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Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP
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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381830/ https://www.ncbi.nlm.nih.gov/pubmed/32765057 http://dx.doi.org/10.2147/JPR.S260761 |
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author | Priebe, Janosch A Haas, Katharina K Moreno Sanchez, Leida F Schoefmann, Karin Utpadel-Fischler, Daniel A Stockert, Paul Thoma, Reinhard Schiessl, Christine Kerkemeyer, Linda Amelung, Volker Jedamzik, Siegfried Reichmann, Jan Marschall, Ursula Toelle, Thomas R |
author_facet | Priebe, Janosch A Haas, Katharina K Moreno Sanchez, Leida F Schoefmann, Karin Utpadel-Fischler, Daniel A Stockert, Paul Thoma, Reinhard Schiessl, Christine Kerkemeyer, Linda Amelung, Volker Jedamzik, Siegfried Reichmann, Jan Marschall, Ursula Toelle, Thomas R |
author_sort | Priebe, Janosch A |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7381830 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-73818302020-08-05 Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP Priebe, Janosch A Haas, Katharina K Moreno Sanchez, Leida F Schoefmann, Karin Utpadel-Fischler, Daniel A Stockert, Paul Thoma, Reinhard Schiessl, Christine Kerkemeyer, Linda Amelung, Volker Jedamzik, Siegfried Reichmann, Jan Marschall, Ursula Toelle, Thomas R J Pain Res Clinical Trial Report 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. Dove 2020-07-17 /pmc/articles/PMC7381830/ /pubmed/32765057 http://dx.doi.org/10.2147/JPR.S260761 Text en © 2020 Priebe et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Clinical Trial Report Priebe, Janosch A Haas, Katharina K Moreno Sanchez, Leida F Schoefmann, Karin Utpadel-Fischler, Daniel A Stockert, Paul Thoma, Reinhard Schiessl, Christine Kerkemeyer, Linda Amelung, Volker Jedamzik, Siegfried Reichmann, Jan Marschall, Ursula Toelle, Thomas R Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP |
title | Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP |
title_full | Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP |
title_fullStr | Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP |
title_full_unstemmed | Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP |
title_short | Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP |
title_sort | digital treatment of back pain versus standard of care: the cluster-randomized controlled trial, rise-up |
topic | Clinical Trial Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381830/ https://www.ncbi.nlm.nih.gov/pubmed/32765057 http://dx.doi.org/10.2147/JPR.S260761 |
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