Saturday, August 13, 2005

The placebo effect of foot orthoses

We all know about the possible placebo effect of our treatments etc etc, but tend not to pay a great deal of attention to it...We have a plantar fasciitis RCT in press at the moment - subjects randomised to one of 3 "inserts" (all of which can be purchased from a retail pharmacy) - these are devices that I would never consider using clinically (they are that bad) ..... to our dismay all but 3 of the subjects got better - the world did not end then....Now just finished the number crunching on a second plantar fasciitis RCT. One group got the comfort model of Formthotics (not the regular one most use) and the other group got the same, but they were modified depending on the presence of risk factors for plantar fasciitis according to a strict protocol (ie tight calf muscles (lunge <38> heel raise; high force to establish windlass --> lateral column elevation; etc) --- we would have thought that this time we would find some differences .... but no - there was no difference between the two groups and everyone showed some symptomatic improvement ..... now you can see why I am in a "mood".At the end of the day, I just now think that when it comes to clinical trials with foot orthoses, that the placebo effect and Hawthorne effects are so powerful, everyone seems to get better .... this is forcing me to have a major rethink about how we really should be designing our foot orthoses clinical trials.

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