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

Charité University Medicine Berlin

Status and phase: Completed; Phase 3

Conditions: Chronic Low Back Pain

Treatments: Drug: placebo solution; Drug: Disci/Rhus toxicodendron comp.®

Study type: Interventional

Funder types: Other

Identifiers

NCT00567736

DISCI-07

EudraCT-Nr. 2006-006390-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Disci/Rhus toxicodendron comp.®

Treatment:

Drug: Disci/Rhus toxicodendron comp.®

2

Placebo Comparator group

Description:

placebo solution

Treatment:

Drug: placebo solution

3

No Intervention group

Description:

waiting list group