Intervertebral Disc DegenerationNCT04702126
Smoking Effect on Lumbar Intervertebral Disc Degeneration
An observational study of Intervertebral Disc Degeneration, run by Fatih Sultan Mehmet Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Intervertebral Disc Degeneration
- How many people
- 360 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Feb 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent lumbar spinal MRI between September 2019 and February 2020 and questioned for smoking status.
Who may be able to join
- Patients who underwent lumbar spinal MRI between September 2019 and February 2020.
Who cannot join
- a history of spinal surgery or instrumentation, spinal fracture, trauma, congenital or acquired spinal deformity tumor or infection,
- heavy physical workers,
- athletes
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34758
Fatih Sultan Mehmet Training and Research Hospital
Istanbul
About this study
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.
Read the 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.
- Conditions
- Intervertebral Disc Degeneration
- Keywords
- Intervertebral disc degeneration, Magnetic resonance imaging, Smoking, Passive smoker
- Medical subject headings
- Intervertebral Disc Degeneration, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Sep 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatma esra bahadir ulger, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Fatma Esra Bahadir Ülger, M.D., Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702126
- Sponsor's protocol ID
- FSMTRHU
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Effect on Lumbar Intervertebral Disc Degeneration
- ClinicalTrials.gov ID
- NCT04702126
- Acronym / sponsor ID
- FSMTRHU
- Conditions
- Intervertebral Disc Degeneration
- Keywords
- Intervertebral disc degeneration, Magnetic resonance imaging, Smoking, Passive smoker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 8 Jan 2021 (actual)
- 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent lumbar spinal MRI between September 2019 and February 2020 and questioned for smoking status.
Key inclusion criteria (1 listed)
- Patients who underwent lumbar spinal MRI between September 2019 and February 2020.
Key exclusion criteria (3 listed)
- a history of spinal surgery or instrumentation, spinal fracture, trauma, congenital or acquired spinal deformity tumor or infection,
- heavy physical workers,
- athletes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 8 Jan 2021.
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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.
Fatma Esra Bahadir Ülger, M.D. principal investigator
Fatih Sultan Mehmet Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration, run by Fatih Sultan Mehmet Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 1 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 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Evaluation of the effect of current, former and passive smoking status on degeneration of lumbar intervertebral discs. (time frame: 3 months). 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 8 Jan 2021.