Clinical trial NCT06579560: Audio Vestibular Assessment in Patients with Fibromyalgia
Official title: Audio Vestibular Assessment in Patients with Fibromyalgia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Keywords: Audiovestibular assessment, Fibromyalgia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 4
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Fibromyalgia recruited from the Rheumatology and Rehabilitation Department at Al-Azhar University Hospital

Brief summary: 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: 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).

Eligibility criteria: 1. Inclusion criteria: - Age: 15-50 years.

   * Sex: Male \& Female.
   * Patients with fulfilling the criteria for the diagnosis of FM
2. Exclusion criteria: Patients not fulfilling the criteria for the diagnosis of FM.

   * 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.

Primary outcomes:
measure: Hearing Sensitivity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine - Assiut University
state: Asyut
Study officials:
affiliation: Assiut University
name: Enass S. Mohamed, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Abdelhafeez M. Moshrif, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Mohamed A. Elmoursy, Professor
role: STUDY_CHAIR
References: