Baseline demographic information was collected and
The control insoles were made of easily compressible low density ethyl vinyl acetate but with no wedging (Foot Function, New Zealand).Outcome measuresA blinded examiner assessed the participants at baseline and 12 months. In participants with bilateral knee osteoarthritis the most symptomatic eligible knee was assessed. Baseline demographic information was collected and participants rated their expectation of a beneficial effect with insole treatment on an ordinal scale from 1 to 5 (0=no effect at all, 5=complete recovery), with higher scores indicating higher expectations.Symptomatic measuresThe primary symptomatic measure was overall average knee pain (past week) using an 11 point numerical rating scale (0=no pain, 10=worst pain possible).19 This has well accepted clinimetric properties and is widely used and recommended for clinical trials on knee osteoarthritis.19 20 21 22Secondary symptomatic measures included pain on walking (measured on the 11 point scale), pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities osteoarthritis index,23 assessment of quality of life instrument,24 and patient perceived global change in pain and in physical function (compared with baseline) measured on a 5 point ordinal scale and dichotomised into improvement (slightly better and much better) and no improvement (much worse, slightly worse, and no change).
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