Fibromyalgia and Small Fiber Neuropathy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Skin punch biopsy to demonstrate small fiber neuropathy
  Skin punch biopsy to assess intrapidermal nerve fiber density

Первичные конечные точки

• 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 [Срок оценки: Baseline and at 6 months]

Вторичные конечные точки (5)

• Correlation between intraepidermal nerve fiber density and pain or other patient reported outcome measures (quality of life, distress, disability...) [Срок оценки: Baseline and at 6 months]
• 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 [Срок оценки: Baseline and at 6 months]
• Monitor the evolution of abnormalities obtained over time (6 months) and correlate them with the evolution of pain and associated symptoms. [Срок оценки: 6 months]
• Determine the sensitivity and diagnostic value of corneal confocal microscopy and laser evoked potentials as compared with skin punch biopsy for exploring nociceptive fibers [Срок оценки: Baseline and at 6 months]
• Determine the diagnostic value of the sudoscan and quantified sensory tests compared with other tests for exploring nociceptive fibers in these patients [Срок оценки: Baseline and at 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 2 центра

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

Идентификаторы

NCT: NCT06527183 · 2020-A03400-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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