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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06440096
Other study ID # YÖMAVD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 30, 2023
Est. completion date January 5, 2024

Study information

Verified date May 2024
Source Sanliurfa Mehmet Akif Inan Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Some indicators generated from hemogram such as neutrophil/lymphocyte (NLR) have been suggested as biomarkers of systemic inflammation. Type I Modic changes (MCs) have inflammatory nature histologically and are more painful clinically than type II MCs. Therefore, we hypothesized that patients with type I MCs may have increased inflammatory biomarkers and low back pain than those with type II MCs. The aim of this study was to test this hypothesis.


Description:

Patients and Methods: A total of 48 patients with MCs (type I/type II=24/24) were included in this study. Their demographic, clinical and hematologic characteristics were recorded. A 10 cm Visual Analog Scale (VAS) was used to detect low back pain intensity. Systemic inflammatory biomarkers including NLR, monocyte/lymphocyte (MLR), platelet/lymphocyte (PLR), neutrophil/lymphocyte*platelet (NLPR), systemic inflammatory index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI) were derived from whole blood cell count. Keywords: Neutrophil-to-lymphocyte ratio, inflammation, Modic changes, back pain.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date January 5, 2024
Est. primary completion date January 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Inclusion criteria were male or female with type I or type II MCs, aged =18 and =64 years old, and accepted informed consent to participation. Exclusion Criteria: - type III MCs and a combination of MCs' types were excluded. In addition, acute low back pain, spinal deformities, inflammatory diseases, cancers, heart diseases, stroke, lactation, pregnancy, psychiatric disorders, and extreme obesity (BMI=40 kg/m²) were also excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
hemogram
hemogram

Locations

Country Name City State
Turkey Harran University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Sanliurfa Sanliurfa

Sponsors (1)

Lead Sponsor Collaborator
Veysel Delen, MD

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemogram-derived inflammation indexes blood-based 10 minutes
See also
  Status Clinical Trial Phase
Terminated NCT03829644 - Lumbar Bracing for People With Type I Modic Changes N/A