NCT04624581: FIDGIS

FIbromyalgia anD GenetIcs Subgroups (FIDGIS)

Completed NA Last updated 8 June 2022

What this trial tests

NA trial testing Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device in Fibromyalgia in 260 participants. Completed in 17 January 2022.

Timeline

30 November 2020

Primary endpoint
17 January 2022

17 January 2022

Quick facts

Lead sponsor	University Hospital, Clermont-Ferrand
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	260
Start date	30 November 2020
Primary completion	17 January 2022
Estimated completion	17 January 2022
Sites	1 location across France

Drugs / interventions tested

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

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

University Hospital, Clermont-Ferrand

Who can join

Adults 18 to 65, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Relationship Between Central Sensitization and Genetic Polymorphisms-A Case-Control Study in Fibromyalgia.
   Macian N, Dualé C, Delay M, Leray V, et al · · 2026 · PMID 42246686 · DOI 10.1002/ejp.70308