M54.5
Conditions
Interventions
Group 1: Asymptomatic control participants without chronic low back pain undergo standardized clinical, functional, biomechanical, imaging-based, and psychosocial assessments performed once within the
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Presence of chronic low back pain (for the cLBP groups) Duration of low back pain = 3 months For the longitudinal analysis: chronic low back pain duration = 10 years Participation in a standardized multimodal pain therapy program (for the longitudinal cLBP cohort) Ability to provide written informed consent Sufficient German language skills Ability to participate in clinical, functional, and imaging-based assessments Willingness to participate in repeated assessments within the longitudinal study design Asymptomatic control participants without chronic low back pain (for the control groups)
Exclusion criteria
Exclusion criteria: Body mass index (BMI) > 29 kg/m² Pregnancy Neurological disorders affecting movement function or gait Acute severe internal medical disease Recent or unstable spinal injuries Active malignant disease Inability to provide informed consent Insufficient German language skills Contraindications for magnetic resonance imaging (MRI) Professional sports participation or very high physical training load (> 600 minutes of intensive physical activity per week) Acute relevant infectious disease Severe psychiatric disorders limiting participation in the study Inability to participate in the functional assessments Previous surgeries or diseases substantially affecting the biomechanical function of the spine or musculoskeletal system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome – Cross-Sectional Analysis Diagnostic precision of multimodal diagnostic models for differentiating asymptomatic individuals and individuals with chronic low back pain. The assessment is performed once within the cross-sectional study design using: functional movement analysis, instrumented gait analysis, surface electromyography (sEMG), static and dynamic spinal shape measurements, magnetic resonance imaging (MRI), ultrasound examinations, psychosocial questionnaires, and machine-learning-based classification models. Diagnostic precision is determined using: sensitivity, specificity, receiver operating characteristic (ROC) analyses, area under the curve (AUC), and classification accuracy. Data collection is performed once within the cross-sectional assessment. Primary Outcome – Longitudinal Analysis Change in functional spinal parameters during and after multimodal pain therapy in patients with chronic low back pain. Assessments are performed: before the start of therapy, repeatedly during therapy, at the end of therapy, and during follow-up using: instrumented movement analysis, spinal motion measurements, standardized spinal function tests, instrumented gait analysis, and surface electromyography (sEMG). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes – Cross-Sectional Analysis Secondary Outcome 1 Subjective pain intensity and pain-related disability in individuals with chronic low back pain. The assessment is performed once within the cross-sectional study design using: visual analogue scale (VAS), numerical rating scale (NRS), Graded Chronic Pain Scale according to von Korff et al. Secondary Outcome 2 Health-related quality of life. The assessment is performed once within the cross-sectional study design using: Short Form Health Survey (SF-36). Secondary Outcome 3 Physical activity during daily life. The assessment is performed once within the cross-sectional study design using: International Physical Activity Questionnaire (IPAQ), long-term spinal motion measurements during daily life. Secondary Outcome 4 Psychosocial factors and behavioral parameters. The assessment is performed once within the cross-sectional study design using: Self-Report Behavioral Automaticity Index (SRBAI), Behavioral Regulation in Sport Questionnaire (BRSQ), questionnaires assessing fear avoidance, self-efficacy, and psychological distress. Secondary Outcome 5 Morphological changes of the spine, paraspinal musculature, and hip. The assessment is performed once within the cross-sectional study design using: magnetic resonance imaging (MRI), ultrasound examinations. Secondary Outcome 6 Static and dynamic postural parameters of the spine. The assessment is performed once within the cross-sectional study design using: static spinal shape measurements, dynamic 24-hour spinal motion measurements. Secondary Outcome 7 Gait and movement parameters in asymptomatic individuals and individuals with chronic low back pain. The assessment is performed once within the cross-sectional study design using instrumented gait analysis in the Berlin Movement Diagnostics (BeMoveD) laboratory under: self-selected walking speed, standardized walking speed (4.0 km/h). Secondary Outcomes – Longitudinal Anal | — |
Countries
Germany
Contacts
Public ContactHendrik Schmidt
Charité – Universitätsmedizin Berlin
Outcome results
None listed