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

Phase 3

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Drug: Disci/Rhus toxicodendron comp.®; Drug: placebo solution

• Registration Number: NCT00567736
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-08
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Disci/Rhus toxicodendron comp.®	Disci/Rhus toxicodendron comp.®
2	placebo solution	placebo solution

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (0-100 mm) low back pain	once after 8 weeks

Secondary Outcome Measures

Name	Time	Method
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 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
visual analogue scale (0-100 mm) low back pain	once after week 26
Back function (back function scale FFbHR)	once at week 8 and 26
days with physician visits because of low back pain	between week 4 and 8

Trial Locations

Locations (1)

o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center; 🇩🇪 Berlin, Germany