Erve Rootblock VErsus Surgery: NERVES

Not Applicable

Completed

• Conditions: Acute sciatica secondary to prolapsed intervertebral disc; Musculoskeletal Diseases; Sciatica

• Registration Number: ISRCTN04820368
• Lead Sponsor: The Walton Centre NHS Foundation Trust (UK)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-05
• Study Completion: 2019-07-09
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 163

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:
1. Newly diagnosed disabling sciatica secondary to prolapsed intervertebral disc (proven on MRI)
2. Duration of symptoms between 6 weeks and 6 months
3. Failed conservative, non-invasive management
4. Age over 16 years
5. Diagnosed with lower extremity radiculopathy (sciatica) secondary to a lumbar disc herniation
6. Medication has not been helpful in treating the patient's pain/symptoms
7. Modification of daily activities has not been helpful in treating the patient's pain/symptoms
8. Physiotherapy has not been helpful in treating the patient's pain/symptoms
9. Patient willing to give consent

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:
1. Neurological deficit (foot-drop/possible cauda-equina compression)
2. Previous surgery at that level
3. Age: < 16
4. Any patient who has not attempted conservative non-operative treatment for a minimum of 6 weeks
5. Any patient who has a contraindication for surgery
6. Any patient who is pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Pilot Study (recruitment from 2 sites for 6 months):<br> Predicted full trial recruitment period <18 months and consent rate >40%<br><br> Full study:<br> Oswestry Disability Questionnaire (ODQ; a condition specific outcome measure with over 30 years of scientific validation) at 3 months post-intervention<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. ODQ at 6 months post intervention<br> 2. ODQ at 9 months post intervention<br> 3. ODQ at 12 months post intervention<br> 4. Visual analogue pain scores for leg and back pain<br> 5. Likert Scale<br> 6. Modified Roland-Morris outcome scale for sciatica<br> 7. Core Outcome Measures Index (COMI)<br> 8. Work status (return to work)<br> 9. QOL<br> 10. Health economic outcomes expressed as the incremental cost per quality-adjusted life-year (QALY)<br>