Epidural and Nerve Root Corticosteroid and Local Anaesthetic Injections for Lumbar Nerve Root Compression
| ISRCTN | ISRCTN12348847 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12348847 |
| Protocol serial number | N0199129906 |
| Sponsor | Department of Health |
| Funder | Royal Berkshire and Battle Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 14/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Mr Robert Marshall
Scientific
Scientific
Orthopaedic Department
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare efficacy in pain relief |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Spinal stenosis |
| Intervention | Randomised, double blind. 50 patients with proplapsed disc, 50 patients with spinal stenosis. Each group randomised into 2 treatment arms (25 in each): 1. Nerve root injection of local anaesthetic and corticosteroid 2. Epidural injection of local anaesthetic and corticosteroid |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Epidural and Nerve Root Corticosteroid and Local Anaesthetic Injections |
| Primary outcome measure(s) |
Pain relief on a visual analogue scale |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 patients with diagnosis of prolapsed disc or spinal stenosis of the lumbar-sacral vertebrae. Unilateral pain radiating from back to below knee lasting 6-28 weeks, with leg pain being greater than back pain. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 15/01/2003 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Orthopaedic Department
Reading
RG1 5AN
United Kingdom
RG1 5AN
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 |
