Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis

May 23, 2024 updated by: Volkan Şah, Yuzuncu Yıl University
Hematological inflammatory indices (Table 2) are currently very popular and have diagnostic, prognostic, and predictive, roles in various diseases. Considering their promising roles, we hypothesized that hematological inflammatory indices may have a distinctive value between brucella spondylodiscitis and type 1 Modic Changes (MCs). If the hypothesis is valid, early diagnosis-differential diagnosis-treatment processes may become easier and more successful. Given that hematological inflammatory indices are faster, practical, simpler, inexpensive, and easily accessible indicators, they may be more appropriate tools in differentiation between brucella spondylodiscitis and type 1 MCs.

Study Overview

Detailed Description

This is a retrospective comparative study focusing to distinguish between brucella spondylodiscitis and type 1 MCs considering hematological inflammatory indexes. Patients' data were obtained from Hospital Information Systems, between 2020 to 2024. A total of 35 patients with brucella spondylodiscitis and 37 type 1 MCs were enrolled in the study. Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR, MLR, PLR, NLPR, SII, SIRI, AISI) were derived from baseline CBC tests.

Based on the diagnostic tools and criteria1,2,14,21, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar MRI, Complete Blood Count (CBC) test, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) results, and aged 18-65 years were selected to yield a study population. On the other hand, cases with inadequate data, aged <18 or >64 years, other infectious spondylodiscitis types than brucella, other MCs types than type 1, and other non-infectious conditions such as rheumatic spondylodiscitis (ankylosing spondylitis or Andersson lesion) were excluded from the study. Also, previous or recurrent brucella spondylodiscitis, involved other spinal levels than the lumbar spine were exclusion causes.

The two groups were statistically assessed and compared for baseline features such as age, gender, symptom duration, CRP, ESR, CBC values, and indexes derived from the CBC.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Van, Turkey, 65040
        • Volkan Şah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

A total of 35 (17 female and 18 male) patients with brucella spondylodiscitis and 37 (26 female and 11 male) type 1 Modic Changes (MCs) were enrolled in the study. Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnotic tools. Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR: neutrophil/lymphocyte; MLR: monocyte/lymphocyte; PLR: platelet/lymphocyte; NLPR: neutrophil/(lymphocyte*platelet); SII (neutrophil*platelet/lymphocyte): systemic inflammatory index; SIRI (neutrophil*monocyte/lymphocyte): systemic inflammatory response index; AISI (neutrophil*platelet*monocyte/lymphocyte): aggregate index of systemic inflammation. ) were derived from baseline CBC tests.

Description

Inclusion Criteria:

  • Clinical diagnosis of lumbar brucella spondylodiscitis in the past 5 years
  • Clinical diagnosis of or lumbar type 1 Modic Changes (MCs) in the past 5 years
  • Having simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) results
  • Being between the ages of 18-65

Exclusion Criteria:

  • Cases with inadequate data
  • Being under 18 years of age and over 65 years of age
  • Having other infectious spondylodiscitis types than brucella
  • Having other MCs types than type 1
  • Having other non-infectious conditions such as rheumatic spondylodiscitis (ankylosing spondylitis or Andersson lesion)
  • Having previous or recurrent brucella spondylodiscitis, involved other spinal levels than the lumbar spine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
37 patients with type 1 Modic Changes (MCs)
Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Based on the diagnostic tools and criteria, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and Erythrocyte Sedimentation Rate (ESR) results, and aged 18-65 years were selected to yield a study population
Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR: neutrophil/lymphocyte; MLR: monocyte/lymphocyte; PLR: platelet/lymphocyte; NLPR: neutrophil/(lymphocyte*platelet); SII (neutrophil*platelet/lymphocyte): systemic inflammatory index; SIRI (neutrophil*monocyte/lymphocyte): systemic inflammatory response index; AISI (neutrophil*platelet*monocyte/lymphocyte): aggregate index of systemic inflammation. ) were derived from baseline CBC tests.
35 patients with brucella spondylodiscitis
Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Based on the diagnostic tools and criteria, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and Erythrocyte Sedimentation Rate (ESR) results, and aged 18-65 years were selected to yield a study population
Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR: neutrophil/lymphocyte; MLR: monocyte/lymphocyte; PLR: platelet/lymphocyte; NLPR: neutrophil/(lymphocyte*platelet); SII (neutrophil*platelet/lymphocyte): systemic inflammatory index; SIRI (neutrophil*monocyte/lymphocyte): systemic inflammatory response index; AISI (neutrophil*platelet*monocyte/lymphocyte): aggregate index of systemic inflammation. ) were derived from baseline CBC tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-Reactive Protein (CRP)
Time Frame: Baseline
As an inflammatory index.
Baseline
Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline
As an inflammatory index.
Baseline
Neutrophil/Lymphocyte Rate (NLR)
Time Frame: Baseline
As a hematological inflammatory index
Baseline
Monocyte/Lymphocyte Rate (MLR)
Time Frame: Baseline
As a hematological inflammatory index
Baseline
Platelet/Lymphocyte Rate (PLR)
Time Frame: Baseline
As a hematological inflammatory index
Baseline
Neutrophil/(Lymphocyte*Platelet) Rate (NLPR)
Time Frame: Baseline
As a hematological inflammatory index
Baseline
(neutrophil*platelet/lymphocyte): Systemic Inflammatory Index (SII)
Time Frame: Baseline
As a hematological inflammatory index
Baseline
(neutrophil*monocyte/lymphocyte): Systemic Inflammatory Response Index (SIRI)
Time Frame: Baseline
As a hematological inflammatory index
Baseline
(neutrophil*platelet*monocyte/lymphocyte): Aggregate Index of Systemic Inflammation (AISI)
Time Frame: Baseline
As a hematological inflammatory index
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ali İrfan Baran, Yüzüncü Yıl Üniversitesi Tıp Fakültesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

March 8, 2024

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • University of Van Yüzüncü Yıl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brucella Spondylitis

Clinical Trials on C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete Blood Count (CBC) values, and indexes derived from the CBC.

Subscribe