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Completed

NCT Number: NCT00567736

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

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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disci/Rhus toxicodendron comp.®

Drug

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

Drug

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

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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • WALA Heilmittel GmbH

Registry information

Official study title

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

Acronym: DISCI

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2007
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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