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
Protocol serial number	N0231139989
Sponsor	Department of Health
Funder	Southampton University Hospitals NHS Trust (UK), NHS R&D Support Funding

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Glucocorticosteroids
Primary outcome measure(s)	1. Oswestry disability score 2. Short form 36
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes