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临床试验/NCT07490886
NCT07490886已完成不适用

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

Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Accuracy of ultrasound in detecting cases with a radiological cobb angle of more than 20 degrees

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • referred for scoliosis screening

排除标准

  • extreme body stature

研究组 & 干预措施

Ultrasound positive

ultrasound positive

ultrasound negative

ultrasound negative

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Cobb angle progression(1 year)

研究者

发起方
Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kwan Cheuk Kin

Clinical Lecturer

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

研究点 (2)

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