Prospektive, randomized, controlled, multicentre, partly double blind study to compare Disci/Rhus toxicodendron comp., placebo and waiting list in patients with chronic low back pain.

• Conditions: chronic low back pain (chronic local or pseudoradiculaere low back pain due to e.g. degenerative basic illness).

• Registration Number: EUCTR2006-006390-24-DE
• Lead Sponsor: WALA Heilmittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

History of chronic low back pain (chronic local or pseudoradiculaere clow back pain due to e.g. degenerative basic illness).
=> Back pain for at least 12 month prior inclusion (= chronic low back pain).
Average value of pain intensity related to the last 7 days (40mm on a visual analog scale of 0 to 100mm).
Therapy of chronic low back pain only medicamentous in the last 4 weeks before enrollment (peripherally active analgesics, non-steroidal antiphlogistics, muscle relaxants).
=> effective contraception for women of childbearing potential. Methods of birth control are considered to effective, when failure rate is less than 1% per year, e.g. combined oral contraceptives, implants, IUDs, diphragm, occlusive pessary or sexual abstinence.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Treatment with Disci medicinal products.
Concomitant therapy with other drugs than peripheral active analgesic, non-steroidal antiphlogistics.
Necessity of taking analgesics due to other disease.
Protrusion or prolapse of one/more intervertebral disks with neurological symtomatic.
History of surgery of the spine or planned surgeries.
History of infectious spondylopathy.
History of back pain due to a malignant and inflammatory illness.
History of ankylosing spondylitis, Reiter´s syndrome, Morbus Behcet.
History of congenital malformation of spine expecting mild lordosis or scoliosis.
History of osteoporosis, spinal stenosis, spondylolysis, spondylolisthosis.
Physiotherapy within 4 weeks prior to inclusion or during study conduction.
Start of new therapy within 4 weeks prior to inclusion or planned new therapy.
Complementary medicine therapy (acupuncture, homeopathy, physiotherapy, neural therapy) within 4 weeks prior to inclusion or planned during study conduction.
Inability to complete the study according to protocol.
History of abuse of alcohol and drugs.
Participation in another study within 3 months prior to inclusion.
History of serious and/ or acute or chronic organic disease and mental disease.
=> History of coagulopathy and intake of drugs which inhibits coagulation.
Pregnant and breastfeeding females.
Current application for pension.
Involvement in the planning and conduct of the study.
Hypersensitivity of any ingredients of IMP.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified