Clinical trial NCT05601739: Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing LDD in Turkish Population
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Degeneration
Low Back Pain
Inflammation
Keywords: lumbar disc degeneration
polymorphism
interleukin 1 beta
low back pain
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was conducted between April and November 2019. This is a two-centre study undertaken at Yeditepe University Hospital's Department of Neurosurgery and the Yeditepe Institute of Health Sciences Department of Molecular Medicine. One of the analytical research approaches used was a case/control study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Genotyping - Interleukin-1β (rs 1143627 T/C) gene polymorphism
timeFrame: baseline
measure: Visual Analog Scale - Pain Assessment
timeFrame: baseline
measure: Oswestry Disability Index - Functional Disability
timeFrame: baseline
measure: The Range of Motion of the lumbar spine
timeFrame: baseline
measure: Modified Schober Test - Lumbar Spine Flexibility
timeFrame: baseline
Secondary outcomes:
measure: Pfirrmann's grading - Total Disc Degenerative Disc Score
timeFrame: baseline
measure: McNab's disc classification - Disc displacements
timeFrame: baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
affiliation: Yeditepe University
name: Dilek Ünsal, M.S.c
role: PRINCIPAL_INVESTIGATOR
References: