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Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533286
First Posted: September 21, 2007
Last Update Posted: September 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Tuebingen
  Purpose
Sixty patients were randomized to receive either placebo or diazepam in addition to mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of clinically and radiologically confirmed lumbar disk prolapse

Condition Intervention Phase
Pain Disability Paresis Drug: benzodiacepine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • (i) median extent of reduction of referred pain [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • median duration of inability to work after discharge [ Time Frame: one year ]

Study Start Date: August 2002
Study Completion Date: April 2007
Arms Assigned Interventions
Placebo Comparator: A
placebo (2 tablets daily)
Drug: benzodiacepine
diazepam (2 x 5 mg/ die)
Experimental: B
diazepam (2 x 5 mg)
Drug: benzodiacepine
diazepam (2 x 5 mg/ die)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sciatica without or with neurological deficit attributable to lumbar disc prolapse
  • CT or MRI confirmation of lumbar disc prolapse
  • informed consent

Exclusion Criteria:

  • bladder or bowel disturbance
  • acute (< 24 h) development of paresis grade 1 or plegia
  • taken benzodiazepines for more than 2 weeks
  • history of benzodiazepine intolerance
  • prior surgery for disc prolapse, or prior trauma to the vertrebral column
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533286


Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Michael Weller, Prof. Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00533286     History of Changes
Other Study ID Numbers: AKF 57-0-0
First Submitted: September 20, 2007
First Posted: September 21, 2007
Last Update Posted: September 21, 2007
Last Verified: September 2007

Keywords provided by University Hospital Tuebingen:
physiotherapy
Tuebingen concept
benzodiazepines
muscle relaxants
disc herniation

Additional relevant MeSH terms:
Prolapse
Paresis
Intervertebral Disc Displacement
Pathological Conditions, Anatomical
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia