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Abstract
The purpose of the study was to examine the clinical efficacy of individually prescribed
laterally wedged orthoses and walking shoes in the treatment of medial knee osteoarthritis
using a prospective, single-blind, block-randomized controlled design. Sixty-six subjects
(29 males, 37 females, mean age 62.4 years, mean BMI 33.0 kg/m(2)) were block-randomized
to a lateral wedge (treatment) or neutral (control) orthotic group. Both groups were
issued a standardized walking shoe for use with the orthoses. Primary outcome measures
included the pain, stiffness, and functional limitations subscales of the Western
Ontario and McMaster Universities index. Secondary outcome measures included the 6-minute
walk distance and pain change, and stair negotiation time and pain change. A significant
interaction (p=0.039) favoring the treatment group was observed for pain change during
the 6-minute walk. The treatment group demonstrated significant improvements at both
1 month (p<0.001) and 1 year (p<0.001) compared to baseline. The control group only
demonstrated significant improvements at 1 year (p=0.017). No other interactions were
observed. Both groups were improved at each follow-up in the WOMAC subscales for pain
(p<0.001), stiffness (p<0.001), and physical function (p<0.001). Both groups also
improved in 6-minute walk test distance (p<0.001), stair negotiation test time (p=0.004),
and stair negotiation test pain change (p<0.001). The results suggest that both neutral
and laterally wedged orthoses may be beneficial in the management of medial knee osteoarthritis
when used with walking shoes. However, the addition of lateral wedging was associated
with early improvements in 6-minute walk test pain change not seen in the control
group.