Wessex epidural steroids trial (WEST)
| ISRCTN | ISRCTN90025501 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90025501 |
| Protocol serial number | HTA 96/31/05 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Peter Rogers
Scientific
Scientific
Department of Anaesthesia
Queen Alexandra Hospital
Portsmouth Hospitals NHS Trust
Cosham
Portsmouth
PO3 3LY
United Kingdom
| Phone | +44 (0)23 92 286279 |
|---|---|
| pdrogers@btinternet.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic multi-centre randomised double blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Wessex epidural steroids trial (WEST) |
| Study acronym | WEST |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | steroid and local anaesthetic epidural |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 240 |
| Key inclusion criteria | 240 patients with sciatica |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 31/03/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthesia
Portsmouth
PO3 3LY
United Kingdom
PO3 3LY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
