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Fibromyalgia and Small Fiber Neuropathy

RecruitingNCT06527183
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Fibromyalgia and Small Fiber Neuropathy : Which Prevalence and Which Relationship With Pain ?
Interventions
  • Diagnostic test: Skin punch biopsy to demonstrate small fiber neuropathy
Sponsor
Hospital Ambroise Paré Paris
Start date
2022-01-04
Primary completion
2025-12
Sex
All
Age range
from 18 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
France
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * litigation or compensation-seeking * cancer for less than 2 years * known cause of small-fiber neuropathy such as diabetes, systemic disease, hypothyroidism, alcohol, renal failure, genetic disease * clinical or EMG neuropathy * peripheral or central nervous system pathology with or without associated neuropathic pain * uncontrolled chronic pathology such as : morbid obesity, sleep apnea, uncontrolled hypertension, etc. - psychosis, previous suicide attempt * drug or psychoactive substance abuse * cognitive or psychological disorders incompatible with compliance with and/or understanding of the protocol * participation in another biomedical research protocol.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06527183