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Open Access 01-12-2024 | Public Health | Study protocol

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

Authors: Sandra Meyer-Moock, Daniel Szczotkowski, Leonie Schouten, Frank Petzke, Lena Milch, Beatrice Metz-Oster, Louise Zinndorf, Christian Geber, Greta Hoffmann, Anke Preißler, Ursula Marschall, Felix Rottke, Anja Waidner, André Möller, Thomas Isenberg, Gabriele Lindena, Anne Gärtner, Ulrike Kaiser, Thomas Kohlmann

Published in: Trials | Issue 1/2024

Abstract

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.

German Clinical Trials Register. https://drks.de/search/de/trial/DRKS00030773. Accessed 13 Sept 2023.

International Association for the Study of Pain. https://www.iasp-pain.org/advocacy/global-year/prevention-of-pain/#:~:text=IASP%20Dedicates%202020%20Global%20Year%20to%20the%20Prevention%20of%20Pain&text=Brona%20Fullen%20and%20Dr.,Esther%20Pogatzki%2DZahn. Accessed 20 Sept 2023.

Wenig CM, Schmidt CO, Kohlmann T, Schweikert B. Costs of back pain in Germany. Eur J Pain. 2009;13:280–6. https://doi.org/10.1016/j.ejpain.2008.04.005.CrossRefPubMed

Wolff R, Clar C, Lerch C, Kleijnen J. Epidemiology of chronic non-malignant pain in Germany. Der Schmerz. 2011;25:26–44.CrossRefPubMed

Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: Prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10:287–333.CrossRefPubMed

Hauser W, Schmutzer G, Hinz A, Hilbert A, Brähler A. Prevalence of chronic pain in Germany. A representative survey of the general population. Schmerz. 2013;27:46–55.PubMed

Dietl M, Korczak D. Over-, under- and misuse of pain treatment in Germany. GMS Health Technol Assess. 2011. https://doi.org/10.3205/hta000094.CrossRefPubMedPubMedCentral

Kouyanou K, Pither C, Wessely S. Iatrogenic factors and chronic pain. Psychosom Med. 1997;59(6):597–604.CrossRefPubMed

Nicholas MK, Linton SJ, Watson P, Main CJ, Decade of the Flags Working Group. Early identification and management of psychological risk factors (“yellow flags”) in patients with low back pain: a reappraisal. Phys Ther. 2011;91:737–53.CrossRefPubMed

10.

Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020;161(9):1976–82.CrossRefPubMedPubMedCentral

11.

IASP terminology. https://www.iasp-pain.org/resources/terminology/. Assessed 20 Sept 2023.

12.

Kaiser U, Treede RD, Sabatowski R. Multimodal pain therapy in chronic noncancer pain – gold standard or need for further clarification? Pain. 2017;158(10):1853–9.CrossRefPubMed

13.

Kaiser U, Petzke F, Nagel B, Marschall U, Casser HR, Isenberg T, Kohlmann T, Lindena G, PAIN2020. Evaluation eines frühen interdisziplinären multimodalen Assessments für Patienten mit Schmerzen. Protokoll einer randomisierten kontrollierten Studie (PAIN2020). Schmerz. 2020; https://doi.org/10.1007/s00482-020-00497-3.

14.

Müller-Schwefe G, Nadstawek J, ToelleT, Nilges P, Überall MA, et al. Struktur der schmerzmedizinischen Versorgung in Deutschland: Klassifikation schmerzmedizinischer Einrichtungen. Schmerz. 2016;30:2018–226.

15.

Pfingsten M, Arnold B, Böger A, Brinkschmidt T, Casser HR, Irnich D, Kaiser U, Klimczyk K, Lutz J, Schiltenwolf M, Seeger D, Zernikow B, Sabatowski R. Sektorenübergreifende interdisziplinäre multimodale Schmerztherapie. Schmerz. 2019;33:191–203.CrossRefPubMed

16.

Arnold B, Brinkschmidt T, Casser HR, Gralow I, Irnich D, Klimczyk K, Müller G, Nagel B, Pfingsten M, Schiltenwolf M, Sittl R, Söllner W. Multimodale Schmerztherapie – Konzepte und Indikationen [Multimodal pain therapy: principles and indications]. Schmerz. 2009;23:112–20.CrossRefPubMed

17.

Von Korff M, Ormel J, Keefe FJ, Dworkin SF. Grading the severity of chronic pain. Pain. 1992;50:133–49.CrossRef

18.

Attkisson C, Zwick R. The client satisfaction questionnaire. Psychometric Properties and Correlations with Service Utilization and Psychotherapy Outcome. Evaluation and Program Planning. 1982. https://doi.org/10.1016/0149-7189(82)90074-x.

19.

Schmidt J, Lamprecht F, Wittmann WW. Zufriedenheit mit der stationären Versorgung. Entwicklung eines Fragebogens und erste Validitätsuntersuchungen. [Satisfaction with inpatient care: Development of a questionnaire and first validity assessments.]. Psychother Psychosom Med Psychol. 1989;39(7):248–55.PubMed

20.

Lovibond SH, Lovibond PF. Manual for the depression anxiety stress scales. Sydney: N.S.W. Psychology Foundation of Australia; 1995.

21.

Nilges P, Essau C. DASS. Depressions-Angst-Stress-Skalen – deutschsprachige Kurzfassung. Trier: ZPID (Leibniz Institute for Psychology) – Open Test Archive. 2021. https://doi.org/10.23668/psycharchives.4579.

22.

Kazis LE, Miller DR, Skinner KM, Lee A, Ren XS, Clark JA, Rogers WH, Spiro A, Selim AJ, Linzer M, Payne S, Mansell D, Fincke G. Patient-reported measures of health: the veterans’ health study. J Ambul Care Manag. 2004;27:70–83.CrossRef

23.

Kazis LE, Selim A, Rogers W, et al. Dissemination of methods and results from the veterans’ health study: final comments and implications for future monitoring strategies within and outside the veterans’ healthcare system. J Ambul Care Manag. 2006;29:310–9.CrossRef

24.

Buchholz I, Kohlmann T, Buchholz M. Vergleichende Untersuchung der psychometrischen Eigenschaften des SF-36/SF-12 vs. VR-36/VR-12. Abschlussbericht. 2017. https://www.reha-vffr.de/images/vffrpdf/projekte/2017/VR-Abschlussbericht_vffr205.pdf. Accessed 13 Sept 2023.

25.

Buchholz I, Feng YS, Buchholz M, Kazis LE, Kohlmann T. Translation and adaptation of the German version of the Veterans Rand-36/12 Item Health Survey. Health Qual Life Outcomes. 2021;19:137.CrossRefPubMedPubMedCentral

26.

Meyer K, Sprott H, Mannion AF. Cross-cultural adaptation, reliability, and validity of the German version of the Pain Catastrophizing Scale. J Psychosom Res. 2008;64(5):469–78.CrossRefPubMed

27.

Schulte D. Messung der Therapieerwartung und Therapieevaluation von Patienten (PATHEV). Z Klin Psychol Psychother. 2005;34:176–87.CrossRef

28.

Finger JD, Tafforeau J, Gisle L, Oja L, Ziese T, Thelen J, Mensink GBM, Lange C. Development of the European Health Interview Survey - Physical Activity Questionnaire (EHIS-PAQ) to monitor physical activity in the European Union. Arch Public Health. 2015;73:59.CrossRefPubMedPubMedCentral

29.

Robert Koch-Institut (Eds). Körperliche Bewegung bei der Arbeit, zur Fortbewegung und in der Freizeit. In: Robert Koch-Institut (Eds). Fragebogen zur Studie “Gesundheit in Deutschland aktuell”: GEDA 2014/2015-EHIS. Journal of Health Monitoring. 2017. https://doi.org/10.17886/RKI-GBE-2017-014.

30.

Baumeister SE, Ricci C, Kohler S, Fischer B, Töpfer C, Finger JD, Leitzmann MF. Physical activity surveillance in the European Union: reliability and validity of the European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ). Int J Behav Nutr Phys Act. 2016;13:61.CrossRefPubMedPubMedCentral

31.

Meyer K. Ausgewählte Konzepte und Instrumente der Eigenschafts- und Verhaltensdiagnostik. In: Persönlichkeit und Selbststeuerung der Generation Z. Wiesbaden: Springer; 2020. https://doi.org/10.1007/978-3-658-32603-6_3.

32.

Wieland R, Latocha K. Gruppentraining zur Förderung der Gesundheitskompetenz für psychisch erkrankte Beschäftigte in einer Werkstatt für behinderte Menschen, Expertise zur ganzheitlichen Gesundheitsförderung bei proviel GmbH. 2012.

33.

Sudeck G, Pfeifer K. Physical activity-related health competence as an integrative objective in exercise therapy – conception and validation of a short questionnaire. Ger J Exerc Sport Res. 2016;46:74–87.

34.

Browne WJ, Lahi MG, Parker RM. A guide to sample size calculations for random effect models via simulation and the MLPowSim software package. Bristol: University of Bristol; 2009.

35.

Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004;8:283–91.CrossRefPubMed

36.

German Pain Society [Deutsche Schmerzgesellschaft e.V]. PAIN2.0 - Patientenorientiert. Abgestuft. Interdisziplinär. Netzwerk Therapie. Zuweiser*innen. https://www.pain2punkt0.de/?page_id=433. Accessed 13 Sept 2023.

37.

German Pain Society [Deutsche Schmerzgesellschaft e.V.]. PAIN2.0 - Patientenorientiert. Abgestuft. Interdisziplinär. Netzwerk Therapie. https://www.pain2punkt0.de/. Accessed 13 Sept 2023.

38.

German Pain Society (Deutsche Schmerzgesellschaft e.V. https://www.schmerzgesellschaft.de/fileadmin/2022/PDFs/DSF_Handbuch_2022.pdf. Accessed 20 Sept 2023.

39.

Twisk J. Applied longitudinal data analysis for epidemiology. Cambridge: Cambridge University Press; 2003.

40.

Rabe-Hesketh S, Skrondal A. Multilevel and longitudinal modeling using Stata. College Station: STATA press; 2008.

41.

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMedPubMedCentral

42.

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral

43.

Schulz KF, Altman DG, Moher D and the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010. https://doi.org/10.1186/1741-7015-8-18.

44.

Elbers S, Wittink H, Konings S, Kaiser U, Kleijnen J, Pool J, Köke A, Smeets R. Longitudinal outcome evaluations of Interdisciplinary Multimodal Pain Treatment programmes for patients with chronic primary musculoskeletal pain: a systematic review and meta-analysis. Eur J Pain. 2022;26(2):310–35.CrossRefPubMed

Title: 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
Authors: Sandra Meyer-Moock
Daniel Szczotkowski
Leonie Schouten
Frank Petzke
Lena Milch
Beatrice Metz-Oster
Louise Zinndorf
Christian Geber
Greta Hoffmann
Anke Preißler
Ursula Marschall
Felix Rottke
Anja Waidner
André Möller
Thomas Isenberg
Gabriele Lindena
Anne Gärtner
Ulrike Kaiser
Thomas Kohlmann
Publication date: 01-12-2024
Publisher: BioMed Central
Keyword: Public Health
Published in: Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-024-07975-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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