• Janne Gierthmühlen, Elena K Enax-Krumova, Nadine Attal, Didier Bouhassira, Giorgio Cruccu, Nanna B Finnerup, Maija Haanpää, Per Hansson, Troels S Jensen, Rainer Freynhagen, Jeffrey D Kennedy, Tina Mainka, Andrew S C Rice, Märta Segerdahl, Søren H Sindrup, Jordi Serra, Thomas Tölle, Rolf-Detlef Treede, Ralf Baron, and Christoph Maier.
• aDivision of Neurological Pain Research and Therapy, Department of Neurology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany bDepartment of Neurology, BG University Hospital Bergmannsheil GmbH, Ruhr-University Bochum, Bochum, Germany cDepartment of Pain Medicine, BG University Hospital Bergmannsheil GmbH, Ruhr-University Bochum, Bochum, Germany dINSERM U-987, Centre d'Evaluation et de Traitement de la Douleur, CHU Ambroise Paré, Boulogne-Billancourt, France eUniversité Versailles-Saint-Quentin, Versailles, France fDepartment Neurology and Psychiatry, Sapienza University, Roma, Italy gDepartment of Neurology and Danish Pain Research Center, Aarhus University Hospital, Aarhus, Denmark hDepartment of Neurosurgery, Helsinki University Central Hospital, Helsinki, Finland iEtera Mutual Pension Insurance Company, Helsinki, Finland jDepartment of Pain Management and Research, Oslo University Hospital, Oslo, Norway kDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden lDepartment of Anaesthesiology, Critical Care Medicine, Pain Therapy & Palliative Care, Pain Center Lake Starnberg, Benedictus Hospital, Tutzing, Germany mNeuroscience Discovery Research, Eli Lilly and Company, Indianapolis, IN, USA nPain Research, Department of Surgery and Cancer, Imperial College, London, United Kingdom oH. Lundbeck A/S, Copenhagen, Denmark pDepartment of Physiology and Pharmacology, Karolinska Institute, Stockholm, Sweden qDepartment of Neurology, Odense University Hospital, Odense, Denmark rNeuroscience Technologies, Barcelona, Spain sDepartment of Neurology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany tChair of Neurophysiology, Center of Biomedicine and Medical Technology Mannheim CBTM, Medical Faculty Mannheim, Heidelberg University, Germany (T. Mainka is now with the Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany).
• Pain. 2015 Nov 1; 156 (11): 2203-11.

AbstractClinical and human experimental pain studies often include so-called "healthy" controls in investigations of sensory abnormalities, using quantitative sensory testing (QST) as an outcome measure. However, the criteria for what is considered "healthy" vary among the different studies and between study centers and investigators, partly explaining the high variability of the results. Therefore, several aspects should be considered during inclusion of healthy volunteers in QST-based trials to have homogenous groups of healthy controls with less variability between human experimental studies, so that results are less likely to be false negative or false positive because of subject-related factors. The EUROPAIN and NEUROPAIN consortia aimed to define factors influencing the variability in selection of healthy subjects in QST-based studies before the start of both projects and to give recommendations how to minimize it based on the current literature and expertise of the participants. The present suggestions for inclusion criteria of healthy volunteers into QST-based trials describe a 2-level approach including standardized questionnaires enabling the collection of relevant information on sociodemographic data, medical history, current health status, coping strategies in dealing with pain, and the motivation of the volunteer to participate in the study. These suggestions are believed to help researchers interpret their results in comparison with others and improve the quality of clinical studies including healthy volunteers as controls or in human experimental pain studies. They aim to reduce any confounding factors. Furthermore, the acquired information will allow post hoc analyses of variance for different potential influencing factors.

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