Fibromyalgia and Small Fiber Neuropathy
ConditionChronic Pain Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Ambroise Paré Paris
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Skin punch biopsy to demonstrate small fiber neuropathy
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov