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Fibromyalgia and Small Fiber Neuropathy

NCT06527183 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • Chronic Pain Syndrome

Interventions

DIAGNOSTIC_TEST

Skin punch biopsy to demonstrate small fiber neuropathy

Skin punch biopsy to assess intrapidermal nerve fiber density

Sponsors & Collaborators

  • Hospital Ambroise Paré Paris

    lead OTHER

Principal Investigators

  • Nadine ATTAL, MD PhD · APHP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2025-12-31
Completion
2026-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06527183 on ClinicalTrials.gov