Actively Recruiting
Fibromyalgia and Small Fiber Neuropathy: Which Prevalence and Relationship With Pain?
Led by Hospital Ambroise Paré Paris · Updated on 2025-09-10
150
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the presence of small fiber neuropathy in patients with fibromyalgia compared to those with other types of chronic pain and healthy individuals. The study aims to better understand the role of small nerve fiber abnormalities in fibromyalgia symptoms and pain. This observational study will use structural and functional tests to explore the characteristics and impact of small fiber neuropathy in these groups. Participants will undergo skin punch biopsies to measure nerve fiber density and several functional tests including quantitative sensory testing, laser evoked potentials, Sudoscan, and confocal corneal microscopy. The study includes three groups: fibromyalgia patients, patients with other chronic pain types, and healthy controls matched by age and gender. These assessments will be done at the start and after six months to monitor changes. During the study, participants will be evaluated through clinical examinations, skin biopsies, and multiple sensory and nerve function tests. Researchers will measure the prevalence of small fiber neuropathy, correlate nerve fiber density with pain and quality of life, and assess the diagnostic value of various tests. The study will last at least six months and includes ongoing monitoring of symptoms and nerve function over time.
CONDITIONS
Brief Title
Fibromyalgia and Small Fiber Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Provided signed consent to participate
- Affiliated with the French social security system
- Able to be followed for the entire study duration
- Able to read and understand French
- Agree to the study principles and able to comply
- Chronic pain lasting at least 6 months with moderate intensity (≥ 4/10)
- Fibromyalgia diagnosed by FiRST questionnaire and WHO criteria, or chronic nociceptive or nociplastic pain without fibromyalgia
- Untreated or stable analgesic treatment for at least 2 weeks prior to inclusion
- Normal neurological examination at inclusion
You will not qualify if you...
- 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 disease with or without neuropathic pain
- Uncontrolled chronic conditions like 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 study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and 6 months
Participants undergo diagnostic tests including skin punch biopsy, quantitative sensory testing, laser evoked potential recordings, Sudoscan, and confocal corneal microscopy to assess small fiber neuropathy and related abnormalities.
2 visits (in-person)
Duration - 6 months
Participants are observed over 6 months to monitor the evolution of abnormalities and symptoms related to small fiber neuropathy and fibromyalgia.
Visits coincide with diagnostic evaluation visits
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
D
Didier BOUHASSIRA, MD PhD
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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