Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis

NCT06510049 | Completed

• 1 other identifier: 2024-KS-467-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with idiopathic scoliosis (IS), especially children and adolescents, require regular follow-up evaluations. Ultrasound imaging offers a reliable, radiation-free method for assessing spinal curvatures in the coronal and sagittal planes. While manual labeling in traditional ultrasound is error-prone, automated labeling reduces inaccuracies but still needs further validation, particularly in the sagittal plane. This study compared three-dimensional (3D) ultrasound assessments with conventional X-ray images--the clinical gold standard. And it is aimed to evaluate the validity and reliability of ultrasound measurements-Ultrasound Curve Angle (UCA) and Ultrasound Lamellar Angle (USLA)-against established radiographic benchmarks like Cobb's angle, Thoracic Kyphosis (TK), and Lumbar Lordosis (LL).

Conditions

Ultrasonography; Coronal; Sagittal; Idiopathic Scoliosis; Validation Studies as Topic; Program Evaluation

Keywords

Ultrasonography; Coronal; Sagittal; Idiopathic Scoliosis; Reliability; Validity

Outcome Measures

Primary Outcomes (2)

• Coronal thorax/thoracolumbar/lumbar cobb angle and sagittal thorax/thoracomaxillary/lumbar anterior and posterior lordosis angles on x-ray

  Coronal thorax/thoracolumbar/lumbar cobb angle and sagittal thorax/thoracomaxillary/lumbar anterior and posterior lordosis angles on x-ray

  January to May 2024

• Coronal thoracic/thoracolumbar/lumbar cobb angle and sagittal thoracic/thoracomaxillary/lumbar anterior-posterior lordosis angle on ultrasound

  Coronal thoracic/thoracolumbar/lumbar cobb angle and sagittal thoracic/thoracomaxillary/lumbar anterior-posterior lordosis angle on ultrasound

  January to May 2024

Secondary Outcomes (3)

• gender

  January to May 2024

• age

  January to May 2024

• BMI

  January to May 2024

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with IS who have been admitted to the Scoliosis Traditional Chinese and Western Medicine Diagnosis and Treatment Center of Zhejiang Provincial Hospital of Traditional Chinese Medicine since May 2023.

You may qualify if:

• Patients with IS who were cooperative with ultrasound procedures.

You may not qualify if:

• Patients with spinal disorders such as Marfan's syndrome, a history of ankylosing spondylitis, or spinal neurofibroma.
• Patients with severe medical or psychiatric conditions that could potentially impact the study results.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

Hangzhou, Zhejiang, 310016, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 19, 2024
• Study Start: January 22, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)