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.

Study Overview

• Status: Recruiting
• Conditions: Adolscent Idiopathic Scoliosis

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Cheuk Kin Kwan, MBChB, MSc; Phone Number: +852 52282369; Email: ericckkwan@cuhk.edu.hk
• Study Contact Backup: Name: Cheuk Wing Ng; Phone Number: +852 3505 3309

Study Locations

• Hong Kong
  • 新界
    • Hong Kong, 新界, Hong Kong
      • Recruiting
      • The Chinese University of Hong Kong
      • Contact: Cheuk Kin Kwan, MBChB, MSc; Phone Number: +852 52282369; Email: ericckkwan@cuhk.edu.hk
      • Contact: Cheuk Wing Ng; Phone Number: +852 3505 3309

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

children referred for scoliosis screening

Description

Inclusion Criteria:

• referred for scoliosis screening

Exclusion Criteria:

• extreme body stature

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ultrasound positive; ultrasound positive
ultrasound negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of ultrasound in detecting cases with a radiological cobb angle of more than 20 degrees	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cobb angle progression	Cobb angle on follow-up will be measured with EOS radiographs	1 year

Collaborators and Investigators

• Sponsor: Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing University
• Collaborators: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.); 2025-391-T (Other Identifier: Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing is not required to fulfill the goal of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No