NErve Rootblock VErsus Surgery: NERVES
| ISRCTN | ISRCTN04820368 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04820368 |
| EudraCT/CTIS number | 2014-002751-25 |
| Secondary identifying numbers | HTA 12/201/10 |
- Submission date
- 03/06/2014
- Registration date
- 05/06/2014
- Last edited
- 11/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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 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
Contact information
Scientific
The Walton Centre NHS Foundation Trust
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom
| nerves@liverpool.ac.uk |
Scientific
Clinical Trials Research Centre
Institute of Child Health
Alder Hey Children's NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Arab Emirates
| Phone | +44 151 794 9768 |
|---|---|
| nerves.trial@liverpool.ac.uk |
Study information
| Study design | Open labelled 2-arm randomised controlled trial with an inbuilt pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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) |
| Study acronym | NERVES |
| Study objectives | 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(s) | NRES Committee North West – Liverpool Central, 08/10/2014, ref: 14/NW/1219 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 17/07/2014 |
| Completion date | 09/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 148 (updated 06/04/2020, previously 200) |
| Total final enrolment | 163 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/07/2014 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
L9 7LJ
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Gillian Hamblin
The Walton Centre NHS Foundation Trust
Lower Lane
Fazakerley
Liverpool
L9 7LJ
England
United Kingdom
| Phone | +44(0)151 556 3389 |
|---|---|
| Gillian.Hamblin@thewaltoncentre.nhs.uk | |
| Website | http://www.thewaltoncentre.nhs.uk |
"ROR" |
https://ror.org/05cvxat96 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/09/2018 | Yes | No | |
| Results article | 01/04/2021 | 14/04/2021 | Yes | No | |
| Results article | 18/03/2021 | 11/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/05/2021: Publication reference added.
14/04/2021: Publication reference added.
18/08/2020: The intention to publish date was changed from 08/07/2020 to 30/11/2020.
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.
