Back Pain
Conditions
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 pain. Inclusion criteria are: age ≥ 18 years, presence of subacute (6-12 weeks) or chronic (\>12 weeks) back pain, attested by a medical certificate (relevant ICD-10-GM diagnoses: M47.8x, M47.9x, M54.5, M54.8x, M54.9x, M51.0x, M51.1x, M51.2), impaired functional ability \[Oswestry Disability Index (ODI) ≥ 21\], consent to participation, sufficient knowledge of the German language. Exclusion criteria are: 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, hip or knee surgery in the past 6 months, history of more than one back surgery in 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. 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.
Interventions
BEHAVIORALrelevis
Participants will receive access to the digital health intervention relevis in addition to TAU.
Sponsors
University Hospital Schleswig-Holstein
Philipps Universität Marburg
Gaia AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Impairment | 3 months | Oswestry Low Back Pain Disability Questionnaire (ODI). Total score ranging from 0-100; higher scores mean higher functional impairment (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptomatology | 3 months | Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptomatology (worse outcome). |
| Work and Social Functioning | 3 months | Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher disability (worse outcome). |
| Intensity of Back Pain | 3 months | Numeric Rating Scale (NRS). Score ranging from 0-10; higher scores mean higher pain (worse outcome). |
| Health-related Quality of Life | 3 months | Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome). |
Countries
Germany
Contacts
Primary ContactGitta A. Jacob, PhD
Backup ContactAntje Riepenhausen, PhD
Outcome results
None listed