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Rheumatology Advance Access originally published online on November 15, 2005
Rheumatology 2006 45(4):449-453; doi:10.1093/rheumatology/kei163
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© The Author 2005. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

The effect of foot orthoses in rheumatoid arthritis

E. de P. Magalhães, M. Davitt1, D. J. Filho2, L. R. Battistella2 and M. B. Bértolo

Department of Rheumatology, State University of Campinas-UNICAMP, 1 Orthotics and Prosthetics Unit, Department of Orthopedics, State University of Campinas-UNICAMP, Campinas and 2 Physical and Medical Rehabilitation Division-DMR, State University of São Paulo-USP, São Paulo/SP, Brazil.

Correspondence to: E. de P. Magalhães, Disciplina de Reumatologia, Departamento de Clínica Médica, FCM/UNICAMP, Campinas (SP), Postal 6111–CEP 13083-970, Brazil. E-mail: epmagalhaes{at}uol.com.br


   Abstract
Top
 Abstract
Introduction
 Materials and methods
 Results
 Discussion
 References
 
Objective. To evaluate the effectiveness of foot orthoses using the foot function index (FFI) in a group of patients with rheumatoid arthritis (RA) during a period of 6 months.

Methods. Thirty-six rheumatoid subjects with foot pain were examined and appropriate foot orthoses were prescribed according to each patient's needs. All the patients were evaluated 30, 90 and 180 days after the baseline visit. FFI values, daily time of wearing the orthoses and adverse effects were noted at each appointment. The Stanford Health Assessment Questionnaire (HAQ) was used at the initial visit to evaluate the influence of physical condition on FFI response.

Results. With the use of foot orthoses, FFI values decreased in all subscales (pain, disability and activity limitation). This reduction was noted in the first month and was maintained throughout the trial. Those using EVA (ethyl-vinyl acetate; n = 28) orthoses presented results similar to those for the total group. Patients wearing made-to-measure orthoses (n = 8) exhibited higher initial FFI values and worse evolution during the trial, significant for pain and disability but not for activity limitation. Minor adverse reactions were noted; none required interruption of treatment. There was no relation between HAQ and FFI evolution.

Conclusions. Foot orthoses were effective as an adjuvant in the management of rheumatoid foot. They significantly reduced pain, disability and activity limitation, as measured by the FFI, with minor adverse effects.

KEY WORDS: Orthoses, Rheumatoid foot, Foot function index, Rheumatoid arthritis


   Introduction
Top
 Abstract
 Introduction
Materials and methods
 Results
 Discussion
 References
 
The feet are one of the most important means of contact between man and his environment, and the maintenance of their function results in liberty and independence of locomotion. In rheumatoid arthritis (RA), there is a high prevalence of foot damage (more than 90% of cases) [1].

The forefoot, especially the metatarsal phalangeal (MTF) joints, is involved in the early stages of the disease, and pain at this site is one of the most common complaint of patients. Instability of these joints can also result in hammer toe deformity. Valgus deformity is common in the first MTF joint, which forces the lesser toes into lateral deviation. Changes in subtalar and talonavicular joints can result in loss of support for the talar head, forcing it to move in a plantar–medial direction, leading to an abducted forefoot position, valgus calcaneus deviation and flat-foot deformity. Involvement of the ankle joint and the tibial posterior muscle may contribute even more to these alterations [2, 3].

As a result of this damage, pain and foot deformity are serious problems in patients with RA. In the treatment of rheumatoid foot, orthoses have been used widely in order to improve joint support, relieve specific pressure points and provide wide distribution of weight with good stability and minimal pain [4]. Although this is a well-established practice among physicians, its efficiency has not been well evaluated in longitudinal studies [5].

The aim of this study was to evaluate a group of rheumatoid patients using foot orthoses, by using the foot function index (FFI) during a 6-month period.


   Materials and methods
Top
 Abstract
 Introduction
 Materials and methods
Results
 Discussion
 References
 
Subjects
Thirty-six rheumatoid patients from the arthritis clinics of the State University of Campinas (UNICAMP), satisfying the 1987 American Rheumatism Association revised criteria for RA, were eligible for this study [6]. The project was explained and subjects signed an informed consent form approved by the local ethics committee. The inclusion criteria were foot pain, age between 20 and 75 yr, and 1 month without the use of other foot orthoses. Patients were excluded if they had been diagnosed with a neurological or muscle disease or diabetes mellitus, if they had skin lesions (ulcers, dermatitis) or previous joint surgery in the lower limbs, and if they were unable to read and give the responses required by the FFI questionnaire.

