statistical power to extrapolate the results to the overall population.
In 3 RCTs,9,31,32 the discontinuation in each treatment group was less than 10%; therefore, unlikely to introduce attrition bias. In 2 RCTs,29,30 the discontinuation rates in the intervention and control groups ranged between 11% and 18%; therefore, there is potential for attrition bias, but the direction of impact is unclear. The reasons for discontinuation were mainly loss to follow-up, unwillingness to wear orthotics, or personal reasons (e.g., medical emergency unrelated to intervention).
The authors reported that there were no conflicts of interest in for any of the 5 RCTs.9,29-32
The economic evaluation33 had the following strengths: the research question and its economic importance were stated; sources of clinical effectiveness estimates, primary outcome, details of the imputation model, and methods for the estimation of unit costs were described; the time horizon and details of statistical tests and sensitivity analyses were given; the incremental analysis was reported; conclusions were given; and the authors stated that they had no conflicts of interest. The economic evaluation33 also had the following limitations: the sample size was insufficient to show statistically significant differences; and the discount rate and current price adjustments for inflation were not provided.
The 2 guidelines34,35 provided a clear description of their scope and purpose. Overall objectives, health questions covered in the guideline, target population, and target users were described. The guideline development groups included individuals from all relevant professional groups, as well as the views and perspectives of patients. In both guidelines,34,35 the systematic methods used to identify evidence and the selection criteria were described. The explicit link between evidence and recommendations was clearly described. The recommendations were unambiguous and easy to identify. A procedure for updating the evidence base and recommendations was described. The guidelines were externally reviewed by stakeholders and experts before publication.34,35
The overall strengths and limitations of the evidence and the methods for formulating and developing the recommendations were reported in both guidelines.34,35 The IWGDF guideline rated the strength of the recommendations using the GRADE system and rated the quality of the evidence using the Scottish Intercollegiate Grouping Network criteria35; but the Diabetic Foot Australia guideline did not rate the strength of the recommendations nor the quality of the evidence supporting the recommendations.34
The 2 guidelines34,35 described the facilitators and barriers to the implementation of the recommendations and addressed the potential resource implications. The IWGDF guideline provided monitoring criteria,35 but the Diabetic Foot Australia guideline did not.34 Finally, while the funding sources did not influence the recommendations in the IWGDF guideline,35 this was unclear in the Diabetic Foot Australia guideline.34
The main findings from the included systematic reviews are summarized in the following sections and Appendix 4. There was some overlap in the primary studies that were included in the systematic reviews; therefore, to avoid duplication of reporting, outcomes data from an individual RCT is reported only once as part of 1 systematic review. If study outcomes were included in the meta-analyses by Morrissey et al.,8 they are reported only in the pooled estimates (and not the individual study level results). A citation matrix illustrating the degree of overlap is presented in Appendix 5.
There was no statistically significant difference in foot pain with custom-made orthotics compared to prefabricated orthotics reported by the 5 RCTs included in the 3 systematic reviews.1,8,27 Four trials were conducted in adults with plantar fasciitis1,8 and 1 study in adults with flatfoot.27 In general, both custom-made and prefabricated orthotics caused pain to decrease in these studies; but no statistically significant differences were found between groups.1,8,27
The meta-analysis by Morrissey et al.8 showed a statistically significant effect on foot pain with custom-made foot orthotics versus sham orthotics in the short term (i.e., up to 3 months) in people with plantar fasciitis. However, there was moderate statistical heterogeneity. In the same systematic review,8 1 RCT found a statistically significant improvement in foot pain in the medium term (i.e., > 3 months and up to 6 months), and another RCT found no effect in the long term (i.e., > 6 months). Two RCTs in patients with plantar fasciitis27,31 also found a statistically significant improvement in short-term and medium-term pain with custom-made foot orthoses compared to sham insoles. However, 2 other trials in people with plantar fasciitis1,32 found no statistically significant difference in pain between custom-made orthotics and sham insoles in the short term. A trial that included patients with cavus foot7 found statistically significant improvement with custom-made foot orthoses compared to sham insoles (follow-up time not reported); but another RCT of patients with rheumatoid arthritis28 found no statistically significant difference in pain between custom-made orthotics and sham insoles in the short term.
