CClinicalTrials.gg
Not yet recruitingNCT07036653Updated Jul 29, 2025

Bone Enhanced Ultrasound (BEUS) Data Library Development Project

An observational study in Lower Back Pain, Facet Joint Pain; Low Back Pain and Osteoarthritis (OA), sponsored by Queen's University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.

Sponsored by Queen's University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Facet joint injection
  • Spine ultrasound
  • 3D ultrasound
  • Low back pain
03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 475 observational studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \< 18 years old
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Study group

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

    Diagnostic Test: spinal ultrasound

Interventions

  • Diagnostic testspinal ultrasound

    Coronal, axial, sagittal scans of the spine using ultrasound

06

What researchers measure

Primary outcomes

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

    Time frame: From enrollment to end of US scan (30 days)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07036653
Lead sponsor
Queen's University
Responsible party
Dr. Glenio Mizubuti (MD, PhD) (Dr., Queen's University) — Principal investigator
First posted
Jun 25, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jul 29, 2025

Study contacts

Eileen S Kim, Dr.
Contact
eileenseungmin.kim@kingstonhsc.ca
613-850-3282

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion