FIbromyalgia anD GenetIcs Subgroups (FIDGIS)

  • STATUS
    Recruiting
  • End date
    Dec 27, 2022
  • participants needed
    300
  • sponsor
    University Hospital, Clermont-Ferrand
Updated on 27 January 2021

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.

Description

This is an exploratory case control pathophysiology study of psychophysical (central sensitization assessment) and genetic (candidate gene panel) characteristics.

The main objectives of this study are :

Primary: Evaluate the central nociception sensitization characteristics and genetic determinants in fibromyalgic syndrome, comparing a group of patients to matched healthy controls.

Secondary :

  • 1) Characterize genetic predispositions of central sensitization in patients with FS compared to matched healthy controls, including confirmation of known genetic markers and potential identification of new genetic variants involved,
  • 2) Compare in the area of central sensitization the population of patients with FS and matched healthy controls,
  • 3) Compare in the domain of temporal summation the population of patients with FS and matched healthy controls,
  • 4) Describe in the clinical field the characteristics of the FS patient population,
  • 5) Compare in the areas of quality of life, anxiety/depression and comorbidities, characteristics of the FS patient population and matched healthy controls,
  • 6) Compare epigenetic biomarkers of the FS patient population with healthy matched controls,
  • 7) Study of the role of the gut microbiota in patients with FS (bio banking)
  • 8) Compare in the areas of pain, sound and light sensitivity the population of patients with FS and matched healthy controls.

Details
Condition Fibromyalgia, Myofascial Pain Syndrome, fibro
Treatment Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device
Clinical Study IdentifierNCT04624581
SponsorUniversity Hospital, Clermont-Ferrand
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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

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 ...)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note