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Randomized controlled trial to assess the effectiveness of the ViViRA digital health app on pain reduction and range of motion in inflammatory low back pain

Randomized controlled trial to assess the effectiveness of the ViViRA digital health app on pain reduction and range of motion in inflammatory low back pain - ViPA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031254
Enrollment
75
Registered
2023-02-10
Start date
2023-03-09
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

Axial psoriatic Arthritis M45

Interventions

Group 1: Group 1 (intervention group): Patients who meet the diagnosis of axial spondyloarthritis or axial psoriatic arthritis according to ACR criteria either participate in the intervention or in th

Sponsors

Uniklinik Erlangen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with spondyloarthritis confirmed by Assessment of Spondylarthritis international Society (ASAS) diagnostic criteria or patients with psoriatic arthritis confirmed by ASAS diagnostic criteria along with psoriasis, stable disease activity, written informed consent.

Exclusion criteria

Exclusion criteria: An existing pregnancy is an exclusion criterion. The following contraindications are listed in the ViViRA Instructions for Use: - Malignant neoplasm of bone and articular cartilage: spine. - Malignant neoplasm: spinal cord membranes - Secondary malignant neoplasm of other and unspecified parts of the nervous system - Secondary malignant neoplasm of bone and bone marrow - Secondary malignant neoplasm of other localizations not otherwise specified - Compression of nerve root and nerve plexus in intervertebral disc damage - Myelopathy in diseases classified elsewhere - Thrombosis, phlebitis and thrombophlebitis - Purulent arthritis - Direct joint infection in infectious and parasitic diseases elsewhere classified - Reactive arthritis - Postinfectious and reactive arthritides in diseases classified elsewhere - Free joint bodies in the knee joint - Free joint bodies: pelvic region and femur - Other inflammatory spondylopathies - Cervical disc damage - Cervical disc damage with radiculopathy - Lumbar and other disc damage with myelopathy - Lumbar and other disc damage with radiculopathy - Bone necrosis - Epiphysis capitis femoris - Osteochondrosis dissecans - Complication due to orthopedic endoprosthesis, implants or transplants - Presence of orthopedic joint implants - Presence of a hip joint prosthesis - Presence of a knee joint prosthesis - Presence of other specified orthopedic joint implants Limitations: Other sports or physical therapy activities are allowed and will be documented with a questionnaire.

Design outcomes

Primary

MeasureTime frame
Painreduktion Change of mobility Change of gait pattern Change of clinical parameters

Secondary

MeasureTime frame
Differences in gait pattern and disease activity between intervention and control groups. Influence of DiGA ViViRA on movement competence, sleep quality, hand strength, work productivity, pain, fear of movement, and quality of life

Countries

Germany

Contacts

Public ContactHarriet Morf

Uniklinik Erlangen

harriet.morf@uk-erlangen.de091318543023

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026