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

Chronic Low Back Pain Clinical Trial

— DISCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567736
• Other study ID #: DISCI-07
• Secondary ID: EudraCT-Nr. 2006
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2007
• Last updated: July 10, 2012
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: August 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Disci/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
• placebo 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

Locations

Country	Name	City	State
Germany	o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	WALA Heilmittel GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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.po — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (0-100 mm) low back pain		once after 8 weeks	No
Secondary	Back function (back function scale FFbHR)		once at week 8 and 26	No
Secondary	visual analogue scale (0-100 mm) low back pain		once after week 26	No
Secondary	days with medication		week 4 to 8	No
Secondary	quality of life (SF-36)		once at week 8 and 26	No
Secondary	pain disability scale (PDI)		once at week 8 and 26	No
Secondary	emotional pain scale (SES)		once at week 8 and 26	No
Secondary	influence of patient expectancy		once at week 8 and 26	No
Secondary	influence of physician expectancy		once at week 8 and 26	No
Secondary	Responder rate 36% VAS pain intensity		once at week 8 and 26	No
Secondary	numbers of days with absence from work		between week 4 and 8	No
Secondary	days with physician visits because of low back pain		between week 4 and 8	No