M54.5
Conditions
Interventions
Group 1: 1500 patients with chronic low back pain and 1500 asymptomatic control participants without chronic low back pain undergo standardized clinical, functional, biomechanical, imaging-based, and
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Written consent to participate in the study Asym. (no LBP) and symptomatic (chronic LBP) Caucasian women and men aged 18–64 years Pain duration >12 weeks Pain localization: lumbopelvic region Indications for surgery: disc degeneration, facet joint arthrosis, spondylolisthesis
Exclusion criteria
Exclusion criteria: Professional, competitive, and top athletes Acute infections Abuse of addictive substances Pregnancy BMI >28 kg/m2 Central or peripheral neurologic impairments (e.g., spinal cord injury, radicular symptoms, sensory deficits) Irritated, inflamed, and infected tissues in the measuring areas of the back Spinal fractures Osteoporosis Tumor diseases and bone metastases Previous spinal surgery Strong drug therapy (opioids, muscle relaxants, antiepileptics) Intake of long-acting antihistamines and/or systemic glucocorticoids and/or immunosuppressive drugs Rheumatic diseases Active systemic diseases (e.g., tuberculosis, collagenosis, multiple sclerosis, autoimmune diseases, acquired immune deficiency syndrome) Internal diseases that pose a potential risk to the study participants during the measurements (e.g. coronary heart diseases) and/or influence the findings Malpositions or anomalies of the lower extremities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the quantification of lumbar lordosis and segmental sagittal spinal alignment in patients with chronic low back pain and asymptomatic control participants. The assessment is performed once within the cross-sectional analysis using: MediMouse, Epionics SPINE, instrumented Vicon gait analysis, and magnetic resonance imaging (MRI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint 1 Static and dynamic back shape as well as spinal movement parameters in patients with chronic low back pain and asymptomatic control participants. The assessment is performed once within the cross-sectional analysis (T0) using: Epionics SPINE, MediMouse, instrumented Vicon gait analysis. In addition, a 24-hour daily-life spinal movement assessment is performed using Epionics SPINE. Secondary Endpoint 2 Physical activity in daily life. The assessment is performed once within the cross-sectional analysis (T0) using: International Physical Activity Questionnaire (IPAQ), long-term Epionics SPINE measurements. Secondary Endpoint 3 Morphological and degenerative changes of the spine and hip. The assessment is performed once within the cross-sectional analysis (T0) using magnetic resonance imaging (MRI), including: osteochondrosis according to Modic, spondylarthrosis according to Fujiwara, intervertebral disc degeneration according to Pfirrmann, spinal canal stenosis according to Schizas, hip osteoarthritis, hip dysplasia, muscular parameters. Secondary Endpoint 4 Pain intensity and pain grading in chronic low back pain. The assessment is performed once within the cross-sectional analysis (T0) using the adapted von Korff pain scale (von Korff et al., 1992). Secondary Endpoint 5 Disability related to low back pain. The assessment is performed once within the cross-sectional analysis (T0) using the Roland-Morris Disability Questionnaire (Roland & Morris, 1983). Secondary Endpoint 6 Health-related quality of life. The assessment is performed once within the cross-sectional analysis (T0) using the Short Form Health Survey (SF-36). | — |
Countries
Germany
Contacts
Public ContactTheresa Ahnert
Charité – Universitätsmedizin Berlin
Outcome results
None listed