Abstract
Background
Conservative treatment is the first therapeutical option for central heads metatarsalgia, a common foot condition. However, to our best knowledge, systematic review and meta-analysis of its effectiveness in terms of plantar pressure improvement have not been yet carried out. Our aim was to answer the following research question: Is bespoke or customized orthotic treatment effective for plantar pressure reduction in patients with mechanical metatarsalgia in the central metatarsal heads?
Methods
A systematic review and meta-analysis of the effectiveness of bespoke or customised orthotic treatment in terms of plantar pressure reduction beneath the central –2nd to 4th - metatarsal heads in mechanical metatarsalgia patients were carried out. Pubmed database was searched from September to November 2022. All type of related-topic studies were included. Cochrane Collaboration tool was used to assess the risk of bias of each study. Descriptive and frequency analyses were performed with SPSS 25.0 software. Review Manager v5.4.1 software was used to analyse the data using the inverse variance method for continuous outcomes according to a fixed or random effects model.
Results
A total of 5 studies met our inclusion criteria, with 158 participants. Bespoke or customised orthotic treatment is effective for the improvement of plantar pressure under 2nd to 4th metatarsal heads in mechanical metatarsalgia patients (MD -37.54 [95 % CI -65.84, −9.24], p = 0.009). Customised orthotic treatment is more effective than no treatment in terms of reducing plantar pressure (MD -78.63 [95 % CI -119.70, −39.16], p = 0.0002), but its effectiveness is similar to standardised footwear, standardised foot orthoses and isolated metatarsal domes.
Conclusions
We found conservative bespoke or customised orthotic treatment to be effective for the improvement of plantar pressure under the central metatarsal heads.
Keywords: Metatarsalgia, Conservative treatment, Foot orthosis, Plantar pressure, Forefoot, Orthopaedics
1. Introduction
Metatarsalgia is defined as the presence of pain in the metatarsal heads. Metatarsal pain has a negative impact on patients’ quality of life.1, 2, 3, 4, 5 Mechanical metatarsalgia of the 2nd–4th metatarsals (also referred as central metatarsalgia) is a common reason for consultation. Estimates indicate that approximately 80 % of the general population will suffer from central metatarsalgia at some point in their lifetime.6
Pain under the first metatarsal head (MTH) is often considered in the literature as a different form of metatarsalgia, with its own etiology and symptoms. Therapeutic research is frequently focused either on first metatarsal alterations or on the pathology of other metatarsals. Although first ray pathology has a close etiological relationship with the development of central metatarsalgia.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
Forefoot pain is secondary to biomechanical or non-mechanical disorders (such as rheumatoid arthritis, diabetes mellitus). Mechanical central metatarsalgia is the result of overload in the forefoot during gait and increased plantar pressure (PP) under 2nd, 3rd or 4th MTH, secondary to structural and functional alterations.3,10,12, 13, 14 During the mid-stance phase of the gait cycle, when the foot is plantigrade, the metatarsal bones are exposed to vertical ground reaction forces. Subsequently, during the push-off phase, the metatarsophalangeal joints reach their maximum extension range and the MTH are also under traction forces.3,7, 8, 9, 10, 11
As confirmed by international clinical practice (ICP) guidelines, non-surgical treatment represents the first therapeutic option for central metatarsalgia.3,15,16 The effects of orthotic treatment aim to redistribute PP in the forefoot, reducing overload on the central MTH and consequently decreasing pain17, 18, 19. Nowadays, a wide variety of conservative treatment options are available, including plantar orthoses, metatarsal domes,20, 21, 22, 23 cushioning metatarsal pads,19, 20, 21, 22, 23, 24, 25 toe taping,26, 27, 28 and footwear modifications.29, 30, 31 In addition, pharmacological treatment, can be used as adjunctive therapy.20,31
A previous systematic review has demonstrated that the use of custom-made foot orthoses improves the level of forefoot pain in rheumatoid arthritis (RA), Hallux Abductus
Valgus (HAV) and secondary central metatarsalgia.32 Nevertheless, we are not aware of any specific systematic review using meta-analyses that has investigated the efficacy of bespoke or customised orthotic treatment in 2nd, 3rd or 4th MTH mechanical metatarsalgia. Therefore, we questioned: (1) Is bespoke or customised orthotic treatment effective for plantar pressure reduction in patients with mechanical metatarsalgia in central MTH?
