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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with fibromyalgia | Patients with fibromyalgia based on ACR criteria |
| |
| Patients with other chronic pain (paired for the other groups) | Patients with chronic pain other than fibromyalgia and neuropathic pain, eg nociplastic pains or nociceptive pains |
| |
| Paired healthy subjects | Healthy subjects paired for gender and age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin punch biopsy to demonstrate small fiber neuropathy | Diagnostic Test | Skin punch biopsy to assess intrapidermal nerve fiber density |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | intraepidermal nerve fiber density | Baseline and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between intraepidermal nerve fiber density and pain or other patient reported outcome measures (quality of life, distress, disability...) | Correlation statistics (Spearman Rho) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with fibromyalgia, other chronic pains (nociplastic or nociceptive) and healthy subjects
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadine ATTAL, MD PhD | Contact | 0033149095931 | nadine.attal@aphp.fr | |
| Didier BOUHASSIRA, MD PhD | Contact | 0033149094556 | didier.bouhassira@inserm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nadine ATTAL, MD PhD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inserm U987 | Recruiting | Boulogne-Billancourt | 92100 | France |
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Direct group comparisons |
| 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 | 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 | 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 | Baseline and at 6 months |
| Centre d'Evaluation et de Traitement de la douleur | Recruiting | Paris | 75014 | France |
|