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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18334053

Enrollment

Registered

2021-05-24

Start date

2021-06-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of painful osteoporotic vertebral fractures Musculoskeletal Diseases

Interventions

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 the

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026