NCT02351206

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
389

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

4.8 years

First QC Date

January 27, 2015

Last Update Submit

November 5, 2018

Conditions

Keywords

X-RaysMagnetic Resonance ImagingSensitivity and Specificity

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Study Arms (2)

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.

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.

Radiation: x-ray, MRI

Interventions

x-ray, MRIRADIATION
The control groupThe experimental group

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • Age 20-25 years
  • L-spine X-ray and L-spine MRIs taken within a week of the other test
  • Native Korean ethnicity

You may not qualify if:

  • Scoliosis with a Cobb's angle of ≥20°
  • Significant vertebral deformity of any etiology (e.g. spondylolisthesis, fracture, spondylitis, neoplasm)
  • Previous spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc DisplacementIntervertebral Disc DegenerationLow Back PainHypersensitivity

Interventions

X-RaysMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and SymptomsImmune System Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

January 30, 2015

Study Start

January 1, 2010

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

November 7, 2018

Record last verified: 2018-11