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Audio Vestibular Assessment in Patients with Fibromyalgia

Audio Vestibular Assessment in Patients with Fibromyalgia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06579560
Enrollment
4
Registered
2024-08-30
Start date
2023-04-16
Completion date
2025-04-16
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Audiovestibular assessment, Fibromyalgia

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).

Interventions

DIAGNOSTIC_TESTAudiovestibular assessment in Patients with Fibromyalgia

Audiovestibular assessment in Patients with Fibromyalgia

Sponsors

Noha Osman
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Hearing Sensitivity2 yearsMeasurement of hearing sensitivity using pure tone audiometry. The outcome will be expressed as hearing thresholds in decibels (dB) at various frequencies (e.g., 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz). \[Unit of Measure: Decibels (dB)\]

Countries

Egypt

Contacts

Primary ContactMohamed A. Ali, MA
moahmed300070@gmail.com+201151791724

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026