Chronic Low Back Pain
Conditions
Keywords
low back pain, complementary therapies
Brief 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.
Detailed 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.
Interventions
DRUGplacebo solution
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
DRUGDisci/Rhus toxicodendron comp.®
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
Sponsors
WALA Heilmittel GmbH
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale (0-100 mm) low back pain | once after 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| visual analogue scale (0-100 mm) low back pain | once after week 26 |
| days with medication | week 4 to 8 |
| quality of life (SF-36) | once at week 8 and 26 |
| pain disability scale (PDI) | once at week 8 and 26 |
| emotional pain scale (SES) | once at week 8 and 26 |
| Back function (back function scale FFbHR) | once at week 8 and 26 |
| influence of physician expectancy | once at week 8 and 26 |
| Responder rate 36% VAS pain intensity | once at week 8 and 26 |
| numbers of days with absence from work | between week 4 and 8 |
| days with physician visits because of low back pain | between week 4 and 8 |
| influence of patient expectancy | once at week 8 and 26 |
Countries
Germany
Outcome results
None listed