NErve Rootblock VErsus Surgery: NERVES

Plain English Summary

Background and study aims
We are carrying out a study of about 200 patients suffering from sciatica resulting from a prolapsed (slipped) disc. The aim is to establish if local anaesthetic and steroid injection (TFESI) administered accurately to the source of radicular leg pain can provide a faster, cheaper and more effective treatment for patients with persistent sciatica than an invasive surgical procedure (microdiscectomy). The study’s findings should help advise clinicians on which treatment type may bring the most benefit to patients.

Who can participate?
Patients aged 16 or over with recently diagnosed sciatica secondary to a prolapsed disc with symptoms of between 6 weeks and 12 months in duration.

What does the study involve?
The trial will be run in out-patient NHS neurosurgical, pain and orthopaedic clinics. Patients who would like to take part will be allocated to either the epidural steroid injection or microdiscectomy by a process called ‘randomisation’ with an aim for a 50/50 split of each treatment. The treatment will take place between 4-6 weeks after randomisation. 3 months after treatment the patient will be asked to complete questionnaires to assess how successful the treatment has been. These questionnaires will be repeated at 6, 9 and 12 months to measure the ongoing results of the treatment options.

What are the possible benefits and risks of participating?
Both of the treatment options offered as part of this trial are currently used by the NHS as treatments for sciatica secondary to a prolapsed disc and are considered effective therapies. There should be benefits to all patients suffering acute radicular leg pain as this should help guide treatment options for these patients in the future. The side effects are those commonly associated with spinal surgery or injection; these are well documented.

Where is the study run from?
The lead centre for NERVES is The Walton Centre for Neurology and Neurosurgery NHS Foundation Trust. It is anticipated that several other specialist centres in Manchester, Cambridge, Glasgow, Preston, Leeds and Middlesborough will also be involved.

When is study starting and how long is it expected to run for?
January 2015 to July 2019

Who is funding the study?
National Institute of Health Research – Health Technology Assessment (NIHR HTA)

Who is the main contact?
Mr Martin Wilby
nerves@liverpool.ac.uk

Trial website

http://www.nervestrial.org.uk/

Type

Scientific

Primary contact

Mr Martin Wilby

ORCID ID

Contact details

The Walton Centre NHS Foundation Trust
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom
-
nerves@liverpool.ac.uk

Type

Scientific

Additional contact

Ms Hannah Short

ORCID ID

Contact details

Clinical Trials Research Centre
Institute of Child Health
Alder Hey Children's NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Arab Emirates
+44 151 794 9768
nerves.trial@liverpool.ac.uk

EudraCT number

2014-002751-25

ClinicalTrials.gov number

Protocol/serial number

HTA 12/201/10

Scientific title

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)

Acronym

NERVES

Study hypothesis

This study is designed to provide an evidence base to potentially inform future treatment of sciatica secondary to prolapsed disc. Transforaminal epidural steroid injection is recognised as a treatment alternative to surgical microdiscectomy, but it is not known how effective and cost effective this treatment is in comparison. This trial will compare the epidural steroid injection and microdiscectomy, and examine the impact of the different treatment modalities on several outcomes such as Oswestry Disability Questionnaire scores, return to work, and other health economic analyses.

Ethics approval

NRES Committee North West – Liverpool Central, 08/10/2014, ref: 14/NW/1219

Study design

Open labelled 2-arm randomised controlled trial with an inbuilt pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Acute sciatica secondary to prolapsed intervertebral disc

Intervention

The technologies to be compared are:
1. Fluoroscopically guided trans-foraminal epidural steroid injection (TFESI) of a standard combination of local anaesthetic and steroid drug and
2. Standard surgical lumbar microdiscectomy

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Pilot Study (recruitment from 2 sites for 6 months):
Predicted full trial recruitment period <18 months and consent rate >40%

Full study:
Oswestry Disability Questionnaire (ODQ; a condition specific outcome measure with over 30 years of scientific validation) at 3 months post-intervention

Secondary outcome measures

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

Overall trial start date

17/07/2014

Overall trial end date

09/07/2019

Reason abandoned (if study stopped)

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

148 (updated 06/04/2020, previously 200)

Total final enrolment

163

Participant 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

Recruitment start date

17/07/2014

Recruitment end date

31/12/2017

Countries of recruitment

United Kingdom

Trial participating centre

The Walton Centre NHS Foundation Trust
Liverpool
L9 7LJ
United Kingdom

Organisation

The Walton Centre NHS Foundation Trust (UK)

Sponsor details

c/o Gillian Hamblin
The Walton Centre NHS Foundation Trust
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom
+44(0)151 556 3389
Gillian.Hamblin@thewaltoncentre.nhs.uk

Sponsor type

Government

Website

http://www.thewaltoncentre.nhs.uk

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

08/07/2020

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30185221

Publication citations

06/04/2020: The following changes have been made: 1. The overall trial end date has been changed from 30/06/2019 to 09/07/2019. 2. The recruitment end date has been changed from 31/10/2017 to 31/12/2017. 3. The intention to publish date has been added. 4. The target number of participants and total target enrolment has been changed from 200 to 148. 5. The sponsor contact details have been updated. 6. The plain English summary has been updated to reflect the changes above. 22/10/2018: A second contact was added. 12/10/2018: The overall trial end date was changed from 31/10/2017 to 30/06/2019. 07/09/2018: Publication reference added. 19/05/2016: Made changes to exclusion and exclusion criteria as indicated in the relevant fields. Added trial website and EudraCT number.