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Preparation of a clinical report 2020-2021 on anonymized, statistically analyzed data of a retrospective data collection on the clinical efficacy of the CE-marked Vivira app "Therapeutic Exercise Program for Home Use"

Preparation of a clinical report 2020-2021 on anonymized, statistically analyzed data of a retrospective data collection on the clinical efficacy of the CE-marked Vivira app "Therapeutic Exercise Program for Home Use" - Vivira RStudy 2020-2021

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00024051
Enrollment
150
Registered
2021-05-31
Start date
2021-06-15
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

M16.0 M54.5 M53.2 M53.8 M53.9 M54.6 M54.8 M54.9 M99.02 M99.03 M99.04 M99.82 M99.83 M99.84 M99.92 M99.93 M99.94 M42.0 M42.1 M42.9 M99.85 M99.86 M99.95 M99.96 M25.55 M25.85 M25.95 M17.0 M99.86 M99.96 M25.56 M25.86

Interventions

Group 1: Arm 1: Retrospective recording of treatment using Vivira app. It is an intraindividual control: i.e. the study is single-armed, the control is the pre-finding (=historical finding) of the sam

Sponsors

Vivira Health Lab GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with chronic musculoskeletal pain and a baseline pain score greater than 1 on the rating scale as of 01/01/2020.

Exclusion criteria

Exclusion criteria: - Patients who were unable to follow the exercise protocol. - Patients with severe visual problems - No pain, pain score=0 - Discontinuation without pain score after week 2: these patients were considered as study users but not ITT users. - Non-premium users: these patients were also considered test users and not ITT users. They were trial users who only tried Vivira for a few days free of charge. - Prescription of analgesics - acute malignant disease - dementia - drug or alcohol abuse - previous use of an exercise therapy DiGA (Vivira, Kaia, etc.) - limited legal capacity - significantly impaired vision or blindness - severe internal illness (condition following heart attack, severe organ failure, need for dialysis, etc.) - severe neurological disorders (stroke, paralysis, multiple sclerosis, convulsions, etc.) - rheumatic disease - osteoporosis - pregnancy - bleeding tendency / hemophilia - gait instability and frequent falls - acute herniated disc or other disease with radiation to the legs (radiculopathy, sensorimotor failure) - herniated disc in the past - Spinal infection in the past or acutely - Spinal surgery - Spinal tumor - Injury to the spine - Joint replacement (TEP) or partial joint replacement - Osteotomy (an operation to correct the leg axis) - joint infection in the past or acutely - free joint body - Osteochondrosis dissecans or bone necrosis - Injury to the knee or hip joint - Hip dysplasia - Arthrodesis (joint fusion) in either knee or hip joint - Acute instability of the knee or hip joint - Knee or hip surgery in the last year - Clinically relevant bone marrow edema

Design outcomes

Primary

MeasureTime frame
VNRS (verbal-numerical rating scale) of pain after 12 weeks

Secondary

MeasureTime frame
Proprietary functional test

Countries

Germany

Contacts

Public ContactHans-Peter Zenner

Clinical Research Organization HP Zenner Clinical GmbH&Co KG

office@hpzenner.de+49707149645

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026