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Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure

Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07490886
Enrollment
150
Registered
2026-03-24
Start date
2025-11-04
Completion date
2026-08-31
Last updated
2026-09-16

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

Conditions

Adolscent Idiopathic Scoliosis

Keywords

Adolscent idiopathic scoliosis

Brief summary

Introduction Scoliosis is a three dimensional spinal deformity, in the coronal plane, sagittal and transverse planes. The conventional method for assessment of severity of scoliosis is by measuring the Cobb angle on x-ray radiographs of the whole spine. The drawback with x-ray radiography is that it involves radiation. In light of this, a radiation-free ultrasound imaging system, the Scolioscan, has been developed for quantitative assessment of spinal deformity. This study aims at evaluating the effectiveness of Scolioscan for screening scoliosis among school children in Hong Kong. Benefit and harm The results of this study will carry significant impacts in that if Scolioscan is proven to be accurate for screening scoliosis among school children, it can be incorporated in the algorithm for screening scoliosis with the intention of reducing unnecessary x-ray exposure. Scolioscan is a radiation-free ultrasound system. Procedures 1. This is a longitudinal study on school children screened for scoliosis at the Student Health Service Centres of Department of Health. If the subject and the guardians agree to participate in the study, ultrasound scanning of the spine using the Scolioscan will be performed. No additional visit is required beyond the routine practice. Clinical assessment of apical rotation of the spine with the subjects bending forward will also be measured using a Scoliometer at the first clinic visit and subsequent clinic follow- up visits at Prince of Wales Hospital. Specialist care for the back problem and scoliosis will be continued at Prince of Wales Hospital as needed. 2. Subjects will be identified at the Student Health Service Centres of Department of Health, Hong Kong. Those who fulfill the recruitment criteria and their guardians will be given full explanation of the study and be invited to participate in the study. During the scanning procedure with the Scolioscan, clients will be asked to stand steadily in different postures, namely erect, right side-bending and left side-bending within the comfort level of the clients. Ultrasound gel will be applied on the back and ultrasound images will be taken along the spine. The scanning itself may last for 1 minute for each posture.

Interventions

None listed

Sponsors

Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing University
Lead SponsorOTHER
The Hong Kong Polytechnic University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* referred for scoliosis screening

Exclusion criteria

* extreme body stature

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of ultrasound in detecting cases with a radiological cobb angle of more than 20 degreesBaselineBoth ultrasound and EOS radiographs will be performed for the participant on the same day. Two by two table will be constructed for calculation of the sensitivity, specificity, positive predictive value, negative predictive value on whether ultrasound could detect cases with radiological cobb angle of more than 20 degrees.

Secondary

MeasureTime frameDescription
Cobb angle progression1 yearCobb angle on follow-up will be measured with EOS radiographs

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026