Evaluating relapse prophylaxis in addition to interdisciplinary multimodal pain therapy for back pain: a randomised controlled trial
DOI:
https://doi.org/10.2340/jrm.v57.42088Keywords:
back pain, pain management, health-related quality of life (HRQOL), Randomized Controlled Trials as Topic, rehabilitation, Secondary Prevention, sick leaveAbstract
Objective: This study aimed to evaluate the effectiveness of a 12-month relapse prophylaxis following a 4-week interdisciplinary multimodal pain therapy approach for patients with back pain. The study examined whether the intervention reduced days of incapacity to work (primary outcome) and improved functional capacity and health-related quality of life (secondary outcomes) compared with interdisciplinary multimodal pain therapy alone.
Design: A randomized controlled trial was conducted. The recruitment period was 24 months.
Subjects/Patients: The study comprised 297 employed patients from a rural region in north-west Germany, diagnosed with back pain in different regions of the spine.
Methods: The analyses were based on quantitative data: claims data and questionnaire data.
Results: The results showed a mean of 70.07 days of incapacity to work after the interdisciplinary multimodal pain therapy for the control group and a lower mean of 56.41 days for the intervention group. The group difference was not significant (p = 0.259). Analysis of change scores revealed statistically significant larger improvements of functional capacity and health-related quality of life in the intervention group.
Conclusion: Findings of this study show improvements in the secondary outcomes. The results indicate that further studies are needed to determine how to sustainably reduce days off work due to back pain.
Downloads
References
Ashrafian S, Schüssel K, Schlotmann A, Weirauch H, Brückner G, Schröder H, et al. Gesundheitsatlas Deutschland – Rückenschmerzen 2023.
Statistisches Bundesamt (Destatis). Genesis online Tabelle 23631-0001 Krankheitskosten, Krankheitskosten je Einwohner: Deutschland, Jahre, Krankheitsdiagnosen. 2022 [cited 2024 Apr 15]. Available from: https://www-genesis.destatis.de/genesis//online?operation=table&code=23631-0001
Bundesärztekammer (BÄK), Kassenärztliche Bundesvereinigung (KBV), Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Nationale Versorgungsleitlinie Nicht-spezifischer Kreuzschmerz – Langfassung. 2. Auflage. Version 1. 2017.
Bialas P. Das biopsychosoziale Krankheitsmodell. Schmerzmed 2022; 38: 56–58. DOI: https://doi.org/10.1007/s00940-022-3405-5
Kaiser U, Treede RD, Sabatowski R. Multimodal pain therapy in chronic noncancer pain: gold standard or need for further clarification? Pain 2017; 158: 1853–1859. DOI: https://doi.org/10.1097/j.pain.0000000000000902
Elbers S, Wittink H, Konings S, Kaiser U, Kleijnen J, Pool J, et al. 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: 310–335. DOI: https://doi.org/10.1002/ejp.1875
Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJEM, Ostelo RWJG, Guzman J, et al. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. Cochrane Database Syst Rev 2014; 2014: CD000963. DOI: https://doi.org/10.1002/14651858.CD000963.pub3
van Middelkoop M, Rubinstein SM, Kuijpers T, Verhagen AP, Ostelo R, Koes BW, et al. A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain. Eur Spine J 2011; 20: 19–39. DOI: https://doi.org/10.1007/s00586-010-1518-3
Jensen IB, Busch H, Bodin L, Hagberg J, Nygren Å, Bergström G. Cost effectiveness of two rehabilitation programmes for neck and back pain patients: a seven year follow-up. Pain 2009; 142: 202–208. DOI: https://doi.org/10.1016/j.pain.2008.12.015
Müller G, Pfinder M, Clement M, Kaiserauer A, Deis G, Waber T, et al. Therapeutic and economic effects of multimodal back exercise: a controlled multicentre study. J Rehabil Med 2019; 51: 61–70. DOI: https://doi.org/10.2340/16501977-2497
Krueger K, Schmetsdorf J, Pavlovic M, Runde W, Zechel G, Hemken N, et al. Evaluation of a multimodal pain therapy approach with relapse prophylaxis for back pain (MMS-RFP study): a study protocol for a cluster randomised controlled trial. BMJ Open 2023; 13: e067412. DOI: https://doi.org/10.1136/bmjopen-2022-067412
Sewöster D. Viel Bewegung in der Reha-Nachsorge. B & G 2019; 35: 276–278. DOI: https://doi.org/10.1055/a-0985-3437
Weier L, Steinhäuser J, Träder JM, Deck R. Hausarztzentrierte Rehabilitationsnachsorge bei chronischen Rückenschmerzen. Rehabilitation 2021; 60: 195–203. DOI: https://doi.org/10.1055/a-1286-2595
Kohlmann T, Raspe H. Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Rehabilitation 1996; 35: I–VIII.