2. Methods
The current systematic review and meta-analysis was conducted in accordance with the general guidelines put forth by: Quality of Reporting of Meta-analyses (QUORUM),33 the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocol (PRISMA) statements.34
Details of the protocol were registered on PROSPERO (ID: CRD42022376095) and can be accessed at https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=376095.
In accordance with Spanish legislation due to the characteristics of the study, ethics committee approval was not required.
2.1. Search strategy
A systematic search of Pubmed database was conducted from 1 September to 1 November 2022. The following search strategies were used: (1) “metatarsalgia AND treatment AND conservative”; (2) “metatarsalgia AND shoe wear”; (3) “metatarsalgia AND foot orthosis”; and (4) “metatarsophalangeal instability AND conservative treatment”.
2.2. Eligibility assessment
Title and abstracts of potentially relevant articles were independently screened by two reviewers. Then, the two reviewers independently assessed the full text of all retrieved studies for eligibility. Eligibility assessment was based on three criteria: (1) patient characteristics, (2) outcomes, and (3) interventions. A third reviewer resolved any discrepancies between the two reviewers.
2.3. Article selection
Inclusion and exclusion criteria for article selection are detailed in Table 1. Article selection was based on the following PICO strategy:
-
-
P (patients): Patients reporting central metatarsal head pain during gait, with a diagnosis of mechanical metatarsalgia, regardless of gender, age, or race.
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I (intervention): Orthotic treatment of mechanical central metatarsalgia. Any custom orthotic device was considered as an intervention, including bespoke or customised foot orthoses, modified footwear, metatarsal domes, and/or cushioning materials placed specifically for the patients' foot characteristics.
-
-
C (comparison): No intervention or placebo treatment was considered a control group.
-
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O (outcome): The reduction in peak plantar pressure (measured in kPa) at the central metatarsal heads, whether the recording was taken on a pressure platform or with an in-shoe pressure measurement system, was considered the main outcome measure.
Table 1.
Articles inclusion and exclusion criteria.
| Inclusion criteria | Exclusion criteria |
|---|---|
| Any prospective or retrospective clinical study. | Patients with a previous diagnosis of non-mechanical metatarsalgia (such as Morton's neuroma, Freiberg's disease) |
| Patients who had a systemic disease that could influence the onset of pain (such as RA, gout). | |
| Articles published in English or Spanish. | Treatment was aimed at treating pain in areas of the forefoot other than the central metatarsals (such as HAV). |
| Publication date: from inception to 1 January 2022. | Orthopaedic treatment was combined with another treatment modality (surgical or pharmacological). |
A wide range of treatments were included as placebo treatment and considered as a comparison. All of the mentioned placebo treatments were either not customised or less personalised than the intervention to which they were compared. Foot orthoses were considered as control when they consisted of a flat insole without any modification or when they incorporated standardised elements, such as a standard metatarsal dome and/or a standard medial longitudinal arch. Custom-made foot orthosis with no specific forefoot elements were also considered as placebo treatments. Footwear was considered as a control when it consisted of a standardised shoe without any therapeutic modifications.
Following the above-described strategy, we included original studies reporting on the population of interest, at least one of the predefined interventions, and a critically important outcome.
2.4. Data extraction
The following outcomes were collected from each study: (1) type of study; (2) demographics (number of subjects, age, and sex); (3) type of control; (4) number and type of interventions; and (5) outcomes of interventions reflected as a reduction in PP.
For a full data analysis, in those cases when a study included two or more separate interventions, their outcomes were crossed separately, as long as one of them could be considered as a control group.
The primary outcome of this study was the effective clinical rate, categorised as effective or ineffective according to the variations in PP before and after conservative orthopaedic treatment. A reduction in PP rates (when PP after treatment is lower than the initial PP) was considered an improvement.
2.5. Assessment of quality of evidence and risk of bias
The selected studies were registered and classified according to the levels of evidence and grades of recommendation given by the Oxford Centre for Evidence-Based Medicine (OCEBM).35
The risk of bias was estimated independently by two experienced reviewers using the Cochrane Collaboration tool.36
2.6. Assessment of missing data
For missing values, we attempted to contact the authors to obtain the data. If data were still missing despite our best efforts to obtain them, the article was eventually excluded. We did not perform any analysis or calculate estimates to extract any missing data. Therefore, the data included in the meta-analysis only consisted of the original data reported in the articles.
2.7. Statistical analysis
Descriptive and frequency analyses were performed with SPSS (IBM Corp. Released 2017. IBM SPSS Statistics for Macintosh, Version 25.0. Armonk, NY, USA: IBM Corp.).
Then, studies reporting similar outcomes were combined for meta-analysis. The meta-analysis was conducted in subgroups differentiated by the control group, while the intervention was held constant.
Data were analysed using Review Manager v5.4.1 software (http://ims.cochrane.org/revman), using the inverse variance method for continuous outcomes according to a fixed or random effects model.
Estimates of intervention effects are expressed as mean differences (MD) at 95 % confidence interval (95 % CI). Heterogeneity was estimated clinically and methodologically, and when the Higgins I2 exceeded 50 %, and a random-effects model was used.36,37
The significance of any discrepancies in treatment effect estimates was assessed using the Cochrane test for heterogeneity and the I2 statistic.
3. Results
3.1. Literature search
Fig. 1 shows the PRISMA flowchart. Initial search strategies identified 145 non-duplicate articles. Then, the title and abstract review excluded 114 articles. Twenty-four additional articles were excluded following their full-text analysis. A total of five articles were finally included.
Fig. 1.
PRISMA flow chart of the literature search and article selection for the systematic review of orthopaedic conservative treatment of metatarsalgia.
3.2. Study characteristics
Among the included studies, one was a randomised controlled clinical trial (RCT),30 one was a clinical trial (CT),39 one was a prospective observational study,40 and two were cross-sectional studies.21,41
All studies were published between 1998 and 2020. The selected articles included 158 participants, with a mean of 31 (±9.5) participants per study. The gender distribution was 3.9:1 with a total of 126 female and 32 male participants. The mean age of participants was 62.1 (±20.23, range 19–88.5) years. The mean follow-up time in the prospective studies was 1.9 (±1.14; range 0.71–3) weeks.
3.3. Quality of evidence and risk of bias assessment
Individual levels of evidence and grades of recommendation according to OCEBM35 can be found in Table 2.
Table 2.
Level of evidence and grade of recommendation for central head metatarsalgia orthopaedic conservative treatment studies included.
Fig. 2, Fig. 3 summarise the risk of bias assessment of the included articles.
Fig. 2.
Risk of bias graph: authors' judgements on each element of risk of bias presented as percentages across all included studies.
Fig. 3.
Review authors' judgement on each risk of bias item for each included study. Red: high risk of bias; Yellow: uncertain risk of bias; Green: low risk of bias.
Most of the included articles showed an unclear risk of realisation bias and detection bias, related to blinding of participants, staff and outcome. Attrition and reporting bias showed a low risk in all included articles. Chang et al.39 reported a high risk of selection bias (randomisation and allocation) for their article.
3.4. Outcome measures
A total of 25 comparisons were extracted from the studies by cross-checking the outcome of the interventions when they could be considered as a control group, for the full data analysis. The total number of patients included in the meta-analysis was 802.
The number of patients included in each study, type of intervention, and percentage reduction in pain are shown in Table 3.
