Menu
Recruiting NCT06579560

Audio Vestibular Assessment in Patients with Fibromyalgia

Observational Fibromyalgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Audiovestibular assessment in Patients with Fibromyalgia.
Who it may be relevant to
Registry conditions: Fibromyalgia. Basic parameters: 15 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 test Audiovestibular assessment in Patients with Fibromyalgia
    Audiovestibular assessment in Patients with Fibromyalgia

Primary outcome measures

  • Hearing Sensitivity [Time frame: 2 years]

Eligibility criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Faculty of Medicine - Assiut University — Asyut

Identifiers

NCT: NCT06579560 · 04-2023-200637

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