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Audio Vestibular Assessment in Patients with Fibromyalgia

NCT ID: NCT06579560

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-16

Study Completion Date

2025-04-16

Brief Summary

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Fibromyalgia (FM) is a common rheumatic illness distinguished by chronic pain, fatigue, cognitive problems, and functional disability. However, the differences between men and women have not yet been comprehensively studied, especially after the development of the last 2016 American College of Rheumatology (ACR) criteria. The disease is more common and more severe in female patients according to a study on gender differences among Egyptian patients (A. Moshrif et al., 2023)

Detailed Description

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Fibromyalgia (FM) is a common rheumatic illness distinguished by chronic pain, fatigue, cognitive problems, and functional disability. However, the differences between men and women have not yet been comprehensively studied, especially after the development of the last 2016 American College of Rheumatology (ACR) criteria. The disease is more common and more severe in female patients according to a study on gender differences among Egyptian patients (A. Moshrif et al., 2023) (FM) is a non-inflammatory chronic disease, characterized by widespread musculoskeletal pain (Tuncer et al., 2021). The etiology is still unknown and (FM) is often misdiagnosed (Tuncer et al., 2021).The estimated prevalence in the general population is between 2 and 11% (Hulens et al., 2023). Although the underling Pathological mechanisms controlling the (FM) have not been determined, neuroendocrine, genetic or molecular factors can be involved (Zeigelboim \& Moreira, 2011).(FM) affects females between the ages of 25 to 65 years old, although it can be seen in all ages and in both sexes (Fitzcharles \& Yunus, 2012), It's more common in females than in males (Müller et al., 2007).

The main symptoms of (FM) include, muscle pain, muscle spasms, insomnia, fatigue, tension, abdominal pain, facial tenderness, sensitivity to noise and bright lights, and central nervous system abnormalities. Various neurological symptoms such as tinnitus, ear fullness, vertigo, and dizziness may also be associated, regardless of the disease severity (Koca et al., 2018) Many patients with FM were reported to have dizziness which may attributed to hypotension and autonomic nervous system (ANS) dysfunction, in this study we want to explore if dizziness and imbalance occur due to these factors only or due to a direct effect of (FM) on the vestibular system (Kanjwal et al., 2010) (Mohamed et al., 2021).

Conditions

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Fibromyalgia

Keywords

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Audiovestibular assessment, Fibromyalgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Audiovestibular assessment in Patients with Fibromyalgia

Audiovestibular assessment in Patients with Fibromyalgia

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Sex: Male \& Female.
* Patients with fulfilling the criteria for the diagnosis of FM

Exclusion Criteria

* Other causes of SNHL as Meniere's disease.
* Other causes of Conductive hearing loss (CHL) as chronic suppurative otitis media CSOM.
* Other causes of collagen and connective tissue diseases.
* Abnormal EMG.
* Abnormal radiological studies of the brain.
* Patients are receiving of ototoxic drugs.
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Noha Osman

OTHER

Sponsor Role lead

Responsible Party

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Noha Osman

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Enass S. Mohamed, Professor

Role: STUDY_CHAIR

Assiut University

Abdelhafeez M. Moshrif, Professor

Role: STUDY_CHAIR

Assiut University

Mohamed A. Elmoursy, Professor

Role: STUDY_CHAIR

Assiut University

Locations

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Faculty of Medicine - Assiut University

Asyut, Asyut Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed A. Ali, MA

Role: CONTACT

Phone: +201151791724

Email: [email protected]

Facility Contacts

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Mohamed A. Ali, MA

Role: primary

Other Identifiers

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04-2023-200637

Identifier Type: -

Identifier Source: org_study_id