The Relationship Between Systemic Immune Inflammation Index and Disease Activity in Patients With Ankylosing Spondylitis

February 18, 2024 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
In this study, the aim was to investigate the relationship between SII and other laboratory parameters with disease activity in AS patients and to discuss its usability in the follow-up and treatment process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aimed to investigate the relationship between the systemic immune inflammation index (SII), platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and disease activity and functional status in patients with ankylosing spondylitis (AS). A cross-sectional clinical study was conducted, and a total of 90 patients diagnosed with AS according to the Modified New York Criteria, aged between 18 and 65, who presented to our outpatient clinics were included in the study. Demographic data, disease duration, age at symptom onset, and laboratory parameters, including platelet, neutrophil, basophil, eosinophil, lymphocyte counts, mean platelet volume (MPV), red blood cell distribution width (RDW), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR), were recorded. NLR and PLR values were calculated. The Systemic Immune Inflammation Index (SII) was calculated by dividing the product of neutrophil and platelet counts by the lymphocyte count. We investigated all of these parameters and disease activity scores. Disease activity was assessed with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), spinal mobility with the Bath Ankylosing Spondylitis Metrology Index (BASMI), and functional status with the Bath Ankylosing Spondylitis Functional Index (BASFI). In addition, during the routine follow-ups of patients, requested blood tests were examined, and platelet, neutrophil, basophil, eosinophil, lymphocyte counts, mean platelet volume (MPV), RDW (red blood distribution width), CRP, and ESR values will be recorded. Neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), and systemic immune inflammation index (SII) were calculated

Study Type

Observational

Enrollment (Actual)

90

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

  • Turkey
    • Bahcelievler
      • Istanbul, Bahcelievler, Turkey, 34147
        • Istanbul Physical Therapy and Rehabilitation Research and Training Hospital

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

No

Sampling Method

Probability Sample

Study Population

Patients between the ages of 18 and 65 who have been diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria

Description

Inclusion Criteria:

  • Patients between the ages of 18 and 65 who have been diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria, have applied to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital outpatient clinic on the specified dates, meet the exclusion criteria, and have complete blood count, CRP, and ESR values in their hospital records.

Exclusion Criteria:

  • Presence of acute or chronic infection

    • Presence of autoimmune diseases other than Ankylosing Spondylitis
    • Pregnancy
    • Diabetes
    • Chronic kidney disease
    • Chronic liver disease
    • Malignancy
    • Cardiovascular disease
    • Hematological disease

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Systemic Immune Inflammation Index (SII)
Time Frame: through study completion, an average of 1 month
The Systemic Immune Inflammation Index (SII) was calculated by dividing the product of neutrophil and platelet counts by the lymphocyte count.
through study completion, an average of 1 month
Neutrophil-to-lymphocyte ratio (NLR)
Time Frame: through study completion, an average of 1 month
NLR is a ratio between the absolute neutrophil count and absolute lymphocyte count.
through study completion, an average of 1 month
Platelet to-lymphocyte ratio (PLR)
Time Frame: through study completion, an average of 1 month
PLR is a ratio between the absolute platelet count and absolute lymphocyte count.
through study completion, an average of 1 month
Mean platelet volume (MPV)
Time Frame: through study completion, an average of 1 month
MPV blood test measures the average size of patient's platelets
through study completion, an average of 1 month
Red blood cell distribution width (RDW)
Time Frame: through study completion, an average of 1 month
A red cell distribution width (RDW) test measures the differences in the volume and size of the red blood cells (erythrocytes).
through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein
Time Frame: through study completion, an average of 1 month
C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there's inflammation in the body.
through study completion, an average of 1 month
Erythrocyte sedimentation rate
Time Frame: through study completion, an average of 1 month
The erythrocyte sedimentation rate (sedimentation rate, sed rate, or ESR for short) is a commonly performed hematology test that may indicate and monitor an increase in inflammatory activity within the body caused by one or more conditions such as autoimmune disease, infections, or tumors
through study completion, an average of 1 month
The Bath Ankylosing Spondylitis Disease Activity Index
Time Frame: through study completion, an average of 1 month
The index indicates that disease activity of AS patients. Higher scores indicate that higher activity
through study completion, an average of 1 month
The Bath Ankylosing Spondylitis Functional Index
Time Frame: through study completion, an average of 1 month
The index helps to evaluate disease activity of AS patients. High scores indicate that worse functional status.
through study completion, an average of 1 month
The Bath Ankylosing Spondylitis Metrology Index
Time Frame: through study completion, an average of 1 month
The index helps to evaluate spinal mobility of AS patients. Higher scores indicate more limited mobility.
through study completion, an average of 1 month
Ankylosing Spondylitis Disease Activity Score with erythrocyte sedimentation rate
Time Frame: through study completion, an average of 1 month
it helps to evaluate disease activity of AS patients by used to esr
through study completion, an average of 1 month
Ankylosing Spondylitis Disease Activity Score with c-reactive protein
Time Frame: through study completion, an average of 1 month
it helps to evaluate disease activity of AS patients by used to crp
through study completion, an average of 1 month

Collaborators and Investigators

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

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Study Chair: Nur Kesiktas, MD, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 2, 2023

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPRMTRH4

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 Ankylosing Spondylitis

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe