| December 4, 2007 |
| August 14, 2009 |
| August 2007 |
| January 2009 (final data collection date for primary outcome measure) |
| Visual analogue scale (0-100 mm) low back pain [ Time Frame: once after 8 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00567736 on ClinicalTrials.gov Archive Site |
- Back function (back function scale FFbHR) [ Time Frame: once at week 8 and 26 ] [ Designated as safety issue: No ]
- visual analogue scale (0-100 mm) low back pain [ Time Frame: once after week 26 ] [ Designated as safety issue: No ]
- days with medication [ Time Frame: week 4 to 8 ] [ Designated as safety issue: No ]
- quality of life (SF-36) [ Time Frame: once at week 8 and 26 ] [ Designated as safety issue: No ]
- pain disability scale (PDI) [ Time Frame: once at week 8 and 26 ] [ Designated as safety issue: No ]
- emotional pain scale (SES) [ Time Frame: once at week 8 and 26 ] [ Designated as safety issue: No ]
- influence of patient expectancy [ Time Frame: once at week 8 and 26 ] [ Designated as safety issue: No ]
- influence of physician expectancy [ Time Frame: once at week 8 and 26 ] [ Designated as safety issue: No ]
- Responder rate 36% VAS pain intensity [ Time Frame: once at week 8 and 26 ] [ Designated as safety issue: No ]
- numbers of days with absence from work [ Time Frame: between week 4 and 8 ] [ Designated as safety issue: No ]
- days with physician visits because of low back pain [ Time Frame: between week 4 and 8 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain |
| Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group |
The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo. |
Chronic low back pain is a significant health problem in industrialized countries. Use of complementary medicine is increasing in patients with low back pain. Until now there is no evidence for the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
| Chronic Low Back Pain |
- Drug: Disci/Rhus toxicodendron comp.®
- Drug: placebo solution
|
- Active Comparator: Disci/Rhus toxicodendron comp.®
- Placebo Comparator: placebo solution
- No Intervention: waiting list group
|
| |
| |
| Completed |
| 150 |
| January 2009 |
| January 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male and female patients, 30 to 75 years
- Willingness of following the study protocol
- Clinical diagnosis of chronic low back pain
- Low back pain since at least 3 months
- Average pain intensity of at least 40 mm on VAS (0-100 mm) in the last 7 days
- In the last 4 weeks only oral NSAD and muscle relaxation treatment
- Effective oral contraception in woman
- Informed consent
Exclusion Criteria:
- Previous treatment with DISCI comp.
- Treatment with other than NSAID
- Routine use of pain drugs for other diseases
- Protrusio or prolapse of one or more intervertebral discs with neurological symptoms
- Previous spine surgery
- (Suspicious) infectious spondylopathy
- Low back pain because of malignant or infectious disease
- Other causes of back pain symptoms (e.g. M. Bechterev, M. Reiter)
- Congenital deformity of spine (without minor lordosis or kyphosis or scoliosis
- (Suspicious) osteoporosis with compression fracture
- (Suspicious) spinal stenosis
- Spondylolysis or spondylolisthesis
- Physiotherapy in the last four weeks or planed during trial
- Begin of a new treatment for low back pain
- Complementary treatment in the last four weeks or planed during trial
- Patients who are not able to cooperate in a sufficient way
- Patients with alcohol or substance abuse
- Participation in another clinical trial
- Severe chronical or acute disease which does not allow study participation
- Patients with bleeding disorders or oral anticoagulation treatment
- Pregnancy and breast feeding
- Patients with application for pension
- Patients involved in planning or coordination of the study
- Hypersensitivity against drug components
|
| Both |
| 30 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00567736 |
| Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin |
| DISCI-07, EudraCT-Nr. 2006-006390-24 |
| Charite University, Berlin, Germany |
| WALA Heilmittel GmbH |
| Principal Investigator: |
Claudia M Witt, MD |
Institute for Social Medicine, Epidemiology, and Health Economics - Charité University Medical Center |
|
|
| Charite University, Berlin, Germany |
| August 2009 |