Disability and Rehabilitation, 2009; 31(8): 638–645

RESEARCH PAPER

Influence of foot orthoses on plantar pressures, foot pain and walking

ability of rheumatoid arthritis patients – a randomised controlled study

PRIMOZ NOVAK1, HELENA BURGER1, MATIJA TOMSIC2, CRT MARINCEK1 &

GAJ VIDMAR1
1
Institute for Rehabilitation, Republic of Slovenia, Linhartova 51, 1000 Ljubljana, Slovenia and 2Department of
Rheumatology, University Medical Centre Ljubljana, Vodnikova 62, 1000 Ljubljana, Slovenia

Accepted May 2008

Abstract
Purpose. To compare the effectiveness of functional foot orthoses and unshaped (flat) orthotic material on plantar pressure
redistribution, forefoot pain reduction and walking ability in rheumatoid arthritis (RA) patients.
Methods. Forty patients with RA were randomised to receive unshaped material (UM) (n ¼ 20) or functional foot orthoses
(n ¼ 20). Plantar pressure measurement was performed with an F-scan system. Foot pain was assessed by the pain subscale
of the Foot Function Index. Walking ability was assessed by the 6-min walking test. Investigations were performed at
baseline, 1 week after the patient received shoes with orthoses and 6 months later.
Results. Plantar pressures were significantly higher at painful than at non-painful foot areas. No differences in plantar
pressure redistribution were found between the groups. Notable reduction of pain and improvement of activity (walking
ability) was observed in both groups. Foot pain has moderate impact on the walking ability of RA patients.
Conclusions. The study showed no clear advantage of functional foot orthoses over UM.

Keywords: Rheumatoid arthritis, foot pain, foot orthoses, plantar pressure measurement, 6-min walking test

pain, activity limitations and gait changes (shorter

Introduction
Rheumatoid arthritis (RA) affects between 0.3 and
1.5% of the population worldwide [1]. Foot involve-
ment occurs in 85–100% of people with RA [2–4],
and often occurs early in the course of the disease
[5]. The progression is related to disease duration [2]
and its severity [6].
The forefoot is most commonly affected, especially
the metatarsophalageal (MTP) joints [1,7–9]. In-
flammation of those joints can lead to pain,
deformities, decreased joint mobility and stiffness,
causing increased stress on the adjacent joints
[1,5,10]. Bony deformities and soft tissue atrophy
change normal plantar pressure distribution [10].
Increased pressure under the forefoot results in
forefoot pain in RA patients [11–13]. These changes
in body structures (foot deformities) and functions
(pain) may lead to significant activity limitations
(walking) [5,14]. A relationship between forefoot
stride length and slow walking speed) has been
demonstrated in RA patients [9,13].
The ultimate goals in managing the RA foot (as
well as other joints) are to prevent and control joint
damage, prevent loss of function and decrease pain
[1,15]. The control of pain is most important in
striving to maintain activity [16]. Conservative
measures, including orthotic interventions, are often
overlooked in the treatment of rheumatoid fore-
foot [17].
Few studies have been published on orthotic
interventions in RA patients. The studies have
evaluated the effect of foot orthoses on plantar
pressures distribution [12,18–20] and/or on forefoot
pain reduction [12,19,21–25]. Selective inclusion of
specific patient groups and different methodological
approaches of these studies hampers the general
conclusions and recommendations to be made [26].
The results of a review by Clark et al. [27] indicated a

Correspondence: Primoz Novak, Institute for Rehabilitation, Republic of Slovenia, Linhartova 51, 1000 Ljubljana, Slovenia. Tel: þ386 1 475 8100.
Fax: þ386 1 437 6589. E-mail: primoz.novak@ ir-rs.si
ISSN 0963-8288 print/ISSN 1464-5165 online ª 2009 Informa Healthcare USA, Inc.
DOI: 10.1080/09638280802239441

need for further investigation to identify most
effective foot orthoses for RA patients with foot
problems.
To the authors’ knowledge, no study has simulta-
neously evaluated the effect of foot orthoses on
plantar pressure redistribution, foot pain reduction
and improved walking ability in a follow-up manner.
Hence, the aim of the study was to compare the
effectiveness of functional foot orthoses and un-
shaped material (UM) (presumably non-functional,
placebo-type flat orthoses) on plantar pressure
redistribution, forefoot pain reduction and walking
ability in RA patients. We anticipated plantar
pressures and foot pain to decrease and walking
ability to improve with the use of functional orthoses,
but not with the UM.
Materials and methods
Subjects
The study included patients with RA and forefoot
pain from the outpatient clinic, the Department of
Rheumatology at the University Medical Centre
Ljubljana. First 40 consecutive eligible patients were
selected from a cohort of *3500 RA patients, who
visited rheumatologists in the period from February
2005 till May 2006. The criteria for patient selection
were: (1) established diagnosis of RA, (2) commu-
nity walker, (3) Disease Activity Score (DAS) 28
[28] 5.1, (4) stable treatment with slow immuno-
modulatory drugs during the last 2 months, (5)
stable treatment with glucocorticoids with daily
doses 58 mg of methylprednisolone during the last
2 months, (6) correctable deformations of midfoot
and/or forefoot (predominantly lowered longitudinal
and transverse plantar arcs, clawed toes and mobile
hallux valgus), (7) intact skin surface of the feet, (8)
currently not using foot orthoses and/or orthopaedic
shoes.
Exclusion criteria were: (1) valgus or varus heel
deformation 4 58, (2) severe ankle pain (ankle
pain:forefoot pain 4 1:2 – assessed with VAS), (3)
previous foot surgery or major foot injuries, (4)
diabetes, central or peripheral nervous system
diseases, other musculoskeletal pathology (sciatic
pain, disc herniation, lower limb length discrepan-
cy 4 0.5 cm), (5) inability to follow instructions.
The patients whose arthritis worsened during the
course of the study were excluded.
All the subjects signed an informed consent. The
study was approved by the State Committee for
Medical Ethics (in accordance with the ethical
standards on human experimentation and with the
Helsinki declaration of 1975, as revised in 1983).
The investigations were carried out by the first
author.
Influence of foot orthoses 639
Interventions
The patients were randomly assigned to one of the
two groups (20 patients in each) by a computer. The
group numbers were placed in sequentially num-
bered sealed envelopes, which were opened by the
orthotist responsible for manufacturing of the
orthoses. The patient and the investigator (the first
author) were not informed about the allocation until
the end of the study (a double-blind randomised
controlled trial).
After the first visit, foot orthoses were designed
and manufactured. All the patients also received
deep orthopaedic shoes made of soft leather. This
was to avoid possible influence of different footwear
on the outcomes. The patients allocated to group 1
received unshaped material (UM, completely flat),
made of three layers: cork (Kunstkork1) 6 mm
(Schein orthopadie sevice KG, Remscheid,
Germany), Plastazote1 3 mm and Dynoshaum1
2 mm (Otto Bock HealthCare, Duderstadt, Ger-
many). The orthoses for the patients allocated to
group 2 were made of the same material but custom-
designed and manufactured by standard protocol
with subtalar joint neutral position plaster casting
technique and handmade corrections during casting
(functional orthoses – FO).
Clinical assessment
Basic patient anthropometric data were measured
and their feet were examined (Table I). MTP joint
tenderness was assessed using a two-finger pressure
technique [29].
Plantar pressure measurement
Plantar pressures were recorded in-shoe using the
F-Scan system, version 5.0 (Tekscan). The system
uses an insole constructed from a matrix of 960 force
sensing resistors (25 mm2 cells) embedded in a very
thin Mylar coating. The electrical resistance at each
cell is inversely proportional to the pressure applied
at its surface. The F-Scan allows the measurement of
pressure due to vertical component of ground
reaction force on foot during walking. Spatial
resolution is good enough to identify small features
in the foot. The insole is thin (0.18 mm) and
unobtrusive in the shoe. Sampling rate (up to 165/
s) is adequate for most clinical applications, software
is user-friendly [30]. Because the sensors have been
found to lose accuracy with prolonged use [30], a
new pair of sensor insoles was used for each patient.
The sensors were cut to fit the shoes and calibrated
using body mass as the applied force. All the patients
were given a warm-up period to accommodate to the
sensors and to allow temperature equilibration of the
640 P. Novak et al.

