Fibromyalgia and Small Fiber Neuropathy : Which Prevalence and Which Relationship With Pain ?

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The primary objective of this study will be to assess the proportion of fibromyalgia patients with diffuse small-fiber neuropathy (i.e. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• patients over 18 years of age with no age limit -

• having given their signed consent to take part in the study

• affiliated to the French social security system

• able to be followed for the entire duration of the study

• reading and understanding French

• accepting the principle of the study and able to comply with its conditions

• suffering from chronic pain for at least six months of at least moderate intensity (≥ 4/10)

• fibromyalgia detected by the FiRST questionnare and defined by the revised diagnostic criteria of the WHO or chronic nociceptive or nociplastic pain without associated fibromyalgia.

• chronic pain for at least 6 months of at least moderate intensity (≥ 4/10)

• untreated or with stable analgesic treatment for at least 2 weeks prior to inclusion- normal neurological examination at inclusion

Locations
Other Locations
France
Inserm U987
RECRUITING
Boulogne-billancourt
Centre d'Evaluation et de Traitement de la douleur
RECRUITING
Paris
Contact Information
Primary
Nadine ATTAL, MD PhD
nadine.attal@aphp.fr
0033149095931
Backup
Didier BOUHASSIRA, MD PhD
didier.bouhassira@inserm.fr
0033149094556
Time Frame
Start Date: 2022-01-04
Estimated Completion Date: 2026-05
Participants
Target number of participants: 150
Treatments
Patients with fibromyalgia
Patients with fibromyalgia based on ACR criteria
Patients with other chronic pain (paired for the other groups)
Patients with chronic pain other than fibromyalgia and neuropathic pain, eg nociplastic pains or nociceptive pains
Paired healthy subjects
Healthy subjects paired for gender and age
Related Therapeutic Areas
Sponsors
Leads: Hospital Ambroise Paré Paris

This content was sourced from clinicaltrials.gov