Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192187922
Study information
Scientific title
Acronym
Study hypothesis
Does 40mg of epidural methyl-prednisolone produce an equivalent improvement in disability scores when compared to 80mg of epidural methyl-prednisolone?
Ethics approval
Not provided at time of registration
Study design
Randomised single-blinded cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
methyl-prednisolone
Primary outcome measures
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 trial start date
24/05/2006
Overall trial end date
28/02/2007
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
1. Blood clotting disorder
2. Anticoagulant (Warfarin) use
Recruitment start date
24/05/2006
Recruitment end date
28/02/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anesthetics Department
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Nottingham University Hospitals NHS Trust (UK), NHS R&D Support Funding
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
1. 2011 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/21564047
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23016755
Publication citations
-
Pilot study
McCahon RA, Ravenscroft A, Hodgkinson V, Evley R, Hardman J, A pilot study of the dose-response of caudal methylprednisolone with levobupivacaine in chronic lower back pain., Anaesthesia, 2011, 66, 7, 595-603, doi: 10.1111/j.1365-2044.2011.06764.x.
-
Results
Whynes DK, McCahon RA, Ravenscroft A, Hardman J, Cost effectiveness of epidural steroid injections to manage chronic lower back pain., BMC Anesthesiol, 2012, 12, 26, doi: 10.1186/1471-2253-12-26.