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

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06094673
Collaborator
(none)
90
1
1
88.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Relationship Between Systemic Immune Inflammation Index and Disease Activity in Patients With Ankylosing Spondylitis
Actual Study Start Date :
Jun 1, 2023
Actual Primary Completion Date :
Jul 1, 2023
Actual Study Completion Date :
Jul 2, 2023

Outcome Measures

Primary Outcome Measures

  1. The Systemic Immune Inflammation Index (SII) [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) [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) [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) [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) [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 Outcome Measures

  1. C-reactive protein [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 [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 [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 [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 [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 [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 [through study completion, an average of 1 month]

    it helps to evaluate disease activity of AS patients by used to crp

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Physical Therapy and Rehabilitation Research and Training Hospital Istanbul Bahcelievler Turkey 34147

Sponsors and Collaborators

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT06094673
Other Study ID Numbers:
  • IstPRMTRH4
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023