Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
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

Dr Peter Rogers

ORCID ID

Contact details

Department of Anaesthesia
Queen Alexandra Hospital
Portsmouth Hospitals NHS Trust
Cosham
Portsmouth
PO3 3LY
United Kingdom
+44 (0)23 92 286279
pdrogers@btinternet.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/31/05

Study information

Scientific title

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

Not provided at time of registration.

Study design

Pragmatic multi-centre randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal diseases: Spinal conditions

Intervention

1. A combination of steroid and local anaesthetic epidural injection
2. Placebo injection

Intervention type

Drug

Phase

Not Specified

Drug names

steroid and local anaesthetic epidural

Primary outcome measures

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 trial start date

01/01/1999

Overall trial end date

31/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

240 patients with sciatica

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

240

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

United Kingdom

Trial participating centre

Department of Anaesthesia
Portsmouth
PO3 3LY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

2005 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/16095548

Publication citations

  1. HTA monograph

    Price C, Arden N, Coglan L, Rogers P, Cost-effectiveness and safety of epidural steroids in the management of sciatica., Health Technol Assess, 2005, 9, 33, 1-58, iii.

Additional files

Editorial Notes