Table 3.
Characteristics of the orthopaedic conservative treatment studies included in this review. ∗Reduction in plantar pressure expressed as percentage of mean differences.
| Author, year | Nº of participants | Control | Intervention | Type of treatment | Plantar pressure reduction (%)∗ |
|---|---|---|---|---|---|
| Postema, 199830 | 31 | No treatment; Isolated metatarsal dome; Standardised foot orthosis |
|
Arm 1: Isolated metatarsal dome. Arms 2 and 3: Foot orthosis |
Control Vs. Arm 1: -6,00 % Control Vs. Arm 2: 0,20 % Control Vs. Arm 3: -6,50 % Arm 1 Vs. Arm 2: 6,20 % Arm 1 Vs. Arm 3: -0,50 % Arm 2 Vs. Arm 3: -6,70 % |
| Schuh, 201440 | 42 | Standardised shoewear |
|
Shoewear | Control Vs. Arm 1: 0,27 % Control Vs. Arm 2: 0,46 % Arm 1 Vs. Arm 2: 0,19 % |
| Chang, 201439 | 21 | Standardised shoewear; Standardised foot orthosis |
|
Arm 1: Cushioning material Arm 2 and 3: Foot orthosis |
Control Vs. Arm 1: -16,99 % Control Vs. Arm 2: -16,76 % Control Vs. Arm 3: -17,15 % Arm 1 Vs. Arm 2: 0,23 % Arm 1 Vs. Arm 3: -0,16 % Arm 2 Vs. Arm 3: -0,38 % |
| Lee, 201441 | 37 | Standardised shoewear |
|
Arms 1- 3: Isolated metatarsal dome. Arm 4: Cushioning material. |
Control Vs. Arm 1: 2,57 % Control Vs. Arm 2: -0,71 % Control Vs. Arm 3: 1,92 % Control VS. Arm 4: - 1,70 % |
| Landorf, 202021 | 36 | No treatment |
|
Isolated metatarsal dome | Control Vs. Arm 1: -4,09 % Control Vs. Arm 2: -3,76 % Control Vs. Arm 3: -2,38 % Control Vs. Arm 4: -13,16 % Control Vs. Arm 5: -3,18 % Control Vs. Arm 6: - 2,03 % |
A meta-analysis of these data estimated the pooled mean difference to be −37.54 (95 % CI –65.84–[–9.24]) in favour of orthopaedic conservative treatment, with high heterogeneity (x2 = 773.97, df = 24, p < 0.00001, I2 = 97 %). As shown in Fig. 4, a statistically significant difference was observed between the groups.
Fig. 4.
Forest plot of metatarsalgia orthopaedic conservative treatment versus control (no treatment, standardised shoewear, standardised foot orthosis and isolated metatarsal dome). Bold text: overall outcomes per subgroups. Green square: Mean difference for each study (measure of effect of each study).
A pooled analysis of the data when divided into subgroups differentiated by the control group showed that interventions reduced PP statistically significantly compared to no treatment (MD –78.63 [95 % CI –119.70– [–39.16]), despite high heterogeneity (x2 = 218.10, df = 11, p < 0.00001, I2 = 95 %) as shown in Fig. 4.
4. Discussion
This systematic review and meta-analysis demonstrated that bespoke or customised orthotic treatment central mechanical metatarsalgia is effective in terms of plantar pressure improvement. However, interventions showed no difference in producing a decrease in PP of the central metatarsal heads when compared with standard footwear or foot orthoses and isolated metatarsal dome although a large heterogeneity between all groups existed.
In an overall analysis, the interventions led to a reduction in PP rates compared to the control (MD –37.54 [95 % CI –65.84–{–9.24}]); p = 0.009). However, they showed high heterogeneity with an I2 statistic value of 97 %. This high heterogeneity could be a consequence of the different materials and design of the treatments considered as interventions.
