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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00533286
Other study ID # AKF 57-0-0
Secondary ID
Status Completed
Phase Phase 2
First received September 20, 2007
Last updated September 20, 2007
Start date August 2002
Est. completion date April 2007

Study information

Verified date September 2007
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
benzodiacepine
diazepam (2 x 5 mg/ die)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Outcome

Type Measure Description Time frame Safety issue
Primary (i) median extent of reduction of referred pain 7 days
Secondary median duration of inability to work after discharge one year
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