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Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  10. Supporting Information

Objective

To identify and critically appraise the evidence for the effectiveness of custom orthoses for the foot and ankle in rheumatoid arthritis.

Methods

Studies were identified in appropriate electronic databases (from 1950 to March 2011). The search term “rheumatoid arthritis” with “foot” and “ankle” and related terms were used in conjunction with “orthoses” and synonyms. Included studies were quantitative longitudinal studies and included randomized controlled trials (RCTs), case–control trials, cohort studies, and case series studies. All outcome measures were investigated. Quality assessment was conducted using the Cochrane Collaboration criteria with additional criteria for sample population representativeness, quality of statistical analysis, and compliant intervention use and presence of cointerventions. Meta-analyses were conducted for outcome domains with multiple RCTs. Qualitative data synthesis was conducted for the remaining outcome domains. Levels of evidence were then assigned to each outcome measure.

Results

The inclusion criteria were met by 17 studies. Two studies had high quality for internal validity and 3 studies had high quality for external validity. No study had high quality for both internal and external validity. Six outcome domains were identified. There was weak evidence for custom orthoses reducing pain and forefoot plantar pressures. Evidence was inconclusive for foot function, walking speed, gait parameters, and reducing hallux abductovalgus angle progression.

Conclusion

Custom orthoses may be beneficial in reducing pain and elevated forefoot plantar pressures in the rheumatoid foot and ankle. However, more definitive research is needed in this area.


INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  10. Supporting Information

Foot and ankle problems continue to be an issue for people with rheumatoid arthritis (RA) (1, 2). With the availability of new biologic agents to reduce overall disease activity, clinical remission is now achievable. However, persistent foot and ankle problems may still occur (3, 4). This greatly impacts people in regard to pain and functional ability, and ultimately, quality of life (5, 6). Consequently, orthoses are commonly used as an adjunct therapy (7). However, the evidence for the effectiveness of orthoses is lacking, as previously shown in other reviews (8, 9).

Although previous reviews have been conducted, they are now outdated and new randomized controlled trials (RCTs) have been completed since they were conducted. It is a recommendation of the Cochrane Collaboration that systematic reviews are updated biannually, and these previous reviews were completed more than 5 years ago (10). Another concern with the previous reviews is the quality assessment systems used to assess the literature. These did not include assessment of sample representativeness, appraisal of statistical analysis quality, or intervention compliance and presence of cointerventions. Therefore, the outdated nature and lack of quality of the previous reviews indicate the need for a more robust review.

The focus of this review will be on custom orthoses. This means the emphasis is on orthotic devices that are specifically made for the participants rather than orthotic devices that can be purchased over the counter. This emphasis is required because the effect of RA on the foot and ankle can be different for each individual person (11).

Therefore, the objective of this review was to identify and critically appraise the evidence for the effectiveness of custom orthoses for the foot and ankle in people with RA for all reported outcome measures.

Significance & Innovations

  • Weak level of evidence supported by meta-analysis for custom foot orthoses decreasing pain in the rheumatoid foot and ankle.

  • Weak level of evidence for custom foot orthoses decreasing forefoot plantar pressures in the rheumatoid foot and ankle.

MATERIALS AND METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  10. Supporting Information

Search strategy.

Studies were identified electronically in the following databases: Medline (1950 to March 2011), Embase (1979 to March 2011), CINAHL (1981 to March 2011), AMED (1987 to March 2011), PEDro (1990 to March 2011), and the Cochrane Library (1974 to March 2011). Studies were also identified by hand searching the reference lists of the electronically identified studies and the authors' own literature databases.

A 3-way search strategy was employed using “rheumatoid arthritis” with “foot” and “ankle” and related anatomic terms and with “orthoses” and related synonyms. Associated wildcards and truncations for each database were also used. The full search strategy is available in Supplementary Appendix A (available in the online version of this article at http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)2151-4658).

Study selection criteria.

Included studies were quantitative longitudinal studies of the following designs: RCTs, case–control trials, cohort studies, and case series studies. Single-case studies were excluded. No restrictions were imposed on language or year of publication.

Studies reporting patients with RA ages ≥18 years were included. Studies reporting any disease duration were included provided a definitive diagnosis of RA had been established, either according to the American College of Rheumatology revised criteria (12) or as confirmed by a rheumatologist. Additionally, studies that involved other rheumatologic conditions were included if RA subgroup data were reported separately, and mixed-age studies (adults and children) were included if adult subgroup data were reported separately.

