Complete Blood Count-derived Indexes in Inflammatory Modic Changes

Completed

• Conditions: Modic Changes
• Interventions: Diagnostic Test: hemogram

• Registration Number: NCT06440096
• Lead Sponsor: Veysel Delen, MD

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 Timeline

• Study Start: 2023-03-30
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05
• Status Verified: 2024-05
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Modic changes type I	hemogram	24 patients with type I Modic changes
Modic changes type II	hemogram	24 patients with type II Modic changes

Primary Outcome Measures

Name	Time	Method
Hemogram-derived inflammation indexes	10 minutes	blood-based

Trial Locations

Locations (1)

Harran University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Şanlıurfa; 🇹🇷 Şanlıurfa, Turkey