Randomized Trial of
Custom Orthoses and Footwear
on Foot Pain and Plantar
Pressure in Diabetic
Peripheral Arterial Disease
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Many
patients with diabetes have
concomitant PAD and
subsequent pain associated
with PAD. These patients are
usually instructed to walk
for exercise, but often do
not comply due to pain.
Since this population
frequently develops chronic
pain, intermittent
claudication, loss of
mobility and function,
research to assess treatment
for the related foot pain is
imperative. The goal of this
study was to determine the
impact of using custom
orthoses on foot pain and
plantar pressure in diabetic
patients with PAD.
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N = 61
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Presence
of diabetes with PAD and weight
bearing musculoskeletal pain of
greater than 6 months
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Two
groups: custom foot orthoses
group and sham insole group
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Both
groups received New Balance W575
athletic footwear
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Data
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Pedar-X
in shoe system to measure
pressure
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Foot
Health Status Questionnaire
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Other
measures: toe-brachial
index, average daily steps,
disability,
patient-perceived comfort
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Follow up
at 8 weeks
RESULTS
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Significant decrease in pressure
beneath the whole foot, rearfoot
and forefoot with custom
orthotic group
Both
conditions improved foot pain
but the difference was not
significant
Both
conditions improved foot
function but the difference was
not significant
Significant decrease in pain was
noted in patients with pre-trial
footwear that was non-fixated
(slip-on)
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Significance of the
Article
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The study showed that
"custom foot orthoses
significantly reduced
plantar pressure compared
with the sham". In both
groups, pain and function
improved with use of
suitable footwear and some
form of insole or orthotic.
Ironically, although the
shoes were not the intended
focus of the study, some
important findings were
described. Both groups
experienced decreased pain
with using the standardized
shoes only. In addition,
subjects who had worn
slip-on shoes before the
study showed significant
improvement in pain after
wearing the study shoes for
8 weeks.
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Significance for
Orthotic Therapy
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Inclusion of
footwear
evaluation and
modification in
conjunction with
orthotic use is
an important
component of
treating the
diabetic/peripheral
arterial disease
population to
assure an
improvement in
quality of life,
as well as
pressure
reduction and
pain reduction.
Selecting a
proper stable
shoe along with
a custom
orthosis for
treatment of
patients with
diabetes and PAD
can
significantly
reduce plantar
pressure and
pain. Note that
only one custom
orthosis type
and one shoe
type were tested
in this study.
Since
manufacturing
design and
materials for
shoes and
orthotics can
vary in
characteristics
such as
shock-absorption,
stability and
compression,
results may
differ. It is
essential that
practitioners
pay attention to
both shoe and
orthotic
variables when
treating this
population.
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