Studies of all types of orthoses for the foot and ankle were selected for further analysis. No limitations were imposed on who provided the orthoses. All of the outcome measures were selected for further analysis. However, plantar pressure outcome parameters were limited to the forefoot only. This limitation was imposed because the forefoot is where pressure is usually highest due to an increased prevalence of metatarsophalangeal joint deformity in RA (13) and the interrelationship between rearfoot position and forefoot pressure in RA (14).

The abstracts of all of the studies found electronically and through hand searching were compared to the inclusion criteria. The selection of abstracts that appeared to meet the inclusion criteria was conducted by 2 independent reviewers (KH and MPMS). For the selected abstracts, full-text articles were obtained and compared to the inclusion criteria prior to quality assessment. Only full-text original research studies were included for quality assessment.

Quality assessment.

Study quality was assessed using criteria that looked at internal validity (i.e., how well an individual trial was conducted) and external validity (i.e., how representative the sample was of the target RA population) (15). The assessment criteria were adapted from the Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0, and included internal validity criteria of sequence generation; allocation concealment; blinding of participants, personnel, and outcome assessors; incomplete outcome data; and selective outcome reporting (10). Additional internal validity criteria were included to determine if the correct statistical analyses were conducted and to determine intervention compliance and the presence of cointerventions.

External validity criteria were added to determine the sample population representativeness of the general population with RA and to determine the restrictiveness of the inclusion and exclusion criteria. Quality assessment was performed by 2 independent reviewers (KH and MPMS). Any disagreement was resolved by a third independent reviewer (JW).

Data extraction/evidence grading.

For outcome measures that had multiple RCTs available, random-effects model meta-analyses were conducted using the standardized mean difference with the 95% confidence interval (95% CI; Review Manager, version 5.1, Cochrane Collaboration). For outcome measures that did not have multiple RCTs available, qualitative data synthesis was conducted. Following the analysis and synthesis of the extracted data, an evidence rating was assigned according to criteria adapted from Ariëns et al in 2000 (16) (Table 1). The interpretation of the findings was based on combining the meta-analyses/qualitative data synthesis and the evidence grading system.

Table 1. Strength of evidence criteria (16)
  • *

    Consistent findings are the agreement of ≥75% of studies.

StrongAt least 2 high-quality studies with consistent findings*
Moderate1 high-quality study and at least 2 low-quality studies with consistent findings*
WeakAt least 2 low-quality studies with consistent findings*
InconclusiveInsufficient or conflicting studies

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  10. Supporting Information

A total of 268 articles were retrieved using the detailed search strategy. Figure 1 outlines the flow chart used to identify studies for inclusion (17). The inclusion criteria were met by 17 studies and each included study is described in Table 2. Two studies had high quality for internal validity and 15 had low quality for internal validity. Three studies had high quality for external validity and 14 had low quality for external validity. No study had high quality for both internal and external validity (Table 3). Six outcome domains were identified from the included studies, consisting of pain, foot function, walking speed, forefoot plantar pressure, gait parameters, and hallux abductovalgus (HAV) angle progression.

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Figure 1. Flow chart of literature search for custom orthoses in rheumatoid arthritis. * = multiple outcome measures meant some trials were used for meta-analysis and qualitative studies. Adapted from ref.17.

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Table 2. Descriptions of included studies*
Author, year (ref.)Study typeParticipant descriptionEntered/ completed study, no.Followup periodInterventionOutcome measures
  • *

    RCT = randomized controlled trial; RA = rheumatoid arthritis; HAV = hallux abductovalgus; MTP = metatarsophalangeal; FFI = Foot Function Index; DAS28 = Disease Activity Score in 28 joints; ST = subtalar; TN = talonavicular; ROM = range of motion; MT = midtarsal; UCBL = University of California Biomechanics Laboratory.

  • Repeat-measures design.

Budiman-Mak et al, 1995 (18)RCTDefinitive RA diagnosis Age 18–75 years Foot pain Radiologic changes, stage  I/II in feet Active disease Flexible functional discrepancies102/883 yearsFunctional foot orthoses Placebo orthosesHAV angle
Chalmers et al, 2000 (19)RCTDefinitive RA diagnosis Age ≥18 years Minimum 2 subluxed MTP joints bilaterally MTP joint pain28/2412 weeksSemirigid orthoses (in  supportive shoes) Soft orthoses (in  supportive shoes) Supportive shoesPain 50-foot walking  test Foot function
Cho et al, 2009 (20)RCTDefinitive RA diagnosis Stable disease Foot pathology Independent walking42/346 monthsCustom semirigid orthoses (in extra-depth forefoot rocker shoes) Ready-made simple soft  insoles (in extra-depth  forefoot rocker shoes)Pain FFI
Conrad et al, 1996 (21)RCTDefinitive RA diagnosis Age 18–75 years Foot pain Radiologic changes, stage  I/II in feet Active disease Flexible functional discrepancies102/883 yearsFunctional foot orthoses Placebo orthosesPain FFI
Mejjad et al, 2004 (22)RCTDefinitive RA diagnosis Age 18–80 years Forefoot pain only No midfoot or hindfoot involvement16/161 monthCustom orthoses (palliative) No orthosesPain Walking speed Gait parameters
Novak et al, 2009 (23)RCTDefinitive RA diagnosis Community walker DAS28 ≤5.1 Stable pharmacologic management Correctable deformities in midfoot/forefoot Intact skin Not using orthoses or orthopedic shoes40/396 monthsFunctional foot orthoses Unshaped materialPlantar pressure Pain 6-minute walking test
Woodburn et al, 2002 (24)RCTDefinitive RA diagnosis History of bilateral ST joint or ankle or TN joint pain Valgus heel deformity Normal ROM for ST joint/ankle/MT joint98/8130 monthsCustom orthoses No orthosesFFI Pain
Woodburn et al, 2003 (25)RCTDefinitive RA diagnosis History of bilateral ST joint or ankle or TN joint pain Valgus heel deformity Normal ROM for ST  joint/ankle/MT joint98/8130 monthsCustom orthoses No orthosesGait parameters
Carl et al, 2006 (26)ObservationalDefinitive RA diagnosis Painful rheumatoid foot deformity Ability to walk on treadmill20/206 monthsCustom orthoses Shoe onlyPain
De P Magalhães et al, 2006 (27)ObservationalDefinitive RA diagnosis Foot pain Age 20–75 years 1 month without orthoses36/36180 daysMade-to-measure orthoses Customized orthosesFFI Pain
Hodge et al, 1999 (28)ObservationalDefinitive RA diagnosis Forefoot pain on shod weight bearing11/11NoneCustom orthoses Custom orthoses with metatarsal dome Custom orthoses with metatarsal bar Prefabricated orthoses Shoe onlyPlantar pressure Pain Gait parameters
Jackson et al, 2004 (29)ObservationalDefinitive RA diagnosis Forefoot pain on shod weight bearing11/11NonePrefabricated insole with metatarsal dome (customized) Prefabricated insole with metatarsal bar (customized) Shoe onlyPlantar pressure Gait parameters
Kavlak et al, 2003 (30)ObservationalDefinitive RA diagnosis Treated by rheumatologist Community walker Stable disease (for 3 months)18/183 monthsCustom orthoses Shoe onlyPain Gait parameters
Li et al, 2000 (31)ObservationalDefinitive RA diagnosis Steinbrocker functional class II Ambulatory No ulceration Foot pain12/12NoneCustom orthoses No orthosesPlantar pressure
Locke et al, 1984 (32)ObservationalDefinitive RA diagnosis Able to walk without shoes or aids Gait not limited by hip, knee, metatarsal area10/10NoneUCBL orthoses Shoes BarefootWalking velocity
MacSween et al, 1999 (33)ObservationalDefinitive RA diagnosis Age ≥16 years Bilateral forefoot pain Prescribed custom orthoses Able to walk unaided8/8NoneCustom orthoses No orthosesGait parameters Walking velocity
Van der Leeden et al, 2011 (34)ObservationalDefinitive RA diagnosis Podiatry referral for RA-related foot symptoms Age ≥18 years Uni- or bilateral foot symptoms Prescribed customized orthoses135/1263.6 monthsCustomized orthosesPain FFI disability subscale 10-meter walking time
Table 3. Quality assessment of included studies*
Author, year (ref.)abcdefInternal validityExternal validity
  • *

    Randomized controlled trial: 5 domains for internal validity (a, b, c, d, and e) and 1 domain for external validity (f). Observational trial: 3 domains for internal validity (c, d, and e) and 1 domain for external validity (f). a = sequence generation/allocation concealment; b = blinding; c = incomplete outcome data; d = selective outcome reporting/statistical issues; e = interventions; f = generalizability; N/A = not applicable.

  • High quality for validity: all included domains are rated high quality. Low quality for validity: ≥1 included domain is rated low quality.

