Do Benzodiazepines Improve the Outcome of Mechanical Phys... | NCT00533286

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

NCT00533286

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Sep 21, 2007Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Pain
Disability
Paresis

Interventions

benzodiacepine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Sep 20, 2007

First Submission Date that Met QC Criteria

Sep 20, 2007

First Posted Date

Sep 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2007

Last Update Posted Date

Sep 21, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Placebo Comparator	placebo (2 tablets daily)	Drug: benzodiacepine
B	Experimental	diazepam (2 x 5 mg)	Drug: benzodiacepine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
benzodiacepine	Drug	diazepam (2 x 5 mg/ die)	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
(i) median extent of reduction of referred pain		7 days

Secondary Outcomes

Measure	Description	Time Frame
median duration of inability to work after discharge		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Weller, Prof.	Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D010291	Paresis
D009123	Muscle Hypotonia
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided