Lateral wedges - a crossover study
during the active treatment periods (months 0
to 2 and 4 to 6) in their daily log books. At the
month 2 and month 6 assessments, participants
rated comfort during the intervention using
an 11-point NRS with terminal descriptors of
0=“maximum discomfort” and 10=“maximum
comfort”. Participants also rated their perceived
overall change in symptoms at follow-up (month
2 and 6) compared to baseline (month 0 and 4)
using a 5-point Likert scale (1=“much worse”,
2= “slightly worse”, 3= “no change”,4=“slightly
better”, and 5=“much better”). Finally, at the
month 6 assessment, participants indicated
which pair of insoles (“first or second”) they
preferred.
STATISTICAL ANALYSIS
All statistical analyses were conducted using
Statistical Analysis Software (SAS, v 9.4; SAS
Institute Inc.: Cary, NC, USA) and p values <0.05
were considered significant. For WOMAC,
FFI-R and timed stair climb outcomes, change
scores were calculated as follow-up minus
baseline values for each intervention period. As
comfort data were only acquired at the follow-
up assessments, these were treated as raw
data rather than change scores. Mixed effects
regression models predicting change variables
against fixed effects for intervention period and
treatment type, and a random subject effect
were developed for each outcome variable.
TABLE 1: Participant characteristics at baseline based on order of intervention. Values are mean (sd) unless otherwise noted
Wedge to Wedge plus arch support
(n = 12) Wedge plus arch support to Wedge
(n = 14) All participants
(n = 26)
Age (years) 66.3 (10.2) 62.1 (5.0) 64.0 (7.6)
Sex (F:M) 9:3 13:1 22:4
Foot Posturea 5 (4,8) 5 (4,9) 5 (4,9)
Body Mass (kg) 65.3 (9.8) 75.0 (15.3) 70.5 (13.8)
BMI (kg/m 2 ) 25.2 (3.0) 28.9 (4.5) 27.2 (4.2)
KL 2 9 7 16
KL 3 3 7 10
Disease Severity (n)
a As quantified by the foot posture index (FPI). Values are reported as median (minimum, maximum)
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