Abbreviations
- AEs
Adverse events
- BMI
Body mass index
- AMSTAR
Assessing the Methodological Quality of Systematic Reviews
- CI
Confidence interval
- FFI
Foot Functional Index
- FHSQ
Foot Health Status Questionnaire
- GRADE
Grading of Recommendations Assessment, Development, and Evaluation
- HTA
Health technology assessment
- ITT
Intention-to-treat
- IU
International unit
- IVH
Intraventricular hemorrhage
- JBI
Joanna Briggs Institute
- MA
Meta-analysis
- MFPDQ
The Manchester Foot Pain Disability Questionnaire
- MD
Mean difference
- NA
Not applicable
- NR
Not reported
- OR
Odds ratio
- PRISMA
Preferred Reporting Items for Systematic Reviews and Meta-Analyses
- RCT
Randomized controlled trial
- ROB
Risk of Bias
- RR
Risk ratio
- SIGN
The Scottish Intercollegiate Guidelines Network
- SFMPQ
The Short Form McGill Pain Questionnaire
- SMD
Standardized mean difference
- SR
Systematic review
- VAS
Visual Analogue Scale
Context and Policy Issues
Foot orthoses (commonly referred as “orthotics”) are devices made to insert into the shoes to provide cushioning and off-loading of foot structures.1 They are either prefabricated or custom-made.2 Custom-made foot orthoses are contoured devices made from a plaster cast or three-dimensional laser scan of the foot.3 Prefabricated foot orthoses (also referred as “over-the-counter” or “non-prescription”) are mass-produced based on foot sizes.4
Foot orthoses are used in adjunct to standard medical care of patients with foot and lower limb problems including pronated foot,5 plantar heel pain,6 rheumatoid arthritis,7 juvenile idiopathic arthritis,8 risk of diabetic plantar ulceration,9 or hallux valgus (bunions).10 They are intended to alter the function of the joints of the foot and lower limb during weight bearing activities including standing, walking or running, to reduce pain and improve the function of the foot and quality of life.11 Global demand of foot orthoses has dramatically increased over the past years and the market is estimated to reach $US 3.5 billion by 2020.12
Although custom-made foot orthoses are generally considered the gold standard, the underlined mechanism is not well understood.11 Several studies found that custom-made orthoses were more effective than prefabricated orthoses for objective outcome measures through biomechanical assessments including dynamic balance,13 and pressure relief and load redistribution across plantar regions.4,14,15 However, a previous systematic review16 found no evidence that custom-made orthoses were more effective than prefabricated orthoses in the treatment of different types of foot pain. As custom-made orthoses are relatively more expensive than prefabricated orthoses,17 their clinical effectiveness and cost-effectiveness need to be evaluated.
The aim of this report is to review the comparative clinical and cost effectiveness of custom-made foot orthoses versus prefabricated foot orthoses for patients requiring a foot orthotics.
Research Question
What is the clinical effectiveness of custom-made foot orthoses for patients requiring a foot orthosis?
What is the cost-effectiveness of custom-made foot orthoses for patients requiring a foot orthosis?
Key Findings
This review included two systematic reviews, one randomized controlled trial and one prospective cohort study. No cost-effectiveness studies of custom-made foot orthoses were identified.
The evidence showed no difference between custom-made and prefabricated foot orthoses for pain reduction or functional improvement after short-term (6 weeks), medium-term (12 weeks) and long-term (12 months) treatment in adult patients with plantar heel pain. There was also no difference between interventions for short-term self-reported recovery and patient satisfaction. Evidence on comfort was mixed.
Methods
Literature Search Methods
A limited literature search was conducted by an information specialist on key resources including PubMed, the Cochrane Library, the University of York Centre for Reviews and Dissemination (CRD) databases, the websites of Canadian and major international health technology agencies, as well as a focused Internet search. The search strategy was comprised of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were custom-made foot orthoses. No filters were applied to limit retrieval by publication type. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2014 and August 20, 2019.
Selection Criteria and Methods
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 .
