Lateral wedges - a crossover study
plus arch support resulted in significant
improvements in all parameters, whilst the
lateral wedges alone did not significantly
change any clinical outcome. However, these
differences generally did not translate into
significant treatment main effects (between
conditions), with the exception of timed stair
climb, where improvements were significantly
greater with the use of the lateral wedges with
arch support compared to lateral wedges alone
(p=0.02). In addition, a significant period effect
(Figs. 2 and 3) was seen for WOMAC Pain scores
(p=0.04). There were no intervention by period
interactions.
Using a minimal clinically important
improvement of 17% for WOMAC pain and 12%
for WOMAC function [29], use of lateral wedges
alone resulted in improved pain in 13 (54%)
participants and improved function in 14 (58%)
participants. When using the lateral wedges
plus arch support, 14 (64%) participants had
improved pain while 17 (77%) participants had
improved physical function.
Wear times were similar between the two
treatment periods, whether expressed as
absolute or relative time values. The mean (sd)
number of hours that participants self-reported
insole wear was 150.7 (86.5) hours for the lateral
wedges and 152.5 (121.0) hours for the lateral
wedges plus arch support over the two-month
intervention periods, which equated to 72.5
(19.2)% and 75.8 (24.4)% of total shoe wear
time, respectively. There were no differences
(p=0.55) in self-reported comfort between the
two conditions (lateral wedges=6.4 (2.6) out
of 10; lateral wedges plus arch support=6.9
(2.5) out of 10). More participants indicated
that they preferred their “first insole” (13/22)
30
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than their “second” (9/22), which translated
into more individuals preferring the lateral
wedges plus arch support (17/22; of these 17,
10 participants were randomized to the lateral
wedges plus arch support first, while the other
7 received the lateral wedges plus arch support
second). When asked to report overall change in
symptoms compared to baseline, 15 individuals
reported improvement with lateral wedges
alone (7=“much better”, 8= “slightly better”)
while 18 individuals reported improvement with
the lateral wedges plus arch support (9=“much
better”,9=“slightly better”).
A total of 16 unique, yet minor, adverse events
were self-reported during the study, 11 of which
occurred during lateral wedges wear and five
during lateral wedges plus arch support wear.
With lateral wedges alone, the most common
complaint was onset of foot pain or discomfort
(n=3), which lasted between one and three
weeks. There were two reports of increased
bunion pain, one lasting two weeks and the
other for the duration of the intervention. Other
complaints included: five weeks of toe cramping
(n=1), three weeks of lateral ankle pain (n=1),
one week of calf tightness (n=1), generalized
lower leg pain lasting three days (n=1), and one
report each of lower back and knee pain lasting
one and ten weeks, respectively. During lateral
wedges plus arch support wear, five individuals
reported foot pain or discomfort ranging from
two days to two weeks. Finally, three individuals
underwent additional treatment during lateral
wedges use (two instances of topical pain relief
gel and one instance of foot and lower leg
massage), while the same two treatments were
completed by another two individuals during
lateral wedges plus arch support wear.