FIbromyalgia anD GenetIcs Subgroups (FIDGIS)

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.

Conditions

• Fibromyalgia

Interventions

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

Sponsors & Collaborators

• Service de pharmacologie et toxicologie cliniques, Hôpitaux Universitaire Genève, Rue Gabrielle Perret-Gentil 4, 1205 Genève, SUISSE

  collaborator UNKNOWN

• Association des Fibromyalgiques d'Auvergne, 19 Place de la Résistance, 63800 Cournon d'Auvergne, FRANCE

  collaborator UNKNOWN

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Gisèle Pickering · University Hospital, Clermont-Ferrand

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-30

Primary Completion

2022-01-17

Completion

2022-01-17

Countries

• France

Study Locations