BACKGROUND AND PURPOSE: Exercise therapy and functional foot orthoses are commonly used for treatment of knee pain. This pilot study aimed to examine the reliability and validity of outcome measures and get preliminary indication of the effectiveness of three interventions to reduce anterior-medial knee pain: exercise regime for the knee, functional foot orthoses or a combined foot orthoses and exercise regime. SUBJECTS: 27 males and females with anterior-medial knee pain. METHOD: "Pilot" randomised trial with three interventions, comparing changes from before to after in aneight week study. Subjects were randomized into an exercise group, orthoses group or a combined group of exercise and orthoses. Main outcome measures were: Global outcome score, knee pain visual analogue scale, transfer and ambulation intensity scales and the SF-36 physical function and pain scales. RESULTS: All outcome measures demonstrated acceptable one-week intratester reliability (ICCs > 0.80). Differences in outcome measures' scores from baselineto four and eight weeks were calculated for each treatment group. There were no significant differences in change of scores of all outcome measures between the three treatments using Kruskal-Wallis analysis and one way ANOVA. Nevertheless, there was a trend for greater improvement in pain and disability in the combined group. CONCLUSIONS AND DISCUSSION: The pilot study lacked statistical power to detect differences between the three groups of treatments due to a small sample size. However, the methods used appeared to be reliable and valid. It is suggested that a further larger study comparing combination therapy to orthoses is worthwhile.

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