Biomechanical mechanisms of chronic low back pain

Biomechanical mechanisms of chronic low back pain - dyn3M–SP2–FOR5177/2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040427

Enrollment

Registered

2026-05-22

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M54.5

Interventions

Group 1: Asymptomatic control participants Asymptomatic control participants without chronic low back pain participate in a longitudinal observational study during a standardized neuromuscular traini

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Ability to provide written informed consent Ability to perform the functional, biomechanical, and training procedures required in the study Sufficient German or English language skills to complete questionnaires and follow study instructions For patient groups: chronic low back pain persisting for at least 3 months For the asymptomatic control group: no current or chronic low back pain Willingness to participate in all scheduled assessment time points, including follow-up examinations Eligibility for MRI examinations Willingness to participate in the standardized neuromuscular training program with EMG-based biofeedback over six weeks Willingness to allow pseudonymized storage and scientific analysis of collected study data

Exclusion criteria

Exclusion criteria: Acute low back pain (< 3 months) Specific spinal pathologies (e.g., tumor, fracture, infection, inflammatory spinal disease) Previous spinal surgery within the last 12 months Severe neurological disorders affecting movement or balance Severe musculoskeletal disorders limiting participation in the training program or functional assessments Severe cardiovascular, pulmonary, or systemic diseases contraindicating physical activity Pregnancy or breastfeeding Contraindications for MRI examinations (e.g., pacemaker, ferromagnetic implants, severe claustrophobia) Current participation in another interventional clinical study Inability to comply with study procedures or follow study instructions Insufficient German or English language skills to complete questionnaires and assessments Current substance abuse or severe psychiatric disorders interfering with study participation Any condition judged by the investigators to compromise safe participation or data quality

Design outcomes

Primary

Measure	Time frame
Primary Endpoint – Arm 1 Change in neuromuscular activation patterns and movement coordination of the lumbar spine in asymptomatic control participants during a standardized neuromuscular training program. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: surface electromyography (sEMG), 3D motion analysis, instrumented gait analysis. Primary Endpoint – Arm 2 Change in neuromuscular activation patterns and movement coordination of the lumbar spine in patients with chronic low back pain and low to moderate pain intensity during a standardized neuromuscular training program. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: surface electromyography (sEMG), 3D motion analysis, instrumented gait analysis. Primary Endpoint – Arm 3 Change in neuromuscular activation patterns and movement coordination of the lumbar spine in patients with chronic low back pain and high pain intensity during a standardized neuromuscular training program. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: surface electromyography (sEMG), 3D motion analysis, instrumented gait analysis.	—

Measure

Time frame

Primary Endpoint – Arm 1 Change in neuromuscular activation patterns and movement coordination of the lumbar spine in asymptomatic control participants during a standardized neuromuscular training program. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: surface electromyography (sEMG), 3D motion analysis, instrumented gait analysis. Primary Endpoint – Arm 2 Change in neuromuscular activation patterns and movement coordination of the lumbar spine in patients with chronic low back pain and low to moderate pain intensity during a standardized neuromuscular training program. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: surface electromyography (sEMG), 3D motion analysis, instrumented gait analysis. Primary Endpoint – Arm 3 Change in neuromuscular activation patterns and movement coordination of the lumbar spine in patients with chronic low back pain and high pain intensity during a standardized neuromuscular training program. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: surface electromyography (sEMG), 3D motion analysis, instrumented gait analysis.

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Secondary

Measure	Time frame
Secondary Endpoint 1 Change in pain intensity and pain-related disability in patients with chronic low back pain. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: Visual Analogue Scale (VAS), Numeric Rating Scale (NRS), Oswestry Disability Index (ODI). Secondary Endpoint 2 Change in health-related quality of life. Assessments are performed: before the intervention (baseline), after 6 weeks, and at 12-week follow-up using: Short Form Health Survey (SF-36). Secondary Endpoint 3 Change in psychosocial and behavioral parameters. Assessments are performed: before the intervention (baseline), after 6 weeks, and at 12-week follow-up using standardized psychosocial questionnaires assessing: fear avoidance, self-efficacy, psychological distress, pain-related behavior. Secondary Endpoint 4 Change in pressure pain thresholds and pain sensitization. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: pressure algometry. Secondary Endpoint 5 Change in morphological and muscular parameters of the lumbar spine. Assessments are performed: before the intervention (baseline), after 6 weeks, and at 12-week follow-up using: magnetic resonance imaging (MRI), bioimpedance analysis. Secondary Endpoint 6 Change in physical activity and functional movement behavior. Assessments are performed: before the intervention (baseline), after 6 weeks, and at 12-week follow-up using: activity assessments, instrumented movement analysis, gait analysis.	—

Measure

Time frame

Secondary Endpoint 1 Change in pain intensity and pain-related disability in patients with chronic low back pain. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: Visual Analogue Scale (VAS), Numeric Rating Scale (NRS), Oswestry Disability Index (ODI). Secondary Endpoint 2 Change in health-related quality of life. Assessments are performed: before the intervention (baseline), after 6 weeks, and at 12-week follow-up using: Short Form Health Survey (SF-36). Secondary Endpoint 3 Change in psychosocial and behavioral parameters. Assessments are performed: before the intervention (baseline), after 6 weeks, and at 12-week follow-up using standardized psychosocial questionnaires assessing: fear avoidance, self-efficacy, psychological distress, pain-related behavior. Secondary Endpoint 4 Change in pressure pain thresholds and pain sensitization. Assessments are performed: before the intervention (baseline), after 3 weeks, after 6 weeks, and at 12-week follow-up using: pressure algometry. Secondary Endpoint 5 Change in morphological and muscular parameters of the lumbar spine. Assessments are performed: before the intervention (baseline), after 6 weeks, and at 12-week follow-up using: magnetic resonance imaging (MRI), bioimpedance analysis. Secondary Endpoint 6 Change in physical activity and functional movement behavior. Assessments are performed: before the intervention (baseline), after 6 weeks, and at 12-week follow-up using: activity assessments, instrumented movement analysis, gait analysis.

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Countries

Germany

Contacts

Public ContactHendrik Schmidt

Charité – Universitätsmedizin Berlin

hendrik.schmidt@bih-charite.de+49 30 450 659 000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026