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Keywords:

  • Heel pain;
  • foot, orthoses

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. REFERENCES
  9. Appendix

Background

Plantar heel pain is a common reason for referral to podiatric practice, and one of the key interventions is the use of orthoses. The aim of the present study was to compare the clinical efficacy of bespoke, casted foot orthoses and prefabricated foot orthoses for plantar heel pain.

Methods

People with plantar heel pain were included if, following initial assessment, foot orthoses were indicated and participants received either bespoke, casted foot orthoses or prefabricated semi-rigid orthoses (Powerstep™). Clinical efficacy was assessed at eight weeks using the Manchester Foot Pain and Disability Questionnaire (MFPDQ).

Results

A total of 67 patients completed the trial and at baseline there were no appreciable differences in the two groups of patients in terms of the MFPDQ score; however, at eight weeks post-treatment both had significantly reduced foot pain and disability (both p < 0.0001). There was no significant difference in effectiveness between the bespoke or prefabricated orthoses. However, prefabricated devices were 38% cheaper per patient compared with the average costs of casted devices.

Conclusion

For most patients with plantar heel pain, prefabricated semi-rigid insoles such as the Powerstep™ devices used in the present trial provide short-term benefit equivalent to that of bespoke, casted foot orthoses, but at considerably reduced costs. Copyright © 2013 John Wiley & Sons, Ltd.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. REFERENCES
  9. Appendix

Plantar heel pain is a common complaint (estimated prevalence 10–15%) and has a negative impact on an individual's quality of life owing to reduced function compromising the activities of daily living (Alshami et al., 2008; Crawford and Thomson, 2008; Hunt et al., 2004; Irving et al., 2008; Landorff et al., 2004; Pribut, 2007). Localized pain in the heel has a number of causes; for example, plantar fasciitis, plantar calcaneal bursitis, nerve entrapment, calcaneal stress fracture and fat pad atrophy have all been described in the literature (Berkson et al., 2007). Plantar fasciitis is likely to be the most common complaint typified by pain of initial weight-bearing, whereas other complaints tend to get progressively worse with weight-bearing or activity. Additionally, inflammatory enthesopathy in systemic diseases such as inflammatory arthritis or sero-negative arthritis is also common in these patient groups, and the overall disease activity needs to be considered in this context, as local management alone may not suffice. Thus, the aetiology of heel pain is complex and multi-factorial; however, mechanical overload is thought to be a key element, with several contributing factors, with obesity and reduced heel pad thickness being reported, and altered foot mechanics being a key component (Irving et al., 2008; Rome, 1998a, 1998b; Stephens and Walker, 1997; Thomas et al., 2010).

Plantar heel reportedly accounts for 11–15% of new patient visits to foot specialists (Rompe et al., 2007), and numerous treatment interventions have been reported, including foot orthoses, corticosteroid injections, non-steroidal anti-inflammatory agents, therapeutic ultrasound, extracorporeal shock wave therapy, stretching exercises, night splints, strapping and surgical intervention (Hunt et al., 2004; Pfeffer et al., 1999; Theodore et al., 2004). Several reports identified custom-made foot orthoses as being the most efficacious intervention (Burns et al., 2006; Roos et al., 2006; Zifchock and Davis, 2008), but these studies tended to focus on a range of lower limb musculoskeletal complaints and not on heel pain per se. Sometimes, foot orthoses were part of a treatment strategy combining other modalities such as strapping and night splints (Turlik et al., 1999), making it difficult to extrapolate the impact made by the provision of orthoses. A Cochrane review (Hawke et al., 2008) identified custom-made foot orthoses as being more effective than placebo foot orthoses for improving function, but not for reducing heel pain. However, others have reported prefabricated foot orthoses to be equally effective in the management of lower limb musculoskeletal complaints, including plantar heel pain (Baldassin et al., 2009; Brocklesby and Wooles, 2009; Landsman et al., 2009; Rome et al., 2004; Stell and Buckley, 1998; Springett et al., 2007). Moreover, methodological quality across studies remains an issue (Hawke et al., 2008) and the need for detailed cost comparisons has been highlighted (Menz, 2009; Redmond et al., 2009; Rome, 1998a, 1998b). In 1994, it was estimated that, in the UK, some £12 million was spent on foot orthoses (Fox and Winston, 1994); yet, there remains little scientific evidence to draw conclusions about the efficacy of different devices. Although some considered bespoke orthoses to be a gold standard (Donatelli, 1996), the time and cost invested in such devices requires justification in the light of continued drives for more cost-effective solutions (Department of Health, 2010a,2010b). The present study aimed to investigate both the clinical efficacy and cost-effectiveness of prefabricated (over-the-counter) compared with custom-made (casted) foot orthoses for the management of plantar heel pain.

Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. REFERENCES
  9. Appendix

Trial design

This was a prospective cohort study, reported in accordance with current guidelines (Figure 1). Both arms of the study were carried out in parallel and the two types of orthoses were allocated on a 1:1 basis.

image

Figure 1. CONSORT 2010 [Schulz et al., 2010] Flow diagram

Download figure to PowerPoint

Participants

The study was carried out in a Community Podiatry department in the South-East of England. Subjects were included if they presented exclusively with plantar heel pain and were between 18 and 60 years of age. Subjects were excluded if they had medical conditions that could compromise tissue viability or orthotic use (e.g. peripheral vascular disease or sensory neuropathy) or if they had a potential systemic cause for heel pain (e.g. inflammatory arthritis). Subjects were also excluded if they had received any previous treatment for their heel pain or had a body mass index (BMI) >29.1, as the latter may alter the type of materials required to provide adequate mechanical control. Inclusion/exclusion criteria were established either from the referral form or from telephone screening carried out by the lead author (K.R.).

Ethical approval was granted from Kent Community Health Research Ethics Committee (REC) (07/H1101/ 81) and from the School of Health Professions Research Ethics and Governance Committee, University of Brighton and permission to use the MFPDQ granted by Isis Outcomes (http://www.isis-innovation.com). At the specific behest of the Research Ethics Committee, a true control group (i.e. receiving no treatment) was excluded from the study, as there is considerable evidence that foot orthoses are an effective treatment for heel pain and therefore it would be inappropriate to withhold such treatment. All participants provided informed, written consent.

Interventions

The primary intervention was with either prefabricated or casted foot orthoses. Importantly, no secondary interventions (exercises, night splints or pharmacological agents) were prescribed and all participants were naïve to treatment for heel pain. For the prefabricated orthoses, a Powerstep™ (Cuxson Gerrard & Co Ltd., Oldbury, UK) full-length device in the correct size for the patients' feet was provided. These have a Shore A durometer ethyl vinyl acetate (EVA) base layer of approximately 45 prior to factory moulding. Following moulding, some areas will have a Shore A durometer of 55–60 but this is not uniform. For the casted orthoses, a foam casting box was used to take an impression of the foot in the sub-talar neutral position defined by Root et al. (1971), described by Guldemond et al. (2006). Dimensions of the cast were compared with the subject's foot while held in a neutral sub-talar joint position, as recommended by Tollafield and Merriman (2004). The impression was filled with plaster of Paris and prepared as described in detail elsewhere (Philps, 1990) Comparable, medium-density (Shore A 50 durometer) EVA was heated (170 °C for 12 minutes) and vacuum formed to the cast, then shaped to fit according to an individual prescription for each subject, based on a routine musculoskeletal assessment carried out in the department.

Outcome measures

Foot pain and disability

The primary clinical outcome measure selected was the Manchester Foot Pain Disability Questionnaire (MFPDQ) (Garrow et al., 2000) (Appendix 1). The MFPDQ is a self-administered instrument designed to assess foot pain and disability, and consists of a19-item questionnaire with three domains: functional limitation (12 items); pain intensity (four items) and personal appearance (three items); scoring is via a three-point Likert-type scale (Garrow et al., 2000). This questionnaire-based outcome measure is quick (<5 minutes) and simple to complete and score, as well as having good content and criterion validity and good internal consistency. The MFPDQ is not disease specific and can be used in any condition where foot pain or disability may be an issue (Helliwell et al., 2005). The higher the score on this questinnaire, the greater pain/disability is being experienced; although normative values for particular conditions have not been reported, the minimum–maximum scores would be 0–38 using this method. Roddy et al. (2009) (supported by Menz et al., 2011) proposed a revised definition in which disabling foot pain is considered to be present if one or more of the ten functional limitation items are reported ‘on most/every day(s)’; this definition was not used, however, as it is more appropriate for epidemiological studies.

Cost-effectiveness

An estimated cost analysis of both devices was carried out by analysing the time taken for the practitioner to manufacture and issue each device, taking into account the appointment time, materials and equipment required for the manufacture of each device. The casted foot orthoses were manufactured on site by one author (K.R.), a commercial laboratory not being used. The costs of equipment and consumables (e.g. rasps, sand paper, plaster of Paris) were approximated from the yearly average (£1,016.79, taken from purchase orders) divided by the number of patients in the podiatry department who were issued with a casted device, which equates to approximately 15 casted devices per week (£1.30 per patient). The cost of clinicians' time was also factored in, based on a manufacture time for each device of 60 minutes from start to finish, and a fitting time of 20 minutes per participant. For prefabricated orthoses, a standard unit cost of these devices, obtained through the NHS supply chain, was used. The assessment time prior to prescribing the devices is the same as that of the casted devices. However, the prefabricated devices can also be fitted during this initial assessment appointment, and the length of time required to do this is approximately the same as that needed to take a cast and write the prescription, for provision of a casted device. This removed the need for a fitting appointment and was accounted for in the cost analysis, with the aim of making the cost estimates as realistic as possible.

Participant satisfaction

To determine orthotic acceptability to participants, subjects were asked to rate their device's suitability on the following factors: ease of use, comfort, hygiene and overall satisfaction, using 10 cm visual analogue scales, as well as criteria to indicate whether they were still wearing the devices and why. This approach has been utilized previously (Springett et al., 2007), has acceptable face validity and enables subjects to provide feedback about orthotic acceptability not covered by the MFPDQ. Each questionnaire was completed anonymously by participants in private, using an individual password to enable identification of each subject's responses and then sealed in an envelope prior to secure storage by the clinic receptionist. Blinded analysis was only carried out at the end of the study by the primary author (K.R.).

Sample size

A sample of at least 68 people (based on an a priori power calculation) with a primary referral from the general practitioner for plantar heel pain was selected.

Allocation

A total of 69 participants, having consented to participate, were allocated to receive either custom-made or prefabricated orthoses on an alternate basis. The two arms of the study (Figure 1) were carried out in parallel.

Blinding

Blinding of the researchers was not included, as this is particularly difficult, if not impossible, to achieve with different mechanical therapies such as foot orthoses. However, both groups of subjects were assessed in exactly the same manner, except those receiving prefabricated insoles did not have a foam impression taken.

Implementation

Prior to orthotic fitting, each participant was invited to complete a baseline MFPDQ. Orthoses were then fitted and all participants were given identical advice about their insoles, and an identical advice sheet; all participants were seen by one author (K.R.). Participants were asked to wear their insoles for four weeks before returning for a review appointment, booked at the time of the initial orthotic fitting. During the review, participants' orthoses were checked by the primary author (K.R.) to ensure no adverse effects (e.g. lesions or poor fit). This is normal departmental protocol following the provision of any orthotic device, not just for the purpose of the research. After eight weeks, subjects attended a further follow-up appointment and completed a second MFPDQ and the acceptability questionnaire.

Data analysis

All raw data were entered into a Microsoft Excel spreadsheet and scored to provide interval data as validated previously (Muller and Roddy, 2009), using a system similar to that advocated in studies using similar outcome measures (Woolf, 2003). Responses were scored from 0–2, where:

  • display math

Data were exported into SPSS (version 17) (SPSS Inc., Chicago, IL, USA) for analysis. As data were ordinal, the non-parametric Wilcoxon Signed Rank test was used for within-group statistical analysis and a significance level of p ≤ 0.05 assigned. Data were compared at outset and after eight weeks. To establish any significant differences, between-groups data were analysed using a Mann–Whitney U test with a significance level of p ≤ 0.05. Measures of central tendency (mean, median and range) were calculated from the satisfaction questionnaire scores to establish any differences in the ease of use, comfort, perceived hygiene or overall satisfaction with the two types of orthotic devices. The estimated cost-effectiveness data were tabulated at each stage for ease of comparison.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. REFERENCES
  9. Appendix

Demographic data

In total, 104 subjects were recruited, 70 of whom entered the trial and 67 completing it (Figure 1), providing a 96.7% completion rate (one subject did not attend follow-up and two did not wish to alter shoes to accommodate orthoses). The male:female ratio was 27:43 and the mean age was 48 years (range 27–63). As defined in the exclusion criteria, subjects' BMIs were all below 29 (range 22–28.75 [mean 26.2; standard deviation (SD) 1.75].

Foot pain and disability

Prior to orthotic intervention, those receiving casted orthoses (n = 35) reported a mean MFPDQ score of 20.5 (SD 8.85), with most participants (68%; n = 24) indicating pain in their feet on some or most days. For those receiving prefabricated devices (n = 34), the mean MFPDQ score was 20.4 (SD 6.8), with the majority of participants (94%; n = 28) reporting having pain in their feet on some or most days. Importantly, no statistical differences in MFPDQ scores between groups were noted at the start of the study (p = 0.462).

