Fibromyalgia and Small Fiber Neuropathy
Key facts
- Who runs it
- Hospital Ambroise Paré Paris
- Where
- Boulogne-Billancourt and Paris, FranceSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 4 Jan 2022
- Planned end
- May 2026
- Type of study
- Observational, 3 groups
- Treatments tested
- Skin punch biopsy to demonstrate small fiber neuropathy
- Record updated
- 10 September 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- uncontrolled chronic pathology such as : morbid obesity, sleep apnea, uncontrolled hypertension, etc. - psychosis, previous suicide attempt
- drug or psychoactive substance abuse
- cancer for less than 2 years
- known cause of small-fiber neuropathy such as diabetes, systemic disease, hypothyroidism, alcohol, renal failure, genetic disease
- cognitive or psychological disorders incompatible with compliance with and/or understanding of the protocol
- litigation or compensation-seeking
- clinical or EMG neuropathy
- peripheral or central nervous system pathology with or without associated neuropathic pain
- participation in another biomedical research protocol
Where in France
- Inserm U987Boulogne-Billancourt, FranceContact: Nadine ATTALTaking people
- Centre d'Evaluation et de Traitement de la douleurParis, FranceContact: Serge PERROTTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Patients with fibromyalgia
Patients with fibromyalgia based on ACR criteria
Treatment: Skin punch biopsy to demonstrate small fiber neuropathy
- Patients with other chronic pain (paired for the other groups)
Patients with chronic pain other than fibromyalgia and neuropathic pain, eg nociplastic pains or nociceptive pains
Treatment: Skin punch biopsy to demonstrate small fiber neuropathy
- Paired healthy subjects
Healthy subjects paired for gender and age
Treatment: Skin punch biopsy to demonstrate small fiber neuropathy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Fibromyalgia and Small Fiber Neuropathy : Which Prevalence and Which Relationship With Pain ?
- Record updated
- 10 September 2025