Lumbar Disc DegenerationNCT05601739
Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing LDD in Turkish Population
An observational study of Lumbar Disc Degeneration and Low Back Pain, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to show the association between the Interleukin-1β (rs 1143627 T/C) gene polymorphism and the patient's pain level, radiological features, functional disability, and spinal flexibility. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Degeneration, Low Back Pain, Inflammation
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2019to 3 Apr 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study was conducted between April and November 2019. This is a two-centre study undertaken at Yeditepe University Hospital's Department of Neurosurgery and the Yeditepe Institute of Health Sciences Department of Molecular Medicine. One of the analytical research approaches used was a case/control study.
Who may be able to join
- Patients with chronic low back pain (over 3 months
- Aged 18-60 years old
- With magnetic resonance imaging (MRI) evidencing LDD with Pfirrmann classification
Who cannot join
- Cauda equina syndrome
- Lumbar spinal stenosis
- Spinal deformities (scoliosis, kyphosis, spondylolisthesis)
- Vertebral fractures
- Inflammatory rheumatic diseases
- Diabetic neuropathy
Show all 11Show fewer
- Pregnancy
- Drug and alcohol dependence
- Psychiatric illness
- Oncologic diseases
- Who refuse to sign the consent form and donate a blood sample for analysis of genomic DNA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing Lumbar Degenerative Disc Disease in Turkish Population: A Preliminary Study
This study aims to show the association between the Interleukin-1β (rs 1143627 T/C) gene polymorphism and the patient's pain level, radiological features, functional disability, and spinal flexibility.
Read the detailed description
Background: Lumbar disc degeneration (LDD), a complex process characterized by phenotypic and genotypic changes, causes low back pain.
Aims: This study aims to show the association between the Interleukin-1β (rs 1143627 T/C) gene polymorphism and the patient's pain level, radiological features, functional disability, and spinal flexibility.
Method: A hospital-based case-control study included 50 LDD patients and 44 healthy controls. In this study, Taqman allelic discrimination analysis was performed for the genotype of the Interleukin-1β (rs 1143627 T/C) gene polymorphism. Differences in Interleukin-1β allele frequencies and genotypes were evaluated between patients and controls. Relationships between allele presence/genotype and disease risk are reported as odds ratios (ORs) with 95% confidence intervals (CIs). The Pfirrmann classification was used to grade the level of disc degeneration on MRI scans, and the McNab's classification was used to classify disc displacements. The pain levels of the patient group were evaluated with VAS and their functional disability with ODI. Spinal flexibility was evaluated using the Modified Schober method and a digital inclinometer.
- Conditions
- Lumbar Disc Degeneration, Low Back Pain, Inflammation
- Keywords
- lumbar disc degeneration, polymorphism, interleukin 1 beta, low back pain
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar degenerative disc disease | The case group was made of 50 patients, 24 women (48%) and 26 men (52%) with several clinical symptoms suggestive of LDD and the condition confirmed by MRI. | |
| Healthy | The control group was made of 44 healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotyping - Interleukin-1β (rs 1143627 T/C) gene polymorphism
Genotype analysis of interleukin-1β variation was analyzed with Real-Time PCR (polymerase chain reaction) using Applied bioscience 7500 Fast-Real Time PCR machine (Applied Biosystem, Foster City, California, USA). For this analysis, we use Taq primer assay which had rs number 1143627 (Thermo Fisher Scientific, Waltham, California, USA). Reverse and forward primer sequences were used defining used for possible mutations in target variations
Measured: baseline
Visual Analog Scale - Pain Assessment
Visual Analog Scale (VAS) was used to assess the pain severity of the patients. According to VAS, for pain intensity, it is generally rated as "no pain" 0 points and "moderate pain"5, worst pain imaginable" as 10 points (100 mm scale). They were asked to mark their average pain levels by considering one week. The pain level was questioned separately during resting and activity.
Measured: baseline
Oswestry Disability Index - Functional Disability
The functional level assessment was evaluated using the Oswestry Disability Index (ODI). This scale is preferred to measure the performance of the activities necessary for daily living and to define their limitations. In this scale, consist of 10 sections are included about pain level, inactivity daily living, heavy lifting, walking, sitting, standing, sleeping, sexual life, social life and travelling. There are 6 options in each question, and the patient is asked to choose the expression of his condition.
Measured: baseline
The Range of Motion of the lumbar spine
Physiotherapist will measure the Range of Motion of the lumbar spine by using digital goniometer
Measured: baseline
Modified Schober Test - Lumbar Spine Flexibility
Physiotherapist will measure. The posterior interval between both spina iliaca was marked for measurement. After determining 10 cm above and 5 cm below the marked area, the patient was asked to perform trunk flexion while standing. The difference between the initial value and is noted in cm. The difference of 0-5 cm in the test shows that the flexion flexibility decreases, and the difference over 10 cm shows that the flexibility increases. Values between 5-10 cm are considered normal.
Measured: baseline
Secondary outcomes (2)
Pfirrmann's grading - Total Disc Degenerative Disc Score
Lumbar sagittal Magnetic Resonance Imaging (MRI) was used for the analysis of disc degeneration, and herniation and sections of 5 mm thick were taken. T2-weighted MR examinations of all cases included in the study, independently by a radiologist who is blind to the clinical condition of the cases it was evaluated. Disc degeneration graded according to Pfirrmann's grading. For each case, all lumbar discs were scored individually (L1-2, L2-3, L3-4, L45, L5-S1) total score was calculated.
Measured: baseline
McNab's disc classification - Disc displacements
Lumbar sagittal Magnetic Resonance Imaging (MRI) was used for the analysis of disc displacements.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start8 Apr 2019
- Primary completion10 Nov 2019
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilek Ünsal, M.S.c, Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601739
- Sponsor's protocol ID
- YeditepeU-DilekÜ-001
- Status last verified
- Jul 2022
- First submitted
- 31 Jul 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing Lumbar Degenerative Disc Disease in Turkish Population: A Preliminary Study
- ClinicalTrials.gov ID
- NCT05601739
- Acronym / sponsor ID
- YeditepeU-DilekÜ-001
- Conditions
- Lumbar Disc Degeneration, Low Back Pain, Inflammation
- Keywords
- lumbar disc degeneration, polymorphism, interleukin 1 beta, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 1 Nov 2022 (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.
This study aims to show the association between the Interleukin-1β (rs 1143627 T/C) gene polymorphism and the patient's pain level, radiological features, functional disability, and spinal flexibility.
Detailed description
Background: Lumbar disc degeneration (LDD), a complex process characterized by phenotypic and genotypic changes, causes low back pain.
Aims: This study aims to show the association between the Interleukin-1β (rs 1143627 T/C) gene polymorphism and the patient's pain level, radiological features, functional disability, and spinal flexibility.
Method: A hospital-based case-control study included 50 LDD patients and 44 healthy controls. In this study, Taqman allelic discrimination analysis was performed for the genotype of the Interleukin-1β (rs 1143627 T/C) gene polymorphism. Differences in Interleukin-1β allele frequencies and genotypes were evaluated between patients and controls. Relationships between allele presence/genotype and disease risk are reported as odds ratios (ORs) with 95% confidence intervals (CIs). The Pfirrmann classification was used to grade the level of disc degeneration on MRI scans, and the McNab's classification was used to classify disc displacements. The pain levels of the patient group were evaluated with VAS and their functional disability with ODI. Spinal flexibility was evaluated using the Modified Schober method and a digital inclinometer.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar degenerative disc disease | – | –The case group was made of 50 patients, 24 women (48%) and 26 men (52%) with several clinical symptoms suggestive of LDD and the condition confirmed by MRI. |
| Healthy | – | –The control group was made of 44 healthy volunteers. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study was conducted between April and November 2019. This is a two-centre study undertaken at Yeditepe University Hospital's Department of Neurosurgery and the Yeditepe Institute of Health Sciences Department of Molecular Medicine. One of the analytical research approaches used was a case/control study.
Key inclusion criteria (3 listed)
- Patients with chronic low back pain (over 3 months
- Aged 18-60 years old
- With magnetic resonance imaging (MRI) evidencing LDD with Pfirrmann classification
Key exclusion criteria (11 listed)
- Cauda equina syndrome
- Lumbar spinal stenosis
- Spinal deformities (scoliosis, kyphosis, spondylolisthesis)
- Vertebral fractures
- Inflammatory rheumatic diseases
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
Genotyping - Interleukin-1β (rs 1143627 T/C) gene polymorphism
Time frame: baseline
Genotype analysis of interleukin-1β variation was analyzed with Real-Time PCR (polymerase chain reaction) using Applied bioscience 7500 Fast-Real Time PCR machine (Applied Biosystem, Foster City, California, USA). For this analysis, we use Taq primer assay which had rs number 1143627 (Thermo Fisher Scientific, Waltham, California, USA). Reverse and forward primer sequences were used defining used for possible mutations in target variations
Visual Analog Scale - Pain Assessment
Time frame: baseline
Visual Analog Scale (VAS) was used to assess the pain severity of the patients. According to VAS, for pain intensity, it is generally rated as "no pain" 0 points and "moderate pain"5, worst pain imaginable" as 10 points (100 mm scale). They were asked to mark their average pain levels by considering one week. The pain level was questioned separately during resting and activity.
Oswestry Disability Index - Functional Disability
Time frame: baseline
The functional level assessment was evaluated using the Oswestry Disability Index (ODI). This scale is preferred to measure the performance of the activities necessary for daily living and to define their limitations. In this scale, consist of 10 sections are included about pain level, inactivity daily living, heavy lifting, walking, sitting, standing, sleeping, sexual life, social life and travelling. There are 6 options in each question, and the patient is asked to choose the expression of his condition.
The Range of Motion of the lumbar spine
Time frame: baseline
Physiotherapist will measure the Range of Motion of the lumbar spine by using digital goniometer
Modified Schober Test - Lumbar Spine Flexibility
Time frame: baseline
Physiotherapist will measure. The posterior interval between both spina iliaca was marked for measurement. After determining 10 cm above and 5 cm below the marked area, the patient was asked to perform trunk flexion while standing. The difference between the initial value and is noted in cm. The difference of 0-5 cm in the test shows that the flexion flexibility decreases, and the difference over 10 cm shows that the flexibility increases. Values between 5-10 cm are considered normal.
2 secondary outcomes
Pfirrmann's grading - Total Disc Degenerative Disc Score
Time frame: baseline
McNab's disc classification - Disc displacements
Time frame: baseline
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 1 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Dilek Ünsal, M.S.c principal investigator
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Degeneration and Low Back Pain, run by Yeditepe University at 1 site 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 3 inclusion and 11 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Genotyping - Interleukin-1β (rs 1143627 T/C) gene polymorphism (time frame: baseline). The study lists 5 primary outcomes in all. 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 1 Nov 2022.