Efficacy and safety of lymphdiaral basistropfen in the treatment of chronic low-back pain
| ISRCTN | ISRCTN88642122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88642122 |
| ClinicalTrials.gov number | NCT01049373 |
| Secondary identifying numbers | PSC 144/03 |
- Submission date
- 18/05/2009
- Registration date
- 17/06/2009
- Last edited
- 16/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andre-Michael Beer
Scientific
Scientific
Klinikum Blankenstein
Modellabteilung für Naturheilkunde
Im Vogelsang 5-11
Hattingen
D 45527
Germany
| andre.beer@klinik-blankenstein.de |
Study information
| Study design | Interventional double-blind randomised placebo-controlled single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy and safety of lymphdiaral basistropfen (a homoeopathic remedy [HDC]) in the treatment of chronic low-back pain considering consitution and diathesism: a double blind, randomised, placebo controlled, single-centre study |
| Study objectives | To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back pain in relation to pain, functional impairment, quality of life, and state of health during a 15-week treatment period. |
| Ethics approval(s) | Bergmannsheil Bochum Ethikkommission, 23/07/2003 |
| Health condition(s) or problem(s) studied | Low-back pain |
| Intervention | 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 some liquid over 15 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lymphdiaral basistropfen |
| Primary outcome measure | Change in FFbH-R following 15 weeks treatment |
| Secondary outcome measures | 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 |
| Overall study start date | 05/12/2003 |
| Completion date | 05/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 (70 verum, 70 placebo) |
| Total final enrolment | 137 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/12/2003 |
| Date of final enrolment | 05/05/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinikum Blankenstein
Hattingen
D 45527
Germany
D 45527
Germany
Sponsor information
PASCOE pharmazeutische Praeparate GmbH (Germany)
Industry
Industry
Schiffenberger Weg 55
Giessen
D-35394
Germany
| anja.braschoss@pascoe.de | |
| Website | http://www.pascoe-global.com |
"ROR" |
https://ror.org/02xbx2821 |
Funders
Funder type
Industry
PASCOE pharmazeutische Praeparate GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 28/06/2012 | 16/04/2019 | Yes | No |
Editorial Notes
16/04/2019: Publication reference and total final enrolment added.
