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Clinical Trials/NCT06440096
NCT06440096CompletedNot Applicable

Harran University Hospital Department of Physical Medicine and Rehabilitation

Veysel Delen, MD1 site in 1 country48 target enrollmentStarted: March 30, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
48
Locations
1
Primary Endpoint
Hemogram-derived inflammation indexes

Study 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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Hemogram-derived inflammation indexes

Time Frame: 10 minutes

blood-based

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Veysel Delen, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Veysel Delen, MD

Harran University Hospital

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Study Sites (1)

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