Exclusion Criteria
Studies were excluded if they did not meet the selection criteria in and if they were published prior to 2014. Primary studies were excluded if they had been included in the identified SRs.
Critical Appraisal of Individual Studies
The AMSTAR-2 checklist was used to assess the quality of SRs.18 The critical appraisal checklists of the Joanna Briggs Institute were used to assess the quality of the included RCTs19 and non-randomized studies.20 Summary scores were not calculated for the included studies; rather, a review of the methodological qualities and limitations were described narratively.
Summary of Evidence
Quantity of Research Available
A total of 301 citations were identified in the literature search. Following screening of titles and abstracts, 282 citations were excluded and 19 potentially relevant reports from the electronic search were retrieved for full-text review. No potentially relevant publications were retrieved from the grey literature search. Of the 19 potentially relevant articles, 15 publications were excluded for various reasons, while four publications including two SRs, one RCT, and one non-randomized study met the inclusion criteria and were included in this report. No economic evaluations were identified. Appendix 1 presents the PRISMA flowchart21 of the study selection.
Summary of Study Characteristics
The characteristics of the identified SRs (),22,23 RCT24 and non-randomized study25 () are presented in Appendix 2.
Study Design
Two SRs22,23 were identified that investigated the effects of foot orthoses for pain and function in adults with plantar heel pain. Both SRs searched for RCTs using multiple databases with search dates from inception to 2017. One SR23 assessed the risk of bias of the included four relevant RCTs using the Cochrane Risk of Bias tool, while the other SR22 assessed the risk of bias of the included five relevant RCTs using criteria recommended by the Cochrane Back Review Group.26
One additional single-blinded parallel RCT24 and one prospective cohort study25 were identified. In the RCT,24 blinding was applied to the assessor only. Both studies were carried out in a single centre.
Country of Origin
The SRs were conducted by the authors from the Netherland22 and Australia.23 The additionally identified RCT and cohort study were conducted by authors from China24 and the UK,25 respectively.
Population
In both SRs,22,23 participants were adult patients with acute or chronic plantar heel pain. The mean age ranged from 44 to 49 years. The proportion of females was higher than males, ranging from 63% to 76%. Participants in the additionally identified RCT24 and cohort study25 were also adult patients with a clinical diagnosis of plantar heel pain. In the RCT,24 the mean age of participants was 41.4 years and 50% were female. In the cohort study,25 the mean age of participants was 48 years and 61% were female.
Interventions and Comparators
Both SRs22,23 included studies comparing foot orthoses with any comparator. Only the findings of customized foot orthoses compared with prefabricated foot orthoses were presented in this review. The identified RCT24 compared customized 3-D printed foot orthoses with prefabricated foot orthoses, while the cohort study25 compared casted foot orthoses with prefabricated foot orthoses.
Treatment duration of the RCTs cited in the SRs22,23 varied from two weeks to 12 months. In both the additionally identified RCT24 and cohort study,25 treatment duration was eight weeks.
Outcomes
The outcomes evaluated in the SRs22,23 were improvement in pain and function. The cited RCTs included in the SRs22,23 measured pain using the Visual Analogue Scale (VAS), the Short Form McGill Pain Questionnaire (SFMPQ), or the Foot Health Status Questionnaire (FHSQ) subscale. Function was measured using Foot Functional Index (FFI) total, or FHSQ. One SR22 included self-reported recovery using the Likert scale as an outcome. The RCT24 measured comfort scores using VAS, while the cohort study25 evaluated foot pain/disability using the Manchester foot Pain Disability Questionnaire (MFPDQ) and participant satisfaction using VAS as clinical outcomes.
Summary of Critical Appraisal
The quality assessments of the identified SRs (),22,23 RCT (),24 and cohort study ()25 are presented in Appendix 3.
Both SRs22,23 provided appropriate research questions, explanations for selection of the study designs for the inclusion in the review, and used comprehensive literature search strategies. In both SRs, study selection and data extraction were performed in duplicate, the authors provided a description of included studies’ characteristics, used satisfactory techniques for assessing the risk of bias of the included studies, used appropriate methods for statistical combination of the results, and incorporated of the risk of bias in individual studies when interpreting or discussing of the results. The authors of both SRs provided explanation and discussion of any heterogeneity observed in the results, and a declaration of conflict of interest. One SR22 had an a priori published protocol, while the other23 did not. Both SRs22,23 did not provide lists of excluded studies, did not report on the sources of funding for the included studies, and did not assess the potential impact of risk of bias in individual studies on the results of the meta-analysis. Investigation of publication bias was not applicable in both SRs22,23 due to the few numbers of included studies.
The identified RCT24 reported an appropriate method for randomization and allocation concealment. The patient characteristics between treatment groups were similar at baseline. The outcome assessor, but not the participants or the therapist, was blinded to treatment assignment. Both treatment groups were treated identically other than the intervention of interest, and all participants completed the follow up. The outcomes were measured in the same way for treatment groups using reliable methods. The comparison of the results was conducted using appropriate statistical analysis.
The cohort study25 provided appropriate research questions and objectives, and included a control group. The participants in treatment groups received similar treatment and care other than the exposure or intervention of interest, and the outcomes of participants were measured in the same and reliable way. The results were analyzed using appropriate statistical analysis. Demographics of participants in both treatment groups were not reported.
Summary of Findings
The main findings and conclusions of the SRs (),22,23 and RCT24 and cohort study25 () are presented in Appendix 4.
What is the clinical effectiveness of custom-made foot orthoses for patients requiring a foot orthosis?
Pain
Both SRs22,23 found no significant difference in short-term (0 to 6 weeks), medium-term (7 to 12 weeks) and long-term (12 months) pain between custom-made and prefabricated orthoses in patients with plantar heel pain.
The identified prospective cohort study25 compared casted foot orthoses with prefabricated foot orthoses in patients with plantar heel pain. The study reported foot pain and disability as a clinical outcome, and found that both types of foot orthoses were effective for the treatment of plantar heel pain, and there was no significant difference between groups at 8 weeks.
Function
Both SRs22,23 found no significant difference in function between custom-made and prefabricated orthoses after 7 to 12 weeks of treatment.
Other outcomes
One RCT cited in the SR22 found a significant effect of self-reported recovery at short-term (8 weeks), which was in favoured of prefabricated orthoses.
The identified RCT24 compared customized 3-D printed foot orthoses with prefabricated foot orthoses in patients with plantar fasciitis. The study reported comfort scores after 8 weeks of treatment, and found a significant effect in favor of the customized 3-D foot orthoses.
The identified prospective cohort study25 found no difference between groups in mean scores measuring patient satisfaction including ease of use, comfort, hygiene and satisfaction. No adverse effects were identified in both groups during treatment.25
What is the cost-effectiveness of custom-made foot orthoses for patients requiring a foot orthosis?
No comparative cost-effectiveness studies of custom-made foot orthoses versus prefabricated foot orthoses were identified; therefore, no summary can be provided.
Limitations
The medical condition in studies cited in the SRs22,23 and additional identified studies24,25 was limited to foot plantar heel pain only, therefore the findings could not be generalizable to other clinical conditions. A broad definition of plantar heel pain was used by the SRs22,23 and the cohort study25 suggesting that there were heterogeneity of included participants with different subcategories of plantar heel pain. It is not possible for participants and physicians to be blinded to the intervention, therefore there was a risk of performance bias or detection bias. One SR23 used the GRADE approach for outcome level assessment, and found that the quality of evidence ranged from very low to low quality, therefore the findings should be interpreted with cautions.
Conclusions and Implications for Decision or Policy Making
This review included two SRs22,23 and two additionally identified primary studies (one RCT24 and one prospective cohort study25) for the comparison between custom-made and prefabricated foot orthoses in adult patients with plantar heel pain. Studies on the clinical effectiveness of foot orthoses in pediatric and older adult populations, as well as cost-effectiveness studies of custom-made foot orthoses were not identified.
