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
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, complementary therapies
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
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
NCT ID
NCT00567736
First Posted
December 4, 2007
Last Updated
July 10, 2012
Sponsor
Charite University, Berlin, Germany
Collaborators
WALA Heilmittel GmbH
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
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Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain
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