Thoracolumbar Junction

Spinal Curvatures Clinical Trial

Official title:

Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction: A Cross-Sectional Study of Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06138912
• Other study ID #: ChonnamNUH
• Status: Completed
• Start date: January 3, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2023
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Several studies have investigated the mechanical behavior of the thoracolumbar spine. However, an accurate reference for normal functional local alignment and segmental motion at the thoracolumbar junction is still illusive. Therefore, we conducted a cross-sectional cohort study with a balanced distribution of age and sex of healthy subjects to examine the normal alignment and segmental motion at the thoracolumbar junction using dynamic plain radiography. This study aimed to provide data that can be used when planning surgery or performing rehabilitation in pathological situations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 78 Years

Eligibility

Inclusion Criteria:

• A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints were included if they successfully met the study's exclusion criteria

Exclusion Criteria:

• (1) coronal deformity (Cobb angle > 10°); (2) a history of prior spine surgery; (3) a history of hip or knee arthroplasty or any other realignment surgery of the lower extremities (osteotomy, trauma, etc.); (4) complaints of back or neck pain that resulted in missed work, affected daily living activities, participation in recreational activities or required narcotic pain medication; (5) degenerative or pathologic conditions of the spine that necessitated physician intervention (i.e., physician appointment or epidural steroid injections); (6) non-ambulatory patients; (7) a history of neuromuscular disorders, inflammatory arthritis, or congenital anomalies; and (8) pregnancy

Related Conditions & MeSH terms

• Spinal Curvatures

Intervention

Radiation:
• plain radiography (x-ray)
Radiographic imaging of the subjects was performed, and anteroposterior, lateral, flexion-extension, and right-left lateral bending radiograph views were obtained

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju	Dong-gu

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction	The present study measured the normal functional Local Alignment and Segmental Motion at the Thoracolumbar junction based on the age and sex of healthy subjects	2year