Volkan Şah
Van, 65040, Turkey (Türkiye)
Completed
NCT Number: NCT06432530
Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis
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.
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete Blood Count (CBC) values, and indexes derived from the CBC.
OtherPatients' 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.
Primary outcomes
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C-Reactive Protein (CRP)
Time frame: Baseline
As an inflammatory index.
-
Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline
As an inflammatory index.
-
Neutrophil/Lymphocyte Rate (NLR)
Time frame: Baseline
As a hematological inflammatory index
-
Monocyte/Lymphocyte Rate (MLR)
Time frame: Baseline
As a hematological inflammatory index
-
Platelet/Lymphocyte Rate (PLR)
Time frame: Baseline
As a hematological inflammatory index
-
Neutrophil/(Lymphocyte*Platelet) Rate (NLPR)
Time frame: Baseline
As a hematological inflammatory index
-
(neutrophil*platelet/lymphocyte): Systemic Inflammatory Index (SII)
Time frame: Baseline
As a hematological inflammatory index
-
(neutrophil*monocyte/lymphocyte): Systemic Inflammatory Response Index (SIRI)
Time frame: Baseline
As a hematological inflammatory index
-
(neutrophil*platelet*monocyte/lymphocyte): Aggregate Index of Systemic Inflammation (AISI)
Time frame: Baseline
As a hematological inflammatory index
Sponsors and collaborators
Lead sponsor
Yuzuncu Yil University
Other
Registry information
Important dates
- Study start
- 2023
- Primary completion
- 2023
- Study completion
- 2024
- First posted
- May 29, 2024
- Registry last updated
- May 29, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.