This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. With a myriad of potential compounds that may be beneficial in neuropathic pain, a more efficient way of demonstrating proof-of-activity (POA) is needed. In order to decrease the number of patients required for the POA study, a more homogeneous population of patients is needed. In addition, endpoints with less variability will also decrease the number of patients required. In this study, the effects of gabapentin, tramadol, and placebo are compared in a gabapentin-responsive, small fiber predominant neuropathy patient population using a crossover design. In this design, gabapentin takes the role of active comparator and tramadol takes the role of the experimental compound. The variability and effect size of several endpoints including pain intensity and temporal summation will be compared. The purpose of this study is to validate the study design and endpoint instruments for use in future POA studies.
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