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

This study has been completed.

Sponsored by:	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

Drug Information available for: Diazepam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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
A: Placebo Comparator placebo (2 tablets daily)	Drug: benzodiacepine diazepam (2 x 5 mg/ die)
B: Experimental 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

Study ID Numbers:	AKF 57-0-0
Study First Received:	September 20, 2007
Last Updated:	September 20, 2007
ClinicalTrials.gov Identifier:	NCT00533286
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

physiotherapy
Tuebingen concept
benzodiazepines
muscle relaxants
disc herniation

Study placed in the following topic categories:

Spinal Diseases
Paresis
Musculoskeletal Diseases
Diazepam
Hernia

Muscle Hypotonia
Pain
Intervertebral Disk Displacement
Bone Diseases
Prolapse

ClinicalTrials.gov processed this record on January 16, 2009