At eight weeks, the casted group reported a mean MFPDQ score of 2.2 (SD 3.9), indicating a highly significant reduction in symptoms (p < 0.0001). Similarly, in the prefabricated group, a highly significant reduction in symptoms was reported, with a mean MFPDQ score of 3.2 (SD 5.66). Again, no statistically significant differences between groups were detected in the MFPDQ scores at eight weeks (p = 0.839).

Table 1. Cost analysis for manufacture of EVA casted orthoses
Level of podiatristAssessment of 45 minutes including taking of castLabour (based on a total time spent on manufacture of 60 minutes)MaterialCasting boxTools and miscellaneous (approx).Cost of 20 minutes fitting appointment (allowing for adjustments)Total
  • This includes filling the negative cast, preparing the positive cast, preparing the material, heating and moulding the material, grinding down the orthotic into the correct shape etc.

  • Based on one 115 × 92 cm sheet of 6 mm Blue ethyl vinyl acetate (EVA) (Shore A50 durometer) at £10.93 ($17.05) per sheet, providing an average of 25 insoles (allowing for some wastage).

Mid-scale staff-grade podiatrist (UK NHS Band 6 point 5) £28,141£10.82£14.43£0.43£1.76£1.30£4.81£33.95

Midpoint specialist podiatrist (UK NHS

Band 7 point 5) £33,603

£12.90£17.23£0.43£1.76£1.30£5.74£39.76
Table 2. Cost analysis for use of standard Powerstep™ prefabricated orthoses
Band of podiatristAssessment and labour required to fit orthotic (Can be done during assessment in the time taken for the cast to be taken in the casted group)Cost of orthotic device (available through UK NHS supply chain)Total
  1. WTE, whole time equivalent

Mid-scale staff grade – UK Band 6, point 5 (£28,141 WTE)£10.82£13.15£23.97
Mid-scale specialist clinician – UK Band 7 point 5 (£33,603 WTE)£12.90£13.15£26.05

Cost-effectiveness

Powerstep™ orthoses can be purchased through the NHS supply chain at a cost of £13.15, including tax, and Table 1 indicates the costs of providing this device compared with estimated costs for casted orthoses, as outlined in Table 2. For each type of orthotic device, the clinician's time was calculated using the mid-point of each pay band, but this will inevitably vary commensurately with an individual clinician's remuneration. Overall, providing Powerstep™ insoles demonstrated a saving of approximately £8.78, or a 38% saving per participant, when compared with the cost of materials and time for all types of casted orthoses.

Table 3. Summary of subject satisfaction scores
QuestionMeanMedianRange
CastedPrefabCastedPrefabCastedPrefab
Ease of use7.37.9783–106–10
0 – very difficult      
10 very easy      
Comfort7.47.67.584–105–10
0 – uncomfortable      
10 very comfortable      
Hygiene7.47.87.586–105–10
0 – not hygienic      
10 – very hygienic      
Satisfaction8.18.388.54–103–10
0 – not satisfied      
10 – very satisfied      

Participant satisfaction

For subjects wearing casted orthoses, visual analogue scale scores indicated that subjects found the casted devices comfortable and easy to use, with high degrees of satisfaction (Table 3). Of the 32 subjects who responded, 26 were still wearing their casted orthoses at eight weeks. For those no longer wearing orthoses, four reported pain resolution, two stated that some of their everyday shoes no longer fit them but discomfort had resolved, and one reported that the insoles had not helped. For those wearing prefabricated orthoses, most were highly satisfied at eight weeks, and found them easy to use and comfortable (Table 3). Of the 34 receiving prefabricated devices, 24 said that they were still wearing orthoses. For those no longer wearing orthoses, seven reported pain resolution, two stated that some of their everyday shoes no longer fit them, and only one reported that insoles did not help. No adverse effects were reported during the trial in either group.

