Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527183
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Fibromyalgia and Small Fiber Neuropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fibromyalgia and Small Fiber Neuropathy Which Prevalence and Which Relationship With Pain
Status:
RECRUITING
Status Verified Date:
2024-07
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:
FIBRO-NEP
Brief Summary:
The primary objective of this study will be to assess the proportion of fibromyalgia patients with diffuse small-fiber neuropathy ie in the upper and lower limbs and compare this proportion to patients with other chronic pains nociplastic nociceptive and with healthy controls Our analysis will be based on the demonstration of structural abnormalities of small nerve fibers by means of skin biopsy but also of functional abnormalities using four validated tests commonly used in this field quantitative sensory testing QST laser evoked potential recordings Sudoscan and confocal corneal microscopy It will thus be possible to verify whether or not patients with small fiber neuropathy have a particular clinical profile in terms of pain physical activity comorbidities or pain impact
Detailed Description:
Small fiber neuropathy has been observed in a large proportion of fibromyalgia patients However the pathophysiological role of these neurological abnormalities in determining the pain and other symptoms of fibromyalgia and the specificity of these abnormalities are not well understood
The primary objective of this study will be to assess the proportion of fibromyalgia patients with diffuse small-fiber neuropathy ie in the upper and lower limbs and compare this proportion to patients with other chronic pains nociplastic nociceptive and with healthy controls Our analysis will be based on the demonstration of structural abnormalities of small nerve fibers by means of skin biopsy but also of functional abnormalities using four validated tests commonly used in this field quantitative sensory testing QST laser evoked potential recordings Sudoscan and confocal corneal microscopy It will thus be possible to verify whether or not patients with small fiber neuropathy have a particular clinical profile in terms of pain physical activity comorbidities or pain impact
The primary objective of this study will be to assess the proportion of fibromyalgia patients with diffuse small-fiber neuropathy ie in the upper and lower limbs and compare this proportion to patients with other chronic pains nociplastic nociceptive and with healthy controls Our analysis will be based on the demonstration of structural abnormalities of small nerve fibers by means of skin biopsy but also of functional abnormalities using four validated tests commonly used in this field quantitative sensory testing QST laser evoked potential recordings Sudoscan and confocal corneal microscopy It will thus be possible to verify whether or not patients with small fiber neuropathy have a particular clinical profile in terms of pain physical activity comorbidities or pain impact
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