There is growing evidence that digital therapeutics can effectively improve the course of diseases. Mostly chronic disorders are addressed by behaviour change or exercise programs. In Germany, so-called DIGAs (Digitale Gesundheits Anwendung = Digital Health Application) now are covered by health insurers as long as they meet certain quality criteria. Currently, 20 DIGAs are included in the directory (see DiGA-Verzeichnis (bfarm.de)).
The indications are always chronic diseases such as psychological disorders (anxiety, depression), tinnitus, migraine, sleep disturbance, obesity, rehabilitation after stroke and smoking cessation.
From the point of view of musculoskeletal diseases, currently there are only two applications in the registry: Vivira for the indication of hip osteoarthritis and Mawendo for disorders of the patella. No DIGAs have yet been approved for immune-mediated diseases so far.
Let´s have a closer look what the two apps offer:
Vivira describes itself as an exercise therapy app. The 12-week programme offers 4 daily exercises that continuously adjust their intensity and complexity based on feedback from the patient. The daily exercises are complemented by weekly health queries, progress visualisation, monthly exercise tests and educational content.
In addition to the indication of hip osteoarthritis, Vivira also provides exercise elements included in guidelines for non-specific low back pain and knee osteoarthritis. It is therefore not a pure hip osteoarthritis tool.
The provisional approval of this app was based on a retrospective registration study with an observation period of 14 weeks and 197 patients with musculoskeletal pain in 2018 and 2019.
The intervention group used the Vivira app for therapeutic training and to get health status information.
The study showed a statistically significant reduction in pain in Vivira users during the observation period. Subgroup analysis of patients with initial pain score of at least 4 on the VNRS scale and regular use of the app showed an average pain reduction of 38% in weeks 2-7 and an average pain reduction of 42% in weeks 8-14. Increasing the number of exercises had a significant impact on therapeutic success.
There is no control group in this study. It is not clear why the Vivira received approval for hip osteoarthritis, which was not specifically studied.
Prospective clinical trials are planned for knee pain, hip pain and back pain, but these have not yet been published.
Mawendo provides exercise programmes with exercise videos, health information and documentation options for patients with patella pain. There is no precision about the cause of patella pain (malalignment, overuse, post-traumatic, tendinitis ect).
In the registration trial, 50 patients with patellofemoral pain syndrome were treated with Mawendo and examined for the endpoint of pain and function after 12 weeks using VAS and Kujala scores.
Significant improvements were seen in both pain and function. In a post-hoc study, the use of this DiGA also showed a significant reduction in pain in 102 patients after 12 weeks.
A controlled (non-blinded) trial with 121 patients against standard physiotherapy for 12 weeks is planned. The intervention group will receive the DiGA Mawendo as a form of therapy. Endpoints are VAS and KOOS score to measure pain and functionality.
To date, there are two musculoskeletal DIGAs for hip osteoarthritis and the patellar pain syndrome. Both have produced positive results according to DIGA guidelines in small, non-controlled studies. Reliable results from controlled trials with serious patient numbers are not yet available. It remains to be seen when and which DIGAs for inflammatory rheumatic diseases will first come onto the market. There are some apps in the queue here, e.g. ABATONbaton, Midaia, Rhecord or Vila Health. But the DIGA directory has also attracted international interest, so hopefully new solutions with robust study results should not be long in coming.