Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579560
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Audio Vestibular Assessment in Patients with Fibromyalgia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Audio Vestibular Assessment in Patients with Fibromyalgia
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2021The 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 2011FM 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 Its 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None