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.

"Declarations Ethics approval and consent to participate {24}Ethics approval for this study was obtained from the following ethics committees:Lead ethics committee/first vote:• Universität zu Lübeck with a letter of confirmation dating from 11/08/2022 (Project No: 22–248)Second vote/Adoption vote:• Ethikkommission der Ärztekammer Hamburg with a letter of confirmation dating from 24/10/2022 (Project No: 2022-200597_BO-bet)• Ethik-Kommission der Universitätsmedizin Göttingen with a letter of confirmation dating from 02/11/2022 (Project No: 8/11/22 Ü)• Ethik-Kommission bei der Landesärztekammer Hessen with a letter of confirmation from 23/11/2022 (Project No: 2022–3176-zvBO)• Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen with a letter of confirmation from 24/01/2023 (Project No: 22-10995_BO)• Ethik-Kommission der Albert-Ludwigs-Universität Freiburg with a letter of confirmation from 29/11/2022 (Project No: 22–1443-S1-AV)• Ethikkommission der Ärztekammer des Saarlandes with a letter of confirmation from 29/11/2022 (Project No: 239/22)• Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität with a letter of confirmation from 29/11/2022 (Project No: 2022–771-b-S) and a further letter of confirmation about the addition of another consortium partner from 04/07/2023 (Project No: 2022–771-b-S)• Ethik-Kommission der Medizinischen Fakultät der Ruhr Universität Bochum with a letter of confirmation from 01/12/2022 (Project No: 22–7703)• Ethikkommission der Medizinischen Fakultät der Universität Heidelberg with a letter of confirmation from 07/12/2022 (Project No: S-706/2022)• Ethik-Kommission der Landesärztekammer Rheinland-Pfalz with a letter of confirmation from 12/12/2022 (Project No: 2022–16771)• Ethik-Kommission der Universität Würzburg with a letter of confirmation from 13/12/2022 (Project No: 206/22_z) and confirmation of change from 31/01/2023• Ethikkommission der Medizinischen Hochschule Hannover with a letter of confirmation from 16/12/2022 (Project No: 10675_BO_K_2022)• Ethik-Kommission der Ärztekammer Nordrhein with a letter of confirmation from 23/12/2022 (Project No: 2022365)• Ethikkommission an der Universitätsmedizin Rostock with a letter of confirmation from 14/12/2022 (Project No: A 2022–0192)• Ethikkommission University Hospital Carl Gustav Carus Dresden with a letter of confirmation from 01/02/2022(Project No: BO-EK-483112022) Consent for publication {32}Not applicable. Competing interests {28}The authors declare that they have no competing interests. Competing interests {28} The authors declare that they have no competing interests."

"Funding {4} Open Access funding enabled and organized by Projekt DEAL. 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 1 April 2022 to 31 March 2025. The Study Protocol has undergone full external peer review by the funding body as part of the peer review process. 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. Gemeinsame Bundesausschuss,01NVF20023 "

"Trial registration The trial PAIN2.0 has been registered in the German Clinical Trials Register (DRKS) since 21/11/2022 with the ID DRKS00030773."