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

NCT04911283 | Completed

• 1 other identifier: SUEADH
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brucellosis; Spinal Degeneration

Outcome Measures

Primary Outcomes (2)

• Serology for brucellosis

  30 minutes

• History of brucellosis

  7 minutes

Study Arms (3)

MCs type 1 patients (study group; n=37)

Other: Brucella serology test; Other: Medical history for brucellosis

MCs type 2 patients (comparator group; n=44)

Other: Brucella serology test; Other: Medical history for brucellosis

healthy controls (n=37)

Other: Medical history for brucellosis

Interventions

Brucella serology test OTHER

MCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test.

MCs type 1 patients (study group; n=37); MCs type 2 patients (comparator group; n=44)

Medical history for brucellosis OTHER

Both of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis.

MCs type 1 patients (study group; n=37); MCs type 2 patients (comparator group; n=44); healthy controls (n=37)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with MCs and age/sex-matched healthy controls

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Veysel Delen: lead

Study Sites (1)

Mehmet Akif İnan Hospital

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brucellosis

Interventions

Health Records, Personal; Pyrin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Tripartite Motif Proteins

Study Officials

• Veysel Delen

  Mehmet Akif İnan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 3, 2021
• Study Start: May 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)