erve Root block Versus Surgery (NERVES)

Phase 1

• Conditions: Chronic radicular pain secondary to a prolapsed intervertebral disc herniation; MedDRA version: 20.0 Level: PT Classification code 10039674 Term: Sciatica System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2014-002751-25-GB
• Lead Sponsor: The Walton Centre NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 148

Inclusion Criteria

Patients with the following characteristics will be eligible for inclusion in the trial:

a.Diagnosed lower extremity radiculopathy (sciatica)
b.Sciatica secondary to prolapsed intervertebral disc (PID) (proven by MRI)
c.Duration of symptoms between 6 weeks and 12 months
d.Leg pain non-responsive to conservative, non-invasive management
e.Age 16 – 65 years
f.Patient has attempted at least one form of conservative (non-operative) treatment* but this has not provided adequate relief of patient’s pain/symptoms
g.Patient has provided written, informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients with the following characteristics will be excluded from the trial:

a.Serious neurological deficit (e.g. foot-drop/possible cauda-equina compression)
b.Previous spinal surgery at the same intervertebral disc (level)
c.Sciatica presentation for longer than 12 months
d.Age < 16
e.Age > 65
f.Patient has not attempted any form of conservative treatment
g.Any patient who has a contraindication for surgery and/or injection
h. Patient known to be pregnant

Study & Design

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