Investigating the role of advanced MR imaging in assessing patients with trapped nerves in the neck
| ISRCTN | ISRCTN43263110 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43263110 |
| IRAS number | 285222 |
| Secondary identifying numbers | IRAS 285222 |
- Submission date
- 04/08/2020
- Registration date
- 19/10/2020
- Last edited
- 17/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Currently standard MRI scans for trapped nerves in the neck are performed using sequential horizontal and vertical cuts through the spine separated by 2 or 3 mm. However, the nerves travel in a canal that is neither in the horizontal or vertical plane and the nerve itself is 2 to 3 mm in diameter. Consequently, nerve root compression can be rather poorly demonstrated on standard MRI sequences. Furthermore, the currently published scoring systems are not well-validated and therefore rarely used in clinical practice. In this study, the researchers will be using standard MRI techniques but at a different angle to image the nerves in the neck at high resolution as they leave the spine. The scans will be angled so that they cut exactly along and across the nerve canal. The aim is to see how this imaging matches the symptoms and whether different locations of compression better respond to one of the two main operations that can be performed.
Who can participate?
Patients who are awaiting surgery to treat cervical brachialgia (pain produced by a trapped nerve in the neck)
What does the study involve?
Participants will have some information recorded and have an additional MRI scan performed before their surgery. Their symptoms will be assessed 1 day and 6 weeks after the surgery. The researchers will measure the width of the nerve canal on standard images and on the images angled along and across the nerve to see which technique is best at predicting the symptoms of nerve root compression and the response to surgical decompression.
What are the possible benefits and risks of participating?
It is expected that the new technique will permit better selection of patients for surgery and inform decisions on whether to perform surgery from the front or from the back of the neck. There are no risks to the participants expected through the use of a clinical MRI machine. All images will be reviewed by a consultant neuroradiologist to exclude unexpected findings. Should an unexpected finding be discovered the participant's GP will be informed and the appropriate clinical referral will be made
Where is the study run from?
Leeds General Infirmary (UK)
When is the study starting and how long is it expected to run for?
September 2018 to August 2023
Who is funding the study?
1. Leeds Neurosurgical Research Fund (UK)
2. Royal College of Surgeons of England (UK)
Who is the main contact?
Dr James Meacock
James.Meacock@nhs.net
Contact information
Scientific
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
 ORCID ID |
0000-0002-2775-1838 |
|---|---|
| Phone | +44 (0)1133927425 |
| James.Meacock@nhs.net |
Public
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| ORCID ID |
0000-0003-4827-1961 |
|---|---|
| Phone | +44 (0)113 3928567 |
| S.Thomson@leeds.ac.uk |
Study information
| Study design | Non-randomized single-institution study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Assessing cervical foraminal stenosis: volumetric MRI study in patients with cervical brachialgia |
| Study hypothesis | There is no difference in the ability of standard imaging and modified plane imaging to predict surgical outcome. |
| Ethics approval(s) | Approved 26/06/2020, Leeds Teaching Hospitals NHS Trust (Great George St, Leeds, LS1 3EX, UK; +44 (0)113 2060483; anne.gowing@nhs.net, ltht.researchoffice@nhs.net), no ref provided |
| Condition | Cervical foraminal stenosis leading in patients with radiculopathy |
| Intervention | Pre-operative patients will be recruited from surgical waiting lists with symptomatic cervical brachialgia for at least six weeks. An additional three-dimensional volumetric MRI scan of the cervical spine will be performed. The data from this will be used to build “standard” T2 axial views with a 2 mm slice thickness. The data will also be used to build modified plane images that align with and are at cross section to the nerve root. Clinical data including the presence of arm pain, neck pain, arm sensory or motor changes will be assessed. The neck disability score will be used as a functional score. Baseline assessments will be made on the day of surgery, one day and six weeks after the operation. The anatomy of the cervical nerve root canal will be analysed to measure the degree of maximal nerve root compression and the length and position of this compression. We will compare the ability of standard and modified plane images to predict clinical symptoms and surgical outcome. Inter and intra rater consistency will also be measured for each type of scan. Automated mathematical modelling measurements of the root canals will also be made, and the consistency of these measurements calculated. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Standard magnetic resonance imaging (MRI), modified plane MRI |
