Skip to main content
. 2024 Feb 23;25:145. doi: 10.1186/s13063-024-07975-4
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.