Thomas E, Silman AJ, Croft PR, Papageorgiou AC, Jayson MI, Macfarlane GJ. Predicting who develops chronic low back pain in primary care: a prospective study. BMJ 1999; 318: 1662–1667. DOI: https://doi.org/10.1136/bmj.318.7199.1662
Croft PR, Macfarlane GJ, Papageorgiou AC, Thomas E, Silman AJ. Outcome of low back pain in general practice: a prospective study. BMJ 1998; 316: 1356–1359. DOI: https://doi.org/10.1136/bmj.316.7141.1356
Graf von der Schulenburg JM, Claes C, Greiner W, Uber A. Die deutsche Version des EuroQol-Fragebogens. Z Gesundh Wiss 1998; 6: 3–20. DOI: https://doi.org/10.1007/BF02956350
Eldridge SM, Ashby D, Kerry S. Sample size for cluster randomized trials: effect of coefficient of variation of cluster size and analysis method. Int J Epidemiol 2006; 35: 1292–1300. DOI: https://doi.org/10.1093/ije/dyl129
Dreyhaupt J, Mayer B, Kaluscha R, Muche R. Cluster-randomisierte Studien: Methodische und praktische Aspekte. Rehabilitation 2020; 59: 54–61. DOI: https://doi.org/10.1055/a-0801-5697
Rutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized trials. Int J Epidemiol 2015; 44: 1051–1067. DOI: https://doi.org/10.1093/ije/dyv113
Lorenz E, Köpke S, Pfaff H, Blettner M. Cluster-randomized studies. Dtsch Arztebl Int 2018; 115: 163–168. https://di.aerzteblatt.de/int/archive/article/196558 DOI: https://doi.org/10.3238/arztebl.2018.0163
Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum; 1988.
Kessler K, Hüppe M, Roesner A. Erwartete Einflussbereiche der Disziplinen Medizin, Psychologie und Physiotherapie in der Schmerztherapie: Eine Umfrage unter Berufszugehörigen. Schmerz 2023; 37: 274–280. DOI: https://doi.org/10.1007/s00482-023-00726-5
Maser D, Müller D, Bingel U, Müßgens D. Ergebnisse einer Pilotstudie zur Rolle der Therapieerwartung bei der interdisziplinären multimodalen Schmerztherapie bei chronischem Rückenschmerz. Schmerz 2022; 36: 172–181. DOI: https://doi.org/10.1007/s00482-021-00590-1
Saldanha IJ, Skelly AC, Ley KV, Wang Z, Berliner E, Bass EB, et al. Inclusion of nonrandomized studies of interventions in systematic reviews of intervention effectiveness: an update. Rockville, MD: Agency for Healthcare Research and Quality; 2022. DOI: https://doi.org/10.23970/AHRQEPCMETHODSGUIDENRSI
Deeks JJ, Dinnes J, D’Amico R, Sowden AJ, Sakarovitch C, Song F, et al. Evaluating non-randomised intervention studies. Health Technol Assess 2003; 7: iii–x, 1–173. DOI: https://doi.org/10.3310/hta7270
Hernán MA, Hernández-Díaz S, Robins JM. A structural approach to selection bias. Epidemiology 2004; 15: 615–625. DOI: https://doi.org/10.1097/01.ede.0000135174.63482.43
Sumbauer H. Kriterien zur Qualitätsbewertung von randomisierten kontrollierten Studien (RCTs). DO 2020; 18: 4–12. DOI: https://doi.org/10.1055/a-0966-5252
Moosbrugger H, Brandt H. Itemkonstruktion und Antwortverhalten. In: Moosbrugger H, Kelava A, editors. Testtheorie und Fragebogenkonstruktion. 3., vollständig neu bearbeitete, erweiterte und aktualisierte Auflage. Berlin: Springer; 2020: p. 67–89. DOI: https://doi.org/10.1007/978-3-662-61532-4_4
Graf von der Schulenburg JM, Lange A, Neubauer S, Zeidler J. Prozessorientierter Leitfaden für die Analyse und Nutzung von Routinedaten der Gesetzlichen Krankenversicherung. Nomos eLibrary; 2017. DOI: https://doi.org/10.5771/9783845281193
Swart E, Ihle P, Gothe H, Matusiewicz D, editors. Routinedaten im Gesundheitswesen: Handbuch Sekundärdatenanalyse: Grundlagen, Methoden und Perspektiven. 2., vollständig überarbeitete und erweiterte Auflage. Bern, München: Verlag Hans Huber; ciando; 2014.
