Chronic non-specific back pain Musculoskeletal Diseases
Conditions
Interventions
In this two-arm monocentric study, male patients diagnosed with chronic nonspecific low back pain will be compared in the following intervention arms:
1st arm: standard rehabilitation (treatment as us
Sponsors
Paracelsus Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years 2. Male 3. Diagnosed with chronic nonspecific low back pain (ICD M40-M54) 4. Sufficient physical fitness to participate in the outdoor activities (PAR-Q) 5. Sufficient linguistic and cognitive abilities to participate in the study, especially in terms of the ability to understand the consent form, to adequately implement exercise instructions from medical and health science professionals and to answer questionnaires 6. Written declaration of consent
Exclusion criteria
Exclusion criteria: 1. Untreated or acute malignant diseases 2. Previous operations in the lumbar spine area 3. Suspected herniated disc causing the current symptoms and contradicting participation in the study programme 4. Contraindications to balneotherapy: manifest concomitant internal diseases, unstable high blood pressure, thrombosis, endocrine diseases such as hyperthyroidism and hyperparathyroidism, other uncontrolled metabolic diseases such as diabetes mellitus, active infectious diseases, incontinence 5. Hernias 6. History of cerebrovascular and neurological diseases 7. Inflammatory rheumatic diseases (including inflammatory rheumatic diseases of the joints, vessels and connective tissue) 8. Primary and secondary immunodeficiencies that do not allow participation in the activity programme (PAR-Q) 9. Severe respiratory diseases that require oxygen supplementation 10. Acute or untreated mental illness (Beck's Depression Inventory >19) 11. Heart failure that does not allow participation in the activity programme (NYHA stages 3 and 4) (PAR-Q) 12. Renal insufficiency that does not allow participation in the activity programme (PAR-Q) 13. CHD patients who do not allow participation in the activity programme (PAR-Q) 14. Alcohol abuse (ICD F10.1), drug abuse (ICD F11-F19) 15. Intake of >5 mg/d prednisone and all glucocorticoids from a corresponding prednisone equivalent 16. DMARD therapy such as azathioprine, colchicine, cyclophosphamide, ciclosporin, methotrexate or interferon preparations 17. Taking preparations from the Jak inhibitor group (Olumiant, Xeljanz etc) or TNF alpha inhibitors 18. Infiltration therapy of the lumbar spine <3 months 19. Insufficient knowledge of German (written and spoken/questionnaires)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Indication-related quality of life measured using the Oswestry Low Back Disability Index (ODI) at the beginning (T1) and end (T2) of back rehabilitation as well as 90 (T3) and 180 days after the end of rehabilitation (T4) 2. Indication-related posture, mobility, postural competence measured using Spine-Check at the beginning (T1) and end (T2) of back rehabilitation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Back muscle strength measured using Back Check at the beginning (T1) and end (T2) of back rehabilitation 2. Static balance measured using MFT-S3-Check at the beginning (T1) and end (T2) of back rehabilitation 3. Pain measured using the visual analogue scale for pain at rest and pain on movement and painkiller consumption at the beginning (T1) and end (T2) of back rehabilitation as well as 90 (T3) and 180 days after the end of rehabilitation (T4) 4. Quality of life measured using the Quality of Life Short Form 12 (SF12) at the beginning (T1) and end (T2) of back rehabilitation as well as 90 (T3) and 180 days after the end of rehabilitation (T4) 5. Wellbeing measured using the World Health Organisation- Five Well-Being Index (WHO-5) at the beginning (T1) and end (T2) of back rehabilitation as well as 90 (T3) and 180 days after the end of rehabilitation (T4) 6. Symptoms of depression and anxiety measured using Patient Health Questionnaire-4 (PHQ-4) at the beginning (T1) and end (T2) of back rehabilitation as well as 90 (T3) and 180 days after the end of rehabilitation (T4) 7. Ability to work measured using the Work Ability Index (WAI) measured using Patient Health Questionnaire-4 (PHQ-4) at the beginning (T1) of back rehabilitation as well as 90 (T3) and 180 days after the end of rehabilitation (T4) 8. Pain-related anxiety measured using the Fear-Avoidance-Beliefs-Questionnaire (FABQ) at the beginning (T1) and end (T2) of back rehabilitation as well as 90 (T3) and 180 days after the end of rehabilitation (T4) 9. Physical activity measured using the European Health Interview Survey - Physical Activity Questionnaire (EHIS-PAQ) at the beginning (T1) of back rehabilitation as well as 90 (T3) and 180 days after the end of rehabilitation (T4) | — |
Countries
Austria
Contacts
Public ContactArnulf Hartl
Outcome results
None listed