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

September 20, 2007 updated by: University Hospital Tuebingen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Michael Weller, Prof., Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 20, 2007

First Posted (ESTIMATE)

September 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2007

Last Update Submitted That Met QC Criteria

September 20, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKF 57-0-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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