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.

ISRCTN	ISRCTN40219386
DOI	https://doi.org/10.1186/ISRCTN40219386
Secondary identifying numbers	N0231139989

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Nicholas Brooke
Scientific

Wessex Neurological Centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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.
Study objectives	Does post-operative glucocorticosteroids alter post-operative outcome after simple lumbar spine surgery?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Glucocorticosteroids
Primary outcome measure	1. Oswestry disability score 2. Short form 36
Secondary outcome measures	Not provided at time of registration
Overall study start date	14/03/2005
Completion date	01/04/2006

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Key inclusion criteria	50 patients from surgical waiting list aged 21-70 years
Key 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.
Date of first enrolment	14/03/2005
Date of final enrolment	01/04/2006

Southampton General Hospital

Southampton
SO16 6YD
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Southampton University Hospitals NHS Trust (UK), NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan