Yeditepe University
Istanbul, Turkey (Türkiye)
NCT Number: NCT05601739
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.
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Notify Me18 year–60 year
All sexes
Observational
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
Time frame: baseline
Physiotherapist will measure the Range of Motion of the lumbar spine by using digital goniometer
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.
Time frame: baseline
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.
Time frame: baseline
Lumbar sagittal Magnetic Resonance Imaging (MRI) was used for the analysis of disc displacements.
Yeditepe University
Other
Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing Lumbar Degenerative Disc Disease in Turkish Population: A Preliminary Study
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