Fibromyalgia and Small Fiber Neuropathy
ConditionChronic Pain Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Ambroise Paré Paris
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with fibromyalgia, other chronic pains (nociplastic or nociceptive) and healthy subjects
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Skin punch biopsy to demonstrate small fiber neuropathy
Diagnostic testSkin punch biopsy to assess intrapidermal nerve fiber density
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Patients with fibromyalgia1 intervention
Group B: Patients with other chronic pain (paired for the other groups)1 intervention
Group C: Paired healthy subjects1 intervention
Trial outcomes
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
intraepidermal nerve fiber density
Time frame
Baseline and at 6 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov