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Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis
BACKGROUND: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012010/ https://www.ncbi.nlm.nih.gov/pubmed/36848211 http://dx.doi.org/10.2196/43775 |
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author | Teepe, Gisbert Wilhelm Kowatsch, Tobias Hans, Felix Patricius Benning, Leo |
author_facet | Teepe, Gisbert Wilhelm Kowatsch, Tobias Hans, Felix Patricius Benning, Leo |
author_sort | Teepe, Gisbert Wilhelm |
collection | PubMed |
description | BACKGROUND: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of “Digitale Gesundheitsanwendungen” (DiGAs; Digital Health Applications) as collectively funded medical services through the “Digitale-Versorgung-Gesetz” (Digital Health Care Act) in 2019. OBJECTIVE: This article presents real-world prescription data collected through the smartphone-based home exercise program “Vivira,” a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. METHODS: This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. RESULTS: Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T(3628)=5308; P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). CONCLUSIONS: This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care. TRIAL REGISTRATION: German Clinical Trials Register DRKS00024051; https://drks.de/search/en/trial/DRKS00024051 |
format | Online Article Text |
id | pubmed-10012010 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-100120102023-03-15 Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis Teepe, Gisbert Wilhelm Kowatsch, Tobias Hans, Felix Patricius Benning, Leo J Med Internet Res Original Paper BACKGROUND: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of “Digitale Gesundheitsanwendungen” (DiGAs; Digital Health Applications) as collectively funded medical services through the “Digitale-Versorgung-Gesetz” (Digital Health Care Act) in 2019. OBJECTIVE: This article presents real-world prescription data collected through the smartphone-based home exercise program “Vivira,” a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. METHODS: This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. RESULTS: Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T(3628)=5308; P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). CONCLUSIONS: This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care. TRIAL REGISTRATION: German Clinical Trials Register DRKS00024051; https://drks.de/search/en/trial/DRKS00024051 JMIR Publications 2023-02-27 /pmc/articles/PMC10012010/ /pubmed/36848211 http://dx.doi.org/10.2196/43775 Text en ©Gisbert Wilhelm Teepe, Tobias Kowatsch, Felix Patricius Hans, Leo Benning. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 27.02.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included. |
spellingShingle | Original Paper Teepe, Gisbert Wilhelm Kowatsch, Tobias Hans, Felix Patricius Benning, Leo Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis |
title | Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis |
title_full | Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis |
title_fullStr | Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis |
title_full_unstemmed | Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis |
title_short | Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis |
title_sort | postmarketing follow-up of a digital home exercise program for back, hip, and knee pain: retrospective observational study with a time-series and matched-pair analysis |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012010/ https://www.ncbi.nlm.nih.gov/pubmed/36848211 http://dx.doi.org/10.2196/43775 |
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