Budiman-Mak et al, 1995 (18)HighHighHighHighHighLowHighLow
Chalmers et al, 2000 (19)HighHighLowHighHighHighLowHigh
Cho et al, 2009 (20)LowLowLowLowLowLowLowLow
Conrad et al, 1996 (21)HighHighHighHighHighLowHighLow
Mejjad et al, 2004 (22)LowLowLowHighLowLowLowLow
Novak et al, 2009 (23)HighHighHighLowLowLowLowLow
Woodburn et al, 2002 (24)HighLowHighHighHighLowLowLow
Woodburn et al, 2003 (25)HighLowHighLowHighLowLowLow
Carl et al, 2006 (26)N/AN/AHighLowLowLowLowLow
De P Magalhães et al, 2006 (27)N/AN/AHighHighLowHighLowHigh
Hodge et al, 1999 (28)N/AN/AHighLowLowLowLowLow
Jackson et al, 2004 (29)N/AN/AHighLowLowLowLowLow
Kavlak et al, 2003 (30)N/AN/ALowLowLowLowLowLow
Li et al, 2000 (31)N/AN/AHighHighLowLowLowLow
Locke et al, 1984 (32)N/AN/ALowLowLowLowLowLow
MacSween et al, 1999 (33)N/AN/AHighLowLowLowLowLow
Van der Leeden et al, 2011 (34)N/AN/AHighHighLowHighLowHigh

Pain.

Six RCTs investigated pain (19–24). The meta- analysis showed a moderate effect for custom orthoses reducing pain, although the result was not significant (effect size 0.45; 95% CI 0.00, 0.90) (Figure 2A). However, due to the strength of the trend, guarded conclusions can be drawn. Additionally, 5 observational studies also investigated pain (26–28, 30, 34). The observational studies supported the meta-analysis by showing significant results for the reduction of pain using custom orthoses. The meta-analysis and observational study results show that there is weak evidence to support the effectiveness of custom orthoses in reducing pain.

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Figure 2. Meta-analyses of custom orthoses versus control for outcome measures of A, pain, B, foot function, and C, walking speed. 95% CI = 95% confidence interval.

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Foot function.

Three RCTs investigated foot function (20, 21, 24). The meta-analysis showed a minimal effect for custom orthoses increasing foot function and the result was not significant (effect size 0.07; 95% CI −0.41, 0.55) (Figure 2B). These RCTs used the Foot Function Index (FFI) as their outcome measure. Another RCT investigated foot function; however, it could not be included in the meta-analysis (19). This was due to the assessment of foot function being 3 portions each of the Robinson Bashall Functional Assessment and the Toronto Activities of Daily Living Measure (6 measures in total), and these were reported individually rather than as a total. The results of this RCT agreed with the meta-analysis in that foot orthoses did not increase foot function. Additionally, 2 observational studies investigated foot function (27, 34). These studies used the FFI and the FFI disability subscale, respectively, as their outcome measures. The observational studies disagreed with the meta-analysis results and showed significant results for increasing foot function. Overall, there was inconclusive evidence for custom orthoses increasing foot function. However, the trend was toward custom orthoses not increasing foot function.

Walking speed.

Three RCTs investigated walking speed (19, 22, 23). The meta-analysis showed a minimal effect for custom orthoses increasing walking speed and the result was not significant (effect size 0.09; 95% CI −0.27, 0.45) (Figure 2C). Additionally, 3 observational studies investigated walking speed. One observational study agreed with the meta-analysis results showing no significant results for custom orthoses increasing walking speed (33). However, the other observational studies did show significant results (32, 34). Overall, there was inconclusive evidence for custom orthoses increasing walking speed. However, the trend was toward custom orthoses not increasing walking speed.

Forefoot plantar pressure.

One RCT (23) and 3 observational studies (28, 29, 31) investigated forefoot plantar pressure. Three of the 4 studies showed significant results for custom orthoses decreasing forefoot plantar pressure. Therefore, there was weak evidence for the ability of custom orthoses to decrease forefoot plantar pressure (Table 4).

Table 4. Qualitative synthesis results and overview of evidence*
Author, year (ref.)ResultsLevel of evidence
  • *

    ↓ = decreased; AP = average pressure; MTH = metatarsal head; CFOD = custom foot orthoses with metatarsal dome; CFOB = custom foot orthoses with metatarsal bar; PFO = prefabricated foot orthoses; MD = mean difference; PP = peak pressure; MT = metatarsal; ↑ = increased; DF = dorsiflexion; PF = plantar flexion; MTI = motion time integral; HAV = hallux abductovalgus; OR = odds ratio.

Plantar pressure  
 Novak et al, 2009 (23)No significant results (0/2)Weak evidence for orthoses ↓ forefoot plantar pressure due to 3 of 4 studies showing significant results
 Hodge et al, 1999 (28)Significant results (11/12) 
All orthoses types ↓ AP more than shoes alone in MTH 1 and 2 (P < 0.05) 
CFOD, CFOB, and PFO ↓ AP more than shoes alone in MTH 3–5 (P < 0.05) 
 Jackson et al, 2004 (29)Significant results (2/6) 
CFOD (MD 33.00; P < 0.02) and CFOB (MD 58.00; P < 0.02)↓ PP in MT joints 2–4 more than shoes alone 
 Li et al, 2000 (31)Significant result (1/1) 
Orthoses ↓ PP in forefoot (MD 0.41; P < 0.0001) 
Gait parameters  
 Mejjad et al, 2004 (22)Significant result (1/24) Orthoses ↑ step length (MD 0.05; P < 0.05)Inconclusive due to conflicting study results
 Woodburn et al, 2003 (25)Significant results (3/6) 
Orthoses changed DF/PF MTI compared to barefoot (MD 614.10; P < 0.0001) 
Orthoses changed inversion/eversion MTI compared to barefoot (MD 537.30; P < 0.0001) and shod (MD 299.30; P < 0.009) 
 Hodge et al, 1999 (28)No significant results (0/4) 
 Jackson et al, 2004 (29)No significant results (0/2) 
 Kavlak et al, 2003 (30)Significant results (2/4) 
Orthoses ↑ step length (MD 10.00; P < 0.05) and stride length (MD 26.00; P < 0.05) 
 MacSween et al, 1999 (33)Significant result (1/2) 
Orthoses ↑ average stride (MD 4.35; P < 0.05) 
HAV angle progression  
 Budiman-Mak et al, 1995 (18)Significant result (1/1) Orthoses ↓ HAV angle progression (OR 0.3, P = 0.05)Inconclusive due to lack of studies

Gait parameters.

Two RCTs (22, 25) and 4 observational studies (28–30, 33) investigated a variety of gait parameters. Although there were 2 RCTs available, a meta- analysis could not be conducted due to the variety of the gait variables assessed. Some studies found significant results for stride and step lengths (22, 30, 33) and joint motion time integral (25). However, the majority of studies showed no significant results for changes in gait parameters. Therefore, the level of evidence for custom orthoses affecting gait parameters was inconclusive due to conflicting study results (Table 4).

HAV angle progression.

One RCT investigated HAV angle progression (18). The study found that custom orthoses did reduce the risk of increasing the HAV angle. However, there is an inconclusive level of evidence due to the lack of conducted studies (Table 4).

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  10. Supporting Information

Weak levels of evidence were found for custom foot orthoses reducing pain and forefoot plantar pressures. Inconclusive evidence was present for foot function, walking speed, gait parameters, and HAV angle progression. Patient-focused outcomes appeared to have higher levels of evidence opposed to mechanistic outcomes. Additionally, the lack of completed studies of custom orthoses led to evidence for some outcomes being classified as inconclusive. These results are similar to previous reviews in this area that showed that foot orthoses may be beneficial for some outcomes such as pain (8, 9). However, unlike previous reviews, effect sizes were able to be calculated for 3 outcome measures and a level of evidence was assigned for all outcome measures. The level of evidence was determined by the quality assessment and as all included studies were rated as low quality, a weak level of evidence was the maximum that was achievable for any outcome domain. Therefore, although the meta-analyses allowed an effect size to be determined, and in combination with qualitative data synthesis allowed the consistency of the results to be ascertained, the level to which these results could be seen as a true reflection of effectiveness was determined by the level of evidence grading.

To our knowledge, this is the only systematic review in this area to have utilized a quality assessment criterion that emphasizes the external validity of the included studies. When assessing study quality, external validity is important because effectiveness studies are conducted primarily to inform clinical practice. The external validity criteria implemented related to the generalizability of the sample population and the restrictiveness of the inclusion and exclusion criteria. Our findings have shown that external validity issues are not adequately addressed in the majority of studies, with only 3 studies having high quality for external validity. The main reason for the low external validity was that studies were conducted using convenience samples within small areas. This is opposed to multicenter studies, which allow for increased generalizability due to their wider recruitment (35). Despite demonstrating low external validity, many of the studies made unsupported generalizations about the use of the intervention in the general population with RA. This means that in future studies the sample population should reflect the general population that the intervention is to be used for (15). Alternatively, restrictions in the applicability of the interventions should be highlighted.

