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 studys 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 June 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
Contact information
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
Additional identifiers
EudraCT number
2014-002751-25
ClinicalTrials.gov number
Protocol/serial number
HTA 12/201/10
Study information
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
30/06/2019
Reason abandoned (if study stopped)
Eligibility
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
200
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
31/10/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Walton Centre NHS Foundation Trust
Liverpool
L9 7LJ
United Kingdom
Sponsor information
Organisation
The Walton Centre NHS Foundation Trust (UK)
Sponsor details
c/o Dave Watling
The Walton Centre NHS Foundation Trust
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom
+44(0)151 525 3611
dave.watling@thewaltoncentre.nhs.uk
Sponsor type
Government
Website
Funders
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
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
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