Table I. Patient data.

Mean + standard deviation (range)

UM FO Total

n 20 20 40
Age (years) 56.75 + 11.10 (42–84) 55.70 + 9.37 (35–75) 56.23 + 10.15 (35–84)
RA duration (years) 11.15 + 6.86 (1–25) 10.55 + 8.17 (1–31) 10.85 + 7.45 (1–31)
Height (cm) 164.05 + 4.26 (153–170) 165.35 + 7.58 (153–182) 164.70 + 10.15 (153–182)
Body weight (kg) 72.75 + 13.15 (48–101) 73.80 + 18.81 (46–130) 73.28 + 16.03 (46–130)
BMI 26.67 + 5.16 (18.5–40) 26.85 + 5.17 (18.50–40) 26.76 + 5.10 (18.5–40)
DAS28 4.0 + 0.7 (2.2–5.1) 4.2 + 0.7 (2.7–5.1) 4.1 + 0.7 (2.2–5.1)

Number of painful metatarsal heads Number (percentage)

Left
1 16 (80%) 15 (75%) 31 (78%)
2 18 (90%) 18 (90%) 36 (90%)
3 19 (95%) 19 (95%) 38 (95%)
4 17 (85%) 15 (75%) 32 (80%)
5 11 (55%) 7 (35%) 18 (45%)
Right
1 15 (75%) 16 (80%) 31 (78%)
2 18 (90%) 20 (100%) 38 (95%)
3 19 (95%) 18 (90%) 37 (92%)
4 17 (85%) 16 (80%) 33 (82%)
5 6 (30%) 8 (40%) 14 (35%)

UM, unshaped material group; FO, functional orthoses group; RA, rheumatoid arthritis; BMI, body mass index.

sensors because the data are influenced by the
temperature of the insole [31]. The recording was
performed while the patients walked along an open
corridor at their normal walking speed. At least five
left and right steps were recorded. The system
software (Timing Analysis Module – TAM) was
used to analyse average peak pressures on seven
predetermined spots of each foot (hallux, metatarsal
head I, II, III–IV, V, midfoot and heel). In
accordance with the system manufacturer instruc-
tions, the first and the last step were excluded from
the analysis and the average peak pressures were
computed from the remaining steps [32]. The system
has been proven useful in recognition of certain
biomechanical abnormalities and monitoring pre-
orthotic and postorthotic use [33–35]. Its reliability
has already been proved in diabetic patients and
healthy subjects [34,36]. A high reliability has also
been proven in RA patients as a separate study at our
Institute (and submitted for publication).
Assessment of pain with pain subscale of the foot function
index
The pain subscale of the Foot Function Index (FFI)
was used to assess function (foot pain) [37]. It
consists of nine items measuring the level of foot pain
in a variety of situations. All the items are rated using
a visual analogue scale (VAS). The values obtained
on VAS are scored from 0 to 9. To obtain a sub-scale
score, the item scores are totalled and then divided
by the maximum total possible for all subscale items,
which the patient indicated applicable. Any item
marked as non-applicable is excluded from the total
possible.
Assessment of walking ability with the 6-min walking test
The influence of pain on the patients’ activity
limitation (walking ability) was objectively assessed
by the 6-min walking test. The subjects walked as fast
as possible for 6 min along a marked 70-m long
circular path in a gymnasium and a corridor, but
were not allowed to run. If necessary, they could
stop, sit down and rest and then continue walking.
The walking distance was measured at 5-m intervals.
Validity of the 6-min walking test has been demon-
strated in idiopathic arthritis patients [38].
The plantar pressure measurement, the assess-
ment of pain and the 6-min walking test were
conducted at baseline (first visit), 1 week after the
patient received shoes with orthoses (second visit)
and 6 months after the second assessment (third
visit).
Statistical analysis
Results were analysed using the SPSS 14.0.2 soft-
ware.
The average plantar pressures at painful and non-
painful MTP joints for all the patients were
compared for each foot using paired-samples t-test.

Plantar pressures were analysed as coefficient of
variation (CV) between measurement spots, sepa-
rated by foot. CV is the standard deviation divided by
the mean.
The pain subscale of the FFI was checked for
internal consistency by calculating the Cronbach’s
alpha for each of the three visits.
Difference scores were analysed for the pain
subscale of the FFI, the plantar pressures and the
results of the 6-min walking tests. Normality was
checked for all the difference scores with histograms
and probability plots. Homogeneity of variances was
checked using Levene’s test. One-way analysis of
covariance (ANCOVA) was used with group as
between subject factor and baseline value (first visit)
as covariate.
Whenever no differences in change scores were
found, the overall time-course for the pooled sample
was tested by means of one-way repeated measures
of ANOVA with Bonferroni-type post hoc compar-
isons.
Pearson’s correlation coefficient was used to
assess association between pain subscale score on
the one hand and the results of walking test on the
other.
Results
Demographic and clinical details
Forty patients were included in the study, 38 women
and 2 men. Baseline and the second assessments
were performed in all the participants. One patient in
group 1 underwent foot surgery (hallux valgus
correction) in the period between the second and
the third assessments and was therefore excluded
from further study. However, her data were included
in the analysis of the baseline results and the initial
results of orthothic intervention. The average age of
the patient was 56.23 (SD: 10.15 years, 35–84 years)
and the disease duration 11.85 (SD: 7.45 years, 1–31
years). Most patients reported three or four tender
MTP joints, with no notable differences between the
feet and MTP joints II, III and IV being most
commonly affected (Table I).
Comparison of plantar pressures at painful and
non-painful MTP joints at first visit
The average plantar pressures at painful MTP joints
on both feet were higher (left mean: 240.80, SD:
110.69 kPa; right mean: 207.10, SD: 75.07 kPa)
than at non-painful MTP joints (left mean: 178.31,
SD: 87.87 kPa; right mean: 144.42, SD: 70.11 kPa).
The differences were statistically significant for the
left (p ¼ 0.018) and the right (p 5 0.001) foot
(Figure 1).
Influence of foot orthoses 641
Assessment of plantar pressures redistribution
The CV was used as a measure of effectiveness of
plantar pressures redistribution. A lower CV indi-
cates plantar pressure more equally distributed across
the joints. The differences in the CV of plantar
pressures between the UM and the FO group were
not statistically significant (Figure 2). In general, the
values decreased at the second visit and then returned
towards baseline at the third visit, whereby the
changes were statistically significant for the left foot
(p ¼ 0.036) but not for the right foot (p ¼ 0.601).
FFI
The pain subscale of FFI at the first visit demon-
strated strong internal consistency with the Cron-
bach’s alpha of 0.905. Even higher alphas were
obtained at the second and third visits (0.936 and
0.910, respectively).
Both groups of patients showed reduction of foot
pain at the second and third visits, compared with
baseline examination ( p 5 0.001), with further im-
provement from the second to the third visit
(p ¼ 0.005). Differences between the first and the
second, as well as between the first and the third visit
in the pain subscale score of the FFI were further
analysed. The patients wearing the FO reported
larger improvement than those wearing the UM, but
the differences between the groups were not statis-
tically significant (p ¼ 0.557 and p ¼ 0.328 for
comparing pain at the first and the second, and the
first and the third visit, respectively) (Table II).
The 6-min walking test
Both groups of patients showed notably improved
walking ability at the second as well as at the third
visit compared with the baseline examination
(p 5 0.001), with no difference between the results
of the second and the third visit (p ¼ 1.000). The
differences between the first and the second, as well
as between the first and the third visit were further
analysed. Comparing the first and the second visit,
the patients wearing the FO showed greater im-
provement in the walking test than those wearing the
UM. The difference was marginally significant
(p ¼ 0.076). Comparing the first and the third visit,
the same pattern remained, although the differences
were not statistically significant (Table II).
Correlation between pain subscale of FFI and result of
6-min walking test
At all the three visits there was significant correlation
between the pain subscale score and the results of the
6-minute walking test ( p 5 0.05). The correlations
642 P. Novak et al.

