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 Ger

Recurrent or persistent pain is common in the German population and causes high costs for patients and society. The A-IMPT aims to improve pain and pain-related impairments in pain patients at risk of chronification, thereby reducing the risk of developing chronic pain with its high socioeconomic burden. This new therapy could easily be integrated into existing therapy programs if positively evaluated. Trial registration The trial PAIN2.0 has been registered in the German Clinical Trials Register (DRKS) since 21/11/2022 with the ID DRKS00030773 [ https://drks.de/search/de/trial/DRKS00030773 ]. This publication provides an update to the original study protocol, which was first published on 23 February 2024 [https://doi.org/10.1186/s13063-024-07975-4, BMC Trials]. Due to recruitment problems during the course of the project, the originally planned number of cases could not be achieved. In order to be able to provide sufficient information about the primary effects of the study, the number of primary endpoints was reduced from 3 to 2. The primary analysis period is now 6 months without including an additional measurement point after 3 months.