Clinical Trial

Fibromyalgia and Small Fiber Neuropathy

Study acronym: FIBRO-NEP
Recruiting
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Record status
This record was last updated September 10, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-24.
Trial Details
NCT Number NCT06527183
Lead Sponsor Hospital Ambroise Paré Paris
Conditions Chronic Pain Syndrome
Enrollment 150 participants
Start Date 2022-01-04
Primary Completion 2025-12 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-09-10