Bone Enhanced Ultrasound (BEUS) Data Library Development Project

NCT07036653 | Not Yet Recruiting

• 1 other identifier: 6043729
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lower Back Pain; Facet Joint Pain; Low Back Pain; Osteoarthritis (OA)

Keywords

Facet joint injection; Spine ultrasound; 3D ultrasound; Low back pain

Outcome Measures

Primary Outcomes (1)

• Accuracy of 3D ultrasound spine reconstruction in adults with chronic low back pain

  From enrollment to end of US scan (30 days)

Study Arms (1)

Study group

Individuals who have had a CT or MRI scans of their spine in the past 5 years

Diagnostic Test: spinal ultrasound

Interventions

spinal ultrasound DIAGNOSTIC_TEST

Coronal, axial, sagittal scans of the spine using ultrasound

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who have had previous CT or MRI scans of their spine in the past 5 years

You may qualify if:

• Individuals who have had previous CT or MRI scans of their spine in the past 5 years

You may not qualify if:

• \< 18 years old

Sponsors & Collaborators

• Queen's University: lead

MeSH Terms

Conditions

Low Back Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Eileen S Kim, Dr.

CONTACT

613-850-3282; eileenseungmin.kim@kingstonhsc.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-06