The AVERT (Acute VertEbRal AugmentaTion) Study
Research type
Research Study
Full 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.
IRAS ID
293210
Contact name
Opinder Sahota
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust, Nottingham Health Science Partners
ISRCTN Number
ISRCTN18334053
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Research Summary:
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.
Summary of Results:
A total of 271 potential participants were screened over the recruitment period from June 2021 to June 2022. Among those screened, 40 (10.8%) were deemed eligible to take part in the study. The most frequent reasons for exclusion were non severe pain on numeric rating scale (NRS) < 7 (n=101, 27.2%), more than 3 vertebral fractures (n=99, 26.7%) and patients who were discharged by the physiotherapist and qualified for conservative management only (n=65, 17.5%). Out of 40 eligible patients, 30 (75%) consented to take part in the study.
Fifteen (50%) participants were randomised to standard care verterbroplasty (VP) and 15 (50%) to nerve block (MBNB). Following randomisation, 3 participants were withdrawn from the study – one in the VP group (AVE 005 – needle phobia at the time of intervention) and two in the MBNB group (AVE 004 – not able to tolerate lying prone, AVE 008 – Covid positive on the day of procedure and withdrawn by the patient’s supervising consultant). Therefore, 14 patients underwent BP and 13 MBNB.
The proportion of completeness of outcome data collection at weeks 1, 4 and 8 was at least 77%, 13 (100%), 12 (92,3%), 10 (76.8%) for MBNB and 14 (100%), 12 (85.7%), 11 (78.9%) for VP, respectively.
There were no significant difference in the clinical outcomes between standard care VP and MBNB, although Nottingham Extended Activities of Daily Living (NEADL) scale almost achieved statistical significance in favour of MBNB (p=0.064). Regression analysis of NEADL for age, procedure type, sex and time to procedure showed no relationship.Summary of Results:
A total of 271 potential participants were screened over the recruitment period from June 2021 to June 2022. Among those screened, 40 (10.8%) were deemed eligible to take part in the study. The most frequent reasons for exclusion were non severe pain on numeric rating scale (NRS) < 7 (n=101, 27.2%), more than 3 vertebral fractures (n=99, 26.7%) and patients who were discharged by the physiotherapist and qualified for conservative management only (n=65, 17.5%). Out of 40 eligible patients, 30 (75%) consented to take part in the study.
Fifteen (50%) participants were randomised to standard care verterbroplasty (VP) and 15 (50%) to nerve block (MBNB). Following randomisation, 3 participants were withdrawn from the study – one in the VP group (AVE 005 – needle phobia at the time of intervention) and two in the MBNB group (AVE 004 – not able to tolerate lying prone, AVE 008 – Covid positive on the day of procedure and withdrawn by the patient’s supervising consultant). Therefore, 14 patients underwent BP and 13 MBNB.
The proportion of completeness of outcome data collection at weeks 1, 4 and 8 was at least 77%, 13 (100%), 12 (92,3%), 10 (76.8%) for MBNB and 14 (100%), 12 (85.7%), 11 (78.9%) for VP, respectively.
There were no significant difference in the clinical outcomes between standard care VP and MBNB, although Nottingham Extended Activities of Daily Living (NEADL) scale almost achieved statistical significance in favour of MBNB (p=0.064). Regression analysis of NEADL for age, procedure type, sex and time to procedure showed no relationship.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
21/YH/0065
Date of REC Opinion
16 Apr 2021
REC opinion
Further Information Favourable Opinion