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NCT Number: NCT07490886

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • referred for scoliosis screening

Exclusion criteria

  • extreme body stature

Treatment and study plan

Primary outcomes

  1. Accuracy of ultrasound in detecting cases with a radiological cobb angle of more than 20 degrees

    Time frame: Baseline

    Both 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 outcomes

  1. Cobb angle progression

    Time frame: 1 year

    Cobb angle on follow-up will be measured with EOS radiographs

Study contacts

Contact information is provided by the study sponsor or research team.

Cheuk Kin Kwan, MBChB, MSc

CONTACT

[email protected]

+852 52282369

Cheuk Wing Ng

CONTACT

+852 3505 3309

Sponsors and collaborators

Lead sponsor

Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing University

Other

Collaborators

  • The Hong Kong Polytechnic University

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.