Wessex epidural steroids trial (WEST)

ISRCTN	ISRCTN90025501
DOI	https://doi.org/10.1186/ISRCTN90025501
Secondary identifying numbers	HTA 96/31/05

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 08/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Peter Rogers
Scientific

Department of Anaesthesia
Queen Alexandra Hospital
Portsmouth Hospitals NHS Trust
Cosham
Portsmouth
PO3 3LY
United Kingdom

Phone	+44 (0)23 92 286279
Email	pdrogers@btinternet.com

Study information

Study design	Pragmatic multi-centre randomised double blind placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Wessex epidural steroids trial (WEST)
Study acronym	WEST
Study hypothesis	The proposed study is a pragmatic multi-centre randomised double blind placebo controlled trial examining the safety and efficacy of epidural steroids in the management of sciatica. It will compare a combination of steroid and local anaesthetic epidural injection with a placebo injection. 120 patients are required in each arm. The study will collect data on functional improvement, pain, physical signs, analgesic intake and impact on global function and mood over one year. A formal cost-effectiveness analysis will be performed. All complications will also be collected. The objectives are to establish the efficacy and cost-effectiveness of epidural steroids as currently used and identify those who will most benefit.
Ethics approval(s)	Not provided at time of registration.
Condition	Musculoskeletal diseases: Spinal conditions
Intervention	1. A combination of steroid and local anaesthetic epidural injection 2. Placebo injection
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	steroid and local anaesthetic epidural
Primary outcome measure	Functional improvement, pain, physical signs, analgesic intake and impact on global function and mood over one year. A formal cost-effectiveness analysis will also be performed.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/01/1999
Overall study end date	31/03/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	240
Participant inclusion criteria	240 patients with sciatica
Participant exclusion criteria	Not provided at time of registration.
Recruitment start date	01/01/1999
Recruitment end date	31/03/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Anaesthesia

Portsmouth
PO3 3LY
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	HTA monograph	01/08/2005		Yes	No

Editorial Notes

08/11/2022: Internal review.