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Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain (DISCI)
This study has been completed.
Study NCT00567736   Information provided by Charite University, Berlin, Germany
First Received: December 4, 2007   Last Updated: August 14, 2009   History of Changes

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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP