Brucella Serology and History of Brucellosis in Patients With Modic Changes Type 1

June 1, 2021 updated by: Veysel Delen

Mehmet Akif İnan Education and Research Hospital

Objective: This study aims to examine Brucella serology and history of brucellosis in patients with lumbar Modic changes (MCs) type 1, considering results from cross-sectional and case-control comparisons.

Design: In comparative cross-sectional design, MCs type 1 patients (study group) and MCs type 2 patients (comparator group) were examined in terms of Brucella serology by using agglutination with Coombs test. In addition, in comparative case-control design, both of the MCs groups and age/sex-matched healthy controls were investigated for their medical history regarding brucellosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

118

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
      • Şanlıurfa, Turkey
        • Mehmet Akif İnan 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with MCs and age/sex-matched healthy controls

Description

Inclusion Criteria:

  • Patients with lumbar Modic changes type 1
  • Patients with lumbar Modic changes type 2
  • Participant who given informed consent for the study

Exclusion Criteria:

  • Patients aged<18 years
  • History of serious lumbar trauma
  • Lumbar spinal surgery
  • Scoliosis
  • Cooperation disorder

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MCs type 1 patients (study group; n=37)
Other: Brucella serology test
MCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test.
Other: Medical history for brucellosis
Both of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis.
MCs type 2 patients (comparator group; n=44)
Other: Brucella serology test
MCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test.
Other: Medical history for brucellosis
Both of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis.
healthy controls (n=37)
Other: Medical history for brucellosis
Both of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serology for brucellosis
Time Frame: 30 minutes
30 minutes
History of brucellosis
Time Frame: 7 minutes
7 minutes

Collaborators and Investigators

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

Sponsor

Veysel Delen

Investigators

  • Principal Investigator: Veysel Delen, Mehmet Akif İnan Hospital

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)

May 1, 2019

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUEADH

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.

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