Complete Blood Count-derived Indexes in Inflammatory Modic Changes

Modic Changes Clinical Trial

Official title:

Harran University Hospital Department of Physical Medicine and Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06440096
• Other study ID #: YÖMAVD
• Status: Completed
• Start date: March 30, 2023
• Est. completion date: January 5, 2024

Study information

• Verified date: May 2024
• Source: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Modic Changes

Intervention

Diagnostic Test:
• hemogram
hemogram

Locations

Country	Name	City	State
Turkey	Harran University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Sanliurfa	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Veysel Delen, MD

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemogram-derived inflammation indexes	blood-based	10 minutes