Effectiveness of a Digital Health Application for Subacute and Chronic Back Pain (Relevis)
NCT ID: NCT06221956
Last Updated: 2024-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
276 participants
INTERVENTIONAL
2024-01-23
2025-01-23
Brief Summary
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Patients will be randomized and allocated to either an intervention group in a 1:1 ratio, in which they will receive access to relevis in addition to treatment as usual (TAU, n = 138), or to a control group, in which they will receive only TAU (n = 138). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e. g. orthopedic surgeon, rheumatologists etc.) which may include physiotherapy, injections in the spine, drug therapy, orthesis, etc. (1,2). The primary endpoint will be the functional impairment, measured by the ODI, with three months post-allocation being the primary time point for assessment of effectiveness (T1). Six months post-allocation (T2) will be used as the follow-up assessment endpoint. Secondary endpoints will be depression, work and social functioning, pain intensity, and health-related quality of life.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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relevis + TAU
Participants allocated to the intervention group will receive access to relevis in addition to treatment as usual (TAU).
relevis is a digital health application designed for individuals with subacute or chronic back pain, accessible through a web browser. The application consists of six physical exercise modules that cover four exercises with thiree different levels of difficulty, each, and ten interactive "conversations" on different topics (changes in the body, pain development and processing, chronic pain, pain and mood, relaxation and mindfulness, becoming active against pain, stress and pain, nutrition and pain, sleep and pain, work and pain). "Conversations" are accompanied by illsutrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.
relevis
Participants will receive access to the digital health intervention relevis in addition to TAU.
TAU
Participants allocated to the control group will receive access to treatment as usual (TAU).
No interventions assigned to this group
Interventions
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relevis
Participants will receive access to the digital health intervention relevis in addition to TAU.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Philipps Universität Marburg
UNKNOWN
Gaia AG
INDUSTRY
Responsible Party
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Principal Investigators
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Kamila Jauch-Chara, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Schleswig-Holstein
Locations
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GAIA AG
Hamburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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relevis RCT 2024
Identifier Type: -
Identifier Source: org_study_id
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