Lateral wedges - a crossover study
Interactions between intervention period
and treatment type were initially included as
predictors in a second model, then dropped
from the models if non-significant (this was true
for all models).
RESULTS
Between July 2014 and June 2015, 127
individuals underwent eligibility screening,
of which 26 were enrolled. Participant
demographics are summarized in Table 1.
Fourteen individuals were randomized to
receive the lateral wedge plus arch support
in the first iteration (months 0-2), while 12
participants received the lateral wedges alone
in the first iteration. Twenty-four individuals
completed their first allocated treatment period,
and of those, 22 completed month 6 assessment.
Of the four participants who did not complete
the study, three were lost-to-follow-up (one
prior to the month 2 follow-up assessment, one
after the month 4 baseline assessment, and one
prior to the month 6 follow-up assessment),
while the fourth withdrew prior to the month
2 follow-up assessment due to health issues
unrelated to the study. Mean (sd) intervention
times were 2.2 (0.2) months for the lateral
wedges and 2.1 (0.2) months for the lateral
wedges plus arch support, with a washout
period of 2.1 (0.3) months.
Table 2 provides results for clinical outcomes
across test conditions. The lateral wedges
Table 2: Outcomes data. Mean (sd) baseline and follow-up outcome data for all variables, as well as model adjusted
differences (follow-up minus baseline; difference (95% confidence intervals)) within each condition as well as between
conditions. Model estimate values represent the within- and between-condition least-square mean differences adjusted for
period and random subject effects from the regression modeling
Lateral wedges (n = 24)
Lateral Wedges plus Arch Support (n =
22)
Between
conditions
comparison
Variable Baseline Follow-up Difference Baseline Follow-up Difference Difference
WOMAC Pain (0-20) 5.9 (3.0) 5.2 (2.9) -0.7 (-1.8,
0.5) 6.3 (3.4) 4.0 (2.5) -1.9 (-3.1,
-0.6)* -1.2 (-2.9,
0.5)
WOMAC Function (0-68) 20.2
(11.0) 17.6 (8.9) -2.5 (-6.2,
1.1) 21.4
(12.5) 14.0 (8.8) -6.1 (-9.9,
-2.3)* -3.6 (-7.9,
0.8)
FFI-R Pain (25-100%) 41.0
(17.4) 38.4 (11.9) -2.7 (-8.9,
3.5) 43.6
(16.2) 33.0 (9.3) -7.0 (-13.5,
-0.6)* -4.3 (-12.0,
3.4)
FFI-R Stiffness (25-100%) 39.2
(15.7) 37.1 (13.7) -2.1 (-7.3,
3.0) 42.8
(19.5) 32.3 (9.4) -6.3 (-11.7,
-0.9)* -4.1 (-11.0,
2.7)
Stair climb (seconds) 5.32
(1.68) 5.35 (1.54) 0.04
(-0.55,
0.63) 6.57
(4.04) 5.58 (2.29) -0.69 (-1.3,
-0.08)* -0.73 (-1.36,
-0.11)*
* p < 0.05
Current Pedorthics | January/February 2019
27