NCT04702126

Brief Summary

Besides normal aging, genetic and environmental factors are important potential determinants of lumbar disc degeneration. Smoking causes serious health problems, particularly lung and other cancers, heart disease and respiratory diseases, and is among the most common causes of death worldwide. Besides these commonly known diseases related to smoking numerous studies have shown that smoking has detrimental effects on the musculoskeletal system and worsens the prognosis and treatment of leukomotor diseases. In the literature there are studies examining the effect of smoking status on disc degeneration. The aim of the study was to investigate the effect of current, former and passive smoking status on degeneration of lumbar intervertebral discs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

September 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

January 5, 2021

Last Update Submit

January 7, 2021

Conditions

Keywords

Intervertebral disc degenerationMagnetic resonance imagingSmokingPassive smoker

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the effect of current, former and passive smoking status on degeneration of lumbar intervertebral discs.

    The lumbar intervertebral discs of patients were evaluated by Pfirrmann disc degeneration grading system using sagittal T2-weighted MR images. The degree of degeneration was classified into five grades with Grades IV and V considered as "severe disc degeneration". Severe disc degeneration was identified between the current, former, passive and non-smoker groups. The relationship between smoking status groups and severe disc degeneration was examined.

    3 months

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent lumbar spinal MRI between September 2019 and February 2020 and questioned for smoking status.

You may qualify if:

  • Patients who underwent lumbar spinal MRI between September 2019 and February 2020.

You may not qualify if:

  • a history of spinal surgery or instrumentation, spinal fracture, trauma, congenital or acquired spinal deformity tumor or infection,
  • heavy physical workers,
  • athletes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34758, Turkey (Türkiye)

Location

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationSmoking

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesBehavior

Study Officials

  • Fatma Esra Bahadir Ülger, M.D.

    Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fatih Sultan Mehmet Training and Research Hospital

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 8, 2021

Study Start

September 1, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 8, 2021

Record last verified: 2021-01

Locations