Title: Spinal Medial Branch Nerve Root Block Intervention compared to Standard Care-Vertebroplasty for the Treatment of Painful Osteoporotic Vertebral Fractures in Hospitalised Older Patients: A Feasibility Study.
Funder: Department of Health and Social Care

Abstract: Research question Is a spinal medial branch nerve root block 'as clinically effective' and 'cost-effective' as routine spinal key-hole surgery, for the treatment of painful vertebral fragility fractures in older, hospitalised patients? Background Vertebral Fragility Fractures (VFF) are the most common osteoporosis related fracture. These are painful, may require admission to hospital and may require surgical intervention. Hospitalised patients are elderly, have multiple co-morbidities and thus surgery is more challenging. Routine surgery involves minimally invasive key-hole augmentation whereby bone cement is injected into the fractured vertebra-vertebroplasty (VP). Although NICE has approved the use of both VP and balloon kyphoplasty (BKP), BKP is more commonly reserved for younger patients with traumatic fractures, in the UK. VP is effective in reducing pain and relatively safe, but requires a general anaesthetic (GA). It may cause complications and is expensive (&pound;4,500 per case). 81 patients underwent VP in Nottingham last year, with some patients requiring multiple level treatment, at an estimated overall cost of &pound;650,000. More recently, the use of a spinal medial branch nerve root block (MBNB) has been shown to be equally 'as effective' in reducing pain, does not require a GA and is one tenth the cost of VP. However whether the analgesic effects and the potential cost saving are sustained, requires further evaluation. Aim Undertake a preliminary study to help design a future trial to evaluate the clinical and cost effectiveness of MBNB compared to routine VP spinal surgery. Objectives -Estimate the number of patients who meet eligibility criteria; adhere to randomisation and complete follow-up; -Pilot the procedures involved in the trial; -Examine completeness and variability of outcome measures and health resources. Methods Design: 18 month, randomised controlled, feasibility study Setting: Secondary care, with week 1 (face to face) and week 4 and 8 (telephone) follow up Target population: Hospitalised older patients (aged 70 yrs and over) awaiting spinal VP surgery Inclusion: ambulatory before the injury; Exclusion criteria: chronic back pain requiring opiate use; spinal malignancy; more than two acute vertebral fractures; Intervention: Routine VP spinal surgery or MBNB Outcome measures: Roland Morris Disability Questionnaire, 10 point pain score, analgesia consumed, activities of daily living, quality of life and health service resource use. In addition, we will conduct semi structured qualitative interviews to explore participant and clinician experiences. Timelines for delivery Dec 2020-Feb 2021 Pre-grant activation phase March 2021- Grant Active March-April 2021 Staff recruitment /training, database development May 2021-Feb 2022 Patient recruitment May-June 2022 Data Cleaning / database lock June-Aug 2022 Analysis / Write-up Anticipated Impact and Dissemination The benefits could be significant. For patients there will be routine access to a treatment which is less invasive and more readily accessible across the UK. For NHS healthcare, there could be significant costs savings both in terms of the procedure and use of spinal surgery beds. Active dissemination will be undertaken through scientific publications, health care journals, conference presentations and public facing newsletters.

Lay abstract: Background: Osteoporosis is a chronic disease, leading to weak bones which commonly results in crush fractures of the spine. These fractures are painful and may require admission to hospital, particularly frail, older people. In hospital, most of these patients are managed with strong morphine based analgesia and physiotherapy, however in a significant proportion, their symptoms are so severe that they require surgery. Routine surgery involves injecting bone cement directly into the spine fracture, using keyhole surgery- vertebroplasty . In Nottingham alone, 81 of these procedures were undertaken last year. However, although 'vertebroplasty' is effective in reducing pain, this procedure requires an operation, may cause complications such a spinal cord injury and clots to the lung (bone cement leakage), increases the risk of adjacent level crush fractures (due to abnormal weight loading of the cement) and from a financial point of view, these procedures are expensive (&pound;4,500 per case). More recently, the use of strong nerve blocks around the crush fracture have been shown to be equally 'as effective' in reducing pain, do not require an operation and are only one tenth the cost of spinal surgery. But whether the analgesic effects are sustained and the potential cost saving requires further evaluation. Aim: Our aim is to undertake a preliminary study to help design a future trial to evaluate the benefits and cost savings of spine nerve block treatment compared to routine key-hole spine surgery. Design and methods: Hospitalised older patients awaiting vertebroplasty spine surgery, will be randomly offered (that is by chance) to continue with their routine surgery (as planned) or undergo spinal nerve block analgesia treatment. We will determine -the number of patients able to take part and reasons for those not taking part; -if patients adhere to the randomisation or whether those patients allocated to spinal nerve block treatment ultimately require 'vertebroplasty' (the rate of crossover); -how easy it is to collect patient data and reasons for non completion; We will also collect important measurements (over 8 weeks) to establish how big and practical a definitive trial will need to be. We will undertake a measure of mobility and disability (the Roland Morris Scale), together with a measure of pain rating, type of pain medication taken, quality of life, activities of daily living, interaction with health services and NHS costs. In addition, we will undertake one to one private interviews with participants and clinicians to explore their experiences. Patient and public involvement: We have worked closely with the Nottingham Osteoporosis support group (250 patient membership), who have informed and influenced the research idea, study design and outcomes. They will be further involved with the study throughout and we have included our lead PPI representative as one of the co-applicants.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: MUSCULOSKELETAL;INJURIES AND ACCIDENTS