Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
24/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nicholas Brooke

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes