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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601739
• Other study ID #: YeditepeU-DilekÜ-001
• Status: Completed
• Start date: April 8, 2019
• Est. completion date: April 3, 2020

Study information

• Verified date: July 2022
• Source: Yeditepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: April 3, 2020
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Inflammation
• Intervertebral Disc Degeneration
• Low Back Pain
• Lumbar Disc Degeneration

Locations

Country	Name	City	State
Turkey	Yeditepe University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotyping - Interleukin-1ß (rs 1143627 T/C) gene polymorphism	Genotype analysis of interleukin-1ß 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	baseline
Primary	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.	baseline
Primary	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.	baseline
Primary	The Range of Motion of the lumbar spine	Physiotherapist will measure the Range of Motion of the lumbar spine by using digital goniometer	baseline
Primary	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.	baseline
Secondary	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.	baseline
Secondary	McNab's disc classification - Disc displacements	Lumbar sagittal Magnetic Resonance Imaging (MRI) was used for the analysis of disc displacements.	baseline