EUCTR2006-006390-24-DE
Active, not recruiting
Not Applicable
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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- chronic low back pain (chronic local or pseudoradiculaere low back pain due to e.g. degenerative basic illness).
- Sponsor
- WALA Heilmittel GmbH
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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