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.
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.
Study Type
OBSERVATIONAL
Enrollment
150
Skin punch biopsy to assess intrapidermal nerve fiber density
Inserm U987
Boulogne-Billancourt, France
RECRUITINGCentre d'Evaluation et de Traitement de la douleur
Paris, France
RECRUITINGPrevalence 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
intraepidermal nerve fiber density
Time frame: Baseline and at 6 months
Correlation between intraepidermal nerve fiber density and pain or other patient reported outcome measures (quality of life, distress, disability...)
Correlation statistics (Spearman Rho)
Time frame: 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
Direct group comparisons
Time frame: 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.
Comparison of intraepidermal nerve fiber density and other diagnostic measures between baseline and 6 months
Time frame: 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
Sensitivity and specificy of these tests compared to skin punch biopsy
Time frame: 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
Sensitivity and specificy of sudoscan and quantitative sensory testing compared to skin punch biopsy
Time frame: Baseline and at 6 months
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