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Background: Up to 27% of the German population suffers from recurrent or persistent pain (lasting more than three months). Therefore, prevention of chronic pain is one major object of pain management interventions. The aim of this nationwide, multicentre, randomised controlled trial is to evaluate the efficacy of a 10-week ambulatory (outpatient) interdisciplinary multimodal pain therapy (A-IMPT) for patients with recurrent pain and at risk of developing chronic pain. This project was initiated by the German Pain Society (Deutsche Schmerzgesellschaft e.V.) and the public health insurance provider BARMER. It is currently funded by the German Innovation Fund (01NVF20023). The study PAIN2.0 focuses on reducing pain intensity and pain-related disability and investigates whether this intervention can improve physical activity, psychological well-being, and health literacy., Methods: PAIN2.0 is designed as a multicentre 1:1 randomised controlled trial with two parallel groups (randomisation at the patient level, planned N = 1094, duration of study participation 12 months, implemented by 22 health care facilities nationwide). After 6 months, patients within the control group also receive the intervention. The primary outcomes are pain intensity and pain-related impairment, measured as Characteristic Pain Intensity (PI) and Disability Score (DS) (Von Korff), as well as patient-related satisfaction with the intervention. Secondary outcomes are the number of sick leave days, sickness allowance, treatment costs, psychological distress, health-related quality of life, and catastrophizing. The effects of the intervention will be analysed by a parallel-group comparison between the intervention and control groups. In addition, the long-term effects within the intervention group will be observed and a pre-post comparison of the control group before and after the intervention will be performed., Discussion: 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 ., (© 2024. The Author(s).)

The current healthcare provision in Germany is established, in particular, for the diagnostics and treatment of chronic pain conditions; however, the current aim is to initiate the diagnostic and therapeutic approaches oriented towards the biopsychosocial pain model in the early stages of pain, i.e. before the onset of chronification, for patients with pain and a risk of chronification in order to actively avoid chronification processes. In this context, multiple risk factors play an important role for the diagnostic and therapeutic approaches as well as for the interdisciplinary multimodal pain therapy developed for this purpose. The Global Year of the International Association for the Study of Pain (IASP) 2020 addressed the prevention of (chronic) pain, a welcome opportunity to provide a short review of the evidence for and clinical experiences with timely diagnostic and therapeutic options and to summarize the current framework conditions and scientific recommendations for Germany. At the end of this article the implications for future research are summarized, particularly for the treatment of patients with pain and risk of chronification.