Compared to no orthotics, 2 trials reported that custom-made orthotics significantly reduced foot pain in the short term in patients with rheumatoid arthritis30 and plantar fasciitis.32 However, 2 studies included in 2 systematic reviews1,7 reported no significant difference in function after wearing custom-made orthotics compared to no foot orthotics in the short term in people with plantar fasciitis,1 or compared to standard care in the short term and long term in patients with flatfoot.7
One RCT in the systematic review by Schuitema et al.,1 found no statistically significant difference between custom-made orthotics and night splints for pain due to plantar fasciitis. In another RCT included in the same systematic review,1 people with plantar fasciitis were randomized to receive foot orthoses, foot orthoses and night splints, or night splints alone. At 1 year, pain reduction was statistically significantly higher in the 2 groups using custom-made foot orthoses compared to those in the anterior night splint only group.
One RCT9 reported that pain relief was statistically significantly higher with custom-made foot orthoses compared to prefabricated heel lifts in children with calcaneal apophysitis in the short term. Another RCT29 reported that pain was statistically significantly improved in children with idiopathic rheumatoid arthritis with custom-made foot orthoses compared to sham insoles in the short term, but there was no statistically significant difference in pain in the medium term or long term.
The effectiveness of custom-made orthotics versus prefabricated orthotics on foot function in people with plantar fasciitis was examined by 3 RCTs identified in 1 systematic review,8 which reported no significant difference in function in the short term and long term. However, 1 RCT31 reported a statistically significant improvement in foot function in the medium term in people with plantar fasciitis.
The meta-analysis by Morrissey et al.8 found no statistically significant difference in foot function with custom-made orthotics compared to placebo insoles in the short-term for plantar fasciitis. Two individual RCTs in the same review of people with plantar fasciitis8 also reported no statistically significant difference in the medium and long term. In the systematic review by Mendes et al.,7 1 RCT of people with cavus foot reported statistically significant improvement in foot function with custom-made orthotics compared to sham insoles, and another RCT in the same review7 reported no significant difference in people with Achilles tendinopathy (follow-up times not reported). One RCT32 also reported that, compared to sham orthotics, there was no significant difference in foot function at 26 weeks in people with plantar fasciitis.
Two RCTs, 1 in adults with rheumatoid arthritis30 and 1 in adults with plantar fasciitis32 reported statistically significant improvement in foot function with custom-made orthotics compared to no orthotics30 or standard care.32
One RCT included in the systematic review by Schuitema et al.,1 reported no statistically significant difference in long-term foot function between custom-made foot orthoses and anterior night splints in people with plantar fasciitis.
The impact of custom-made orthotics on disability was assessed in 2 RCTs of adults with plantar fasciitis. In the RCT by Gaino et al.,30 there was a statistically significant improvement in short-term disability with custom-made orthotics compared to simple insoles. The other RCT included in a systematic review28 reported no statistically significant difference in short-term disability between custom-made orthotics and no foot orthotics.
The RCT of children with idiopathic rheumatoid arthritis29 reported no statistically significant improvement in disability with custom-made foot orthoses compared to sham insoles in the short term (3 months), medium term (6 months) or long term (1 year).
One RCT of people with plantar fasciitis32 showed that custom-made orthotics resulted in a statistically significant improvement in short-term quality of life compared to sham insoles and compared to standard care. An RCT included in the systematic review by Schuitema et al.,1 reported no statistically significant difference in long-term quality of life between custom-made foot orthoses and anterior night splints in people with plantar fasciitis.
