NCT06138912

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 14, 2023

Last Update Submit

November 14, 2023

Conditions

Keywords

Thoracolumbar spineAlignmentRange of motion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Age

20-29, 30-39, 40-49, 50-59, 60-69, and 70-79

Radiation: plain radiography (x-ray)

sex

each group included 10 subjects

Radiation: plain radiography (x-ray)

Interventions

Radiographic imaging of the subjects was performed, and anteroposterior, lateral, flexion-extension, and right-left lateral bending radiograph views were obtained

Agesex

Eligibility Criteria

Age20 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hospital

Gwangju, Dong-gu, 61469, South Korea

Location

MeSH Terms

Conditions

Spinal Curvatures

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neurosurgery

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

January 3, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations