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)
Investigators
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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