A study to compare the clinical effectiveness and cost effectiveness of Medial Branch Nerve Block (MBNB) to routine Vertebroplasty (VP) surgical care in hospitalised older people with painful vertebral fracture
| ISRCTN | ISRCTN18334053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18334053 |
| IRAS number | 293210 |
| Secondary identifying numbers | CPMS 49269, IRAS 293210 |
- Submission date
- 21/05/2021
- Registration date
- 24/05/2021
- Last edited
- 10/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoporosis is a common chronic disease resulting in fragile bones. Across Europe, 22 million women and 5 million men have osteoporosis. Fractures of the spine, ‘vertebral fragility fracture-VFF’ are the most common osteoporotic fracture. These constitute a major health problem, leading to both acute and chronic back pain, substantial spinal deformity, functional disability, decreased quality of life and increased mortality. Many patients who sustain a VFF have mild to moderate symptoms, however a significant proportion develop substantial pain and disability which require hospital admission. Non surgical treatment for these patients consists of bed-rest, painkillers and, in some units spinal bracing, but these are poorly tolerated, with the adverse effects of painkillers and immobilisation leading to additional health problems. Surgical treatment-vertebroplasty (VP) is a minimally invasive, image-guided key-hole procedure that involves injection of bone cement into the fractured spine, to provide pain relief and stability. This is routinely undertaken for those patients with continuing pain, and has been found to be safe, effective and recommended by NICE. However, another potential treatment may be to offer a spinal nerve block. This is much less invasive and avoids the need of a general anaesthetic. We hypothesise that a spinal nerve block will be ‘as effective’ as VP in reducing acute pain and allowing early return to function. This would alter the management of these patients in hospital and given the cost of a spinal nerve block in only one tenth of VP, this may have significant financial savings to the NHS. Given the scale of this problem and the simplicity of the proposed intervention, we believe that if the results are successful, they will be rapidly adopted by the NHS in hospitals.
Who can participate?
Patients aged 70 years and over admitted to hospital who has been diagnosed with painful spinal fracture.
What does the study involve?
Patients presenting to the Nottingham University Hospital NHS Trust with an acute painful VFF and awaiting spinal surgery will be recruited into the study. Those who indicate that they are interested in hearing more about the trial will be introduced to the research team. The research team will explain the details of the study provide a patient information sheet (PIS) and answer any questions. Patients will have the opportunity to discuss this with their family and to ask any questions they might have. Whenever possible, they will have at least 24 hours to consider participation in the study before giving informed consent.
A member of the research team will make contact with the participant after they have been recruited into the study to see how they are doing. There will be:
1. A face-to-face meeting a week after joining the study
2. A telephone follow-up four weeks after joining the study
3. A telephone follow-up eight weeks after joining the study
What are the possible benefits and risks of participating?
The benefit of taking part of this study is patients will receive treatment for the fracture of their spine, which would either be via Vertebroplasty(VP), which is considered to be standard of care or via Medial Branch Nerve Block (MBNB), which is considered to be less invasive and postulated to be as effective as VP in reducing pain due to your fracture.
The risk involve is exposure to a small amount of ionising radiation, but patient would still be exposed to this even if they are not participating in the research.
Where is the study run from?
Nottingham University Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
January 2021 to December 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Prof. Opinder Sahota, opinder.sahota@nuh.nhs.uk
Contact information
Scientific
Depart HCOP
B Floor South Block
Queens Medical Centre Campus (QMC)
Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0003-0055-7637 |
|---|---|
| Phone | +44 (0)1159 249924 Ext 66325 |
| opinder.sahota@nuh.nhs.uk |
Study information
| Study design | Randomised; Both; Design type: Treatment, Surgery, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN18334053_PIS(Personal Consultee)_v1.2_12Apr2021.docx |
| Scientific title | Spinal Medial Branch Nerve Root Block (MBNB) intervention compared to standard care-Vertebroplasty (VP) for the treatment of painful osteoporotic vertebral fractures in hospitalised older patients: a feasibility study. The AVERT (Acute VertEbRal AugmentaTion) Study |
| Study acronym | AVERT |
| Study objectives | A spinal nerve block will be ‘as effective’ as VP in reducing acute pain and allowing early return to function |
| Ethics approval(s) | Approved 16/04/2021, Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8109; bradfordleeds.rec@hra.nhs.uk), ref: 21/YH/0065 |
| Health condition(s) or problem(s) studied | Treatment of painful osteoporotic vertebral fractures |
| Intervention | Participants will be randomly allocated to receive standard care-vertebroplasty or spinal nerve block treatment. Participants of the study will be identified by the by the ward clinical staff when they are admitted to hospital and diagnosed with an acute fracture of the spine. Should they be interested in discussing about the study will be introduced to the research team. The research team will then assess the eligibility of the patient by referring to the inclusion and exclusion criteria stated in the study protocol. Once this criteria has been met, the research team will then approach the patient and explain their role and provide an information sheet and answer any questions. Patients will then have at least 24 hours to consider if they would like to be part in the study. They will be informed that entry to the study will be entirely voluntary, and that their treatment and care will not be affected by their decision. They will also be informed that, if they did agree to participate, they can withdraw at any time and this will not impact on future care. They may be asked to give reasons for withdrawal to help with the study, but will not be obliged to. Participants will be allocated by chance, at random, which will be done via an electronic system, to receiving either standard care vertebroplasty or the spinal nerve root block treatment. Participants will be allocated on a 1:1 ratio, meaning that 15 participants will be allocated to having treatment with the nerve block and 15 participants will be allocated to vertebroplasty. Participants and their GPs will be notified of the allocated treatment. The allocated procedure will be undertaken within 72 hours of randomization, as part of the routine spinal emergency surgical theatre. Following treatment, we will follow up participants at 1 week, 4 weeks and 8 weeks. The follow ups will be conducted as a face to face interview in hospital at week 1, taking up to 30 minutes. At week 4 and 8, these will be shorter interviews over the telephone or face to face (if the participant is still in hospital). In a small group of patients and a small number of clinicians, we will also undertake semi structured interviews. We aim to interview 10 patients and 5 clinicians. The purpose of this is to gain an insight into the design of the study and how they felt during the whole process and would seek recommendations for improving the study design. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured at weeks 1, 4, and 8 post randomisation and at the completion of data collection using data collected on Redcap Cloud: 1. Number of eligible patients 2. Rate of participant recruitment and randomisation 3. Reasons why participants are not recruited or randomised 4. Rate of participant adherence to randomisation (cross-over) and retention 5. Completion of study rates and reasons for non-completion 6. Completeness of data (see secondary outcome measures) 7. Time from randomisation to delivery of the intervention |
| Secondary outcome measures | Outcomes for subsequent definitive trial measured at 1, 4, and 8 weeks from the time of intervention: 1. Functional disability as measured by the 24 point Roland Morris Disability Questionnaire (RMDQ) 2. Pain as measured by the 0-11 NRS 3. Quality of Life as measured by the EQ5D-5L and (where appropriate) proxy EQ5D-5L 4. Activities of daily living as measured by the Nottingham Extended Activities of Daily Living (NEADL) scale 5. Record of pain medication use (using the opioid dose equivalence table) |
| Overall study start date | 01/06/2021 |
| Completion date | 30/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 35; UK Sample Size: 35 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Patients aged 70 years and over admitted to hospital 2. Ambulatory prior to injury 3. <3 weeks from date of injury 4. Numeric Rated Pain Scale (NRS) 7 or more on standing 5. MRI confirmed oedema at the site of fracture 6. Ability to adhere to study procedures and complete follow-up |
| Key exclusion criteria | 1. Chronic back pain requiring opiate use 2. Substantial fracture retropulsion; acute infection, spinal malignancy 3. 3 or more acute vertebral fractures 4. Bed bound prior to fracture 5. Receiving palliative care 6. Lack of capacity and no consultee 7. Spinal deformity which contraindicates VP |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 30/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Hospital/treatment centre
Trust Headquarters
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
| Phone | +44 (0)115 9709049 |
|---|---|
| researchsponsor@nuh.nhs.uk | |
| Website | http://www.nuh.nhs.uk/ |
"ROR" |
https://ror.org/05y3qh794 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in relevant national and international journals on completion of data analysis and write up of study. |
| IPD sharing plan | Current IPD sharing plan as of 14/08/2023: The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Opinder Sahota, opinder.sahota@nuh.nhs.uk. Previous IPD sharing plan: The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.2 | 12/04/2021 | 24/05/2021 | No | Yes |
| Participant information sheet | version v1.1 | 26/03/2021 | 24/05/2021 | No | Yes |
| Protocol file | version V1.2 | 07/05/2021 | 24/05/2021 | No | No |
| Protocol article | 13/06/2022 | 15/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | 14/08/2023 | No | No | ||
| Results article | 13/10/2023 | 10/06/2025 | Yes | No |
Additional files
- ISRCTN18334053_PIS(Personal Consultee)_v1.2_12Apr2021.docx
- uploaded 24/05/2021
- ISRCTN18334053_PIS+(Patients)_v1.1_26Mar2021.docx
- uploaded 24/05/2021
- ISRCTN18334053_Protocol__V1.2_07May2021.docx
- uploaded 24/05/2021
- ISRCTN18334053_Other unpublished results.pdf
Editorial Notes
10/06/2025: Publication reference added.
14/08/2023: The following changes were made:
1. Unpublished results added.
2. The individual participant data (IPD) sharing plan and summary were updated.
09/06/2023: Internal review.
07/06/2023: Publication reference added.
06/12/2022: The following changes were made:
1. The recruitment end date was changed from 30/03/2022 to 30/08/2022.
2. The total final enrolment was changed from 31 to 30.
15/09/2022: IPD sharing statement added.
14/09/2022: Total final enrolment added. The overall trial end date was changed from 30/09/2022 to 30/12/2022.
15/06/2022: Publication reference added.
24/05/2021: The following changes were made:
1. Uploaded protocol (not peer-reviewed) as an additional file. Version 1.2. 7 May 2021.
2. The participant information sheets were uploaded as additional files.
21/05/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
