Seroprevalence of Brucella Antibodies in High-Risk Patients With Low Back Pain: A Case-Control Study

NCT07112677 | Completed

• 1 other identifier: AUN-BRU-LBP-2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational case-control study is to assess the presence of Brucella antibodies in patients with low back pain who are at high risk for brucellosis exposure, such as those with animal contact or consumption of unpasteurized dairy products. The main question it aims to answer is: Is there a significant association between Brucella seropositivity and low back pain in high-risk individuals? Researchers will compare patients with low back pain to age- and sex-matched healthy controls without back pain but with similar exposure risks, to see if Brucella antibodies are more frequent in the patient group. Participants will: Undergo a detailed clinical history and physical examination Provide blood samples for serological testing using ELISA for Brucella IgG/IgM/IgA Be evaluated for other symptoms such as fever, fatigue, and joint pain

Conditions

Brucellosis; Low Back Pain

Keywords

brucella antibodies; low back pain

Outcome Measures

Primary Outcomes (2)

• Prevalence of Brucella Antibodies in High-Risk Patients with Low Back Pain

  The presence of Brucella antibodies (IgG, IgM, and IgA) in serum was assessed using the SERION ELISA classic Brucella kit. A positive result indicates prior or current exposure to Brucella species. The outcome compares the proportion of seropositive individuals between patients with low back pain and matched controls.

  February 2024 to February 2025

• Prevalence of Brucella Antibodies in High-Risk Patients with Low Back Pain

  The presence of Brucella antibodies (IgG, IgM, and IgA) in serum was assessed using the SERION ELISA classic Brucella kit. A positive result indicates prior or current exposure to Brucella species. The outcome compares the proportion of seropositive individuals between patients with low back pain and matched controls.

  At enrollment

Study Arms (1)

Group 1 (Patients): Low Back Pain Group, Group 2 (Controls): Control Group

Diagnostic Test: Brucella Antibody Testing (ELISA)

Interventions

Brucella Antibody Testing (ELISA) DIAGNOSTIC_TEST

Serological testing for Brucella antibodies using the SERION ELISA classic Brucella IgG/IgM/IgA kit (Institut Virion\\Serion GmbH, Würzburg, Germany). The test detects Brucella-specific IgG, IgM, and IgA antibodies in serum samples to assess current or past exposure. All samples were processed and interpreted according to the manufacturer's instructions. This diagnostic intervention was used for both the low back pain group and the control group.

Group 1 (Patients): Low Back Pain Group, Group 2 (Controls): Control Group

Eligibility Criteria

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

Study Population

Adults with high risk of Brucella exposure (e.g., animal contact or consumption of unpasteurized dairy products), including patients presenting with non-specific low back pain and healthy controls without back pain. Participants were recruited from outpatient clinics and inpatient wards at Assiut University Hospital.

You may qualify if:

• Adults of any sex at high risk of Brucella exposure (e.g., contact with livestock or consumption of unpasteurized dairy products)
• Patients presenting with non-specific low back pain
• Willing and able to provide informed consen

You may not qualify if:

• Evidence of tuberculosis (Pott's disease)
• Evidence of septic spondylitis
• Known metastatic bone lesions
• Known degenerative or autoimmune rheumatologic spinal diseases
• History of prior spinal surgery or trauma

Sponsors & Collaborators

• Elham Ahmed Hassan: lead

Study Sites (2)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Brucellosis; Low Back Pain

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Tropical Medicine and Gastroenterology, Assiut University

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: February 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)