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COMPLETED

NCT04624581

FIbromyalgia anD GenetIcs Subgroups (FIDGIS)

Sponsor: University Hospital, Clermont-Ferrand

View on ClinicalTrials.gov

Summary

Fibromyalgia syndrome (FS) is characterized by widespread pain and affect 0.5 to 5 % of the general population, with a higher prevalence in women. Recognized as disease by World Health Organization since 1992, FS concern 1.2 to 2 million of French people and his etiology need to be clarified. This affection is characterized by a higher sensitivity to nociceptive stimulus, articular and muscular pain and associated to: fatigue, headache, sleep disorders, depression and irritated bowel syndrome. The presentation of this symptoms varied according to the patient with a heterogeneity of the clinical, physical, social and psychologic conditions and of the therapeutic responses. Faced to the heterogeneity of FS, various hypotheses about the development mechanisms exist. Central sensitization could be one of the key mechanisms of FS, it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms, which results in permanent or chronic pain. Moreover, work on the familial character of FS suggests that a genetic component may be involved in its development, but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS. The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group, matched in age, sex and menopausal status.

Official title: Genetic Characteristics and Determinants of Central Sensitization of Nociception in Fibromylagic Syndrome

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2020-11-30

Completion Date

2022-01-17

Last Updated

2026-08-05

Healthy Volunteers

Yes

Conditions

Fibromyalgia

Interventions

DEVICE

Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device

This intervention measures the response to electrical stimulation of the sural nerve using a pair of percutaneous electrodes placed at the external malleolar retro passage of the nerve (2 cm apart) and connected to the stimulation device (Nicolet Vicking). Reflex muscle responses will be collected using surface electrodes placed on the femoral biceps muscle of the participant and connected to an Electromyogram recording device. The RIII will be determined twice (rest period between each 10-minute). In order to induce the reflex nociceptive flexion response, repeated cutaneous electrical stimulations (30 to 40) will be applied at the level of the sural nerve following a variable interval of 6 to 10 seconds in order to overcome the phenomena of habituation and predictability. Each stimulus test will consist of a single rectangular pulse of 0.5 ms, of variable intensity (0-100mA) until a reflex nociceptive flexion threshold is detected or a maximum current of 100 mA is reached

Patient Inclusion criteria : * Patient between 18 and 65 years old (included), * Patient with fibromyalgia according to the criteria of the 2016 ACR, * Patient weighing more than 45kg * Cooperation and understanding sufficient to comply with the requirements of the study, * Acceptance to give written consent, * Affiliation to the French Social Security system, Patient exclusion criteria : * treated with antibiotics in the three months prior to inclusion, * who has reported gastroenteritis in the two months prior to inclusion, * having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test * of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman. * participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 4500 over the 12 months preceding the start of the trial, * benefiting from a measure of legal protection (guardianship, guardianship, deprivation of liberty, safeguard of justice), Subject inclusion criteria: * Aged of more than 18 years, * weighing more than 45kg * non-painful subjects matched by age (+/- 5 years), by sex, 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. Subject exclusion criteria : * treated with antibiotics in the three months prior to inclusion, * who has reported gastroenteritis in the two months prior to inclusion, * Medical and / or surgical history judged by the investigator or his representative to be incompatible with the test, * Intake of any drugs in the 7 days before inclusion, * 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, * Benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...)

Locations (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France