Bone Enhanced Ultrasound (BEUS) Data Library Development Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: spinal ultrasound.
- Who it may be relevant to
- Registry conditions: Lower Back Pain, Facet Joint Pain; Low Back Pain, Osteoarthritis (OA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
A common treatment for low back pain involves fluoroscopy-guided spinal facet joint injections and/or medial branch nerve blocks. Unfortunately, fluoroscopy requires expensive equipment and personnel and exposes patients and healthcare providers to ionizing radiation. Ultrasound offers a safer, lower-cost alternative, but the traditional 2-dimensional (2D) ultrasound systems are limited due to poor image quality, particularly in patients with higher body mass index (BMI). As an alternative, a novel Bone Enhanced Ultrasound (BEUS) technology uses artificial intelligence (AI) to create real-time 3-dimensional (3D) images of the spine to guide needle placement for these injections. The AI software is trained by overlaying computed tomography (CT) and ultrasound images from a patient dataset to recognize anatomical landmarks. BEUS aims to ultimately replace fluoroscopy for spinal injections, reducing radiation exposure, lowering healthcare costs, and improving accessibility, especially in rural settings where CT and fluoroscopy are unavailable. A key limitation, however, is that the current AI system is trained based primarily on patients (mostly pediatric) undergoing perioperative assessment of scoliosis. To address this, the current study aims to develop a new, more clinically relevant training AI dataset by collecting spinal ultrasounds from up to 100 adult participants (most/all of whom are followed at the local chronic pain clinic for low back pain) with existing spinal CT or magnetic resonance imaging (MRI) scans. This dataset will be used to retrain the current AI model to enhance the accuracy of 3D spinal reconstructions, thereby improving the clinical relevance of the BEUS system.
Interventions
- Diagnostic test spinal ultrasound
Coronal, axial, sagittal scans of the spine using ultrasound
Primary outcome measures
- Accuracy of 3D ultrasound spine reconstruction in adults with chronic low back pain [Time frame: From enrollment to end of US scan (30 days)]
Eligibility criteria
Inclusion criteria
- Individuals who have had previous CT or MRI scans of their spine in the past 5 years
Exclusion criteria
- < 18 years old
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07036653 · 6043729