Assessing small fiber neuropathy in fibromyalgia patients

Fibromyalgia and Small Fiber Neuropathy : Which Prevalence and Which Relationship With Pain ?

This study is trying to see how common small fiber nerve damage is in people with fibromyalgia compared to those with other chronic pain conditions and healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Ambroise Paré Paris (other)
• Locations: 2 sites (Boulogne-Billancourt and 1 other locations)
• Trial ID: NCT06527183 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old suffering from chronic pain for at least six months, with a diagnosis of fibromyalgia or other chronic pain conditions.

Not a fit: Patients with known causes of small-fiber neuropathy, such as diabetes, or those seeking litigation or compensation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of fibromyalgia and related chronic pain conditions.

How similar studies have performed: While small fiber neuropathy has been observed in fibromyalgia patients, this specific approach to assessing its prevalence and clinical implications is relatively novel.

Eligibility criteria

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 this trial is running

Boulogne-Billancourt and 1 other locations

• 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

Conditions: Chronic Pain Syndrome