Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain (DISCI)

This study has been completed.
Sponsor:
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
  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 April 17, 2014