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

Sponsor:	Charite University, Berlin, Germany
Collaborator:	WALA Heilmittel GmbH
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00567736

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 III

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:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

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 ]

Estimated 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

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

More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Nov 8.

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:	August 14, 2009
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 February 12, 2012