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. REFERENCES
  9. Appendix

The results of the present trial demonstrated that both casted and prefabricated devices provided successful outcomes in the treatment of plantar heel pain over an eight-week period, with no substantial differences in overall patient satisfaction between the two types of device. In cases of uncomplicated heel pain, for those deemed suitable to receive prefabricated insoles manufactured from medium-density EVA, these were a more cost-effective alternative to the use of casted orthoses (manufactured from comparable materials) while achieving similar efficacy. Moreover, given the enormous pressure on NHS services to provide optimal patient care, while reducing waiting lists and being clinically effective, we found a considerable cost saving of approximately £8.78, or a 38% saving per participant, with the use of the prefabricated device. The outcomes of the current study support the work of previous authors (Baldassin et al., 2009; Rome et al., 2004; Springett et al., 2007), some of whom (Springett et al., 2007) argued that prefabricated devices are effective because a considerable level of biomechanical control is offered, particularly in terms of improved frontal plane alignment. A small study by Redmond and colleagues (2009) in people who were prescribed foot orthoses for flat feet indicated a similar change in plantar foot loading with both semi-rigid customized orthoses and semi-rigid prefabricated orthoses. Interestingly, we found a much greater cost saving than Brocklesby and Wooles (2009), who also reported similar clinical outcomes from bespoke and prefabricated foot orthoses, but a cost saving of only £4.21. Redmond et al. (2009) reported a larger cost differential, with customized orthoses costing 2.5 times more than the prefabricated devices and 3.5 times more costly when the entire episode of care was considered. Given the prevalence of plantar heel pain, extrapolating the per-patient savings we report could amount to a national figure of £50,000 (£75,000 annually), which is a particularly important factor in light of the recent Department of Health Quality, Innovation, Productivity and Prevention challenge (Department of Health, 2010c). Perhaps more importantly, the use of the prefabricated insoles would enable clinicians to issue the devices at the point of diagnosis, rather than having to wait for the devices to be manufactured.

Our findings should be considered alongside a number of limitations. Our results provide evidence that orthotic devices (both custom and prefabricated) are an effective intervention for the treatment of uncomplicated heel pain, but it is impossible to ascertain how many of the subjects' symptoms would have shown some improvement without orthotic intervention. However, a number of subjects had been on a waiting list for a considerable length of time without any noticeable improvement in symptoms, suggesting that spontaneous resolution was unlikely. Our findings are limited by the short duration of the study, but the rapid and significant reduction in symptoms is worthy of note. A longer follow-up study to determine the longevity of the devices and long-term outcomes would be of value, but, typically, given the magnitude of improvements that have been reported, patients are subsequently discharged from the service, making follow-up particularly difficult. Similarly, although obesity is reported to be an aetiological factor in heel pain, only three participants were excluded because their BMI was greater than 29.1, suggesting that our results are broadly generalizable in non-obese populations.

In conclusion, plantar heel pain is a common complaint, and prefabricated insoles are a cost-effective alternative to custom devices for the effective management of uncomplicated heel pain and provide a useful adjunct to podiatric practice. The prefabricated orthoses used in the present study provided the same therapeutic outcomes for heel pain as the casted orthoses but were cheaper to supply and could be held as a stock item for immediate supply to the patient, thereby improving the patient experience. Prefabricated orthoses were reported to be easy and hygienic to use, and generally fit into a range of footwear.

Acknowledgements

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. REFERENCES
  9. Appendix

The authors wish to thank Cuxson Gerrard & Co. Ltd (Oldbury, UK) for their technical advice; those subjects who took the time to participate and complete the questionnaires; and Mr A. McInnes and Ms K. Carter for their helpful comments during the preparation of this manuscript.

REFERENCES

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. REFERENCES
  9. Appendix
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Appendix

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. REFERENCES
  9. Appendix

Manchester Foot Pain Disability Questionnaire

Below are some statements about problems people have because of pain in their feet. For each statement please indicate if these have applied to you during the past month.

PLEASE TICK A BOX FOR EACH STATEMENT

During the past month this has applied to me
 None of the timeOn some daysOn most/every day(s)
Because of pain in my feet   
I avoid walking outside at all   
I avoid walking long distances   
I don't walk normally   
I walk slowly   
I have to stop and rest my feet   
I avoid hard or rough surfaces whenever possible   
Because of pain in my feet   
I avoid standing for a long time   
I catch a bus or use a car more often   
I need help with housework of shopping   
I still do everything, but with more pain or discomfort   
I get irritable when my feet hurt   
I get self-conscious about my feet   
I get self-conscious about the shoes I have to wear   
I have constant pain in my feet   
My feet are worse in the morning   
My feet are more painful in the evening   
I get shooting pains in my feet   
Because of pain in my feet   
I am unable to carry out my previous work   
I am unable to do all my previous activities (sport, dancing, walking etc)   
Please tick when you have completed all statements on this page