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

NCT05601739 | Completed

• 1 other identifier: YeditepeU-DilekÜ-001
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Degeneration; Low Back Pain; Inflammation

Keywords

lumbar disc degeneration; polymorphism; interleukin 1 beta; low back pain

Outcome Measures

Primary Outcomes (5)

• Genotyping - Interleukin-1β (rs 1143627 T/C) gene polymorphism

  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

  baseline

• 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

• 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

• The Range of Motion of the lumbar spine

  Physiotherapist will measure the Range of Motion of the lumbar spine by using digital goniometer

  baseline

• 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 Outcomes (2)

• Pfirrmann's grading - Total Disc Degenerative Disc Score

  baseline

• McNab's disc classification - Disc displacements

  baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Patients with chronic low back pain (over 3 months
• Aged 18-60 years old
• With magnetic resonance imaging (MRI) evidencing LDD with Pfirrmann classification

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Interleukin 1-β (rs 1143627 T/C) Gene Polymorphism

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain; Inflammation

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Dilek Ünsal, M.S.c

  Yeditepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: November 1, 2022
• Study Start: April 8, 2019
• Primary Completion: November 10, 2019
• Study Completion: April 3, 2020
• Last Updated: November 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)