Actively Recruiting
Fibromyalgia and Small Fiber Neuropathy
Led by Hospital Ambroise Paré Paris · Updated on 2025-09-10
150
Participants Needed
2
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Fibromyalgia and Small Fiber Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age with no upper age limit
- Signed consent to participate in the study
- Affiliated with the French social security system
- Able to be followed throughout the entire study duration
- Able to read and understand French
- Accept the study's principle and able to follow its conditions
- Have chronic pain lasting at least six months with moderate intensity (≥ 4/10)
- Diagnosed with fibromyalgia by the FiRST questionnaire and WHO revised criteria or have chronic nociceptive or nociplastic pain without fibromyalgia
- Untreated or on stable pain medication for at least 2 weeks before inclusion
- Have a normal neurological exam at inclusion
You will not qualify if you...
- Currently involved in litigation or seeking compensation
- Cancer diagnosis within the last 2 years
- Known causes of small-fiber neuropathy such as diabetes, systemic disease, hypothyroidism, alcohol use, kidney failure, or genetic disease
- Clinical or EMG neuropathy
- Peripheral or central nervous system diseases with or without neuropathic pain
- Uncontrolled chronic conditions such as morbid obesity, sleep apnea, uncontrolled hypertension
- Psychosis or previous suicide attempt
- Drug or psychoactive substance abuse
- Cognitive or psychological disorders preventing protocol compliance or understanding
- Participation in another biomedical research protocol
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Inserm U987
Boulogne-Billancourt, France, 92100
Actively Recruiting
2
Centre d'Evaluation et de Traitement de la douleur
Paris, France, 75014
Actively Recruiting
Research Team
N
Nadine ATTAL, MD PhD
CONTACT
D
Didier BOUHASSIRA, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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