CompletedNot Applicable

FIbromyalgia anD GenetIcs Subgroups (FIDGIS)

France260 participantsStarted 2020-11-30

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 R…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of nociception flexion reflex (RIII) threshold by electromyography

Timeframe: Day 1

Trial details

NCT IDNCT04624581

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-17

View on ClinicalTrials.gov More Fibromyalgia trials