Physiotherapy - Research Publications
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ItemEffects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial(BMC, 2007-09-24)BACKGROUND: Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA. METHODS/DESIGN: Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. DISCUSSION: Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA. TRIAL REGISTRATION: ACTR12605000503628; NCT00415259.
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ItemLaterally wedged insoles in knee osteoarthritis: do biomechanical effects decline after one month of wear?(BMC, 2009-11-25)OBJECTIVE: This study aimed to determine whether the effect of laterally wedged insoles on the adduction moment in knee osteoarthritis (OA) declined after one month of wear, and whether higher reported use of insoles was associated with a reduced effect on the adduction moment at one month. METHODS: Twenty people with medial compartment OA underwent gait analysis in their own shoes wearing i) no insoles and; ii) insoles wedged laterally 5 degrees in random order. Testing occurred at baseline and after one month of use of the insoles. Participants recorded daily use of insoles in a log-book. Outcomes were the first and second peak external knee adduction moment and the adduction angular impulse, compared across conditions and time with repeated measures general linear models. Correlations were obtained between total insole use and change in gait parameters with used insoles at one month, and change scores were compared between high and low users of insoles using general linear models. RESULTS: There was a significant main effect for condition, whereby insoles significantly reduced the adduction moment (all p < 0.001). However there was no significant main effect for time, nor was an interaction effect evident. No significant associations were observed between total insole use and change in gait parameters with used insoles at one month, nor was there a difference in effectiveness of insoles between high and low users of the insoles at this time. CONCLUSION: Effects of laterally wedged insoles on the adduction moment do not appear to decline after one month of continuous use, suggesting that significant wedge degradation does not occur over the short-term.