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

Brucellosis Clinical Trial

Official title:

Mehmet Akif İnan Education and Research Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911283
• Other study ID #: SUEADH
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: June 2021
• Source: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brucellosis
• Spinal Degeneration

Intervention

Other:
• Brucella serology test
MCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test.
• Medical history for brucellosis
Both of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis.

Locations

Country	Name	City	State
Turkey	Mehmet Akif Inan Hospital	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Veysel Delen

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serology for brucellosis		30 minutes
Primary	History of brucellosis		7 minutes