NCT04624581

FIbromyalgia anD GenetIcs Subgroups (FIDGIS)

Genetic Characteristics and Determinants of Central Sensitization of Nociception in Fibromylagic Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-30
• Primary completion: 2022-01-17
• Completion: 2022-01-17
• First posted: 2020-11-12
• Last updated: 2022-06-08

Locations

1 site across 1 country: France