Title {1} | PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients with risk factors of developing chronic pain in Germany |
Trial registration {2a and 2b} | The trial PAIN2.0 has been registered in the German Clinical Trials Register (DRKS) since 21/11/2022 with the ID DRKS00030773 [1] |
Protocol version {3} |
Date and version identifier: • Study protocol vs1.0 14/07/2022: Original • Study protocol vs1.1 06/12/2022: Minor changes concerning randomisation • Study protocol vs1.2 19/12/2022: Amendment to ethical and legal aspects The latest version of the study protocol (version 1.2 dating from 19/12/2022) serves as basis of this publication. |
Funding {4} | The study is funded by the German Federal Joint Committee’s Innovation Fund (Innovationsausschuss beim G-BA, Postfach 120606, 10596 Berlin, Germany, grant number 01NVF20023) from April 1st 2022 to March 31st 2025. |
Author details {5a} |
Sandra Meyer-Moock, Institute for Community Medicine, University Medicine Greifswald, Germany Daniel Szczotkowski, Institute for Community Medicine, University Medicine Greifswald, Germany Leonie Schouten, Department of Anaesthesiology, University Medical Centre Göttingen, Germany Frank Petzke, Department of Anaesthesiology, University Medical Centre Göttingen, Germany Lena Milch, German Red Cross Pain Centre Mainz, Germany Beatrice Metz-Oster, German Red Cross Pain Centre Mainz, Germany Louise Zinndorf, German Red Cross Pain Centre Mainz, Germany Christian Geber, German Red Cross Pain Centre Mainz, Germany Greta Hoffmann, University Pain Centre, University Hospital Carl Gustav Carus Dresden, Germany Anke Preißler, University Pain Centre, University Hospital Carl Gustav Carus Dresden, Germany Ursula Marschall, BARMER, Wuppertal, Germany Felix Rottke, German Pain Society, Berlin, Germany Anja Waidner, German Pain Society, Berlin, Germany André Möller, German Pain Society, Berlin, Germany Thomas Isenberg, German Pain Society, Berlin, Germany Gabriele Lindena, CLARA Klinische und Versorgungsforschung, Kleinmachnow, Germany Anne Gärtner, University Pain Centre, University Hospital Carl Gustav Carus Dresden, Germany Ulrike Kaiser, University Hospital Schleswig–Holstein/Lübeck, Germany Thomas Kohlmann, Institute for Community Medicine, University Medicine Greifswald, Germany |
Name and contact information for the trial sponsor {5b} | n/a There is no “sponsor” of the trial as it does not include medication or medical device investigations |
Role of sponsor {5c} | The funding body has no role in the design of the study and will not have any role during the collection, analysis, interpretation of data, and writing the manuscript. |