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
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