Fibromyalgia and Small Fiber Neuropathy

Last updated: July 24, 2024
Sponsor: Hospital Ambroise Paré Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuropathy

Chronic Pain

Pain

Treatment

Skin punch biopsy to demonstrate small fiber neuropathy

Clinical Study ID

NCT06527183
2020-A03400-39
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 reviseddiagnostic criteria of the WHO or chronic nociceptive or nociplastic pain withoutassociated 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 toinclusion- normal neurological examination at inclusion

Exclusion

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 associatedneuropathic pain

  • uncontrolled chronic pathology such as : morbid obesity, sleep apnea, uncontrolledhypertension, etc. - psychosis, previous suicide attempt

  • drug or psychoactive substance abuse

  • cognitive or psychological disorders incompatible with compliance with and/orunderstanding of the protocol

  • participation in another biomedical research protocol.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Skin punch biopsy to demonstrate small fiber neuropathy
Phase:
Study Start date:
January 04, 2022
Estimated Completion Date:
January 31, 2026

Study Description

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.

Connect with a study center

  • Inserm U987

    Boulogne-Billancourt, 92100
    France

    Active - Recruiting

  • Centre d'Evaluation et de Traitement de la douleur

    Paris, 75014
    France

    Active - Recruiting

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