Status:
RECRUITING
Fibromyalgia and Small Fiber Neuropathy
Lead Sponsor:
Hospital Ambroise Paré Paris
Conditions:
Chronic Pain Syndrome
Eligibility:
All Genders
18+ years
Brief 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 pat...
Detailed Description
Small fiber neuropathy has been observed in a large proportion of fibromyalgia patients. However, the pathophysiological role of these neurological abnormalities in determining the pain and other symp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06527183
Start Date
January 4 2022
End Date
May 1 2026
Last Update
September 10 2025
Active Locations (2)
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1
Inserm U987
Boulogne-Billancourt, France, 92100
2
Centre d'Evaluation et de Traitement de la douleur
Paris, France, 75014