Clinical trial NCT00567736: Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain
Official title: Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Keywords: low back pain
complementary therapies
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: WALA Heilmittel GmbH
First posted: 2007-12-05
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale (0-100 mm) low back pain
timeFrame: once after 8 weeks
Secondary outcomes:
measure: Back function (back function scale FFbHR)
timeFrame: once at week 8 and 26
measure: visual analogue scale (0-100 mm) low back pain
timeFrame: once after week 26
measure: days with medication
timeFrame: week 4 to 8
measure: quality of life (SF-36)
timeFrame: once at week 8 and 26
measure: pain disability scale (PDI)
timeFrame: once at week 8 and 26
measure: emotional pain scale (SES)
timeFrame: once at week 8 and 26
measure: influence of patient expectancy
timeFrame: once at week 8 and 26
measure: influence of physician expectancy
timeFrame: once at week 8 and 26
measure: Responder rate 36% VAS pain intensity
timeFrame: once at week 8 and 26
measure: numbers of days with absence from work
timeFrame: between week 4 and 8
measure: days with physician visits because of low back pain
timeFrame: between week 4 and 8
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia M Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pach D, Brinkhaus B, Roll S, Wegscheider K, Icke K, Willich SN, Witt CM. Efficacy of injections with Disci/Rhus toxicodendron compositum for chronic low back pain--a randomized placebo-controlled trial. PLoS One. 2011;6(11):e26166. doi: 10.1371/journal.pone.0026166. Epub 2011 Nov 8.