The RCT of children with idiopathic rheumatoid arthritis29 reported no statistically significant improvement in quality of life with custom-made foot orthoses compared to sham insoles in the short or medium term. There was an improvement in quality of life in the long term; however, this difference was only statistically significant when measured by parent-report and not statistically significant when self-reported by the children.29
Four RCTs in 1 systematic review5 reported the effects of custom-made foot orthotics on the recurrence of DFU. One RCT5 found a reduction in DFUs at 15 months when compared to prefabricated foot orthotics. Two RCTs5 found a reduction in DFU rates at 1 year among participants who wore custom-made foot orthotics compared to no orthotics or usual care. The fourth RCT5 randomized patients with diabetes to 3 groups: therapeutic footwear with custom-made cork orthotics, therapeutic footwear with prefabricated polyurethane orthotics, and usual footwear. At 2 years, there was no statistically significant difference in ulcer relapse between the 3 groups.5
No systematic reviews or primary studies included adverse events as an outcome. However, 3 RCTs did report how many participants dropped out of the study due to negative effects of the trial interventions. The RCT by Fellas et al.29 in children with idiopathic rheumatoid arthritis reported that 1 child (3%) in the custom-made foot orthotics group withdrew due to discomfort with the assigned orthotics. The child reported the presence of blistering shortly after wearing them and opted to withdraw from the study. The RCT by Cohena-Jimenez et al. of adults with plantar fasciitis31 reported that 1 adult (2%) in the custom-made foot orthotics group and 2 adults (5%) in the placebo orthotics group dropped out due to increased pain after 24 weeks. In the RCT by Gaino et al.,30 1 adult (2%) with rheumatoid arthritis in the custom-made orthotics group discontinued the intervention because that person could not adapt to using the orthotics due to the tightness of the footwear.
The systematic review by Clarke et al.28 reported that custom-made foot orthotics were less cost-effective that simple insoles in people with rheumatoid arthritis, based on the cost-utility analysis by Rome et al. There was a small, statistically insignificant QALY loss of −0.03 when comparing custom-made orthotics to simple insoles, controlling for baseline utility. The simple insoles group was dominant, having an incremental gain in QALY at a lower cost compared to the custom-made orthotics group. That is, custom-made orthotics were far more expensive with no significant cost per QALY gain, in comparison to simple insoles. The same systematic review28 also reported that custom-made foot orthotics were less cost-effective than prefabricated foot orthotics in people with heel pain, based on the cost-effectiveness analysis by Ring and Otter.28 No ICER was reported in either economic evaluation.
The economic evaluation33 reported that custom-made foot orthotics were not cost-effective in comparison to GP-led usual care in people with plantar fasciitis, with an ICER of € –150,548 per QALY gained from a health care payer perspective.
The 2 evidence-based guidelines34,35 made recommendations regarding the use of custom-made orthotics for people with diabetes. The IWGDF guideline35 made a strong recommendation, based on low-quality evidence, for the use of therapeutic footwear in people with diabetes at moderate risk of DFU or with a healed non-plantar DFU, as well as the consideration of foot orthotics in people with foot deformity or pre-ulcerative signs. Another strong recommendation, based on moderate-quality evidence, was made in favour of therapeutic footwear (including custom-made foot orthotics) for people with a healed plantar DFU to help prevent recurrence.
The Diabetic Foot Australia guideline34 also recommended custom-made foot orthotics for people with foot deformities or pre-ulcerative lesions, but the strength of the recommendation was not provided, and the quality of the evidence was not rated. The guideline34 also recommend medical-grade footwear plus orthoses or insoles for people with healed plantar DFUs, based on 2 RCTs and alignment with IWDF recommendations; however, the strength of the recommendation and quality of evidence were not included. The Diabetic Foot Australia guideline34 included a recommendation that health care providers review prescribed orthotics every 3 months for continued fit, protection, and support. This recommendation was based on 1 RCT and was aligned with the Australian National Health and Medical Research Council guideline.
Appendix 4 presents the main study findings and authors’ conclusions.
There are several limitations that prevent a definitive conclusion regarding the clinical effectiveness of custom-made foot orthotics for all patients with lower-limb conditions. Most of the included RCTs, as well as the economic evaluations, were limited by relatively small sample sizes: 65% of included trials involved fewer than 100 participants and a small percentage of studies (1%) had more than 200 participants. In the meta-analyses conducted by Morrissey et al.,8 there were between 214 and 254 adults in the pooled analyses. Results can be imprecise when studies include relatively few patients and few events.
There were also several reporting issues in the systematic reviews, such as inconsistent (or lack of) detail about the study population, settings, development of the custom-made orthotics (e.g., design, manufacturing, and adaption of orthotics to footwear or patient), interventions (e.g., characteristics, frequency of wearing orthotics), and findings (e.g., outcome data, effect sizes, P values). There was considerable heterogeneity among the RCTs identified in the systematic reviews1,5,7,8,27,28 in terms of customization of orthotics, application of cointervention (e.g., orthopedic footwear, exercise program, information booklets), duration of intervention, and assessment of outcomes. The risk of bias ranged from low to high for the RCTs in the included systematic reviews (as assessed by the systematic review authors).1,5,7,8,27,28 Common methodological limitations included unclear allocation concealment (selection bias), nonblinding of participants and personnel (performance bias), nonblinding of outcome assessment (detection bias), incomplete outcome data (attrition bias), and selective reporting. Any quality issues from the primary studies causes uncertainty in the findings presented in the systematic review.
The 2 economic evaluations included in the systematic review by Clarke et al.28 had time horizons shorter than 6 months, which is insufficient time to capture all material differences in costs and benefits, and may overstate the cost-effectiveness of less durable interventions (e.g., replacement of simple insoles) for people with long-term or chronic lower limb conditions. The systematic review authors28 identified other limitations, including inadequate measurement of costs, no reporting of discounting, and no sensitivity analyses.
In the IWGDF guideline,35 the level of evidence of the recommendations varied. The Diabetic Foot Australia guideline34 did not assess the strength of their recommendations or the level of evidence. The studies making up the evidence base for the guideline recommendations were also small, with varying risks of bias.34,35
Evidence on clinical effectiveness was available for people with the following conditions: plantar fasciitis,1,8,31 DFUs,5 rheumatoid arthritis,28-30 flatfoot,7,27 calcaneal apophysitis,9 cavus foot,7 and heel pain.32 Evidence on cost-effectiveness was available for people with rheumatoid arthritis28 and heel pain.28,33 The included guidelines targeted people with diabetes.34,35 None of the selected primary studies or guidelines included people with Charcot foot, hallux valgus, gout, or metatarsal amputation. Also, no studies were identified that reported the effect of custom-made orthotics on amputation in people with lower-limb conditions.
None of the included systematic reviews or RCTs reported adverse events; as a result, this report focused on the benefits of custom-made orthotics. Without also assessing harms, results may be unbalanced and biased toward favouring the intervention.
One systematic review28 reported the countries in which the included studies were conducted (England), but 5 systematic reviews1,5,7,8,27 did not report this information. The RCTs9,29-32 and economic evaluation33 were not conducted in Canada. Similarly, the 2 included guidelines34,35 were not specifically intended for use in Canada, although the IWGDF guideline35 was intended for worldwide use. Taken together, the generalizability of the findings and recommendations to the Canadian context are unknown because of substantial variations in health care systems and available resources for delivering health services across countries. The information provided in the included studies was also insufficient to determine the generalizability of the findings to populations belonging to specific geographical, ethnic, or cultural groups in Canada.
This review comprised 6 systematic reviews,1,5,7,8,27,28 5 RCTs,9,29-32 1 economic evaluation,33 and 2 evidence-based guidelines.34,35 Most of the evidence included in this report pertained to adults with plantar fasciitis1,8,31-33 and diabetes mellites.5,34,35
Evidence from meta-analyses8 and individual trials1,27 found no effect of custom-made orthotics compared to prefabricated foot orthotics on pain reduction and foot function in the short term and long term in adults with plantar fasciitis. Evidence on prevention of DFU recurrence with custom-made orthotics compared to prefabricated orthotics in the long term was conflicting;5 1 trial with low risk of bias (according to systematic review authors)5 reported long-term reduction in DFU recurrence with custom-made foot orthotics, but another trial with uncertain risk or bias (according to systematic review authors)5 found no statistically significant difference in recurrence of DFU between groups.
The meta-analysis by Morrissey et al.8 reported strong evidence (according to systematic review authors) of a positive effect of custom-made orthotics on short-term pain reduction, limited evidence of a positive effect on medium-term pain reduction, and moderate evidence of no effect for long-term pain relief in patients with plantar fasciitis. Findings from RCTs supported the positive effect of custom-made orthotics on short-term pain in people with flatfoot27 and cavus foot,7 and the positive effect on medium-term pain in people with plantar fasciitis.31 However, 3 other RCTs found no effect on short-term pain in patients with rheumatoid arthritis28 or plantar fasciitis.1,32
Moderate evidence (according to systematic review authors) from the meta-analysis8 found no statistically significant difference in foot function with custom-made orthotics compared to sham orthotics in the short term, medium term, and long term. Two small RCTs7,32 also found no effect of custom-made orthotics on short-term foot function, but 1 trial in people with cavus foot did find a positive effect on foot function.7 One RCT also found that custom-made foot orthotics improved disability compared to sham orthotics,7 and another RCT reported that custom-made foot orthotics improved short-term health-related quality of life.32
Compared to no orthotics, custom-made orthotics significantly reduced foot pain and improved quality of life in the short term,30,32 but did not affect foot function.1,7 Two trials with varying risks of bias (according to systematic review authors)5 reported long-term reduction in DFU recurrence with custom-made foot orthotics compared to no orthotics or usual care. However, another trial with uncertain risk of bias (according to systematic review authors)5 found no statistically significant difference in recurrence of DFU between custom-made orthotics and no orthotics.
Custom-made orthotics were compared to tension night splints in people with plantar fasciitis.1 There was no significant difference between groups regarding pain at short term, according to 1 trial with high risk of bias (according to systematic reviews).1 There was significantly lower pain, similar foot function, and similar quality of life with custom-made orthotics at long term, according to another trial with low risk of bias (according to systematic reviews).1
Custom-made orthotics provided significantly improved pain relief to children in the short term,9,29 but not in the medium or long term when compared to prefabricated heel lifts for calcaneal apophysitis9 and not compared to sham orthotics for idiopathic rheumatoid arthritis.29 In children with idiopathic rheumatoid arthritis, custom-made orthotics did not improve disability;29 and their effect on quality of life in the long term differed between self-report and parent-report.29
In general, this review found that custom-made foot orthotics had a beneficial or neutral effect on clinical outcomes compared to other interventions, which is similar to the findings of the 2020 CADTH report.12 There were no differences between custom-made and prefabricated foot orthotics on pain reduction and foot function in adults with plantar heel pain.1,8,27 These results are similar to those of the 2019 CADTH report.13 Custom-made orthotics were better than or similar to prefabricated orthotics, no orthotics, or standard care in preventing DFU relapse in patients with diabetes.5 These results are in alignment with the guideline recommendations in support of custom-made orthotics for the prevention of new and recurring DFU.34,35
Although no studies reported that custom-made orthotics had a negative impact on clinical outcomes compared to other interventions, the dearth of evidence about adverse events creates uncertainty about these positive results. Further research set in Canada on both benefits and harms, and based on adequately powered high-quality RCTs with long-term follow-up, is needed to better understand the clinical effectiveness of custom-made foot orthotics in people with lower-limb conditions.
Custom-made foot orthotics were not cost-effective in comparison to placebo insoles, prefabricated orthotics, and GP-led usual care in the short term and medium term.28,33 Further economic evaluations, also set in Canada, with longer-term time horizons, proper cost measurements, discounting, and sensitivity analyses, are warranted.
diabetic foot ulcer
general practitioner
Grading of Recommendations Assessment, Development and Evaluation
incremental cost-effectiveness ratio
International Working Group on the Diabetic Foot
Physiotherapy Evidence Database
quality-adjusted life-years
randomized controlled trial
Note that this appendix has not been copy-edited.
Selection of Included Studies.
Characteristics of Included Systematic Reviews.
Characteristics of Included Primary Clinical Studies.
Characteristics of Included Economic Evaluations.
Characteristics of Included Guidelines.
Note that this appendix has not been copy-edited.
Strengths and Limitations of Systematic Reviews and Meta-Analyses Using AMSTAR 222.
Strengths and Limitations of Clinical Studies Using the Downs and Black Checklist.
Strengths and Limitations of Economic Evaluation Using the Drummond Checklist.
Strengths and Limitations of Guidelines Using AGREE II.
Note that this appendix has not been copy-edited.
Summary of Findings by Outcome — Foot Pain in Adults.
Summary of Findings by Outcome — Foot Pain in Children.
Summary of Findings by Outcome — Foot Function in Adults.
Summary of Findings by Outcome — Disability in Adults.
Summary of Findings by Outcome — Disability in Children.
Summary of Findings by Outcome — Quality of Life in Adults.
Summary of Findings by Outcome — Quality of Life in Children.
Summary of Findings by Outcome — DFU Recurrence.
Summary of Findings of Included Economic Evaluations.
Summary of Recommendations in Included Guidelines.
Note that this appendix has not been copy-edited.
Overlap in Relevant Primary Studies Between Included Systematic Reviews.
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