- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04702126
Smoking Effect on Lumbar Intervertebral Disc Degeneration
January 7, 2021 updated by: fatma esra bahadir ulger, Fatih Sultan Mehmet Training and Research Hospital
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.
Study Overview
Status
Completed
Conditions
Detailed Description
This retrospective study was performed by obtaining medical records of patients who underwent lumbar spinal MRI between September 2019 and February 2020.
After the application of exclusion criteria 955 patients determined between the specified dates.
These patients were called by phone to be questioned about their smoking status and whether they were working in heavy work and whether they were athletes.
Heavy workers and athletes were also excluded from the study and a total of 360 patients whose smoking status information could be obtained were included in the study.The patients were grouped according to their smoking status as "current smoker", "former smoker", "non-smoker" and "passive smoker".
The cumulative smoking dose for current and former smokers was calculated in terms of pack-years and categorized further into two subgroups: smoked ≤9 pack-years or >9 pack-years.
The number of pack-years was calculated by dividing the number of cigarettes consumed per day by 20 and multiplying by the years that the patient had smoked.
Age, gender, weight, and height were recorded, and body mass index (BMI) was calculated as weight/(height)2.
Lumbar spinal MRI was performed using a 1.5 Tesla imaging system (General Electric Healthcare, Milwaukee, WI), using the following settings: amplitude: 44 mT/m; slew rate gradient configuration: 200 T/m/s.
MRI images were evaluated using a GE Advantage Workstation (GE Healthcare, Buc, France) and Volume Share software v.7.0.
The lumbar lordosis angle was measured and the lumbar intervertebral discs were evaluated by Pfirrmann disc degeneration grading system using sagittal T2-weighted MR images (TR/TE: 2500/85 ms, matrix: 320x224, slice thickness: 4 mm, FOV: 32) (23).
The degree of degeneration was classified into five grades with Grades IV and V considered as "severe disc degeneration".
Radiologist reviewing the MRI studies was blinded to the smoking status of the participants.
Study Type
Observational
Enrollment (Actual)
360
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34758
- Fatih Sultan Mehmet Training and Research Hospital
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Istanbul, Turkey
- Fatih Sultan Mehmet Training and Research Hospital
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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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent lumbar spinal MRI between September 2019 and February 2020 and questioned for smoking status.
Description
Inclusion Criteria:
- Patients who underwent lumbar spinal MRI between September 2019 and February 2020.
Exclusion Criteria:
- a history of spinal surgery or instrumentation, spinal fracture, trauma, congenital or acquired spinal deformity tumor or infection,
- heavy physical workers,
- athletes
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-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the effect of current, former and passive smoking status on degeneration of lumbar intervertebral discs.
Time Frame: 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fatma Esra Bahadir Ülger, M.D., Fatih Sultan Mehmet Training and Research Hospital
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)
September 1, 2019
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
January 5, 2021
First Submitted That Met QC Criteria
January 7, 2021
First Posted (Actual)
January 8, 2021
Study Record Updates
Last Update Posted (Actual)
January 8, 2021
Last Update Submitted That Met QC Criteria
January 7, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FSMTRHU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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