Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP
Received 30 April 2020
Accepted for publication 19 June 2020
Published 17 July 2020 Volume 2020:13 Pages 1823—1838
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Robert B. Raffa
Janosch A Priebe,1 Katharina K Haas,1 Leida F Moreno Sanchez,1,2 Karin Schoefmann,1 Daniel A Utpadel-Fischler,1 Paul Stockert,1 Reinhard Thoma,3 Christine Schiessl,3 Linda Kerkemeyer,4 Volker Amelung,4 Siegfried Jedamzik,2 Jan Reichmann,5 Ursula Marschall,6 Thomas R Toelle1
1Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany; 2Bayerische TelemedAllianz (BTA), Ingolstadt, Germany; 3Pain Clinic, Algesiologikum Pain Center, Munich, Germany; 4Institute for Applied Health Services Research, inav GmbH, Berlin, Germany; 5StatConsult GmbH Magdeburg, Magdeburg, Germany; 6Barmer Hauptverwaltung, Wuppertal, Germany
Correspondence: Thomas R Toelle
Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technische Universität München, Ismaninger Str. 22, Munich 81675, Germany
Purpose: Non-specific low back pain (NLBP) causes an enormous burden to patients and tremendous costs for health care systems worldwide. Frequently, treatments are not oriented to existing guidelines. In the future, digital elements may be promising tools to support guideline-oriented treatment in a broader range of patients. The cluster-randomized controlled “Rise-uP” trial aims to support a General Practitioner (GP)-centered back pain treatment (Registration No: DRKS00015048) and includes the following digital elements: 1) electronic case report form (eCRF), 2) a treatment algorithm for guideline-based clinical decision making of GPs, 3) teleconsultation between GPs and pain specialists for patients at risk for development of chronic back pain, and 4) a multidisciplinary mobile back pain app for all patients (Kaia App).
Methods: In the Rise-uP trial, 111 GPs throughout Bavaria (southern Germany) were randomized either to the Rise-uP intervention group (IG) or the control group (CG). Rise-uP patients were treated according to the guideline-oriented Rise-uP treatment algorithm. Standard of care was applied to the CG patients with consideration given to the “National guideline for the treatment of non-specific back pain”. Pain rating on the numeric rating scale was the primary outcome measure. Psychological measures (anxiety, depression, stress), functional ability, as well as physical and mental wellbeing, served as secondary outcomes. All values were assessed at the beginning of the treatment and at 3-month follow-ups.
Results: In total, 1245 patients (IG: 933; CG: 312) with NLBP were included in the study. The Rise-uP group showed a significantly stronger pain reduction compared to the control group after 3 months (IG: M=− 33.3% vs CG: M=− 14.3%). The Rise-uP group was also superior in secondary outcomes. Furthermore, high-risk patients who received a teleconsultation showed a larger decrease in pain intensity (− 43.5%) than CG patients (− 14.3%). ANCOVA analysis showed that the impact of teleconsultation was mediated by an increased training activity in the Kaia App.
Conclusion: Our results show the superiority of the innovative digital treatment algorithm realized in Rise-uP, even though the CG also received relevant active treatment by their GPs. This provides clear evidence that digital treatment may be a promising tool to improve the quality of treatment of non-specific back pain. In 2021, analyses of routine data from statutory health insurances will enable us to investigate the cost-effectiveness of digital treatment.
Keywords: NLBP, eHealth, mHealth, digital medicine, guideline-oriented treatment, chronic pain, STarT Back
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