A Pilot Study of Small Fiber Neuropathy Prevalence in Fibromyalgia Patients Compared to Healthy Subjects Using Sudoscan®

NCT03347669 | Unknown

• 1 other identifier: CHU-362
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia (FM) is characterized by chronic diffuse pain and affects 0.5 to 5% of the population, with a higher prevalence in women1. This condition is characterized by joint and muscle pain, also associated with fatigue, migraine, sleeps disorders, depression and irritable bowel syndrome2. The presentation of these various symptoms varies greatly from one patient to another, with great heterogeneity in clinical, physical, social, psychological and therapeutic responses. . A recent parliamentary inquiry report called for recognition of the disease and recommended to build a unified care path for patients; a collective expertise is led by INSERM to help in patient care. Faced with the heterogeneity of FM, several international studies have attempted to identify subgroups of patients based essentially on clinical symptoms of the disease3-8, including a recent Korean study of 313 patients9, which suggested four groups, but with methodological limitations, not taking into account the new criteria10 for evaluating FM. Recent studies have also shown that there is a peripheral neuropathic component in the mechanisms of this pathology, demonstrated by a decrease in the density of the epidermal nerve fibers11-12, called small fiber neuropathy (SFN) neuropathy. It is an attack of small sensory and sympathetic nerve fibers, causing pain, paresthesia as well as disturbances of the autonomous system. Other studies also suggested that a significant proportion of patients diagnosed with fibromyalgia had SFN, demonstrated by cutaneous biopsy13-14 or confocal microscopy of the cornea15. A new device, the Sudoscan®, makes it possible to detect a SFN much simpler, faster and less invasive than the technique of ophthalmology or biopsy. Although this Sudoscan® test has been used extensively in conditions such as diabetes16-19, no study has been used to assess the presence of SFN in FM. The aim of this pilot study is to identify the prevalence of SFN in FM patients, using this new non-invasive device, in order to have a better defined representation of the prevalence of small-fiber neuropathy in an FM population compared to a group of healthy volunteer matched in age, sex, BMI and by menopausal status for women.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Small fiber neuropathy; Sudoscan®

Outcome Measures

Primary Outcomes (1)

• Measure of the electrochemical conductance (µS) using Sudoscan®

  Evaluation of the prevalence of fibromyalgia patients with small fibro neuropathy in comparison with healthy volunteers by measuring the electrochemical conductance of the palms of the hands (middle right and left hands) and feet (middle right and left) in μS using Sudoscan®.

  at day 1

Secondary Outcomes (15)

• Biometric criteria

  at day 1

• Biometric criteria

  at day 1

• Biometric criteria

  at day 1

• Biometric criteria

  at day 1

• Numerical scale

  at day 1

Study Arms (2)

FM patients

EXPERIMENTAL

50 fibromyalgia patients/50 healthy subjects

Device: Sudoscan®

Healthy subjects

ACTIVE COMPARATOR

50 fibromyalgia patients/50 healthy subjects

Device: Sudoscan®

Interventions

Sudoscan® DEVICE

Sudoscan® is a new device that provides rapid, non-invasive and reproducible quantitative assessment of sweat function. It makes it possible to measure the ability of the sweat glands to release chloride ions in response to electrochemical activation and thus to detect the presence of a neuropathy with small fibers. This new device therefore makes it possible to detect an SFN in a much simpler and faster way than the technique of ophthalmology, or biopsy. Sudoscan® has been tested to assess the neuropathies of small nerve fibers in several diseases, in particular diabetes, chemotherapy-induced polyneuropathy, familial amyloid polyneuropathy or Fabry disease. The interest of Sudoscan® lies in the fact that this device is non-invasive and rapid. Its diagnostic value has been compared with other neurophysiological tests.

FM patients; Healthy subjects

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 over 18 years of age and under 65 years of age,
• Male or female patient,
• Patient with fibromyalgia (according to the ACR criteria of 2016),
• Cooperation and understanding sufficient to comply with the requirements of the study,
• Acceptance of written consent,
• Affiliation to the French Social Security system.
• Subject of more than 18 years,
• Woman or man,
• Healthy voluntary non-painful subjects matched by age (+/- 5 years), by sex, by BMI (+/- 10%) 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.

You may not qualify if:

• Patient with a physical inability to place the palms of the hands or the soles of the feet on the electrodes of Sudoscan®,
• Patient with a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test (in particular a disease known to give neuropathies of small fibers: diabetes, Gougerot-Sjögren's disease, vasculitis, sarcoidosis, chronic ethylism ...),
• Pregnant or nursing woman
• Patient benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...),
• Patient not affiliated to the French Social Security system.
• Physical inability to place the palms of the hands or the soles of the feet on the electrodes of Sudoscan®.
• Medical and / or surgical history judged by the investigator or his representative to be incompatible with the test,
• Pregnant or nursing woman
• Cooperation and an understanding that does not permit strict compliance with the conditions laid down in the Protocol,
• Benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...),
• Not affiliated to the French Social Security system.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (20)

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  PMID: 31705738 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Peripheral Nervous System Diseases

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 20, 2017
• Study Start: November 6, 2017
• Primary Completion: April 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 5, 2017

Record last verified: 2017-12

Locations

FR (1)