JMIR Publications

ABSTRACT

Background:

Musculoskeletal conditions are the main drivers of the global disease burden and cause significant direct and indirect healthcare costs. Increasingly, digital health applications improve access to and availability of adequate care. The German healthcare system established a pathway for the approval of digital health applications (DiGA) as collectively funded medical services through the “Digital Health Care Act” (DVG) 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 back-, hip- and knee pain.

Methods:

For this study, we included 3’629 patients (72% female, on average 47 years old (SD = 14.2)). Primary outcomes were self-reported pain scores, assessed with a verbal numerical rating scale. Secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a two-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using a Wilcoxon Signed Rank-Test.

Results:

Our results show a significant reduction in self-reported pain intensity after two, four, eight, and 12 weeks by a Skillings-Mack Test (T(3628) = 5308, P < .001). The changes are 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 post-marketing observational data from one of the first DiGA for unspecific and degenerative musculoskeletal pain. We demonstrate significant improvements in self-reported pain intensity throughout an observation period of twelve weeks that reach clinical relevance. Additionally, we identify a complex response pattern of function scores assessed. Lastly, we highlight the challenges of relevant attrition to follow-up and potential opportunities for evaluating digital health applications. Although not of confirmatory power, our findings illustrate the potential benefits of digital health applications to improve clinical care. Clinical Trial: German Clinical Trials Register (DRKS.de/drks_web/), DRKS00024051.