Post-marketing effectiveness of a digital therapeutic for unspecific and degenerative back, hip and knee pain during an extended probation period: An observational study of patient-reported outcome data

• Conditions: M53.2; M53.8; M42.9; M42.0; M42.1; M54.4; M54.5; M54.6; M54.8; M54.9

• Registration Number: DRKS00028920
• Lead Sponsor: Vivira Health Lab GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-05-10
• Study Start: 2022-07-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 7842

Inclusion Criteria

1. prescription of the DiGA Vivira with one of the above diagnoses (back, hip, and knee diagnosis groups) by a health care provider; 2. an initial pain intensity of > 0 on the VNRS (0-10); 3. any specified duration of pain (acute, subacute, chronic); 4. at least one completed exercise

Exclusion Criteria

Any exclusion criterion according to the approval of the use by the Federal Institute for Drugs and Medical Devices (BfArM) (https://diga.bfarm.de/de/verzeichnis/387).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported pain intensity, assessed with a verbal-numerical rating scale (VNRS)

Secondary Outcome Measures

Name	Time	Method
Physical level of activity, assessed in the dimensions of mobility, strength and coordination based on a discrete scale