Epidural steroid injection in chronic lumbar back pain: a cross-over, single-blinded study of methyl-prednisolone 80mg versus methyl-prednisolone 40mg
| ISRCTN | ISRCTN43299460 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43299460 |
| Secondary identifying numbers | N0192187922 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 01/10/2012
- 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 A Ravenscroft
Scientific
Scientific
Anesthetics Department
City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Study information
| Study design | Randomised single-blinded cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Does 40mg of epidural methyl-prednisolone produce an equivalent improvement in disability scores when compared to 80mg of epidural methyl-prednisolone? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Low back pain |
| Intervention | 1. 80mg methyl-prednisolone repeated three months later with 40mg dose 2. 40mg methyl-prednisolone repeated three months later with 80mg dose |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | methyl-prednisolone |
| Primary outcome measure | Evidence that a reduced dose of methyl-prednisolone given epidurally does not cause a significant worsening of the primary outcome measure ie the Oswestry Low Back Pain Disability Index. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 24/05/2006 |
| Completion date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 60 |
| Key inclusion criteria | Patients attending Nottingham City Hospital Day Case Unit, with chronic back pain who are presenting for repeat epidural steroid injection as part of their chronic pain management programme. |
| Key exclusion criteria | 1. Blood clotting disorder 2. Anticoagulant (Warfarin) use |
| Date of first enrolment | 24/05/2006 |
| Date of final enrolment | 28/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anesthetics Department
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Nottingham University Hospitals NHS Trust (UK), NHS R&D Support Funding
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | pilot study | 01/07/2011 | Yes | No | |
| Results article | results | 27/09/2012 | Yes | No |
