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

Primary Purpose

Pain, Disability, Paresis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
benzodiacepine
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring physiotherapy, Tuebingen concept, benzodiazepines, muscle relaxants, disc herniation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    A

    B

    Arm Description

    placebo (2 tablets daily)

    diazepam (2 x 5 mg)

    Outcomes

    Primary Outcome Measures

    (i) median extent of reduction of referred pain

    Secondary Outcome Measures

    median duration of inability to work after discharge

    Full Information

    First Posted
    September 20, 2007
    Last Updated
    September 20, 2007
    Sponsor
    University Hospital Tuebingen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00533286
    Brief Title
    Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse
    Official Title
    Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital Tuebingen

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Disability, Paresis
    Keywords
    physiotherapy, Tuebingen concept, benzodiazepines, muscle relaxants, disc herniation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Placebo Comparator
    Arm Description
    placebo (2 tablets daily)
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    diazepam (2 x 5 mg)
    Intervention Type
    Drug
    Intervention Name(s)
    benzodiacepine
    Intervention Description
    diazepam (2 x 5 mg/ die)
    Primary Outcome Measure Information:
    Title
    (i) median extent of reduction of referred pain
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    median duration of inability to work after discharge
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Weller, Prof.
    Organizational Affiliation
    Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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