| Primary outcome measure | Self-rated disability assessed using Neck Disability Index (NDI) at 6 weeks post-surgery |
| Secondary outcome measures | 1. Self-rated disability assessed Neck Disability Index (NDI) at 1 day post-surgery 2. Pain intensity assessed using Numerical Rating Scales for neck and upper limb pain 1 day and 6 weeks post-surgery. 3. Neuropathic pain assessed using PainDETECT at day 0 and at 1 day and 6 weeks post-surgery 4. Extent and severity of spinal cord and upper limb functional impairment assessed using a restricted version of the ASIA score at the pre-operative assessment and at 1 day and 6 weeks post-surgery 5. Complications occurring during the initial trial operative procedure and postoperative complications recorded up to 6 weeks post-surgery |
| Overall study start date | 01/09/2018 |
| Overall study end date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 11 |
| Participant inclusion criteria | 1. Age over 18 years 2. Diagnosis of brachialgia 3. Able to provide fully informed written consent 4. Able to lie flat for 1 hour in an MRI scanner 5. Awaiting either an anterior cervical discectomy or a posterior cervical foraminotomy for brachialgia 6. Females of childbearing age must be using effective contraception 7. Sufficient understanding of English to participate in the trial |
| Participant exclusion criteria | 1. Cervical myelopathy 2. Radiological evidence of cord compression 3. History of cervical trauma 4. Evidence of suspected or histologically proven tumour 5. Previous cervical spine surgery 6. Non-MRI compatible implantable device e.g. pacemaker 7. Unable to have MRI scan due to claustrophobia 8. Female participants must not be pregnant and if of childbearing age must be using adequate contraception |
| Recruitment start date | 01/04/2021 |
| Recruitment end date | 31/08/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Great George Street
Leeds
LS1 3EX
United Kingdom
Sponsor information
Hospital/treatment centre
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
England
United Kingdom
| Phone | +44 (0)113 2060483 |
|---|---|
| anne.gowing@nhs.net | |
| Website | http://www.leedsth.nhs.uk/home/ |
"ROR" |
https://ror.org/00v4dac24 |
Funders
Funder type
Research organisation
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RCS
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study will be registered with an authorised registry, according to the International Committee of Medical Journal Editors (ICMJE) Guidelines, prior to the start of recruitment. The success of the study depends upon the collaboration of all participants. For this reason, credit for the main results will be given to all those who have collaborated in the study, through authorship and contribution. Uniform requirements for authorship for manuscripts submitted to medical journals will guide authorship decisions. These state that authorship credit should be based only on substantial contribution to: 1. Conception and design, or acquisition of data, or analysis and interpretation of data 2. Drafting the article or revising it critically for important intellectual content 3. And final approval of the version to be published, 4. And that all these conditions must be met (http://www.icmje.org) In light of this, the Chief Investigator and other investigators will be named as authors in any publication. To maintain the scientific integrity of the study, data will not be released prior to the first publication of the analysis of the primary endpoint, either for study publication or oral presentation purposes. It is planned that publications will be in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Simon Thomson (S.Thomson@leeds.ac.uk) on study publication for 7 years for researchers wishing to confirm the findings or undertake metanalysis by secure data transfer, consent from participants was obtained, data will be anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V5 | 19/10/2020 | 19/10/2020 | No | No |
Additional files
- ISRCTN43263110_PROTOCOL_V5_19Oct20.docx
- Uploaded 19/10/2020
Editorial Notes
17/03/2025: Total final enrolment added. The intention to publish date was changed from 31/08/2024 to 01/12/2025.
06/09/2023: The public contact email was updated and the IPD sharing plan was amended accordingly.
20/06/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/08/2022 to 31/08/2023.
2. The intention to publish date was changed from 31/08/2021 to 31/08/2024.
3. The plain English summary was updated to reflect these changes.
24/02/2021: The recruitment start date was changed from 01/02/2021 to 01/04/2021.
19/10/2020: Uploaded protocol Version 5, 19 October 2020 (not peer reviewed).
05/08/2020: Trial's existence confirmed by Leeds Teaching Hospitals NHS Trust.
