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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: WALA Heilmittel GmbH

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