Ignite Creation Date:
2024-05-06 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03347669
Status:
UNKNOWN
Last Update Posted:
2017-12-05
First Post:
2017-11-08
Brief Title:
A Pilot Study of Small Fiber Neuropathy Prevalence in Fibromyalgia Patients Compared to Healthy Subjects Using Sudoscan
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
A Pilot Study of Small Fiber Neuropathy Prevalence in Fibromyalgia Patients Compared to Healthy Subjects Using Sudoscan
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEFI
Brief Summary:
Fibromyalgia FM is characterized by chronic diffuse pain and affects 05 to 5 of the population with a higher prevalence in women1 This condition is characterized by joint and muscle pain also associated with fatigue migraine sleeps disorders depression and irritable bowel syndrome2 The presentation of these various symptoms varies greatly from one patient to another with great heterogeneity in clinical physical social psychological and therapeutic responses A recent parliamentary inquiry report called for recognition of the disease and recommended to build a unified care path for patients a collective expertise is led by INSERM to help in patient care Faced with the heterogeneity of FM several international studies have attempted to identify subgroups of patients based essentially on clinical symptoms of the disease3-8 including a recent Korean study of 313 patients9 which suggested four groups but with methodological limitations not taking into account the new criteria10 for evaluating FM
Recent studies have also shown that there is a peripheral neuropathic component in the mechanisms of this pathology demonstrated by a decrease in the density of the epidermal nerve fibers11-12 called small fiber neuropathy SFN neuropathy It is an attack of small sensory and sympathetic nerve fibers causing pain paresthesia as well as disturbances of the autonomous system Other studies also suggested that a significant proportion of patients diagnosed with fibromyalgia had SFN demonstrated by cutaneous biopsy13-14 or confocal microscopy of the cornea15 A new device the Sudoscan makes it possible to detect a SFN much simpler faster and less invasive than the technique of ophthalmology or biopsy Although this Sudoscan test has been used extensively in conditions such as diabetes16-19 no study has been used to assess the presence of SFN in FM
The aim of this pilot study is to identify the prevalence of SFN in FM patients using this new non-invasive device in order to have a better defined representation of the prevalence of small-fiber neuropathy in an FM population compared to a group of healthy volunteer matched in age sex BMI and by menopausal status for women
Recent studies have also shown that there is a peripheral neuropathic component in the mechanisms of this pathology demonstrated by a decrease in the density of the epidermal nerve fibers11-12 called small fiber neuropathy SFN neuropathy It is an attack of small sensory and sympathetic nerve fibers causing pain paresthesia as well as disturbances of the autonomous system Other studies also suggested that a significant proportion of patients diagnosed with fibromyalgia had SFN demonstrated by cutaneous biopsy13-14 or confocal microscopy of the cornea15 A new device the Sudoscan makes it possible to detect a SFN much simpler faster and less invasive than the technique of ophthalmology or biopsy Although this Sudoscan test has been used extensively in conditions such as diabetes16-19 no study has been used to assess the presence of SFN in FM
The aim of this pilot study is to identify the prevalence of SFN in FM patients using this new non-invasive device in order to have a better defined representation of the prevalence of small-fiber neuropathy in an FM population compared to a group of healthy volunteer matched in age sex BMI and by menopausal status for women
Detailed Description:
Only one visit 2 to 3h
Inclusion of the patient Clinical examination evaluation of pain for FM patients Measurement of the electrochemical conductance of the hands and feet using Sudoscan Evaluation of quality of life anxiety depression sleep quality fatigue catastrophizing and social precarity End of study
Inclusion of the patient Clinical examination evaluation of pain for FM patients Measurement of the electrochemical conductance of the hands and feet using Sudoscan Evaluation of quality of life anxiety depression sleep quality fatigue catastrophizing and social precarity End of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None