Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain (DISCI)
This study has been completed.
Sponsor:
Charite University, Berlin, Germany
Collaborator:
WALA Heilmittel GmbH
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00567736
First received: December 4, 2007
Last updated: July 10, 2012
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Low Back Pain |
Drug: Disci/Rhus toxicodendron comp.® Drug: placebo solution |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group |
Resource links provided by NLM:
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- Visual analogue scale (0-100 mm) low back pain [ Time Frame: once after 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 150 |
| Study Start Date: | August 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Disci/Rhus toxicodendron comp.®
|
Drug: Disci/Rhus toxicodendron comp.®
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
|
|
Placebo Comparator: 2
placebo solution
|
Drug: placebo solution
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
|
|
No Intervention: 3
waiting list group
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567736
Locations
| Germany | |
| o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center | |
| Berlin, Germany, 10117 | |
Sponsors and Collaborators
Charite University, Berlin, Germany
WALA Heilmittel GmbH
Investigators
| Principal Investigator: | Claudia M Witt, MD | Charite University, Berlin, Germany |
More Information
Publications:
| Responsible Party: | Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin |
| ClinicalTrials.gov Identifier: | NCT00567736 History of Changes |
| Other Study ID Numbers: | DISCI-07, EudraCT-Nr. 2006-006390-24 |
| Study First Received: | December 4, 2007 |
| Last Updated: | July 10, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
low back pain complementary therapies |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013