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NCT Number: NCT06579560

Audio Vestibular Assessment in Patients with Fibromyalgia

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)

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Key information

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine - Assiut University

Asyut, Asyut Governorate, 71111, Egypt

Location status: Recruiting

Location contact

Mohamed A. Ali, MA

CONTACT

[email protected]

01151791724

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria: - Age: 15-50 years.
  • Sex: Male & Female.
  • Patients with fulfilling the criteria for the diagnosis of FM
  • 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.

Treatment and study plan

Audiovestibular assessment in Patients with Fibromyalgia

Diagnostic Test

Audiovestibular assessment in Patients with Fibromyalgia

Primary outcomes

  1. Hearing Sensitivity

    Time frame: 2 years

    Measurement 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)]

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed A. Ali, MA

CONTACT

[email protected]

+201151791724

Sponsors and collaborators

Lead sponsor

Noha Osman

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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