FIbromyalgia anD GenetIcs Subgroups (FIDGIS)

NCT04624581 | Completed

• 2 other identifiers: RBHP 2020 PICKERING2020-A01724-35
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia syndrome; Chronic pain; Widespread pain; genetics; central sensitization

Outcome Measures

Primary Outcomes (1)

• Evaluation of nociception flexion reflex (RIII) threshold by electromyography

  Patient rested comfortably in a supine position in order to obtain muscular relaxation. Cutaneous electrodes will be applied, and the sural nerve will be stimulated in its retromaleolar track. Electromyographic responses will recorded using the Nicolet Vicking device with a pair of surface electrodes placed over the tendon of the ipsilateral biceps femoris. The R-III reflex (objective threshold) will be identified as a multiphasic signal appearing at least 90 ms but less than 250 ms after each stimulation and will be considered to be present when the corrected computed surface was \>0.5 mV/ms (positive response).

  Day 1

Secondary Outcomes (14)

• Evaluation of genetic polymorphism using OpenArray technology

  day 1

• Evaluation of central sensitization

  Day 1

• Mechanical temporal summation by numerical scale (0 to 10)

  Day 1

• Concise Pain Questionnaire (QCD)

  Day 1

• Detection of fibromyalgia using the FIRST questionnaire

  Day 1

Study Arms (2)

Patient with fibromyalgia syndrome

EXPERIMENTAL

250 patients with fibromyalgia syndrome (according to American College of Rheumatology 2016) will realize explorations to characterize central sensitization: reflex nociceptive flexion threshold by electrophysiological measure and blood sampling for evaluate the distribution of gene polymorphism.

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

Healthy subjects

SHAM COMPARATOR

50 healthy matched volunteers (age, sex and menopausal status for women) will realize explorations to characterize central sensitization: reflex nociceptive flexion threshold by electrophysiological measure and blood sampling for evaluate distribution of gene polymorphism

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

Interventions

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

Healthy subjects; Patient with fibromyalgia syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.
• benefiting from a measure of legal protection (guardianship, guardianship, deprivation of liberty, safeguard of justice),
• 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.
• Medical and / or surgical history judged by the investigator or his representative to be incompatible with the test,
• Pregnant or nursing woman
• Benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Service de pharmacologie et toxicologie cliniques, Hôpitaux Universitaire Genève, Rue Gabrielle Perret-Gentil 4, 1205 Genève, SUISSE: collaborator
• Association des Fibromyalgiques d'Auvergne, 19 Place de la Résistance, 63800 Cournon d'Auvergne, FRANCE: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gisèle Pickering

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory case control pathophysiology study of psychophysical (central sensitization assessment) and genetic (candidate gene panel) characteristics.

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: November 30, 2020
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: June 8, 2022

Record last verified: 2020-12

Locations

FR (1)