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

Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Drug: Disci/Rhus toxicodendron comp.®; Drug: placebo solution

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
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual analogue scale (0-100 mm) low back pain	once after 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Back function (back function scale FFbHR)	once at week 8 and 26
visual analogue scale (0-100 mm) low back pain	once after week 26
days with medication	week 4 to 8
quality of life (SF-36)	once at week 8 and 26
pain disability scale (PDI)	once at week 8 and 26
emotional pain scale (SES)	once at week 8 and 26
influence of patient expectancy	once at week 8 and 26
influence of physician expectancy	once at week 8 and 26
Responder rate 36% VAS pain intensity	once at week 8 and 26
numbers of days with absence from work	between week 4 and 8
days with physician visits because of low back pain	between week 4 and 8

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: WALA Heilmittel GmbH
• Investigators: Principal Investigator: Claudia M Witt, MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (Estimate): December 5, 2007

Study Record Updates

• Last Update Posted (Estimate): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: low back pain; complementary therapies
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: DISCI-07; EudraCT-Nr. 2006-006390-24