At the first visit, all patients were examined, foot deformities and skin callosities were noted, and the main pain sites were located. Foot orthoses were then prescribed in accordance with each patient's needs. The orthoses were made of microrubber [ethyl-vinyl acetate (EVA)] in the Orthotics Prosthetics Unit of the State University of Campinas, and their purpose was supportive but not corrective. The following modifications were applied to each insole: for patients with flat foot, a medial arch support; for those with metatarsalgia or callosities under the metatarsal heads, a pad supporting the diaphysis of the second, third and fourth metatarsal bones; for those with pain in the plantar area of the heel, a soft local pad; for those with callosities on specific plantar surfaces or under bone pre-eminences, soft supports under these areas were used to reduce local overload. For very deformed feet, made-to-measure (MM) insoles were preferred. These were made from a plaster cast mould and, if necessary, with the modifications described above. The subjects were then instructed to use the insoles for brief periods of the day at the beginning of the study; when they felt more comfortable, with pain relief, they could use them for most of the day.

After the first evaluation, other visits were scheduled at 30, 90 and 180 days. At each appointment the patients reported the daily wearing time (h/day) and adverse effects. They were also asked to answer the FFI questionnaire.

The FFI consists of 23 items about the impact of foot impairments in three subscales: foot pain (FFI pain) (nine items), foot disability (nine items) and activity limitation (five items) [7]. In the Brazilian version of FFI, the original 100 mm visual analogue scale was changed to an analogue scale (0–10) to make it more comprehensive to the local population [8]. Each patient was asked to mark the number who best reflected his or her condition on each situation. To obtain a subscale score, the values of each item were totalled and divided by the number of items considered applicable by the patient. Calculating the average of the three subscale scores produced a total FFI score (FFI total).

The Stanford Health Assessment Questionnaire (HAQ) was administered at the first visit and it was used to evaluate the influence of physical condition on the patient's FFI response [9].

Statistical analysis
To analyse the impact of insole use on the FFI values during the study, analysis of variance for repeated measures was used. For comparisons between different times, profile analysis was used. Because of the absence of a normal distribution, the variables were transformed into ranks.

To investigate the influence of HAQ on the FFI results, we calculated Spearman correlation coefficients for HAQ and FFI differences between the initial visit and subsequent appointments.

For statistical analysis, we used the SAS System for Windows (Statistical Analysis System), version 6.12 (SAS Institute, Cary, NC, USA).

A significance level of P<0.05 was considered to indicate significance.


   Results
Top
 Abstract
 Introduction
 Materials and methods
 Results
Discussion
 References
 
Thirty-six patients fulfilled the criteria for entry into the study: 31 women and 5 men. Their age ranged from 32 to 68 yr (mean, 46.08 yr) with a mean disease duration of 11 yr (range, 1–34 yr).

Insoles were prescribed according to each patient's needs. For 28 patients, EVA-based insoles were indicated: in 21 cases, where metatarsalgia was the main problem, a metatarsal pad was used, with medial arch support when there was a flat foot (11 patients); in the other seven cases, hindfoot pain was the major complaint and medial arch support was used, in three cases with a heel pad because there was calcaneodinia.

For the remaining eight patients, with very deformed feet, we preferred to use MM orthoses with a plaster cast mould and medial arch support (five patients) and soft support under tender points (five patients).

Minor adverse effects were noted in the first month: heat foot (seven patients), tight shoes (three patients) and pain (one patient). None of them required interruption of the treatment. The patient with pain was using inappropriate shoes and felt more comfortable after using larger sized shoes.

Orthoses were worn on average for 7.14 h in the first month, without significant differences from other visits (6.53 and 6.94 h at 3 and 6 months, respectively; P = 0.228).

Table 1 shows the mean values of FFI pain, FFI disability, FFI activity limitation and FFI total scores for all the patients studied (total group) and for the patients using EVA or MM orthoses. When evaluating the results of the total group, it was noted that these values showed an early decline, in the first month after using orthoses, and that this improvement was maintained in the follow-up period. A similar outcome was seen in patients using EVA, whether the patients had metatarsalgia or hindfoot pain as their major complaint. For the group of patients treated with MM orthoses the results were worse, with an improvement in FFI pain, FFI disability and FFI total, but not FFI activity limitation (Table 2). Figure 1 shows the evolution of patients during the study. The EVA group (with metatarsalgia or hindfoot problems) presented almost an overlapping evolution, very similar to the total group. Unlike these patients, those using MM orthoses, with higher initial FFI values, had lesser reduction of the indexes.


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  		TABLE 1. Values of the FFI index in patients with rheumatoid foot for the total group, patients using EVA orthoses and patients using made-to-measure (MM) orthoses

 

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  		TABLE 2. Results of analysis of variance (ANOVA) for repeated measures for FFI indexes, for the total group and for patients using EVA or made-to-measure (MM) orthoses

 

Figure 1
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  		FIG. 1. Evolution of FFI scores after the use of insoles in the total group and in patients using EVA (with metatarsalgia or hindfoot problems) and made-to-measure (MM) orthoses. Note the early reduction in indexes in the first month and the maintenance of the reduction during 60 and 180 days for the total group and for those using EVA orthoses. The patients with MM orthoses had the poorer results.

 
The mean HAQ score was 1.29, ranging from 0.25 to 2.63, and there was no significant correlation between this score and the evolution of FFI in the group of patients studied (Table 3).


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  		TABLE 3. Correlation between HAQ and FFI

 

   Discussion
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
References
 
Foot orthoses are commonly used in the management of patients with RA, with the intention of giving better joint support and preventing deformity, providing pain relief and reducing disability. Many strategies have been proposed, such as metatarsal pads or bars to relieve pressure and pain in the forefoot, and medial arch support to limit pronation by holding the subtalar joint in a neutral position [10, 11]. Nevertheless, a limited number of studies have been published regarding the efficacy of foot orthoses [5].

In this study, foot orthoses were effective in the management of rheumatoid foot. The evolution of FFI revealed significant reduction in pain, disability, activity limitation and total indexes for the patients using foot orthoses. This improvement was sustained during the whole trial. When studying only patients using EVA, we noted a similar evolution of FFI values for metatarsalgia and hindfoot complaints. Patients with MM orthoses presented worse results, with less improvement in FFI values, which were significant for pain and disability but not for activity limitation. In the small number of patients using this kind of orthosis, the presence of a more deformed foot and higher initial FFI values may explain the poorer results. Further study with a larger number of patients, including both mild and severe conditions, may confirm our findings.

In a randomized study of rheumatoid foot with correctable valgus deformity, Woodburn et al. [12] also found good results. During 30 months of follow-up, they observed reductions in FFI pain, FFI disability and FFI total indexes. However, when they considered FFI activity limitation, despite a tendency for the index to improve in the intervention group, there was no significant difference compared with the control group, without orthoses. As was the case in our study, this improvement was seen early in the follow-up and was sustained during all the trial, with minor adverse reactions. On the contrary, in a study comparing similar foot orthoses vs placebo, Conrad et al. [13] found no clinical benefit for the former. However, their subjects were atypical older male rheumatoid patients and the placebo orthoses used could have interfered in the final results.

When treating metatarsalgia, Chalmers et al. [14], in a blinded study with rheumatoid patients using supportive shoes alone vs supportive shoes with soft (Subortholen) or semirigid (Plastazote) orthoses, found significant MTP joint pain relief in a group using semirigid orthoses but not in others. This effect occurred in the first 6 weeks of treatment and was maintained throughout the trial. No functional improvement was found. Similar results were observed by Mejjad et al. [15], who verified pain relief without improvement in gait parameters in a group of rheumatoid patients with metatarsalgia using foot orthoses.

Craxford et al. [16], comparing surgery with conservative treatment, found significant pain relief with surgical shoes with total-contact Plastazote. In other studies, improvement of pain and function in rheumatoid patients has been obtained with footwear modifications [17, 18].

The good results obtained with the foot orthoses can be explained by a better distribution of pressure under the foot. Investigating the effectiveness of foot orthoses with metatarsal support, Hodge et al. [19] concluded that they could reduce pressure beneath the metatarsal heads and alleviate the patients’ pain ratings. Li et al. [20] and Magalhães et al. [21] also found better redistribution of plantar pressure in rheumatoid feet using insoles.

In this trial we used foot orthoses according to each patient's needs. Kavlak et al. [22] used the same proceeding during a 3-month trial and also found significant differences in foot pain and function in their patients.

This was not a controlled study and we cannot rule out a placebo effect of the insoles. However, the long daily wearing time (about 7 h/day) and the maintenance of FFI improvement throughout the study (6 months) support a specific effect of the foot orthoses. It is also difficult to evaluate control groups in trials with foot orthoses. As suggested by Conrad et al. [13], the placebo orthosis may itself have an effect like that of a treatment orthosis. The use of a control group without treatment could also increase the number of patients withdrawing, or may be unethical.

The results of this trial and others published previously strongly suggest that foot orthoses are effective as an adjuvant treatment for rheumatoid foot. Also, they are readily available, adverse reactions are minor, and they are well accepted by rheumatoid patients independently of their health status. Relief of pain may be their primary benefit, but they can also have an effect on disability. Studies regarding plantar pressure distribution and comparisons among different materials will provide more evidence of the benefits of foot orthoses and will improve their efficiency.

