Spinal medial branch nerve root block (MBNB) intervention compared to standard care-vertebroplasty (VP) for the treatment of painful osteoporotic vertebral fractures in frail, older hospitalised patients: a feasibility study.

Our study aimed to assess the feasibility outcomes comparing spinal medial branch nerve root block intervention to standard care vertebroplasty for the treatment of painful osteoporotic vertebral fractures in frail, hospitalised older patients. We found the study to be feasible and now propose a clinical effectiveness, cost effectiveness and safety evaluation. INTRODUCTION: Vertebroplasty (VP) is a key-hole procedure involving injection of bone cement into a fractured vertebral body, to reduce pain and increase vertebral body stability, although it is associated with a small risk of complications, particularly in frail, older hospitalised patients. Medial branch spinal nerve block (MBNB) may be an alternative treatment to alleviate pain symptoms, with less complications; however, no study has prospectively compared the clinical effectiveness, cost-effectiveness and safety of MBNB to VP, in frail, older hospitalised patients. The aim of our study was to conduct a 1st stage feasibility study, exploring recruitment, retention and several outcomes measures (means and SDs), together with qualitative interviews to assess participant and clinician views, to inform a definitive larger study. METHODS: We conducted a two-arm feasibility randomised controlled trial with participants allocated to continue with routine surgical care-VP or MBNB treatment, with an embedded qualitative study. Data was collected at baseline, week 1, 4, and week 8. RESULTS: Out of 40 eligible patients, 30 (75%) consented to take part in the study. The overall median time from randomisation to intervention was 3 days, IQR 1-7 days, 5 (1-7) days for VP and 2 (1-3) days for MBNB. Median (IQR) length of hospital stay for the VP group was 20 (8) days and for the MBNB 15(22) days. The proportion of completeness of outcome data collection at weeks 1, 4 and 8 was at least 77%: 14 (100%), 12 (85.7%) and 11(78.9%) for VP and 13 (100%), 12 (92.3%) and 10 (76.8%) for MBNB, respectively. There were no significant difference in the clinical outcomes or adverse events between the two groups. DISCUSSION: Our study was feasible in achieving is target recruitment, participants adhered to the randomisation and at least 77% completeness of data at the 8 week end-point (target 75%). We now plan to conduct a definitive clinical effectiveness, cost effectiveness and safety outcome study, comparing VP to MBNB in frail, older patients hospitalised with an acute vertebral osteoporotic fracture.

A 3-year retrospective analysis of patients admitted with clinical vertebral fragility fractures across hospitals in England, UK.

Our database aimed to assess the impact of vertebral fragility fractures (VFFs) on hospitalisation in England. The results showed that admissions secondary to VFF are increasing annually, more significantly in patients aged 75 years and over. Vertebral augmentation has been showed to reduce length of stay in hospital. INTRODUCTION: Vertebral fragility fractures (VFFs) are the most common osteoporotic fracture. VFF can result in significant pain requiring hospitalisation. However, there are little data on patient numbers, hospital bed days, and costs, contributed to by these patients. METHODOLOGY: We report a retrospective analysis of patients aged 55 years and over admitted to hospitals across England from 2017 to 2019. ICD-10 classifications for VFF and OPCS codes were used to identify admissions and patients who had undergone vertebral augmentation (VA). RESULTS: There were 99,370 patients (61% female) admitted during this period, with 64,370 (65%) patients aged over 75 years. There was a 14.3% average increase in admissions annually. Patients aged over 75 years accounted for 1.5 million bed days, costing £465 million (median length of stay (MLOS) 14.4 days). In comparison, those aged 55-74 years, accounted for 659,000 bed days, costing £239 million (MLOS 10.7 days). The majority of patients (84%) were admitted under a non-surgical speciality and were primarily older (median age 76.8 vs 67.6 years, MLOS 8.2 vs 6.0 days), compared to those admitted to surgical wards 1755 patients underwent vertebral augmentation (VA) (1.8% of the total cohort). The median age of patients undergoing VA was 73.3 years, with 775 (44.2%) of these were aged 75 years and over. In comparison, the median age of patients managed conservatively (non-surgically) was 75.7 years, with 63,595 patients (65.1%) aged 75 years and over. The MLOS and cost per patient admission were lower in the VA group compared to those managed non-surgically. CONCLUSION: Hospitalised VFF patients represented a significant number, cost, and use of bed days. Those undergoing VA had a significantly shorter length of stay. Further studies are necessary to define those who may benefit from early VA.

The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vertebral fragility fractures.

INTRODUCTION: Vertebral fragility fractures (VFFs) are the most common type of osteoporotic fracture found in older people, resulting in increasing morbidity and excess mortality. These fractures can cause significant pain, requiring admission to hospital. Vertebroplasty (VP) is effective in reducing pain and allowing early mobilisation in hospitalised patients. However, it may be associated with complications such as cement leakage, infection, bleeding at the injection site and fracture of adjacent vertebrae. It is also costly and not readily accessible in many UK hospitals.A recent retrospective study reported that spinal medial branch nerve block (MBNB), typically used to treat facet arthropathy, had similar efficacy in terms of pain relief compared with VP for the treatment of painful VFF. However, to date, no study has prospectively compared MBNB to VP. We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients. METHOD: A parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. Follow-up will be at weeks 1, 4 and 8 post intervention. The primary objective is to determine the feasibility and design of a future trial, including specific outcomes of recruitment, adherence to randomisation and safety. Embedded within the trial will be a health economic evaluation to understand resource utilisation and implications of the intervention and a qualitative study of the experiences and insights of trial participants and clinicians. Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data. ETHICS AND DISSEMINATION: Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee (reference 21/YH/0065). AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority (reference IRAS 293210) and is sponsored by Nottingham University Hospitals NHS Trust (reference 21HC001). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion. TRIAL REGISTRATION NUMBER: ISRCTN18334053.

Infection of male rats with Toxoplasma gondii results in enhanced delay aversion and neural changes in the nucleus accumbens core.

Rats infected with the protozoan parasite Toxoplasma gondii exhibit reduced avoidance of predator odours. This behavioural change is likely to increase transmission of the parasite from rats to cats. Here, we show that infection with T. gondii increases the propensity of the infected rats to make more impulsive choices, manifested as delay aversion in an intertemporal choice task. Concomitantly, T. gondii infection causes reduction in dopamine content and neuronal spine density of the nucleus accumbens core, but not of the nucleus accumbens shell. These results are consistent with a role of the nucleus accumbens dopaminergic system in mediation of choice impulsivity and goal-directed behaviours. Our observations suggest that T. gondii infection in rats causes a syndromic shift in related behavioural constructs of innate aversion and making foraging decisions.