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Completed

NCT Number: NCT06440096

Complete Blood Count-derived Indexes in Inflammatory Modic Changes

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.

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Key information

Conditions

Modic Changes

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Harran University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Şanlıurfa

Sanliurfa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hemogram

Diagnostic Test

hemogram

Primary outcomes

  1. Hemogram-derived inflammation indexes

    Time frame: 10 minutes

    blood-based

Sponsors and collaborators

Lead sponsor

Veysel Delen, MD

Other

Registry information

Official study title

Harran University Hospital Department of Physical Medicine and Rehabilitation

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2024
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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