Sensory profiling, subgroups and the impact on power calculations

Sensory profiling in the form of quantitative sensory testing is a psycho-physical method to assess the function of the nervous system, in form of both loss of function (i.e. hypaesthesia) and gain of function (hyperalgesia and allodynia). Using the comprehensive protocol of the German Research Network on Neuropathic pain, three international consortia collected data from over 1,000 patients suffering from peripheral neuropathic pain, from which three emerging phenotypes emerged. These data did not only match prior hypothesized phenotypes but could also be reproduced in a dataset of human surrogate models with well described mechanisms. Following the updated guidelines from the European Medicines Agency EMA, trials on neuropathic pain can use these phenotypes to stratify for subgroups of interest, for which a method and power calculation method will be presented.