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

Sponsor

Yeditepe University (Other)

Overall Status

Completed

CT.gov ID

NCT05601739

Collaborator

(none)

Enrollment

Location

11.9

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Disc Degeneration Low Back Pain Inflammation

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 Design

Study Type:

Observational

Actual Enrollment :

94 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

Apr 8, 2019

Actual Primary Completion Date :

Nov 10, 2019

Actual Study Completion Date :

Apr 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Lumbar degenerative disc disease The case group was made of 50 patients, 24 women (48%) and 26 men (52%) with several clinical symptoms suggestive of LDD and the condition confirmed by MRI.
Healthy The control group was made of 44 healthy volunteers.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.