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ISRCTN
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ISRCTN40219386
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ClinicalTrials.gov identifier
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Public title
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Randomised, double-blind and controlled trial of lumbar microdiscectomies and laminectomies comparing post-operative course and results over one year with and without post-operative glucocorticosteroids.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0231139989
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Study hypothesis
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Does post-operative glucocorticosteroids alter post-operative outcome after simple lumbar spine surgery?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Surgery: Lumbar
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Participants - inclusion criteria
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50 patients from surgical waiting list aged 21-70 years
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Participants - exclusion criteria
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Although extremely uncommon, if a patient had a lumbar or caudal epidural using glucocorticosteroid post operatively, they would be excluded from the trial.
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Anticipated start date
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14/03/2005
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Anticipated end date
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01/04/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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Patients pre-selected for appropriate surgery from surgical waiting list will be approached at the time of consenting to be entered into therapeutic trial. One additional injection post-op vs standard practice.
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Primary outcome measure(s)
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1. Oswestry disability score
2. Short form 36
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Southampton University Hospitals NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Nicholas
Brooke
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Address
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Wessex Neurological Centre
Southampton General Hospital
Tremona Road
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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29/06/2009
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Date ISRCTN assigned
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30/09/2005
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