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

NCT06432530 | Completed

• 1 other identifier: University of Van Yüzüncü Yıl
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brucella Spondylitis

Outcome Measures

Primary Outcomes (9)

• C-Reactive Protein (CRP)

  As an inflammatory index.

  Baseline

• Erythrocyte Sedimentation Rate (ESR)

  As an inflammatory index.

  Baseline

• Neutrophil/Lymphocyte Rate (NLR)

  As a hematological inflammatory index

  Baseline

• Monocyte/Lymphocyte Rate (MLR)

  As a hematological inflammatory index

  Baseline

• Platelet/Lymphocyte Rate (PLR)

  As a hematological inflammatory index

  Baseline

• Neutrophil/(Lymphocyte*Platelet) Rate (NLPR)

  As a hematological inflammatory index

  Baseline

• (neutrophil*platelet/lymphocyte): Systemic Inflammatory Index (SII)

  As a hematological inflammatory index

  Baseline

• (neutrophil*monocyte/lymphocyte): Systemic Inflammatory Response Index (SIRI)

  As a hematological inflammatory index

  Baseline

• (neutrophil*platelet*monocyte/lymphocyte): Aggregate Index of Systemic Inflammation (AISI)

  As a hematological inflammatory index

  Baseline

Study Arms (2)

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

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

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

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

Interventions

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

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; 37 patients with type 1 Modic Changes (MCs)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Volkan Şah

Van, 65040, Turkey (Türkiye)

Location

MeSH Terms

Interventions

C-Reactive Protein; Blood Sedimentation; Blood Cell Count

Intervention Hierarchy (Ancestors)

Albumins; Proteins; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Immunoproteins; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Count; Cytological Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ali İrfan Baran

  Yüzüncü Yıl Üniversitesi Tıp Fakültesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 29, 2024
• Study Start: January 9, 2023
• Primary Completion: September 15, 2023
• Study Completion: March 8, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)