Status:
UNKNOWN
A Pilot Study of Small Fiber Neuropathy Prevalence in Fibromyalgia Patients Compared to Healthy Subjects Using Sudoscan®
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Fibromyalgia (FM) is characterized by chronic diffuse pain and affects 0.5 to 5% of the population, with a higher prevalence in women1. This condition is characterized by joint and muscle pain, also a...
Detailed Description
Only one visit (2 to 3h) : Inclusion of the patient Clinical examination ; evaluation of pain for FM patients Measurement of the electrochemical conductance of the hands and feet using Sudoscan® Eval...
Eligibility Criteria
Inclusion
- \- Patient over 18 years of age and under 65 years of age,
- Male or female patient,
- Patient with fibromyalgia (according to the ACR criteria of 2016),
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Acceptance of written consent,
- Affiliation to the French Social Security system.
- Inclusion criteria healthy subjects:
- Subject of more than 18 years,
- Woman or man,
- Healthy voluntary non-painful subjects matched by age (+/- 5 years), by sex, by BMI (+/- 10%) and by menopausal status for women,
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Acceptance of written consent,
- Affiliation to the French Social Security system,
- Registration or acceptance of registration in the National Register of Volunteers participating in research.
Exclusion
- Exclusion criteria patients:
- Patient with a physical inability to place the palms of the hands or the soles of the feet on the electrodes of Sudoscan®,
- Patient with a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test (in particular a disease known to give neuropathies of small fibers: diabetes, Gougerot-Sjögren's disease, vasculitis, sarcoidosis, chronic ethylism ...),
- Pregnant or nursing woman
- Patient participating in another clinical trial, or in a period of exclusion, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial,
- Patient benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...),
- Patient not affiliated to the French Social Security system.
- Exclusion criteria healthy subjects :
- Physical inability to place the palms of the hands or the soles of the feet on the electrodes of Sudoscan®.
- Medical and / or surgical history judged by the investigator or his representative to be incompatible with the test,
- Pregnant or nursing woman
- Participating in another clinical trial, or within the exclusion period, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial,
- Cooperation and an understanding that does not permit strict compliance with the conditions laid down in the Protocol,
- Benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...),
- Not affiliated to the French Social Security system.
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03347669
Start Date
November 6 2017
End Date
September 1 2018
Last Update
December 5 2017
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003