Status:
RECRUITING
Effectiveness of a Digital Health Application for Subacute and Chronic Back Pain (Relevis)
Lead Sponsor:
Gaia AG
Collaborating Sponsors:
University Hospital Schleswig-Holstein
Philipps Universität Marburg
Conditions:
Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial with 276 patients with subacute or chronic back pain aims to investigate the effectiveness of the unguided digital therapeutic relevis for patients with subacute or chronic back pa...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Presence of subacute (6-12 weeks) or chronic (\>12 weeks) back pain
- Submission of a medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses of back pain:
- M47.8x - Spondylosis
- M47.9x - Other spondylosis
- M54.5 - Back pain
- M54.8x - Other back pain
- M54.9x - Unspecified back pain
- M51.0x - Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with myelopathy
- M51.1x - Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy
- M51.2 - Other thoracic, thoracolumbar and lumbosacral intervertebral disc displacement
- Impaired functional ability (ODI ≥ 21)
- Consent to participate
- Sufficient knowledge of the German language
Exclusion
- Change in treatment of back pain in the past month
- Planned change in treatment of back pain in the next 3 months
- Prior use of other online programs/apps for back pain
- History of back, knee or hip surgery in the past 6 months
- History of more than one back surgery during lifetime
- Presence of a specific cause for back pain, e.g.:
- Fracture
- Infection
- Neuropathies (except when due to disc prolapse)
- Axial spondyloarthritis
- Tumor or metastases
- Cauda equina syndrome
- Acute myocardial infarction
- Unstable coronary heart disease/angina pectoris or heart failure
- Acute thrombosis
- Manifest osteoporosis
- Acute fevers
- Rheumatic autoimmune diseases
Key Trial Info
Start Date :
January 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 23 2025
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT06221956
Start Date
January 23 2024
End Date
January 23 2025
Last Update
February 9 2024
Active Locations (1)
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1
GAIA AG
Hamburg, Germany, 22085