Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT06221956
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06221956
Study Brief:
Protocol Section:
NCT06221956