Skip to content

Effectiveness of two cheneaue orthoses made by the CADCAM method and the conventional method in correcting idiopathic scoliosis in adolescent girls

Comparison of two Cheneanu brace made by two methods: "using a frame and 3D scanning" and "conventional" method on cobb angle correction, apical vertebral rotation, kyphosis and lordosis in adolescent girls with idiopathic scoliosis: a randomized clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231110060014N1
Enrollment
30
Registered
2024-01-06
Start date
2024-01-21
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis.

Interventions

Intervention 1: Intervention group: Cheneau Brace made using targeted framework and 3D scanning and design technology. Intervention 2: Control group: Cheneau brace made in the conventional method.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
10 Years to 14 Years

Inclusion criteria

Inclusion criteria: Risser sign between 0 and 2 Major curvature in the thoracolumbar or lumbar region The curvature between 20 and 45 degrees No history of surgery, trauma or fracture Do not be overweight Did not used braces or other treatment methods before entering the study Do not have heart or respiratory disease

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Cobb's angle: In general, the apex of any curve is the farthest vertebra from the central vertical sacral line with it. The top and bottom end beads in each curve define the boundaries of that particular curve. Cobb's angle is an index used to quantitatively evaluate the lateral deviation of the spine in the frontal plane and is usually known as the gold standard for diagnosing and evaluating the severity and predicting the progression of the deviation in scoliosis patients. Timepoint: In both the control and experimental groups, each subject will have three radiological photographs in a standing position from two anterior-posterior and lateral views. Once before receiving the brace, when the brace is prescribed and the patient is prepared for casting or scanning. 20 days after the patient adapts to the orthosis, while the patient wears the brace, radiology imaging is done. The third imaging of the entire spine, without orthosis, is done for the long-term evaluation of the progress of the curve, with an interval of 6 months from the beginning. Method of measurement: To measure the angle of the spine, the patient's spine should be taken with an anterior-posterior view while standing in a normal position.;Apical vertebral rotation: Vertebral rotation takes place in the transverse plane. The amount of rotation of the vertebrae is of key importance in the prognosis of the disease and the effect of orthotic treatment or other interventions. The highest rotation is related to the vertex. Examining the rotation of the vertebral column around its longitudinal axis is an essential parameter in the study of adolescent idiopathic scoliosis. Timepoint: In both the control and experimental groups, each subject will have three radiological photographs in a standing position from two anterior-posterior and lateral views. Once before receiving the brace, when the brace is prescribed and the patient is prepared for casting or scanning. 20 days after the patient adapts to the orthosi

Secondary

MeasureTime frame
Kyphosis and lordosis: Kyphosis and lordosis, respectively, refer to an anterior and posterior concavity of the spine in the sagittal plane, caused by the shape of the vertebral bodies and intervertebral discs. Timepoint: Each subject will have three radiological photographs in standing position from two anterior-posterior and lateral views. Once before receiving the brace, when the brace is prescribed and the patient is prepared for casting or scanning. 20 days after the patient adapts to the orthosis, while the patient wears the brace, radiology imaging is done. The third imaging of the whole spine, without orthosis, is done for long-term evaluation of curve progress, with an interval of 6 months from the beginning. Method of measurement: By measuring Cobb's angle, kyphosis and lordosis in teenagers, it is in the normal range between 20 to 40 and 35 to 60 degrees, respectively.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDavood Farahmandi najafabadi

Esfahan University of Medical Sciences

D.farahmandi@rehab.mui.ac.ir+98 31 4263 3389

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026