Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing Lumbar Degenerative Disc Disease in Turkish Population: A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Genotyping - Interleukin-1β (rs 1143627 T/C) gene polymorphism
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with chronic low back pain (over 3 months
- •Aged 18-60 years old
- •With magnetic resonance imaging (MRI) evidencing LDD with Pfirrmann classification
排除标准
- •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.
结局指标
主要结局
Genotyping - Interleukin-1β (rs 1143627 T/C) gene polymorphism
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline
Physiotherapist will measure the Range of Motion of the lumbar spine by using digital goniometer
Modified Schober Test - Lumbar Spine Flexibility
时间窗: 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.
次要结局
- Pfirrmann's grading - Total Disc Degenerative Disc Score(baseline)
- McNab's disc classification - Disc displacements(baseline)