Figure 1. Boxplots for comparison of plantar pressures at painful and non-painful MTP joints for left and right foot. The box represents
interquartile range, which contains the middle 50% of the values. Whiskers are the lines that extend from the box to the highest and lowest
values, excluding outliers. The outliers are the cases with values between 1.5 and 3 box lengths from the upper or lower edge of the box. The
line across the box indicates the median. Circles, outliers; MTP, metatarsophalangeal. The differences were significant ( p 5 0.05).

Figure 2. Boxplots for assessment of differences in coefficient of variation of plantar pressures for left and right foot. The differences between
the groups were not significant ( p 4 0.05). White box, first visit; dark grey box, second visit; light grey box, third visit; circles, outliers; CV,
coefficient of variation; UM, unshaped material; FO, functional orthoses.
 Influence of foot orthoses 643

ranged between 0.352 and 0.554 (moderate correla- forefoot pain reduction and walking ability in RA
tion), being lower at the second visit than at the first patients.
and the third visit (Figure 3). The study demonstrated that the average peak
plantar pressures in RA patients were significantly
higher at the painful than at the non-painful forefoot
Discussion
areas. Previous studies have confirmed the relation-
The purpose of the study was to compare the effec- ship between forefoot pressure and walking pain
tiveness of functional and presumably nonfunctional [12,13].
foot orthoses on plantar pressure redistribution, We proposed that the reduction of increased
plantar pressures on the painful spots could be
attained by their redistribution to foot areas with
Table II. Differences (absolute improvement; mean + standard
deviation) for pain subscale score of the FFI and the results of the lower pressure (by increasing total contact area).
6-min walking test between first and second and first and third Therefore, a difference in the CV of plantar pressures
visit. was chosen as a measure of the effectiveness of
orthotic intervention in this study. However, no
p for group
UM FO effect
differences between the UM and the FO were found.
Only a few investigators have examined the effects of
DFFIpain1–2 8.40 + 16.76 13.15 + 16.72 0.557 foot orthoses on plantar pressure [12,18,20]. A
DFFIpain1–3 13.37 + 22.43 23.30 + 17.10 0.328 beneficial effect of foot orthoses has been shown in
DWT1–2 22.25 + 45.46 45.50 + 38.90 0.076
all of them. However, the methodological approach
DWT1–3 28.95 + 55.32 44.50 + 49.12 0.362
was quite different among the studies. Barrett [18]
FFIpain, pain subscale of Foot Function Index; DFFIpain1–2, used a semi-quantitative test. The other two studies
difference in pain subscale score between first and second visits; compared absolute pressures, but on different plantar
DFFIpain1–3, difference in pain subscale score between first and
spots. Hodge et al. [12] pooled the third, fourth and
third visit; DWT1–2, difference in result of the 6-min walking test
between first and second visit; DWT1–3, difference in result of the fifth metatarsal heads into one measurement spot,
6-min walking test between first and third visits; UM, unshaped whereas Jackson et al. [20] pooled central metatarsal
material group; FO, functional orthoses group. heads (second, third and fourth). Therefore, we

