Clinical trial NCT04624581: FIbromyalgia anD GenetIcs Subgroups (FIDGIS)
Official title: Genetic Characteristics and Determinants of Central Sensitization of Nociception in Fibromylagic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia syndrome
Chronic pain
Widespread pain
genetics
central sensitization
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Service de pharmacologie et toxicologie cliniques, Hôpitaux Universitaire Genève, Rue Gabrielle Perret-Gentil 4, 1205 Genève, SUISSE
name: Association des Fibromyalgiques d'Auvergne, 19 Place de la Résistance, 63800 Cournon d'Auvergne, FRANCE
First posted: 2020-11-12
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Exploratory case control pathophysiology study of psychophysical (central sensitization assessment) and genetic (candidate gene panel) characteristics.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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 ...)

Primary outcomes:
measure: Evaluation of nociception flexion reflex (RIII) threshold by electromyography
timeFrame: Day 1
Secondary outcomes:
measure: Evaluation of genetic polymorphism using OpenArray technology
timeFrame: day 1
measure: Evaluation of central sensitization
timeFrame: Day 1
measure: Mechanical temporal summation by numerical scale (0 to 10)
timeFrame: Day 1
measure: Concise Pain Questionnaire (QCD)
timeFrame: Day 1
measure: Detection of fibromyalgia using the FIRST questionnaire
timeFrame: Day 1
measure: Evaluation of the impact of fibromyalgia using the FIQ questionnaire
timeFrame: Day 1
measure: Evaluation of the Suspended Symmetrical Dorsal Cellulalgia
timeFrame: Day 1
measure: Quality of life by SF-36 quality of life questionnaire
timeFrame: Day 1
measure: Emotional status by Hospital Anxiety and Depression scale (HAD)
timeFrame: Day 1
measure: Evaluation of micro ARN using OpenArray technology
timeFrame: Day 1
measure: Analysis of the microbiota (stool samples),
timeFrame: Day 1
measure: Evaluation of sensitivity to pain by PSQ questionnaire
timeFrame: Day 1
measure: Evaluation of sensitivity to sound by audiometer
timeFrame: Day 1
measure: Evaluation of sensitivity to light by led panel
timeFrame: Day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle Pickering
role: PRINCIPAL_INVESTIGATOR
References: