The sham of shams in orthotic research exposed

There continues to be much debate about the benefit of orthotics (insoles) in ameliorating common foot and ankle issues. The best way to study this is in a randomised controlled trial where a patient is either given the treatment insole or a fake insole (sham) acting as the placebo. Any improvement in symptoms in the treatment group can then be attributed to the treatment insole use.

In this recent article @EileenTomorrow @TimTheologis and myself have highlighted that most studies that use a sham insole as a placebo have not tested whether a) patients can tell the difference or not or b) whether it actually may have a treatment effect. As such we are not sure how well we can trust the results of these studies.

Ultimately we advocate a proper validation of whether a sham insole is truly a sham before the study is undertaken. This will bring us a step closer to understanding whether insoles really work!

Link to article:-

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