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.

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 .

[Development of two outpatient interdisciplinary group modules in the treatment of patients with pain and risk of chronification]. / Entwicklung zweier ambulanter gruppentherapeutischer interdisziplinärer Therapiemodule in der Behandlung von Patienten mit Schmerzen und Chronifizierungsrisiko.

BACKGROUND AND OBJECTIVE: An early treatment of patients who suffer from pain and show risk factors for chronification is meaningful as these patients can benefit from an early interdisciplinary multimodal pain treatment (IMST). In view of the insufficient treatment, two outpatient treatment modules for the secondary prevention of pain chronification are developed within the framework of PAIN2020: the educative and accompanying IMST (E­IMST and B­IMST). MATERIAL AND METHODS: The developmental process of both IMSTs is presented. In this context two target groups of patients were defined for which 1 session (E­IMST) or 10 intervention appointments (B­IMST) were planned, depending on the chronification, impairment and complexity of the disorder. The conception was carried out in five steps: development of the objectives, development of the main contents, workshop on the content and conceptional design (contents, mediation, exercises), preparation of a time schedule and processing of the results (manual, presentations, worksheets, handbook). The B­IMST was initially developed from which the contents for the E­IMST were subsequently extracted. Additionally, a concept for testing the feasibility and a working model for a pilot study were developed. RESULTS: The objectives for both forms of IMST are improvement of the understanding of pain and contributing factors, the increase of the experience of control and self-efficacy and the increase in self-responsibility with respect to strategies to reduce pain. Differences between the two treatment modules arise from the needs and framework conditions. Medical, physiotherapeutic and psychotherapeutic contents and schedules were organized for both IMST modules. The B­IMST consists of five modules each with two sessions as group interventions (biopsychosocial model, activation planning, regulation of needs, sleep and medication, routine transfer). The 3­h E­IMST group intervention mainly intends to mediate knowledge on pain and the biopsychosocial pain model. Theoretical and practical interventions, empirical knowledge and experience-oriented methods are employed. CONCLUSION: There are now two interdisciplinary structured manuals for the secondary preventive treatment of patients with recurrent pain and a risk profile for chronification. These approaches must now prove themselves with respect to feasibility and effectiveness.