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

Phase 2

Completed

• Conditions: Pain; Disability; Paresis
• Interventions: Drug: benzodiacepine

• Registration Number: NCT00533286
• Lead Sponsor: University Hospital Tuebingen

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study Completion: 2007-04
• Status Verified: 2007-09
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Last Update Submitted: 2007-09-20
• Study First Posted: 2007-09-21
• Last Update Posted: 2007-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	benzodiacepine	diazepam (2 x 5 mg)
A	benzodiacepine	placebo (2 tablets daily)

Primary Outcome Measures

Name	Time	Method
(i) median extent of reduction of referred pain	7 days

Secondary Outcome Measures

Name	Time	Method
median duration of inability to work after discharge	one year