Assessing small fiber neuropathy in fibromyalgia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the prevalence of diffuse small-fiber neuropathy in patients with fibromyalgia and compare it to individuals with other types of chronic pain and healthy controls. It will utilize skin biopsies to identify structural abnormalities in small nerve fibers, alongside functional assessments using validated tests such as quantitative sensory testing and laser evoked potential recordings. The goal is to determine if patients with small fiber neuropathy exhibit distinct clinical profiles regarding pain, physical activity, and comorbidities. This observational study will provide insights into the relationship between small fiber neuropathy and fibromyalgia symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Inserm U987
  Boulogne-Billancourt, France Recruiting
• Centre d'Evaluation et de Traitement de la douleur
  Paris, France Recruiting

Study contacts

• Principal investigator: Nadine ATTAL, MD PhD — Aphp
• Study coordinator: Nadine ATTAL, MD PhD
• Email: nadine.attal@aphp.fr
• Phone: 0033149095931

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.