Figure 3. Scatterplot with superimposed regression lines and separate panels by group for correlation between pain subscale score of FFI and
the results of 6-min walking test. Circles and thick solid line, first visit; triangles and thin solid line, second visit; crosses and dotted line, third
visit; UM, unshaped material; FO, functional orthoses; FFI, foot function index.
644 P. Novak et al.
believe that the data from those studies cannot be
adequately compared among themselves or with the
present study. Furthermore, different measurement
systems were used in different studies.
We are convinced that plantar pressures on painful
spots should be reduced, although absolute values
are not necessarily most important. The duration of
the pressure as well as shear forces may also play an
important role.
The study demonstrated that foot orthoses and
orthopaedic shoes are effective in forefoot pain
treatment in RA patients. Both groups of patients
showed reduction of foot pain after one week
compared to the baseline examination with further
improvement 6 months later. The differences be-
tween the groups were not statistically significant.
Different types of foot orthoses were evaluated in
different previous studies [12,18,21–25]. Pain was
assessed in many different ways, at different time
intervals and circumstances. A follow-up was con-
ducted in most of the studies [21–25]. A significant
reduction of foot pain with foot orthoses has been
reported in all the studies, except for the study by
Conrad et al. [21]. Because FO results in our study
tended to be better, it would be justified to conduct a
larger study, which would likely prove their
superiority.
The redistribution of plantar pressures and the
reduction of forefoot pain in the UM group in the
study could be attributed to the soft material as well
as soft deep orthopaedic shoes. By making more
room for the forefoot, pressure on the metatarsal
heads from the side and top could be reduced. A
beneficial effect of extra-depth shoes on foot pain has
already been observed by Fransen et Edmonds [39],
whereas in the study by Chalmers et al. [22], they
were ineffective. As all patients in our study were
given the same type of shoes, the differences between
groups due to footwear were eliminated.
Because the ability to walk long distances is
important for functional mobility, the 6-min walking
test was chosen in the study. Both groups of patients
improved their walking ability after one week as well
as after 6 months compared with the baseline
examination, with no differences between the results
of the second and the third visits. The differences
between the groups were not significant, although
the FO group showed a tendency towards greater
improvement. Again, a larger study could prove the
superiority of FO over UM. The correlation between
the walking ability and the foot pain was moderate
and significant. The test was found to reflect joint
status more than aerobic fitness [38]. The achieve-
ment in the test was found to be associated with foot
pain in diabetic patients [40]. The impact of foot
orthoses on the walking ability of RA patients has
been observed in some previous studies. Various gait
parameters were analysed (stride and step length,
walking speed, cadence, walking time) in short-
distance tests (up to 15 m). Improved walking ability
was demonstrated only by Kavlak et al. [23], whereas
other studies showed no improvement with orthotic
intervention [12,22,24]. It is possible that pain may
not have such impact on short distance as it does on
long distance walking. Furthermore, the 6-min
walking test has been recommended for assessment
of locomotor ability of RA patients [41].
The improvement in the 6-min walking test with
both test groups can be partly attributed to the
reduction of foot pain. Hence, by prescribing proper
foot orthoses (and shoes) we can reduce foot pain
and consequently improve patients’ activity and
participation.
Conclusions
1. Plantar pressures in RA patients are signifi-
cantly higher at painful than at non-painful
foot areas.
2. Redistribution of plantar pressures was noted
with the FO as well as with the UM. However,
no statistically significant difference in plantar
pressure redistribution was found between the
groups.
3. Notable reduction of pain and improvement
of activity (walking ability) was observed, with
no significant differences between the groups.
4. Foot pain has moderate impact on the walking
ability of RA patients.
5. A larger study is indicated, which would likely
prove the superiority of the FO over the UM.
Declaration of interest: The authors report no
conflicts of interest. The authors alone are respon-
sible for the content and writing of the paper.
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