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Completed

NCT Number: NCT06094673

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

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Inflammation Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Therapy and Rehabilitation Research and Training Hospital

Istanbul, Bahcelievler, 34147, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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).

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Feb 20, 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.

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