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ISRCTN
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ISRCTN43299460
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ClinicalTrials.gov identifier
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Public title
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Epidural steroid injection in chronic lumbar back pain: a cross-over, single-blinded study of methyl-prednisolone 80mg versus methyl-prednisolone 40mg
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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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N0192187922
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Study hypothesis
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Does 40mg of epidural methyl-prednisolone produce an equivalent improvement in disability scores when compared to 80mg of epidural methyl-prednisolone?
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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, single-blinded, cross-over 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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Musculoskeletal Diseases: Low back pain
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Participants - inclusion criteria
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Patients attending Nottingham City Hospital Day Case Unit, with chronic back pain who are presenting for repeat epidural steroid injection as part of their chronic pain management programme.
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Participants - exclusion criteria
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Blood clotting disorder, anticoagulant (Warfarin) use.
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Anticipated start date
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24/05/2006
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Anticipated end date
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28/02/2007
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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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60
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Interventions
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Randomised, single-blinded, cross-over trial with two treatment arms:
1. 80mg methyl-prednisolone repeated three months later with 40mg dose
2. 40mg methyl-prednisolone repeated three months later with 80mg dose
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Primary outcome measure(s)
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Evidence that a reduced dose of methyl-prednisolone given epidurally does not cause a significant worsening of the primary outcome measure ie the Oswestry Low Back Pain Disability Index.
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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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Nottingham University Hospitals NHS Trust
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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Dr
A
Ravenscroft
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Address
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Anesthetics Department
City Hospital
Hucknall Road
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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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 - 2007 Update - Department of Health
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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
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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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28/09/2007
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Last edited
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25/10/2007
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Date ISRCTN assigned
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28/09/2007
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