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

Primary Purpose

Fibromyalgia

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Sudoscan®

About this trial

This is an interventional diagnostic trial for Fibromyalgia focused on measuring Fibromyalgia, Small fiber neuropathy, Sudoscan®

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- 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.

Inclusion criteria healthy subjects:

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.

Exclusion Criteria:

Exclusion criteria patients:
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 participating in another clinical trial, or in a period of exclusion, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial,
Patient benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...),
Patient not affiliated to the French Social Security system.

Exclusion criteria healthy subjects :

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
Participating in another clinical trial, or within the exclusion period, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial,
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.

Sites / Locations

CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FM patients

Healthy subjects

Arm Description

50 fibromyalgia patients/50 healthy subjects

Outcomes

Primary Outcome Measures

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®.

Secondary Outcome Measures

Biometric criteria

Collection of the age in years

Biometric criteria

Collection of sex, (male or female)

Biometric criteria

Collection weight in kilograms, height in meters, weight and eight will be combined to report BMI in kg/m²,

Biometric criteria

phototype Fitzpatrick classification

Numerical scale

This scale allows the patient to note pain on a graduation with a minimum score of 0 and a maximum score of 10. Higher value represent worse outcome.

Brief Pain Inventory

The BPI gives two main scores: a pain severity score and a pain interference score

Fibromyalgia Impact Questionnaire

The revised FIQ questionnaire is a 10-item self-questionnaire that assesses the impact of fibromyalgia. The first item is subdivided into 10 questions that assess the impact of the disease in everyday life

Quality of life (SF-12)

12 questions and an index is determined for both physical and mental health (0-100). Higher scores indicate greater physical and mental health

Anxiety and Depression (HAD)

The HAD scale is a 14-item self-administered questionnaire completed by the patient. These items are divided into two subscales: 7 items to assess depression and 7 items to assess anxiety. Higher value represent worse outcome.

Depression (Beck Depression Inventory)

Each item consists of 4 sentences corresponding to 4 degrees of increasing intensity of a symptom: from 0 to 3. In the counting, it is necessary to take into account the highest rating chosen for the same series. The overall score is obtained by adding the scores of the 13 items. The range of the scale is from 0 to 39. The higher the score, the more the subject is depressed.

Pittsburgh Sleep Quality Index

19-item self-administered questionnaire used to assess the quality of sleep. Higher value represent worse quality of sleep.

Chronic fatigue Severity Scale

9-item self-questionnaire to assess the patient's fatigue intensity. The patient is asked to circle a number from 1 to 7 for each question, a low value representing a low intensity. Higher value represents worse fatigue.

Pain Catastrophizing Scale

This questionnaire consists of 13 items. The patient will have to indicate how much he has thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question. Higher value represent worse outcome.

Assessment of socio-professional category, precariousness and health inequalities (Score EPICES).

The EPICES questionnaire consists of 11 binary questions (yes / no) to calculate an individual score indicating the precariousness and inequalities of health ranging from 0 to 100. Higher value represent worse outcome.

Measure of the electrochemical conductance (µS) using Sudoscan®

Assess the reproducibility (2 passes) of Sudoscan® in each participant: measurement of the electrochemical conductance of the palms of the hands (middle right and left hands) and feet (middle right and left) in μS using the Sudoscan®, 30 minutes after the first measurement.

Full Information

NCT ID

NCT03347669

First Posted

November 8, 2017

Last Updated

December 1, 2017

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT03347669

Brief Title

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

Acronym

NEFI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 6, 2017 (Actual)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

Only one visit (2 to 3h) : Inclusion of the patient Clinical examination ; evaluation of pain for FM patients Measurement of the electrochemical conductance of the hands and feet using Sudoscan® Evaluation of quality of life, anxiety, depression, sleep quality, fatigue, catastrophizing and social precarity End of study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Small fiber neuropathy, Sudoscan®

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

No masking

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FM patients

Arm Type

Experimental

Arm Description

50 fibromyalgia patients/50 healthy subjects

Arm Title

Healthy subjects

Arm Type

Active Comparator

Arm Description

50 fibromyalgia patients/50 healthy subjects

Intervention Type

Device

Intervention Name(s)

Sudoscan®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measure of the electrochemical conductance (µS) using Sudoscan®

Description

Time Frame

at day 1

Secondary Outcome Measure Information:

Title

Biometric criteria

Description

Collection of the age in years

Time Frame

at day 1

Title

Biometric criteria

Description

Collection of sex, (male or female)

Time Frame

at day 1

Title

Biometric criteria

Description

Collection weight in kilograms, height in meters, weight and eight will be combined to report BMI in kg/m²,

Time Frame

at day 1

Title

Biometric criteria

Description

phototype Fitzpatrick classification

Time Frame

at day 1

Title

Numerical scale

Description

This scale allows the patient to note pain on a graduation with a minimum score of 0 and a maximum score of 10. Higher value represent worse outcome.

Time Frame

at day 1

Title

Brief Pain Inventory

Description

The BPI gives two main scores: a pain severity score and a pain interference score

Time Frame

at day 1

Title

Fibromyalgia Impact Questionnaire

Description

Time Frame

at day 1

Title

Quality of life (SF-12)

Description

12 questions and an index is determined for both physical and mental health (0-100). Higher scores indicate greater physical and mental health

Time Frame

at day 1

Title

Anxiety and Depression (HAD)

Description

Time Frame

at day 1

Title

Depression (Beck Depression Inventory)

Description

Time Frame

at day 1

Title

Pittsburgh Sleep Quality Index

Description

19-item self-administered questionnaire used to assess the quality of sleep. Higher value represent worse quality of sleep.

Time Frame

at day 1

Title

Chronic fatigue Severity Scale

Description

Time Frame

at day 1

Title

Pain Catastrophizing Scale

Description

Time Frame

at day 1

Title

Assessment of socio-professional category, precariousness and health inequalities (Score EPICES).

Description

Time Frame

at day 1

Title

Measure of the electrochemical conductance (µS) using Sudoscan®

Description

Time Frame

at day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - 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. Inclusion criteria healthy subjects: 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. Exclusion Criteria: Exclusion criteria patients: 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 participating in another clinical trial, or in a period of exclusion, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial, Patient benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...), Patient not affiliated to the French Social Security system. Exclusion criteria healthy subjects : 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 Participating in another clinical trial, or within the exclusion period, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial, 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gisèle PICKERING

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

First Name & Middle Initial & Last Name & Degree

Gisèle PICKERING

First Name & Middle Initial & Last Name & Degree

Claude DUBRAY

First Name & Middle Initial & Last Name & Degree

Gilles DUCHEIX

First Name & Middle Initial & Last Name & Degree

Christian DUALE

First Name & Middle Initial & Last Name & Degree

Xavier MOISSET

First Name & Middle Initial & Last Name & Degree

Jean-Jacques DUBOST

First Name & Middle Initial & Last Name & Degree

Fabienne MARCAILLOU

12. IPD Sharing Statement

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

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