Subgroup analysis showed that conservative orthopaedic treatment for central metatarsalgia was more effective than no treatment (MD –78.63 [95 % CI –119.70– {-} 39.16]; p = 0.0002) in terms of PP improvement. This subgroup analysis included the largest number of comparisons, summing up to 12 comparisons (372 patients) extracted from three studies.21,30,39
Cushioning under the central MTH produced a reduction in PP by 16.99 %.38 According to Chang et al.,39 a decrease of 16.70 % in peak PP was achieved with standard insoles and it decreased up to 17.15 % with customized foot orthoses when compared with peak PP registered under central MTH that remained without specific treatment. Both types of insoles were manufactured in a combination of low and medium hardness (ranging from 15 to 40 Shore A hardness) materials widely used in orthopaedics.39
In cases when a metatarsal dome was included in the design of the foot orthosis, a reduction of 2 % was achieved with the standardised orthosis and 6.5 % with the customised ones compared to the control group, respectively. As described by Postema et al.,30 the materials used to fabricate both types of insoles were similar and both incorporated a metatarsal dome placed immediately proximal to the MTH and with it maximum height (5 mm) under the second and third MTH. Both insoles were manufactured according to the foot shape and, the custom-made ones, included a 25 mm heel elevation.30
When compared with no treatment, isolated metatarsal domes or bars directly placed in the patient's shoe also reduced PP under the central MTH. The maximum reduction in PP (13.16 %) with an isolated metatarsal dome was achieved when it consisted of a teardrop-shaped dome placed 5 mm proximal to the painful MTH. The mentioned dome was made of a soft material (20 shore A hardness) and its maximum height was 6 mm, as reported by Landorf et al.21
According to the results of this subgroup, the higher effectiveness of the interventions compared to the control treatment is related to the use of soft or medium hardness materials39 and the position of the metatarsal dome proximal to the metatarsal heads.21
The remaining comparisons showed that customised orthotic treatment did not appear to be more effective in reducing peak PP below the central MTH when compared to standardised footwear (MD 3.67 [95 % CI –-15.86–{–}23.20]; p = 0.71) bespoke orthotic treatment (MD –1.93 [95 % CI –9.23–5.37]; p = 0.60) or isolated metatarsal domes (MD 25.80 [95 % CI –39.65–{–91.34}]; p = 0.44).
Among the included studies, two evaluated bespoke or customised orthotic treatment versus standardised footwear, allowing up to seven comparisons in 274 patients with central metatarsalgia. The results of Lee et al.41 showed a 0.71 % reduction in PP when a metatarsal dome was placed 5 mm distal to the central MTH and a 1.7 % reduction when it was placed directly under them. Despite the lack of statistical significance, we believe that this improvement may be due to the cushioning properties of the employed materials41 rather than their position itself. On the other hand, Schuh et al.40 used custom-made sandals as an intervention, not reporting reductions in PP in any of the comparisons made. The sole of the sandals was modelled in Ethyl Vinyl Acetate (EVA) to the foot and a metatarsal bar was added. The authors did not specify the thickness or hardness.40 The overall results of the subgroups could be explained by the heterogeneity of the treatments included in the intervention group.
Although PP improvement rates favoured customised orthotic treatment conservative orthopaedic treatment of central metatarsalgia, with MD –1.93 (95 % CI –9.23–[–5.37]), no statistically significant differences were observed when standardised foot orthoses were considered as control. The absence of statistically significant results can be explained by the heterogeneity of the insole treatments, regarding variations in their hardness, thickness, fabrication, and fitting.30,39 According to the results of this subgroup, interventions based on custom-made or personalised orthotics showed no greater effectiveness than standarized orthoses.
Regarding the level of evidence and the grade of recommendation of the included studies, their quality is generally poor. Up to 80 % (4/5) of the included articles are observational or quasi-experimental, with levels of evidence Ib (20 %),30 II (40 %),39,40 III (40 %)21,41 and grades of recommendation A (20 %),30 B (40 %),39,40 and C (40 %).21,41 As a result, the outcomes of our analysis may have limited validity.