There was no difference between custom-made and prefabricated foot orthoses for pain reduction or functional improvement after short-term (6 weeks), medium-term (12 weeks) and long-term (12 months) treatment in adult patients with plantar heel pain from very low-quality evidence to low-quality evidence. There was also no difference between interventions for short-term self-reported recovery and patient satisfaction. Evidence on comfort was mixed. The overall methodological quality of the included studies in this review was strong. More studies are needed to determine the comparative clinical effectiveness custom-made foot orthoses versus prefabricated foot orthoses in different populations with different foot disorders. Cost-effectiveness studies of custom-made foot orthoses are also warranted.
References
- 1.
- 2.
- 3.
Landorf
K, Keenan
AM, Rushworth
RL. Foot orthosis prescription habits of Australian and New Zealand podiatric physicians.
J Am Podiatr Med Assoc. 2001;91(4):174–183. [
PubMed: 11319247]
- 4.
Redmond
AC, Landorf
KB, Keenan
AM. Contoured, prefabricated foot orthoses demonstrate comparable mechanical properties to contoured, customised foot orthoses: a plantar pressure study.
J Foot Ankle Res. 2009;2:20. [
PMC free article: PMC2711934] [
PubMed: 19531262]
- 5.
Gijon-Nogueron
G, Palomo-Toucedo
I, Gil-Tinoco
A, Ortega-Avila
AB, Munuera-Martinez
PV. Effect produced on ground reaction forces by a prefabricated, weight-bearing and non-weight-bearing foot orthosis in the treatment of pronated foot: Pilot study.
Medicine (Baltimore). 2018;97(22):e10960. [
PMC free article: PMC6393007] [
PubMed: 29851844]
- 6.
Wrobel
JS, Fleischer
AE, Crews
RT, Jarrett
B, Najafi
B. A randomized controlled trial of custom foot orthoses for the treatment of plantar heel pain.
J Am Podiatr Med Assoc. 2015;105(4):281–294. [
PubMed: 25941995]
- 7.
Tenten-Diepenmaat
M, Dekker
J, Heymans
MW, Roorda
LD, Vliet Vlieland
TPM, van der Leeden
M. Systematic review on the comparative effectiveness of foot orthoses in patients with rheumatoid arthritis.
J Foot Ankle Res. 2019;12:32. [
PMC free article: PMC6567436] [
PubMed: 31210785]
- 8.
Coda
A, Fowlie
PW, Davidson
JE, Walsh
J, Carline
T, Santos
D. Foot orthoses in children with juvenile idiopathic arthritis: a randomised controlled trial.
Arch Dis Child. 2014;99(7):649–651. [
PubMed: 24636956]
- 9.
Parker
DJ, Nuttall
GH, Bray
N, Hugill
T, Martinez-Santos
A, Edwards
RT, et al. A randomised controlled trial and cost-consequence analysis of traditional and digital foot orthoses supply chains in a National Health Service setting: application to feet at risk of diabetic plantar ulceration.
J Foot Ankle Res. 2019;12:2. [
PMC free article: PMC6325812] [
PubMed: 30636974]
- 10.
Nakagawa
R, Yamaguchi
S, Kimura
S, Sadamasu
A, Yamamoto
Y, Muramatsu
Y, et al. Efficacy of foot orthoses as nonoperative treatment for hallux valgus: A 2-year follow-up study.
J Orthop Sci. 2019;24(3):526–531. [
PubMed: 30509733]
- 11.
Landorf
KB, Keenan
AM. Efficacy of foot orthoses. What does the literature tell us?
J Am Podiatr Med Assoc. 2000;90(3):149–158. [
PubMed: 10740997]
- 12.
- 13.
Abbasi
F, Bahramizadeh
M, Hadadi
M. Comparison of the effect of foot orthoses on Star Excursion Balance Test performance in patients with chronic ankle instability.
Prosthet Orthot Int. 2019;43(1):6–11. [
PubMed: 30101681]
- 14.
Caravaggi
P, Giangrande
A, Lullini
G, Padula
G, Berti
L, Leardini
A. In shoe pressure measurements during different motor tasks while wearing safety shoes: The effect of custom made insoles vs. prefabricated and off-the-shelf.
Gait Posture. 2016;50:232–238. [
PubMed: 27662483]
- 15.
Bus
SA, Ulbrecht
JS, Cavanagh
PR. Pressure relief and load redistribution by custom-made insoles in diabetic patients with neuropathy and foot deformity.
Clin Biomech (Bristol, Avon). 2004;19(6):629–638. [
PubMed: 15234488]
- 16.
Hawke
F, Burns
J, Radford
JA, du Toit
V. Custom-made foot orthoses for the treatment of foot pain.
Cochrane Database Syst Rev. 2008(3):Cd006801. [
PubMed: 18646168]
- 17.
- 18.
- 19.
- 20.
- 21.
Liberati
A, Altman
DG, Tetzlaff
J, Mulrow
C, Gotzsche
PC, Ioannidis
JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.
J Clin Epidemiol. 2009;62(10):e1–e34. [
PubMed: 19631507]
- 22.
Rasenberg
N, Riel
H, Rathleff
MS, Bierma-Zeinstra
SMA, van Middelkoop
M. Efficacy of foot orthoses for the treatment of plantar heel pain: a systematic review and meta-analysis.
Br J Sports Med. 2018;52(16):1040–1046. [
PubMed: 29555795]
- 23.
Whittaker
GA, Munteanu
SE, Menz
HB, Tan
JM, Rabusin
CL, Landorf
KB. Foot orthoses for plantar heel pain: a systematic review and meta-analysis.
Br J Sports Med. 2018;52(5):322–328. [
PubMed: 28935689]
- 24.
Xu
R, Wang
Z, Ma
T, Ren
Z, Jin
H. Effect of 3D printing individualized ankle-foot orthosis on plantar biomechanics and pain in patients with plantar fasciitis: A randomized controlled trial.
Med Sci Monit. 2019;25:1392–1400. [
PMC free article: PMC6394143] [
PubMed: 30789873]
- 25.
Ring
K, Otter
S. Clinical efficacy and cost-effectiveness of bespoke and prefabricated foot orthoses for plantar heel pain: a prospective cohort study.
Musculoskeletal care. 2014;12(1):1–10. [
PubMed: 23801649]
- 26.
Furlan
AD, Pennick
V, Bombardier
C, van Tulder
M. 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group.
Spine. 2009;34(18):1929–1941. [
PubMed: 19680101]
Appendix 1. Selection of Included Studies
Appendix 2. Characteristics of Included Studies
Table 2Characteristics of Included Systematic Reviews
View in own window
First Author, Publication Year, Country, Funding | Objectives, Types and Numbers of Primary Studies Included, Quality Assessment Tool, Databases and Search Date | Patient Characteristics | Types of Comparisons, Treatment Setting, Duration of Treatment | Outcomes |
---|
Rasenberg et al., 201822 The Netherlands Funding: None | Objective: To investigate the effects of different orthoses on pain, function and self-reported recovery in patients with plantar heel pain Total 20 RCTs; 5 RCTs (n = 449) comparing custom-made versus prefabricated orthoses Quality assessment tool: Cochrane Back Review Group Databases: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL Search date: Since inception to January 2017 | Adult patients with clinical diagnosis of plantar heel pain Mean age: 44 to 49 years % Female: 63 to 75 Duration of pain: < 1 year | Customized (n = 226) Prefabricated (n = 223) Setting: Clinics for podiatric care Treatment duration: 2 weeks to 12 months |
- –
Pain (VAS, SFMPQ, FFI subscale, FHSQ subscale) - –
Function (FFI total, FHSQ) - –
Self-reported recovery (Likert)
|
Whittaker et al., 201823 Australia Funding: Public | Objective: To investigate the effectiveness of foot orthoses for pain and function in adults with plantar heel pain Total 19 RCTs; 4 RCTs (n = 413) comparing custom-made versus prefabricated orthoses Quality assessment tool: Cochrane Risk of Bias Outcome level assessment: GRADE approach Databases: Medline, CINAHL, SPORTDiscus, EMBASE, Cochrane Library Search date: Since inception to 14 July 2016. Search was updated on 26 June 2017 | Adult patients with clinical diagnosis of plantar heel pain Mean age: 47.3 to 49.6 years % Female: 63 to 76 Duration of pain: NR | Customized (n = 214) Prefabricated (n = 199) Setting: Clinics for podiatric care Treatment duration: 2 weeks to 12 months |
- –
Pain (VAS, FFI subscale, FHSQ subscale) - –
Function (FFI total, FHSQ)
|
FFI = Foot Functional Index; FHSQ = Foot Health Status Questionnaire; GRADE = Grading Recommendations Assessment, Development and Evaluation; NR = not reported; SFMPQ = the Short Form McGill Pain Questionnaire; VAS = Visual Analogue Scale
Table 3Characteristics of Included Primary Studies
View in own window
First Author, Publication Year, Country, Funding | Study Design and Analysis | Patient Characteristics | Interventions | Comparators | Outcomes |
---|
Xu et al., 201924 China Funding: NR | Single-blinded, parallel RCT Single-centre ITT analysis: NR Sample size calculation: No Statistical analysis: Appropriate | Adult patients with bilateral plantar fasciitis Mean age: 41.4 years (range: 31 to 60) Mean BMI: 26.1 kg/m2 (range: 15.9 to 28.3) % Female: 50 | Customized 3-D printed foot orthosis (n = 30) Treatment duration: 8 weeks | Prefabricated foot orthosis (n = 30) Treatment duration: 8 weeks | Comfort (VAS) |
Ring and Otter 201425 UK Funding: NR | Prospective cohort study Single-centre Sample size calculation: Yes Statistical analysis: Appropriate ITT analysis: No | Adult patients with clinical diagnosis of plantar heel pain Mean age: 48 years (range: 27 to 63) Mean BMI: 26.2 kg/m2 (range: 22 to 28.75) % Female: 61 | Casted foot orthosis (n = 35) Treatment duration: 8 weeks | Prefabricated foot orthosis (n = 34) Treatment duration: 8 weeks | Foot pain and disability (MFPDQ)
- –
Functional limitation - –
Pain intensity - –
Personal appearance
Participation satisfactionAdverse effects |
BMI = body mass index; ITT = intention-to-treat; MFPDQ = the Manchester Foot Pain Disability Questionnaire; NR = not reported; VAS = Visual analogue Scale
Appendix 3. Quality Assessment of Included Studies
Table 4Quality Assessment of Systematic Reviews
View in own window
AMSTAR 2 Checklist18 | Rasenberg et al., 201822 | Whittaker et al., 201823 |
---|
1. Did the research questions and inclusion criteria for the review include the components of PICO? | Yes | Yes |
2. Did the report of the review contain an explicit statement that the review methods were established prior to the conduct of the review and did the report justify any significant deviations from the protocol? | Yes | No |
3. Did the review authors explain their selection of the study designs for inclusion in the review? | Yes | Yes |
4. Did the review authors use a comprehensive literature search strategy? | Yes | Yes |
5. Did the review authors perform study selection in duplicate? | Yes | Yes |
6. Did the review authors perform data extraction in duplicate? | Yes | Yes |
7. Did the review authors provide a list of excluded studies and justify the exclusions? | No | No |
8. Did the review authors describe the included studies in adequate detail? | Yes | Yes |
9. Did the review authors use a satisfactory technique for assessing the risk of bias (RoB) in individual studies that were included in the review? | Yes | Yes |
10. Did the review authors report on the sources of funding for the studies included in the review? | No | No |
11. If meta-analysis was performed did the review authors use appropriate methods for statistical combination of results? | Yes | Yes |
12. If meta-analysis was performed, did the review authors assess the potential impact of RoB in individual studies on the results of the meta-analysis or other evidence synthesis? | No | No |
13. Did the review authors account for RoB in individual studies when interpreting/discussing the results of the review? | Yes | Yes |
14. Did the review authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in the results of the review? | Yes | Yes |
15. If they performed quantitative synthesis did the review authors carry out an adequate investigation of publication bias (small study bias) and discuss its likely impact on the results of the review? | NA | NA |
16. Did the review authors report any potential sources of conflict of interest, including any funding they received for conducting the review? | Yes | Yes |
AMSTAR = Assessing the Methodological Quality of Systematic Reviews; NA = not applicable; PICO = Population, Intervention, Comparator, and Outcome
Table 5Quality Assessment of Randomized Controlled Trials
View in own window
JBI Critical Appraisal Checklist for RCT19 | Xu et al., 201924 |
---|
1. Was true randomization used for assignment of participants to treatment groups? | Yes |
2. Was allocation to treatment groups concealed? | Yes |
3. Were treatment groups similar at the baseline? | Yes |
4. Were participants blind to treatment assignment? | No |
5. Were those delivering treatment blind to treatment assignment? | No |
6. Were outcomes assessors blind to treatment assignment? | Yes |
7. Were treatment groups treated identically other than the intervention of interest? | Yes |
8. Was follow up complete and if not, were differences between groups in terms of their follow up adequately described and analyzed? | Yes |
9. Were participants analyzed in the groups to which they were randomized? | Yes |
10. Were outcomes measured in the same way for treatment groups? | Yes |
11. Were outcomes measured in a reliable way? | Yes |
12. Was appropriate statistical analysis used? | Yes |
13. Was the trial design appropriate, and any deviations from the standard RCT design (individual randomization, parallel groups) accounted for in the conduct and analysis of the trial? | Yes |
JBI = Joanna Briggs Institute; RCT = randomized controlled trial
Table 6Quality Assessment of Non-Randomized Studies
View in own window
JBI Critical Appraisal Checklist for Non-Randomized Studies20 | Ring and Otter, 201425 |
---|
1. Is it clear in the study what is the ‘cause’ and what is the ‘effect’ (i.e. there is no confusion about which variable comes first)? | Yes |
2. Were the participants included in any comparisons similar? | NR |
3. Were the participants included in any comparisons receiving similar treatment/care, other than the exposure or intervention of interest? | Yes |
4. Was there a control group? | Yes |
5. Were there multiple measurements of the outcome both pre and post the intervention/exposure? | Yes |
6. Was follow up complete and if not, were differences between groups in terms of their follow up adequately described and analyzed? | Yes |
7. Were the outcomes of participants included in any comparisons measured in the same way? | Yes |
8. Were outcomes measured in a reliable way? | Yes |
9. Was appropriate statistical analysis used? | Yes |
Appendix 4. Main Study Findings and Author’s Conclusions
Table 7Summary of Findings of Systematic Reviews
View in own window
Main Study Findings | Author’s Conclusions |
---|
Rasenberg et al., 201822 |
---|
Prefabricated Foot Orthoses versus Customized Foot Orthoses Pain
- –
Short-term (8 to 12 weeks; 5 RCTs [1 moderate ROB, 1 high ROB], n = 449; 3 low ROB,) SMD (95% CI) = 0.03 (-0.15 to 0.22); I2 = 0%; P = 0.73 - –
Long-term (12 months; 1 RCT [low ROB], n = 88) MD (95% CI) = 2.30 (-5.60 to 10.10)
Function
- –
Short-term (8 to 12 weeks; 2 RCTs [low ROB], n = 194) SMD (95% CI) = -0.17 (-0.45 to 0.12); I2 = 0%; P = 0.25 - –
Long-term (12 months; 1 RCT [low ROB], n = 88) MD (95% CI) = 1.20 (-6.10 to 8.50)
Self-reported recovery
- –
Short-term (8 weeks; 1 RCT [moderate ROB], n = 76) OR (95% CI) = 2.03 (1.35 to 3.06)
| “There was no difference in improvement in pain or function between prefabricated, custom-made and sham orthoses in the treatment of patients with plantar heel pain.”22 p. 7 |
Whittaker et al., 201823 |
---|
Customized Foot Orthoses versus Prefabricated Foot Orthoses Pain
- –
Short-term (0 to 6 weeks; 2 RCTs, n = 190) SMD (95% CI) = -0.04 (-0.33 to 0.24); I2 = 0%; P = 0.76 Quality of evidencea: Very low - –
Medium-term (7 to 12 weeks; 4 RCTs, n = 413) SMD (95% CI) = -0.07 (-0.26 to 0.12); I2 = 0%; P = 0.48 Quality of evidencea: Low - –
Long-term (52 weeks; 1 RCT, n = 90) MD (95% CI) = 0.04 (-0.38 to 0.45); P = 0.87 Quality of evidence: Very low
Function
- –
Medium-term (7 to 12 weeks; 2 RCTs, n = 121) SMD (95% CI) = -0.06 (-0.39 to 0.27); I2 = 0%; P = 0.71 Quality of evidencea: Low
| “This review found no difference between customized and prefabricated foot orthoses for pain or function from very-low quality evidence to low quality evidence. As such, health practitioners may considered using prefabricated foot orthoses that are appropriately contoured to the foot rather than customized foot orthoses, as they may be less expensive.”23 p. 7 |
CI = confidence interval; GRADE = Grading Recommendations Assessment, Development and Evaluation; MD = mean difference; OR = odds ratio; RCT = randomized controlled trial; ROB = risk of bias; RR = risk ratio; SMD = standardized mean difference
- a
Quality of evidence was assessed by the authors using GRADE
Table 8Summary of Findings of Included Primary Studies
View in own window
Main Study Findings | Author’s Conclusions |
---|
Xu et al., 201924 |
---|
Customized 3-D Printed Foot Orthoses versus Prefabricated Foot Orthoses
Comfort scorea
- –
At week 0: 7.34 ± 3.43 versus 8.72 ± 3.93; P > 0.05 - –
At week 8: 3.12 ± 0.51 versus 5.25 ± 1.22; P < 0.05
| “This study supports the efficiency of customized 3D printing foot orthosis for reducing damage associated with plantar lesions an improving comfort in patients with plantar fasciitis compared with prefabricated foot orthosis.”24 p. 1392 |
Ring and Otter, 201425 |
---|
Casted Foot Orthoses versus Prefabricated Foot Orthoses
Foot pain and disability (MFPDQ score)
- –
At baseline: 20.5 ± 8.85 versus 20.4 ± 6.8; P = 0.462 - –
At week 8: 2.2 ± 3.9 versus 3.2 ± 5.66; P = 0.839
Participant satisfaction (mean scores)
- –
Ease of use: 7.3 versus 7.9 - –
Comfort: 7.4 versus 7.6 - –
Hygiene: 7.4 versus 7.8 - –
Satisfaction: 8.1 versus 8.3
Adverse effects: Not identified | “For most patients with plantar heel pain, prefabricated semi-rigid insoles such as Powerstep™ devices used in the present trial provide short-term benefit equivalent to that of bespoke, casted foot orthoses, but at considerably reduced costs.”25 p. 1 |
- a
10-cm VAS score: 0 indicates no discomfort and 10 indicated the highest level of discomfort
MFPDQ = = the Manchester Foot Pain Disability Questionnaire; VAS = Visual analogue Scale
About the Series
CADTH Rapid Response Report: Summary with Critical Appraisal
Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
Suggested citation:
Custom-Made Foot Orthoses versus Prefabricated Foot Orthoses: A Review of Clinical Effectiveness and Cost-Effectiveness. Ottawa: CADTH; 2019 Sep. (CADTH rapid response report: summary with critical appraisal).
Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.
While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.
CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials.
This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites.
Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third party supplier of information.
This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user’s own risk.
This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.