Harran University Hospital Department of Physical Medicine and Rehabilitation

Veysel Delen, MD1 site in 1 country48 target enrollmentMarch 30, 2023

ConditionsModic Changes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Modic Changes
Sponsor: Veysel Delen, MD
Enrollment: 48
Locations: 1
Primary Endpoint: Hemogram-derived inflammation indexes
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Some indicators generated from hemogram such as neutrophil/lymphocyte (NLR) have been suggested as biomarkers of systemic inflammation. Type I Modic changes (MCs) have inflammatory nature histologically and are more painful clinically than type II MCs. Therefore, we hypothesized that patients with type I MCs may have increased inflammatory biomarkers and low back pain than those with type II MCs. The aim of this study was to test this hypothesis.

Detailed Description

Patients and Methods: A total of 48 patients with MCs (type I/type II=24/24) were included in this study. Their demographic, clinical and hematologic characteristics were recorded. A 10 cm Visual Analog Scale (VAS) was used to detect low back pain intensity. Systemic inflammatory biomarkers including NLR, monocyte/lymphocyte (MLR), platelet/lymphocyte (PLR), neutrophil/lymphocyte\*platelet (NLPR), systemic inflammatory index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI) were derived from whole blood cell count. Keywords: Neutrophil-to-lymphocyte ratio, inflammation, Modic changes, back pain.

Registry

clinicaltrials.gov

Start Date

March 30, 2023

End Date

January 5, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Veysel Delen, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Veysel Delen, MD

Harran University Hospital

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria were male or female with type I or type II MCs, aged ≥18 and ≤64 years old, and accepted informed consent to participation.

Exclusion Criteria

•type III MCs and a combination of MCs' types were excluded. In addition, acute low back pain, spinal deformities, inflammatory diseases, cancers, heart diseases, stroke, lactation, pregnancy, psychiatric disorders, and extreme obesity (BMI≥40 kg/m²) were also excluded.