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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Patients): Low Back Pain Group, Group 2 (Controls): Control Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University Hospital | Asyut | 71515 | Egypt | |||
| Assiut University |
I do not have specific consent from participants to share individual-level data.
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| ID | Term |
|---|---|
| D002006 | Brucellosis |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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|
| Asyut |
| 71515 |
| Egypt |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |