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Clinical Trials/ISRCTN04820368
ISRCTN04820368
Completed
未知

Multi-centre randomised control trial comparing the clinical and cost effectiveness of trans-foraminal epidural steroid injection to surgical microdiscectomy for the treatment of chronic radicular pain secondary to prolapsed intervertebral disc herniation: Nerve rootblock versus surgery (NERVES)

The Walton Centre NHS Foundation Trust (UK)0 sites163 target enrollmentJune 5, 2014

Overview

Phase
未知
Intervention
Not specified
Conditions
Acute sciatica secondary to prolapsed intervertebral disc
Sponsor
The Walton Centre NHS Foundation Trust (UK)
Enrollment
163
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30185221 2021 results in https://pubmed.ncbi.nlm.nih.gov/33845941/ (added 14/04/2021) (published 01/04/2021) 2021 results in https://pubmed.ncbi.nlm.nih.gov/33969319/ (added 11/05/2021)

Registry
who.int
Start Date
June 5, 2014
End Date
July 9, 2019
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Walton Centre NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • As of 19/05/2016:
  • 1\. Diagnosed lower extremity radiculopathy (sciatica)
  • 2\. Sciatica secondary to prolapsed intervertebral disc (PID) (proven on MRI)
  • 3\. Duration of symptoms between 6 weeks and 12 months
  • 4\. Leg pain non\-responsive to conservative, non\-invasive management
  • 5\. Age 16 – 65 years
  • 6\. Patient has attempted at least one form of conservative (non\-operative) treatment\* but this has not provided adequate relief of patient’s pain/symptoms
  • 7\. Patient willing and able to give consent
  • \*including but not limited to; medication, physiotherapy, modification of daily activities
  • Previous inclusion criteria:

Exclusion Criteria

  • As of 19/05/2016:
  • 1\. Serious neurological deficit (e.g. foot\-drop/possible cauda\-equina compression)
  • 2\. Previous spinal surgery at the same intervertebral disc (level)
  • 3\. Sciatica presentation for longer than 12 months
  • 4\. Age \< 16
  • 5\. Age \> 65
  • 6\. Patient has not attempted any form of conservative treatment
  • 7\. Any patient who has a contraindication for surgery and/or injection
  • 8\. Patient known to be pregnant
  • Previous exclusion criteria:

Outcomes

Primary Outcomes

Not specified

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