Low-back pain Musculoskeletal Diseases Dorsalgia
Conditions
Interventions
Intervention: lymphdiaral basistropfen, a homoeopathic remedy of 12 drugs, oral solution
Control: placebo oral solution
Each is to be taken 3 times daily, 10 drops in
Sponsors
PASCOE pharmazeutische Praeparate GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients 2. Aged 18 - 75 years 3. Chronic low-back pain lasting at least for 6 months 4. Hanover functional ability questionnaire (FFbH-R) score less than 70% 5. At least one of the following diagnoses: 5.1. Chronic lumbar ischialgia with or withour radicular radiation 5.2. Chronic degenerative lumbar syndrome 5.3. Spondylarthrosis 5.4. Chronic facette syndrome 5.5. Lumbage with protrusion of the intervertebral disc 5.6. Lumbar radiculopathia 5.7. Lumbar and other intervertebral disc impairments with radiculopathia 5.8. Back pain at different locations of the spine 6. Written, informed consent
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial/GCP-trial within 30 days prior to screening 2. Participation in this trial in an earlier time 3. Treatment with lymphdiaral basistropfen within 3 month prior to enrolment 4. Pregnancy and lactation 5. Non-compliance 6. Incapability to understand the sense of the study 7. Abuse of analgesics, opiates or other drugs 8. Chronic pain that are as strong as or even stronger than the pain caused by the low-back and that need to be treated with analgesics 9. Malign diseases 10. Pathological neurological states 11. Epilepsy 12. Operation of the spine within 3 month prior to enrolment 13. Fractures of the spine 14. Bechterew's disease 15. Alcohol abuse 16. Consuming diseases 17. Cachexia 18. Palsy of the legs or anal sphincter due to acute impairment of the intervertebral disc 19. Catheterisation or CT-controlled intra-articular injection in the lumbar region 20. Hypersensitivity against one of the ingredients or excipients of the study drugs or against composite plants in general 21. Systemic, progressive diseases like tuberculosis, leucosis, collagenosis, multiple sclerosis, acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection, or other auto-immune diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FFbH-R following 15 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in FFbH-R following 2 weeks treatment 2. Change in pain score (SES) following 2 weeks treatment 3. Change in pain score (ES) following 15 weeks treatment 4. Change in strength of pain (Visual analog scale VAS) following 2 weeks treatment 5. Change in strength of pain (Visual analog scale VAS following 15 weeks treatment 6. Change in state of health (BF-S) following 2 weeks treatment 7. Change in state of health (BF-S) following 15 weeks treatment 8. Change in Oswestry Score following 2 weeks treatment 9. Change in Oswestry Score following 15 weeks treatment 10. Change in short form health survey 12 items (SF-12) following 2 weeks treatment 11. Change in short form health survey 12 items (SF-12) following 15 weeks treatment 12. Correlation of efficacy with the constitutional type of the patient, measured by the Hattinger Konstitutional Manual (HKM) and the Hattinger Konstitutional Questionnaire (HKF) 13. Amount of analgesics used 14. Number of days with incapability to work under 15 weeks treatment 15. Tolerability within 15 weeks treatment | — |
Countries
Germany
Outcome results
None listed