Physicians should always be able to identify causes of pain in rheumatoid foot and to prescribe foot orthoses with appropriate modifications in situations in which they could be helpful.


   Acknowledgments
 
We would like to thank Dr Sandra R. M. Fernandes for critical review of this article, and the Research Chamber/Statistic Division of Medical Science School of UNICAMP for statistical analysis.

The authors have declared no conflicts of interest.


   References
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 

  1. Shi K, Tomita T, Hayashida K, Owaki H, Ochi T. Foot deformities in rheumatoid arthritis and relevance of disease severity. J Rheumatol 2000;27:84–9.[Medline]
  2. Smyth C, Janson RW. Rheumatologic view of rheumatoid foot. Clin Orthop Relat Res 1997;340:7–17.
  3. Cracchiolo A. Rheumatoid arthritis. Hindfoot disease. Clin Orthop Relat Res 1997;340:58–68.
  4. Merritt JL. Advances in orthotics for the patient with rheumatoid arthritis. J Rheumatol Suppl 1987;14(Suppl. 15):62–7.
  5. Marks MB, McKendry RJ. Orthoses for rheumatoid feet: does it matter what's underfoot? Lancet 1996;347:1639.[Medline]
  6. Arnett FC, Edworthy SM, Bloch DA et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315–24.[Web of Science][Medline]
  7. Budiman-Mak E, Conrad KJ, Roach KE. The foot function index: a measure of foot pain and disability. J Clin Epidemiol 1991;44:561–70.[CrossRef][Web of Science][Medline]
  8. Oliveira LM, Alves CM, Mizuzaki J, Natour J. Adaptação e validação para língua portuguesa do ‘The Foot Function Index’. Rev Bras Reum Suppl 2002;42:S58.
  9. Ferraz MB, Oliveira LM, Araújo PM, Atra E, Tugwell P. Crosscultural reliability of the physical ability dimension of the health assessment questionnaire. J Rheumatol 1990;17:813–7.[Web of Science][Medline]
  10. Grifka JK. Shoes and insoles for patients with rheumatoid foot. Clin Orthop Relat Res 1997;340:18–25.
  11. Janisse DJ. Prescription footwear for arthritis of the foot and ankle. Clin Orthop Relat Res 1998;349:100–7.
  12. Woodburn J, Barker S, Helliwell PS. A randomized controlled trial of foot orthoses in rheumatoid arthritis. J Rheumatol 2002;29:1377–83.[Abstract/Free Full Text]
  13. Conrad KJ, Budiman-Mak E, Roach KE, Hedeker D. Impacts of foot orthoses on pain and disability in rheumatoid arthritics. J Clin Epidemiol 1996;49:1–7.[CrossRef][Web of Science][Medline]
  14. Chalmers AC, Busby C, Goyert J, Porter B, Schulzer M. Metatarsalgia and rheumatoid arthritis – a randomized, single blind, sequential trial comparing 2 types of foot orthoses and supportive shoes. J Rheumatol 2000;27:1643–7.[Web of Science][Medline]
  15. Mejjad O, Vittecoq O, Pouplin S, Grassin-Delyle L, Weber J, Le Loët X. Foot orthotics decrease pain but do not improve gait in rheumatoid arthritis patients. Joint Bone Spine 2004;71:542–5.[Medline]
  16. Craxford AD, Stevens J, Park C. Management of the deformed rheumatoid forefoot. A comparison of conservative and surgical methods. Clin Orthop Relat Res 1982;166:121–6.
  17. Moncur C, Ward JR. Heat moldable shoes for management of forefoot problems in rheumatoid arthritis. Arthritis Care Res 1990;3:222–6.
  18. Fransen M, Edmonds J. Off-the-shelf orthopedic footwear for people with rheumatoid arthritis. Arthritis Care Res 1997;10:250–6.[Web of Science][Medline]
  19. Hodge MC, Bach TM, Carter GM. Orthotic management of plantar pressure and pain in rheumatoid arthritis. Clin Biomech 1999;14:567–75.[CrossRef][Medline]
  20. Li CY, Imaishi K, Shiba N et al. Biomechanical evaluation of foot pressure and loading force during gait in rheumatoid arthritic patients with and without foot orthoses. Kurume Med J 2000;47:211–7.[Medline]
  21. Magalhães EP, Jorge-Filho D, Battistella LR. Rheumatoid feet: evaluation with computerized dynamic pedobarography and functional restoration with foot orthoses. Acta Fisiatr 2003;10:78–82.
  22. Kavlak Y, Uygur F, Korkmaz C, Bek N. Outcome of orthoses intervention in the rheumatoid foot. Foot Ankle Int 2003;24:494–9.[Medline]
Submitted 5 June 2005; revised version accepted 14 September 2005.
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