search
Back to results

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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Disci/Rhus toxicodendron comp.®
placebo solution
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, complementary therapies

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

1

2

3

Arm Description

Disci/Rhus toxicodendron comp.®

placebo solution

waiting list group

Outcomes

Primary Outcome Measures

Visual analogue scale (0-100 mm) low back pain

Secondary Outcome Measures

Back function (back function scale FFbHR)
visual analogue scale (0-100 mm) low back pain
days with medication
quality of life (SF-36)
pain disability scale (PDI)
emotional pain scale (SES)
influence of patient expectancy
influence of physician expectancy
Responder rate 36% VAS pain intensity
numbers of days with absence from work
days with physician visits because of low back pain

Full Information

First Posted
December 4, 2007
Last Updated
July 10, 2012
Sponsor
Charite University, Berlin, Germany
Collaborators
WALA Heilmittel GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT00567736
Brief Title
Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain
Acronym
DISCI
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 Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
WALA Heilmittel GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, complementary therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Disci/Rhus toxicodendron comp.®
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo solution
Arm Title
3
Arm Type
No Intervention
Arm Description
waiting list group
Intervention Type
Drug
Intervention Name(s)
Disci/Rhus toxicodendron comp.®
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo solution
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual analogue scale (0-100 mm) low back pain
Time Frame
once after 8 weeks
Secondary Outcome Measure Information:
Title
Back function (back function scale FFbHR)
Time Frame
once at week 8 and 26
Title
visual analogue scale (0-100 mm) low back pain
Time Frame
once after week 26
Title
days with medication
Time Frame
week 4 to 8
Title
quality of life (SF-36)
Time Frame
once at week 8 and 26
Title
pain disability scale (PDI)
Time Frame
once at week 8 and 26
Title
emotional pain scale (SES)
Time Frame
once at week 8 and 26
Title
influence of patient expectancy
Time Frame
once at week 8 and 26
Title
influence of physician expectancy
Time Frame
once at week 8 and 26
Title
Responder rate 36% VAS pain intensity
Time Frame
once at week 8 and 26
Title
numbers of days with absence from work
Time Frame
between week 4 and 8
Title
days with physician visits because of low back pain
Time Frame
between week 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M Witt, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22087222
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs