Clinical trial NCT06510049: Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis
Official title: Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Coronal
Sagittal
Idiopathic Scoliosis
Validation Studies as Topic
Program Evaluation
Keywords: Ultrasonography
Coronal
Sagittal
Idiopathic Scoliosis
Reliability
Validity
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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).

Detailed description: This study was structured into two fundamental segments: 1) a dual-operator analysis focused on evaluating both intra- and inter-operator reliability of the UCA and USLA; and 2) a validation study of radiographic indices, specifically the coronal Cobb angle, TK, and LL, in correlation with UCA and USLA measurements. Initially, 100 patients diagnosed with IS were subjected to both standard radiographic and 3D ultrasound examinations. Owing to various exclusion criteria, 20 patients were subsequently disqualified from the study, resulting in a final sample of 80 patients for statistical evaluation. Reliability assessments were conducted using the Intraclass Correlation Coefficient (ICC). Furthermore, the validity of the UCA and USLA measurements was rigorously analyzed by comparing them against established radiographic benchmarks, utilizing Pearson correlation coefficients and Bland-Altman plots for comprehensive evaluation. All expected or unexpected adverse events from this study will be recorded and monitored.For comprehensive analysis, participants were systematically categorized based on multiple demographic and clinical parameters: coronal angle (either ≥20° or \<20°), gender (male or female), age (either\>14 years or ≤14 years), and nutritional status (classified as normal or abnormal).

Eligibility criteria: Inclusion Criteria:

* Patients with IS who were cooperative with ultrasound procedures.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Coronal thorax/thoracolumbar/lumbar cobb angle and sagittal thorax/thoracomaxillary/lumbar anterior and posterior lordosis angles on x-ray
timeFrame: January to May 2024
measure: Coronal thoracic/thoracolumbar/lumbar cobb angle and sagittal thoracic/thoracomaxillary/lumbar anterior-posterior lordosis angle on ultrasound
timeFrame: January to May 2024
Secondary outcomes:
measure: gender
timeFrame: January to May 2024
measure: age
timeFrame: January to May 2024
measure: BMI
timeFrame: January to May 2024
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
state: Zhejiang
Study officials:
References: