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

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ClinicalTrials.gov Identifier: NCT00567736
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : July 11, 2012
Sponsor:
Collaborator:
WALA Heilmittel GmbH
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Disci/Rhus toxicodendron comp.® Drug: placebo solution Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : August 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Visual analogue scale (0-100 mm) low back pain [ Time Frame: once after 8 weeks ]

Secondary Outcome Measures :
  1. Back function (back function scale FFbHR) [ Time Frame: once at week 8 and 26 ]
  2. visual analogue scale (0-100 mm) low back pain [ Time Frame: once after week 26 ]
  3. days with medication [ Time Frame: week 4 to 8 ]
  4. quality of life (SF-36) [ Time Frame: once at week 8 and 26 ]
  5. pain disability scale (PDI) [ Time Frame: once at week 8 and 26 ]
  6. emotional pain scale (SES) [ Time Frame: once at week 8 and 26 ]
  7. influence of patient expectancy [ Time Frame: once at week 8 and 26 ]
  8. influence of physician expectancy [ Time Frame: once at week 8 and 26 ]
  9. Responder rate 36% VAS pain intensity [ Time Frame: once at week 8 and 26 ]
  10. numbers of days with absence from work [ Time Frame: between week 4 and 8 ]
  11. days with physician visits because of low back pain [ Time Frame: between week 4 and 8 ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: August 2009

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