Condition category
Musculoskeletal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/03/2014
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

Mr Robert Marshall

ORCID ID

Contact details

Orthopaedic Department
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0199129906

Study information

Scientific title

Acronym

Study hypothesis

To compare efficacy in pain relief

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

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 names

Epidural and Nerve Root Corticosteroid and Local Anaesthetic Injections

Primary outcome measures

Pain relief on a visual analogue scale

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/01/2003

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

15/01/2003

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthopaedic Department
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Royal Berkshire and Battle Hospitals NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes