- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02351206
Lumbar Disc Space Height in Young Disc Herniation and Degeneration Patients
November 5, 2018 updated by: Jaseng Hospital of Korean Medicine
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
389
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- Age 20-25 years
- L-spine X-ray and L-spine MRIs taken within a week of the other test
- Native Korean ethnicity
Exclusion Criteria:
- Scoliosis with a Cobb's angle of ≥20°
- Significant vertebral deformity of any etiology (e.g. spondylolisthesis, fracture, spondylitis, neoplasm)
- Previous spinal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
January 27, 2015
First Submitted That Met QC Criteria
January 29, 2015
First Posted (Estimate)
January 30, 2015
Study Record Updates
Last Update Posted (Actual)
November 7, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS-CT-2014-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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