Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain
NCT ID: NCT00567736
Last Updated: 2012-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2007-08-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Disci/Rhus toxicodendron comp.®
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
2
placebo solution
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
3
waiting list group
No interventions assigned to this group
Interventions
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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 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
75 Years
ALL
No
Sponsors
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WALA Heilmittel GmbH
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Charité University Medical Center Berlin
Principal Investigators
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Claudia M Witt, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, , Germany
Countries
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References
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Pach D, Brinkhaus B, Roll S, Wegscheider K, Icke K, Willich SN, Witt CM. Efficacy of injections with Disci/Rhus toxicodendron compositum for chronic low back pain--a randomized placebo-controlled trial. PLoS One. 2011;6(11):e26166. doi: 10.1371/journal.pone.0026166. Epub 2011 Nov 8.
Other Identifiers
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EudraCT-Nr. 2006-006390-24
Identifier Type: -
Identifier Source: secondary_id
DISCI-07
Identifier Type: -
Identifier Source: org_study_id