Intervertebral Disc DisplacementNCT02351206
Lumbar Disc Space Height in Young Disc Herniation and Degeneration Patients
An observational study of Intervertebral Disc Displacement and Intervertebral Disc Degeneration, run by Jaseng Hospital of Korean Medicine.
Trial summary
As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic intervertebral disc change in young adults holds high clinical relevance as a common structural cause of LBP. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervertebral Disc Displacement, Intervertebral Disc Degeneration, Low Back Pain
- What is being tested?
- x-ray, MRI
- Type of treatment
- Surgery or procedure
- How many people
- 389 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Nov 2014
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients visiting Jaseng hospital of Korean Medicine, a spine specializing Korean medicine hospital designated by the Korean ministry of health and welfare, from January, 2010 to October 2014
Who may be able to join
- Age 20-25 years
- L-spine X-ray and L-spine MRIs taken within a week of the other test
- Native Korean ethnicity
Who cannot join
- Scoliosis with a Cobb's angle of ≥20°
- Significant vertebral deformity of any etiology (e.g. spondylolisthesis, fracture, spondylitis, neoplasm)
- Previous spinal surgery
About this study
Official title: Lumbar Intervertebral Disc Space Height in Disc Herniation and Degeneration Patients in Their Early 20s
As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic intervertebral disc change in young adults holds high clinical relevance as a common structural cause of LBP. The investigators therefore assessed the feasibility of using X-ray disc space height measurements as a predictive evaluation method of lumbar disc herniation (LDH) and degeneration in LBP patients in their early 20s.
- Being tested
- x-ray, MRI
- Keywords
- X-Rays, Magnetic Resonance Imaging, Sensitivity and Specificity
- Medical subject headings
- Intervertebral Disc Displacement, Intervertebral Disc Degeneration, Low Back Pain, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-ray, MRIRadiation
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Patients with intervertebral disc protrusion, extrusion, or migration at L4/5 randomly selected from a population pool of 665 patients with L-spine X-ray and L-spine MRIs taken within a week of the other test. Receives: Radiation: x-ray, MRI | |
| The control group | Patients with normal or disc bulging readings at L4/5 randomly selected from a population pool of 665 patients with L-spine X-ray and L-spine MRIs taken within a week of the other test. Receives: Radiation: x-ray, MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance between the 2 midpoints of the inferior and superior borders of the vertebral bodies surrounding the L4/5 intervertebral disc space divided by the AP diameter of the inferior border of the L4 vertebral body
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJan 2010
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DisplacementStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Hospital of Korean Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351206
- Sponsor's protocol ID
- JS-CT-2014-05
- Status last verified
- Nov 2018
- First submitted
- 27 Jan 2015
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Intervertebral Disc Space Height in Disc Herniation and Degeneration Patients in Their Early 20s
- ClinicalTrials.gov ID
- NCT02351206
- Acronym / sponsor ID
- JS-CT-2014-05
- Keywords
- X-Rays, Magnetic Resonance Imaging, Sensitivity and Specificity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Jaseng Hospital of Korean MedicineUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Jan 2015 (estimated)
- 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.
As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic intervertebral disc change in young adults holds high clinical relevance as a common structural cause of LBP. The investigators therefore assessed the feasibility of using X-ray disc space height measurements as a predictive evaluation method of lumbar disc herniation (LDH) and degeneration in LBP patients in their early 20s.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | – | Radiation: x-ray, MRIPatients with intervertebral disc protrusion, extrusion, or migration at L4/5 randomly selected from a population pool of 665 patients with L-spine X-ray and L-spine MRIs taken within a week of the other test. |
| The control group | – | Radiation: x-ray, MRIPatients with normal or disc bulging readings at L4/5 randomly selected from a population pool of 665 patients with L-spine X-ray and L-spine MRIs taken within a week of the other test. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients visiting Jaseng hospital of Korean Medicine, a spine specializing Korean medicine hospital designated by the Korean ministry of health and welfare, from January, 2010 to October 2014
Key inclusion criteria (3 listed)
- Age 20-25 years
- L-spine X-ray and L-spine MRIs taken within a week of the other test
- Native Korean ethnicity
Key exclusion criteria (3 listed)
- Scoliosis with a Cobb's angle of ≥20°
- Significant vertebral deformity of any etiology (e.g. spondylolisthesis, fracture, spondylitis, neoplasm)
- Previous spinal surgery
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 |
|---|---|---|
| x-ray, MRI | Radiation | The control group, The experimental group |
Primary outcome
The distance between the 2 midpoints of the inferior and superior borders of the vertebral bodies surrounding the L4/5 intervertebral disc space divided by the AP diameter of the inferior border of the L4 vertebral body
Time frame: Baseline
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 7 Nov 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Displacement and Intervertebral Disc Degeneration, run by Jaseng Hospital of Korean Medicine.
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 3 inclusion and 3 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The distance between the 2 midpoints of the inferior and superior borders of the vertebral bodies surrounding the L4/5 intervertebral disc space divided by the AP diameter of the inferior border of the L4 vertebral body (time frame: Baseline). 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 7 Nov 2018.