A Randomised Prospective Pilot Study Comparing the Outcomes of Patients with Lumbar Nerve Root Pain Secondary to Lumbar Disc Prolapse Treated by Nerve Root Block with or without the Addition of Clonidine. - 1.Treatment of lumbar nerve root pain with nerve block +/- clonidine

Phase 1

• Conditions: umbar nerve root pain secondary to disc prolapse.

• Registration Number: EUCTR2010-023262-46-GB
• Lead Sponsor: Royal Devon & exeter Foundation trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-08
• Study Completion: 2015-02-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients aged 18-65 y.o. complaining of nerve root pain, radiating into one leg, caused by an MRI scan proven lumbar nerve root compression secondary to lumbar disc prolapse at a single level of the lumbar spine. They will not have undergone any previous secondary care intervention (surgery, previous nerve root block) for this current nor a previous complaint.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients refusing informed consent for admission to the study. This will include patients who opt for surgical treatment as their first treatment option.
•Patients aged under 18 or over 65 y.o.
•Previous secondary care intervention in the lumbar spine (surgery, previous nerve root block)
•Nerve root pain caused by infection, fracture, tumour, cauda equina syndrome, spinal stenosis (central, lateral recess or foraminal)
•Lumbar disc prolapse causing cauda equina syndrome- a condition which compromises the nerves that control bladder, bowel and sexual function. This is a condition requiring urgent surgical decompression and it would not be ethical to include patients with this condition in this study.
•Disc prolapse causing nerve root compression at more than one level of the lumbar spine
•Pregnancy
•Patients unable to understand the consenting process
- Patient allergic to any of the injectates
-Patients with known ischaemic heart disease, exertional angina
-Patients with known hypotension

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified