Epidural and Nerve Root Corticosteroid and Local Anaesthetic Injections for Lumbar Nerve Root Compression

ISRCTN ISRCTN12348847
DOI https://doi.org/10.1186/ISRCTN12348847
Secondary identifying numbers N0199129906
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
14/03/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Robert Marshall
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study objectivesTo compare efficacy in pain relief
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Spinal stenosis
InterventionRandomised, 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Epidural and Nerve Root Corticosteroid and Local Anaesthetic Injections
Primary outcome measurePain relief on a visual analogue scale
Secondary outcome measuresNot provided at time of registration
Overall study start date15/01/2003
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100
Key inclusion criteria100 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment15/01/2003
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Orthopaedic Department
Reading
RG1 5AN
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Royal Berkshire and Battle Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan