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

Pain Clinical Trial

Official title:

Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533286
• Other study ID #: AKF 57-0-0
• 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
• 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

• Disability
• Pain
• Paresis

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