Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse
Information source: University Hospital Tuebingen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Disability; Paresis
Intervention: benzodiacepine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Hospital Tuebingen Official(s) and/or principal investigator(s):
Michael Weller, Prof., Principal Investigator, Affiliation: Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany
Summary
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
Clinical Details
Official title: Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: (i) median extent of reduction of referred pain
Secondary outcome: median duration of inability to work after discharge
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: August 2002
Ending date: April 2007
Last updated: September 20, 2007
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