Clinical trial NCT06432530: Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis
Official title: Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brucella Spondylitis
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: C-Reactive Protein (CRP)
timeFrame: Baseline
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline
measure: Neutrophil/Lymphocyte Rate (NLR)
timeFrame: Baseline
measure: Monocyte/Lymphocyte Rate (MLR)
timeFrame: Baseline
measure: Platelet/Lymphocyte Rate (PLR)
timeFrame: Baseline
measure: Neutrophil/(Lymphocyte*Platelet) Rate (NLPR)
timeFrame: Baseline
measure: (neutrophil*platelet/lymphocyte): Systemic Inflammatory Index (SII)
timeFrame: Baseline
measure: (neutrophil*monocyte/lymphocyte): Systemic Inflammatory Response Index (SIRI)
timeFrame: Baseline
measure: (neutrophil*platelet*monocyte/lymphocyte): Aggregate Index of Systemic Inflammation (AISI)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Volkan Şah
Study officials:
affiliation: Yüzüncü Yıl Üniversitesi Tıp Fakültesi
name: Ali İrfan Baran
role: PRINCIPAL_INVESTIGATOR
References: