chronic low back pain (chronic local or pseudoradiculaere low back pain due to e.g. degenerative basic illness).
Conditions
Interventions
Trade Name: Disci/ Rhus toxicodendron comp.
Product Name: DISCI-Studie/ disrhu-1
Pharmaceutical Form: Solution for injection
Other descriptive name: Aconitum napellus e tubere ferm 33c
Concentration u
Sponsors
WALA Heilmittel GmbH
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): none;Main Objective: The primary objective of the study is to investigate whether treatment with Disci/ Rhus toxicodendron comp. of chronic low back pain is more effective than no treatment (group of waiting list) and more effective than a placebo. Primary objective parameter is average pain related to the last 7 days (measured on the basis of a visual analog scale (VASO-100mm)) after 8 weeks.;Secondary Objective: The secondary objectives are to investigate whether treatment with Disci/ Rhus toxicodendron comp. is more effective by the following parameters than no treatment ( group of waiting list) and more effective than placebo: 1. Back function (Questionnaire Hanover-Back FFbH-R) 2. Number of days with acute medication need in the weeks 4 to 8 (patient diary) 3. Number of days of inability to work of employed study participants. 4. Healthy-referred quality of life (SF-36) 5. Emotional pain evaluation (pain sensation scale SES) 6. Evaluation of impairment in every day life (Pain Disability Index) 7. Influence of expectation attitude of patient on the outcome 8. Influence of expectation attitude of physicians on the outcome. | — |
Countries
Germany
Outcome results
None listed