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NCT Number: NCT06527183

Fibromyalgia and Small Fiber Neuropathy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inserm U987, Boulogne-Billancourt, France

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About this study

Small fiber neuropathy has been observed in a large proportion of fibromyalgia patients. However, the pathophysiological role of these neurological abnormalities in determining the pain and other symptoms of fibromyalgia, and the specificity of these abnormalities, are not well understood.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin punch biopsy to demonstrate small fiber neuropathy

Diagnostic Test

Skin punch biopsy to assess intrapidermal nerve fiber density

Other names: Other diagnostic tests will include laser evoked potentiels, quantitative sensory testing, sudoscan, and confocal corneal microscopu

Primary outcomes

  1. Prevalence of small fiber neuropathy or pathology as assessed with skin punch biopsy in patients with fibromyalgia as compared to patients with other chronic pains and healthy subjects

    Time frame: Baseline and at 6 months

    intraepidermal nerve fiber density

Secondary outcomes

  1. Correlation between intraepidermal nerve fiber density and pain or other patient reported outcome measures (quality of life, distress, disability...)

    Time frame: Baseline and at 6 months

    Correlation statistics (Spearman Rho)

  2. Investigate the potential specificity of the results obtained by comparing them with pain patients without fibromyalgia or nerve damage (patients with any nociceptive or nociplastic pain without fibromyalgia) matched for age and gender

    Time frame: Baseline and at 6 months

    Direct group comparisons

  3. Monitor the evolution of abnormalities obtained over time (6 months) and correlate them with the evolution of pain and associated symptoms.

    Time frame: 6 months

    Comparison of intraepidermal nerve fiber density and other diagnostic measures between baseline and 6 months

  4. Determine the sensitivity and diagnostic value of corneal confocal microscopy and laser evoked potentials as compared with skin punch biopsy for exploring nociceptive fibers

    Time frame: Baseline and at 6 months

    Sensitivity and specificy of these tests compared to skin punch biopsy

  5. Determine the diagnostic value of the sudoscan and quantified sensory tests compared with other tests for exploring nociceptive fibers in these patients

    Time frame: Baseline and at 6 months

    Sensitivity and specificy of sudoscan and quantitative sensory testing compared to skin punch biopsy

Study contacts

Contact information is provided by the study sponsor or research team.

Didier BOUHASSIRA, MD PhD

CONTACT

[email protected]

0033149094556

Nadine ATTAL, MD PhD

CONTACT

[email protected]

0033149095931

Sponsors and collaborators

Lead sponsor

Hospital Ambroise Paré Paris

Other

Registry information

Official study title

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

Acronym: FIBRO-NEP

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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