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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028920
Enrollment
8000
Registered
2022-07-21
Start date
2022-04-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M42.0 M42.1 M42.9 M53.2 M53.8 M54.4 M54.5 M54.6 M54.8 M54.9 M99.02 M99.03 M99.04 M99.82 M99.83 M99.84 M99.92 M99.93 M99.94 M16.0 M16.1 M16.2 M16.3 M16.4 M16.5 M16.6 M16.7 M16.9 M99.85 M99.86 M99.95 M99.96 M25.55 M25.85 M25.95 M17.0 M17.1 M17.2 M17.3 M17.4 M17.5 M17.9 M99.86 M99.96 M25.86 M25.96

Interventions

Group 1: Intra-individual pre-post comparison of patients with non-specific and degenerative musculoskeletal conditions according to the included ICD-10 codes undergoing a twelve-week individualized h

Sponsors

Vivira Health Lab GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Self-reported pain intensity, assessed with a verbal-numerical rating scale (VNRS)

Secondary

MeasureTime frame
Physical level of activity, assessed in the dimensions of mobility, strength and coordination based on a discrete scale

Countries

Germany

Contacts

Public ContactLeo Benning

Universitäts-Notfallzentrum (UNZ), Universitätsklinikum Freiburg

leo.benning@uniklinik-freiburg.de076127018409

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026