Hüppe A, Zeuner C, Karstens S, Hochheim M, Wunderlich M, Raspe H. Feasibility and long-term efficacy of a proactive health program in the treatment of chronic back pain: a randomized controlled trial. BMC Health Serv Res 2019; 19: 714. DOI: https://doi.org/10.1186/s12913-019-4561-8
Anema JR, Steenstra IA, Bongers PM, Vet HCW de, Knol DL, Loisel P, et al. Multidisciplinary rehabilitation for subacute low back pain: graded activity or workplace intervention or both? A randomized controlled trial. Spine 2007; 32: 291–298; discussion 299–300. DOI: https://doi.org/10.1097/01.brs.0000253604.90039.ad
Langagergaard V, Jensen OK, Nielsen CV, Jensen C, -Labriola M, Sørensen VN, et al. The comparative effects of brief or multidisciplinary intervention on return to work at 1 year in employees on sick leave due to low back pain: a randomized controlled trial. Clin Rehabil 2021; 35: 1290–1304. DOI: https://doi.org/10.1177/02692155211005387
Pedersen KKW, Langagergaard V, Jensen OK, Nielsen CV, Sørensen VN, Pedersen P. Two-year follow-up on return to work in a randomised controlled trial comparing brief and multidisciplinary intervention in employees on sick leave due to low back pain. J Occup Rehabil 2022; 32: 697–704. DOI: https://doi.org/10.1007/s10926-022-10030-1
Fisker A, Langberg H, Petersen T, Mortensen OS. Effects of an early multidisciplinary intervention on sickness absence in patients with persistent low back pain: a randomized controlled trial. BMC Musculoskelet Disord 2022; 23: 854. DOI: https://doi.org/10.1186/s12891-022-05807-7
Schmidt AM, Schiøttz-Christensen B, Foster NE, Laurberg TB, Maribo T. The effect of an integrated multidisciplinary rehabilitation programme alternating inpatient interventions with home-based activities for patients with chronic low back pain: a randomized controlled trial. Clin Rehabil 2020; 34: 382–393. DOI: https://doi.org/10.1177/0269215519897968
Schmidt AM, Laurberg TB, Moll LT, Schiøttz-Christensen B, Maribo T. The effect of an integrated multidisciplinary rehabilitation programme for patients with chronic low back pain: long-term follow up of a randomised controlled trial. Clin Rehabil 2021; 35: 232–241. DOI: https://doi.org/10.1177/0269215520963856
Deck R, Schramm S, Hüppe A. Begleitete Eigeninitiative nach der Reha (“neues Credo”) – ein -Erfolgsmodell? -Rehabilitation 2012; 51: 316–325. https://doi.org/10.1055/s-0031-1291279 DOI: https://doi.org/10.1055/s-0031-1291279
Schramm S, Hüppe A, Jürgensen M, Deck R. Begleitete Eigeninitiative nach der Reha (“Neues Credo”) – Langzeitergebnisse der quasiexperimentellen Interventionsstudie. Rehabilitation 2014; 53: 297–304. DOI: https://doi.org/10.1055/s-0033-1358388
Tavafian SS, Jamshidi AR, Mohammad K. Treatment of chronic low back pain: a randomized clinical trial comparing multidisciplinary group-based rehabilitation program and oral drug treatment with oral drug treatment alone. Clin J Pain 2011; 27: 811–818. DOI: https://doi.org/10.1097/AJP.0b013e31821e7930
Monticone M, Ambrosini E, Rocca B, Cazzaniga D, Liquori V, Foti C. Group-based task-oriented exercises aimed at managing kinesiophobia improved disability in chronic low back pain. Eur J Pain 2016; 20: 541–551. DOI: https://doi.org/10.1002/ejp.756
Additional Files
Published
How to Cite
License
Copyright (c) 2025 Julia Schmetsdorf, Kathrin Krüger, Jacqueline Posselt, Runde Werner, Hans-Georg Zechel, Thomas Kohlmann, Christian Krauth

This work is licensed under a Creative Commons Attribution 4.0 International License.
All digitalized JRM contents is available freely online. The Foundation for Rehabilitation Medicine owns the copyright for all material published until volume 40 (2008), as from volume 41 (2009) authors retain copyright to their work and as from volume 49 (2017) the journal has been published Open Access, under CC-BY-NC licences (unless otherwise specified). The CC-BY-NC licenses allow third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material for non-commercial purposes, provided proper attribution to the original work.
From 2024, articles are published under the CC-BY licence. This license permits sharing, adapting, and using the material for any purpose, including commercial use, with the condition of providing full attribution to the original publication.