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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 09, 2014