Spinal CurvaturesNCT06138912
Thoracolumbar Junction
An observational study of Spinal Curvatures, run by Chonnam National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Curvatures
- What is being tested?
- plain radiography (x-ray)
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints
Who may be able to join
- 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
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hospital
Gwangju, Dong-gu, 61469
About this study
Official title: Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction: A Cross-Sectional Study of Healthy Subjects
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.
- Conditions
- Spinal Curvatures
- Being tested
- plain radiography (x-ray)
- Keywords
- Thoracolumbar spine, Alignment, Range of motion
- Medical subject headings
- Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plain radiography (x-ray)Radiation
Radiographic imaging of the subjects was performed, and anteroposterior, lateral, flexion-extension, and right-left lateral bending radiograph views were obtained
| Study group | Role | What they receive |
|---|---|---|
| Age | 20-29, 30-39, 40-49, 50-59, 60-69, and 70-79 Receives: Radiation: plain radiography (x-ray) | |
| sex | each group included 10 subjects Receives: Radiation: plain radiography (x-ray) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start3 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal CurvaturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Moon-Soo, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138912
- Sponsor's protocol ID
- ChonnamNUH
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction: A Cross-Sectional Study of Healthy Subjects
- ClinicalTrials.gov ID
- NCT06138912
- Acronym / sponsor ID
- ChonnamNUH
- Conditions
- Spinal Curvatures
- Keywords
- Thoracolumbar spine, Alignment, Range of motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age | – | Radiation: plain radiography (x-ray)20-29, 30-39, 40-49, 50-59, 60-69, and 70-79 |
| sex | – | Radiation: plain radiography (x-ray)each group included 10 subjects |
Who may qualify
- Ages
- 20 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Radiation | Age, sex |
Primary outcome
Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction
Time frame: 2year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Curvatures, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction (time frame: 2year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.