CClinicalTrials.gg
Sign In
CompletedNCT00567736DISCIUpdated Jul 11, 2012

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

A Phase 3 interventional study of Disci/Rhus toxicodendron comp.® and placebo solution in Chronic Low Back Pain, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-07-11.

Sponsored by Charite University, Berlin, Germany · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Low Back Pain

Keywords

  • low back pain
  • complementary therapies
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 150 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    1

    Disci/Rhus toxicodendron comp.®

    Drug: Disci/Rhus toxicodendron comp.®

  • Placebo comparator
    2

    placebo solution

    Drug: placebo solution

  • No intervention
    3

    waiting list group

Interventions

  • 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

  • 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

06

What researchers measure

Primary outcomes

  1. Visual analogue scale (0-100 mm) low back pain

    Time frame: once after 8 weeks

Secondary outcomes

  1. Back function (back function scale FFbHR)

    Time frame: once at week 8 and 26

  2. visual analogue scale (0-100 mm) low back pain

    Time frame: once after week 26

  3. days with medication

    Time frame: week 4 to 8

  4. quality of life (SF-36)

    Time frame: once at week 8 and 26

  5. pain disability scale (PDI)

    Time frame: once at week 8 and 26

  6. emotional pain scale (SES)

    Time frame: once at week 8 and 26

  7. influence of patient expectancy

    Time frame: once at week 8 and 26

  8. influence of physician expectancy

    Time frame: once at week 8 and 26

  9. Responder rate 36% VAS pain intensity

    Time frame: once at week 8 and 26

  10. numbers of days with absence from work

    Time frame: between week 4 and 8

  11. days with physician visits because of low back pain

    Time frame: between week 4 and 8

07

Study locations

1 site
  • o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
    Berlin, 10117, Germany
08

References and documents

Publications

  • 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. PubMed 22087222 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00567736
Lead sponsor
Charite University, Berlin, Germany
Collaborators
WALA Heilmittel GmbH
First posted
Dec 5, 2007
Start date
Aug 2007
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Jul 11, 2012

Study contacts

Claudia M Witt, MD
principal investigator · Charite University, Berlin, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Back Pain→

Other studies from this sponsor

Charite University, Berlin, Germany

Start the discussion