Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT03347669
Eligibility Criteria:
Inclusion Criteria:
* \- 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 Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03347669
Study Brief:
Protocol Section:
NCT03347669