Randomized controlled trial to assess the effectiveness of the ViViRA digital health app on pain reduction and range of motion in inflammatory low back pai
- Conditions
- Axial psoriatic ArthritisM45Ankylosing spondylitis
- Registration Number
- DRKS00031254
- Lead Sponsor
- niklinik Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Painreduktion <br>Change of mobility <br>Change of gait pattern<br>Change of clinical parameters
- Secondary Outcome Measures
Name Time Method Differences in gait pattern and disease activity between intervention and control groups. <br>Influence of DiGA ViViRA on movement competence, sleep quality, hand strength, work productivity, pain, fear of movement, and quality of life