M54.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients an age between 18 to 65 years 2. Pre-existing diagnosis of a chronic low back pain, established by a specialist (orthopaedics, neurology, pain therapy) since at least 3 months 3. Average low back pain intensity with a minimum of 40 mm on VAS from 0 to 100 mm
Exclusion criteria
Exclusion criteria: 1. Invasive treatments in the spine within the last 6 weeks or planned within the next 8 weeks 2. Acute prolapse of vertebral disk (diagnosis within the last 3 months) 3. Congenital anomalies in the lumbar spine area 4. Rheumatoid arthritis 5. Acute mental illness 6. Serious pathology, somatic diseases 7. Pregnancy 8. Regularly exercised mindfulness meditation 9. Concurrent participation in another clinical study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Roland-Morris Disability Index; 100 mm VAS for the average interference by low back pains during the last week; Questionnaires for the assessment of the pain-conditioned barrier in different areas of life by low back pain; Evaluation of the general state of health with SF 36; Overall assessment of the effectiveness and compatibility (Likert scale); Mood, fear, depression (Zerssen, POMS,HADS); Affective pain assessment („SES“); Intensity / frequency of analgesic basic medication and demand medication (diary); Compatibility based on query of the adverse events. | — |
Primary
| Measure | Time frame |
|---|---|
| 100 mm VAS for the average low back pain intensity during the last week (Baseline versus End) | — |
Countries
Germany