NCT06440096

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

May 28, 2024

Last Update Submit

May 28, 2024

Conditions

Modic Changes

Outcome Measures

Primary Outcomes (1)

  • Hemogram-derived inflammation indexes

    blood-based

    10 minutes

Study Arms (2)

Modic changes type I

24 patients with type I Modic changes

Diagnostic Test: hemogram

Modic changes type II

24 patients with type II Modic changes

Diagnostic Test: hemogram

Interventions

hemogramDIAGNOSTIC_TEST

hemogram

Modic changes type IModic changes type II

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male or female patients with type I or type II Modic changes, aged ≥18 and ≤64 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Şanlıurfa

Sanliurfa, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Harran University Hospital

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 3, 2024

Study Start

March 30, 2023

Primary Completion

January 5, 2024

Study Completion

January 5, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations

TU(1)