Randomized cross-over evaluation of investigator gender on pain thresholds in healthy volunteers.

Abstract

Background and aims: This randomized cross-over study in healthy volunteers was designed primarily to evaluate the potential impact of investigator gender on electrical pain threshold (EPT) and corresponding pain intensity levels, and secondly to evaluate potential differences in those interventions between female and male study participants. Methods: Forty adult volunteers (22 females) were included. An electrical stimulation device was used to determine EPT levels (in pain magnitude scores) in series of three in each study participant - once by a female, and once by a male investigator - according to a predefined cross-over design schedule. Corresponding levels of pain intensity were scored on a visual analog scale (VAS) slide ruler. Results: Study data was obtained and analysed in all participants. Significantly higher EPT levels were determined by the female investigator compared with the male investigator (median 22 (IQR 12-31) vs. 8 (6-10) pain magnitude scores; p<0.0001), despite similar levels of reported pain intensity (1.9 (1.2-3.0) vs. 2.0 (1.1-3.4) VAS units; p>0.300). There were no differences in EPT levels between female and male subjects evaluated by female (p>0.300) and male (p=0.125) investigators, or between the first and second series of stimulation (p>0.300). Conclusions: Our finding of significantly higher EPT levels when study participants of both genders - despite no difference in reported pain intensity - were evaluated by a female than by a male investigator, indicates a potential impact of investigator gender on the individual perception of pain. Implications: By contributing to a better understanding of how individual pain threshold levels are potentially influenced by investigator gender, this study might facilitate future evaluation of pain conditions in both preclinical and clinical settings.