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

This study has been completed.
Information provided by:
University Hospital Tuebingen Identifier:
First received: September 20, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

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
Drug: benzodiacepine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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)


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00533286

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

No publications provided Identifier: NCT00533286     History of Changes
Other Study ID Numbers: AKF 57-0-0
Study First Received: September 20, 2007
Last Updated: September 20, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Intervertebral Disk Displacement
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia processed this record on April 17, 2014