| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN43299460 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0192187922 |
| Public title | Epidural steroid injection in chronic lumbar back pain: a cross-over, single-blinded study of methyl-prednisolone 80mg versus methyl-prednisolone 40mg |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Low back pain |
| Study hypothesis | Does 40mg of epidural methyl-prednisolone produce an equivalent improvement in disability scores when compared to 80mg of epidural methyl-prednisolone? |
| Design/methodology | Randomised, single-blinded, cross-over trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - exclusion criteria | Blood clotting disorder, anticoagulant (Warfarin) use. |
| Patient information material |
|
| Anticipated start date | 24/05/2006 |
| Anticipated end date | 28/02/2007 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | Randomised, single-blinded, cross-over trial with two treatment arms:
1. 80mg methyl-prednisolone repeated three months later with 40mg dose
2. 40mg methyl-prednisolone repeated three months later with 80mg dose |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Nottingham University Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr A Ravenscroft |
| Contact details | Anesthetics Department
City Hospital
Hucknall Road
Nottingham
United Kingdom
NG5 1PB |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN43299460 |
| Date last extracted from ISRCTN register | 17/04/2008 |
