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Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing LDD in Turkish Population

Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing Lumbar Degenerative Disc Disease in Turkish Population: A Preliminary Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05601739
Enrollment
94
Registered
2022-11-01
Start date
2019-04-08
Completion date
2020-04-03
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Low Back Pain, Lumbar Disc Degeneration

Keywords

lumbar disc degeneration, polymorphism, interleukin 1 beta, low back pain

Brief 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.

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.

Interventions

None listed

Sponsors

Yeditepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with chronic low back pain (over 3 months * Aged 18-60 years old * With magnetic resonance imaging (MRI) evidencing LDD with Pfirrmann classification

Exclusion criteria

* Cauda equina syndrome * Lumbar spinal stenosis * Spinal deformities (scoliosis, kyphosis, spondylolisthesis) * Vertebral fractures * Inflammatory rheumatic diseases * Diabetic neuropathy * 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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale - Pain AssessmentbaselineVisual 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 pain5, 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.
The Range of Motion of the lumbar spinebaselinePhysiotherapist will measure the Range of Motion of the lumbar spine by using digital goniometer
Modified Schober Test - Lumbar Spine FlexibilitybaselinePhysiotherapist 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.
Genotyping - Interleukin-1β (rs 1143627 T/C) gene polymorphismbaselineGenotype 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
Oswestry Disability Index - Functional DisabilitybaselineThe 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.

Secondary

MeasureTime frameDescription
McNab's disc classification - Disc displacementsbaselineLumbar sagittal Magnetic Resonance Imaging (MRI) was used for the analysis of disc displacements.
Pfirrmann's grading - Total Disc Degenerative Disc ScorebaselineLumbar 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026