Additional internal validity criteria were added to the quality assessment to increase its robustness. This was required because previous reviews had not used predefined criteria or used criteria that emphasized double blinding. Double blinding is not generally possible in physical intervention studies. This leads to a scale that is not responsive enough to differentiate levels of quality in these studies (36, 37). Extended criteria including compliant use of interventions and the presence of cointerventions addressed potential bias resulting from the use of pharmacologic interventions for a systemic disease. This has also been overlooked in previous reviews. Therefore, using amended quality assessment criteria, although nonstandard, was necessary to account for these issues.

This is also the first review to have utilized a meta- analysis to investigate the effectiveness of custom foot orthoses on various outcome measures. This was possible because more RCTs have been completed since previous reviews were conducted and multiple RCTS are required for this type of analysis.

The management of RA has recently taken a more targeted and aggressive pharmacologic approach with the introduction of biologic agents (38). Even though this is the case, custom orthoses are still an important adjunct therapy (11). This is due to a number of reasons: 1) persistent foot and ankle problems still occur even after clinical remission is reached (3), 2) people with increased disease states may have mechanical foot impairments that need treatment in conjunction with systemic management, and 3) people who have not responded to or are ineligible for biologic agents continue to have active foot impairments (11).

It is arguable, therefore, that the implementation of custom orthoses should take a more targeted and aggressive approach (11). The included studies had populations that were very heterogeneous in regard to disease duration, which is good for generalizability to the broader population that has RA. However, with a more targeted and aggressive approach to orthoses treatment, studies are required that specifically establish optimal timing for interventions or mechanisms of action, particularly in early disease. Unfortunately, only 2 included studies (using the same sample population) focused on relatively early RA (24, 25). These issues need to be addressed in further research with the implementation of a definitive RCT for custom foot orthoses.

There was conflicting evidence for one outcome, due to 3 observational studies showing a reduction in the outcome and 1 RCT showing no reduction. Due to the low quality of this RCT, it was assigned no greater weighting than the observational studies for this outcome domain. Therefore, as 75% of the studies were in agreement, a weak level of evidence was assigned.

The limitations of this systematic review mainly relate to the assumptions made in order to conduct the meta- analyses. The first assumption was that even though designs and materials used for the custom orthoses were different, the orthoses were all made specifically for each individual participant. Although it is usually difficult to compare different designs and materials in this type of analysis, it is justified because this diversity reflects current clinical practice. In clinical practice, orthoses are made according to the individual requirements of the person. This is seen in the different designs and modifications of the orthoses and also the materials that are used to manufacture them (11). The assumption of nonstandardization was also employed for the control conditions. The control conditions in the included trials were either shoe-only (no orthoses) or placebo orthoses. This meant that there may have been an overestimation of effect in the trials that had shoe-only control. This may have had implications for the meta-analysis in that larger effect sizes were being combined. However, conversely there may have been an underestimation of effect of the custom orthoses in the trials that had a placebo control. This is due to these trials making the assumption that the placebo control had no effect, even though this was not tested.

The second assumption was that the outcome measures within each domain were the same even if the methods of determining these outcomes were different (for example, pain is pain, no matter the measurement method). The differences in outcome measures were accounted for in the meta-analyses by using standardized mean differences (39).

In conclusion, current evidence suggests that custom orthoses are beneficial for the treatment of pain and elevated forefoot plantar pressures in the rheumatoid foot and ankle. However, due to the generally low quality of studies, their effectiveness has not been established unequivocally. Therefore, a definitive RCT is still needed for custom orthoses in the treatment of the rheumatoid foot and ankle.

AUTHOR CONTRIBUTIONS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  10. Supporting Information

All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be published. Ms Hennessy had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study conception and design. Hennessy, Woodburn, Steultjens.

Acquisition of data. Hennessy, Steultjens.

Analysis and interpretation of data. Hennessy, Woodburn, Steultjens.

Acknowledgements

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  10. Supporting Information

The authors would like to acknowledge librarians Marion Kelt and Elizabeth Crawford for their help with developing the search strategy.

REFERENCES

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  10. Supporting Information
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Supporting Information

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  10. Supporting Information

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