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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Disci/Rhus toxicodendron comp.®
* Drug: placebo solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Disci/Rhus toxicodendron comp.® | Drug: Disci/Rhus toxicodendron comp.®<br>* 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<br>|
| Placebo Comparator: 2<br>placebo solution | Drug: placebo solution<br>* 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<br>|
| No Intervention: 3<br>waiting list group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (0-100 mm) low back pain |  | once after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back function (back function scale FFbHR) |  | once at week 8 and 26 | 
| 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 | 
| influence of patient expectancy |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, complementary therapies