Previous related research by Arias-Marin et al.32 showed forefoot pain improvement within the use of customized foot orthoses in RA, HAV and secondary metatarsalgia.32 We chose to relate the effectiveness of the treatment to the reduction in PP instead of pain. Furthermore, we only considered as intervention the orthopaedic treatment, excluding all studies in which it was combined with other therapeutic options. Our aim was to provide specific results of the effectiveness of the isolated conservative orthopaedic treatment. Moreover, we focused in central mechanical metatarsalgia, excluding studies in which participants were previously diagnosed with any other systematic condition that could have an influence in pain development or perception. Despite the methodological differences, our results are consistent to show the improvement in common forefoot conditions with conservative orthopaedic interventions.32
To our knowledge, this study is the first systematic review and meta-analysis that specifically evaluates the effectiveness of bespoke or customised orthotic treatments and other orthotic conservative interventions for central MTH metatarsalgia in terms of PP improvement. Therefore, it is not possible to make comparisons with previous similar studies.
This systematic review and meta-analysis has some limitations that should be taken into account. First of all, most of the included studies are not homogeneous in terms of study design, treatment arms, or follow-up time. The characteristics of the orthopaedic treatment itself make blinding of participants difficult; most of the included studies did not blind patients or investigators. The great difficulty in blinding could bias the results and should be highlighted. It is also a limitation to our results the fact that the included studies do not establish a minimally clinical important difference (MCID) as a value of clinical significance, despite reporting significative differences in plantar pressures. A measure like MCID has proven to be useful for the assessment of clinical results so we suggest that future experimental studies regarding changes in plantar pressure establish an MCID as a measure of clinical relevance.42 Another important limitation is we evaluated the reduction of plantar pressures under central MTH, but our results do not take into account whether it is related with the reduction in pain and its secondary effects, such as a possible PP increase under the neighbour MTH. Finally, it is a limitation the lack of high quality RCTs related to this topic. In addition, the absence of certain data in the published studies precludes their inclusion. More data and higher quality studies could have increased the information provided by this systematic review and meta-analysis.
5. Conclusions
In conclusion, bespoke or customised orthotic treatment is effective for the improvement of plantar pressure under the central metatarsal heads. Bespoke or customised orthotic treatment is more effective than no treatment in terms of reducing plantar pressure, but its effectiveness is similar to standardised footwear, standardised foot orthoses, and isolated metatarsal domes.
Funding declaration
The authors declare no conflicts of interest.
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Guardian/Patient's consent
The current study consists of a Systematic Review and Metaanalysis.
Since the data was obtained thorough already published articles, not conducting any direct experimental research on humans or animals.
For this reason, there is no available a specific Informed Patient's or Guardian Consent document to be attached.
Ethical statement
The current study consists of a Systematic Review and Metaanalysis. Since the data was obtained thorough already published articles, not conducting any direct experimental research on humans or animals there is not an Ethics Committee approval Nevertheless, the present study is related to a larger investigation whose protocol was approved by Ethics Committee at Hospital Clínico San Carlos (Internal Code: 20/065-E).
Declaration of competing interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
CRediT authorship contribution statement
Maria Ruiz-Ramos: Conceptualization, Methodology, Software, Formal analysis, Investigation, Data curation, Writing – original draft, Writing – review & editing, Visualization. Ángel Manuel Orejana-García: Conceptualization, Methodology, Validation, Supervision, Project administration. Sara García-Oreja: Conceptualization, Methodology, Software, Formal analysis, Data curation, Visualization. Maria del Mar Calvo-Wright: Investigation, Data curation, Writing – review & editing. José Luis Lázaro-Martínez: Validation, Resources, Supervision, Project administration. Raúl Juan Molines-Barroso: Conceptualization, Methodology, Formal analysis, Writing – review & editing, Visualization, Project administration.
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