Complete Blood Count-derived Indexes in Inflammatory Modic Changes

NCT ID: NCT06440096

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-30

Study Completion Date

2024-01-05

Brief Summary

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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

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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.

Conditions

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Modic Changes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Modic changes type I

24 patients with type I Modic changes

hemogram

Intervention Type DIAGNOSTIC_TEST

hemogram

Modic changes type II

24 patients with type II Modic changes

hemogram

Intervention Type DIAGNOSTIC_TEST

hemogram

Interventions

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hemogram

hemogram

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Veysel Delen, MD

OTHER

Sponsor Role lead

Responsible Party

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Veysel Delen, MD

Harran University Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Sanliurfa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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YÖMAVD

Identifier Type: -

Identifier Source: org_study_id

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