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

This study has been completed.

First Received on September 20, 2007. No Changes Posted

Sponsor:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00533286

Purpose

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
Pain Disability Paresis	Drug: benzodiacepine	Phase II

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)

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533286

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Michael Weller, Prof.

Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany

More Information

No publications provided

ClinicalTrials.gov 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:

physiotherapy
Tuebingen concept
benzodiazepines
muscle relaxants
disc herniation

Additional relevant MeSH terms:

Paresis
Prolapse
Intervertebral Disk Displacement
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia

ClinicalTrials.gov processed this record on February 09, 2012