Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0231139989
Study information
Scientific title
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.
Acronym
Study hypothesis
Does post-operative glucocorticosteroids alter post-operative outcome after simple lumbar spine surgery?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Lumbar
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Glucocorticosteroids
Primary outcome measures
1. Oswestry disability score
2. Short form 36
Secondary outcome measures
Not provided at time of registration
Overall trial start date
14/03/2005
Overall trial end date
01/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
50 patients from surgical waiting list aged 21-70 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
Although extremely uncommon, if a patient had a lumbar or caudal epidural using glucocorticosteroid post operatively, they would be excluded from the trial.
Recruitment start date
14/03/2005
Recruitment end date
01/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Southampton University Hospitals NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary