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

Completed

• Conditions: Inflammation; Lumbar Disc Degeneration; Low Back Pain

• Registration Number: NCT05601739
• Lead Sponsor: Yeditepe University

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.

Study Timeline

• Study Start: 2019-04-08
• Primary Completion: 2019-11-10
• Study Completion: 2020-04-03
• Status Verified: 2022-07
• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Study First Posted: 2022-11-01
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genotyping - Interleukin-1β (rs 1143627 T/C) gene polymorphism	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	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	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	baseline	Physiotherapist will measure the Range of Motion of the lumbar spine by using digital goniometer
Modified Schober Test - Lumbar Spine Flexibility	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.

Secondary Outcome Measures

Name	Time	Method
Pfirrmann's grading - Total Disc Degenerative Disc Score	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.
McNab's disc classification - Disc displacements	baseline	Lumbar sagittal Magnetic Resonance Imaging (MRI) was used for the analysis of disc displacements.

Trial Locations

Locations (1)

Yeditepe University; 🇹🇷 Istanbul, Turkey