## Protocol Section
### Identification Module
**NCT ID:** NCT06432530

**Brief Title:** 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

#### Organization Study ID Info
**ID:** University of Van Yüzüncü Yıl
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2024-03-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-15

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-09

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yuzuncu Yıl University

#### Responsible Party

**Investigator Affiliation:** Yuzuncu Yıl University

**Investigator Full Name:** Volkan Şah

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Brucella Spondylitis

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 72

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

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

**Label:** 37 patients with type 1 Modic Changes (MCs)

#### Arm Group 2

**Description:** 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

**Intervention Names:**

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

**Label:** 35 patients with brucella spondylodiscitis

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 35 patients with brucella spondylodiscitis

- 37 patients with type 1 Modic Changes (MCs)

**Description:** 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.

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

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** As an inflammatory index.

**Measure:** C-Reactive Protein (CRP)

**Time Frame:** Baseline

**Description:** As an inflammatory index.

**Measure:** Erythrocyte Sedimentation Rate (ESR)

**Time Frame:** Baseline

**Description:** As a hematological inflammatory index

**Measure:** Neutrophil/Lymphocyte Rate (NLR)

**Time Frame:** Baseline

**Description:** As a hematological inflammatory index

**Measure:** Monocyte/Lymphocyte Rate (MLR)

**Time Frame:** Baseline

**Description:** As a hematological inflammatory index

**Measure:** Platelet/Lymphocyte Rate (PLR)

**Time Frame:** Baseline

**Description:** As a hematological inflammatory index

**Measure:** Neutrophil/(Lymphocyte*Platelet) Rate (NLPR)

**Time Frame:** Baseline

**Description:** As a hematological inflammatory index

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

**Time Frame:** Baseline

**Description:** As a hematological inflammatory index

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

**Time Frame:** Baseline

**Description:** As a hematological inflammatory index

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

**Time Frame:** Baseline

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Van

**Country:** Turkey

**Facility:** Volkan Şah

**Zip:** 65040

#### Overall Officials

**Official 1:**

**Affiliation:** Yüzüncü Yıl Üniversitesi Tıp Fakültesi

**Name:** Ali İrfan Baran

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001850

- Term: Bone Diseases, Infectious

- ID: D000007239

- Term: Infections

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000013122

- Term: Spinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M15961

- Name: Spondylitis

- Relevance: HIGH

- As Found: Spondylitis

- ID: M17996

- Name: Discitis

- Relevance: HIGH

- As Found: Spondylodiscitis

- ID: M23035

- Name: Spondylarthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5129

- Name: Bone Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013166

- Term: Spondylitis

- ID: D000015299

- Term: Discitis

### Misc Info Module

- Version Holder: 2024-05-31
