Condition category
Musculoskeletal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
01/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A Ravenscroft

ORCID ID

Contact details

Anesthetics Department
City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

  2. 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.

Additional files

Editorial Notes