A Pilot Study of Small Fiber Neuropathy Prevalence in Fibromyalgia Patients Compared to Healthy Subjects Using Sudoscan®
NCT ID: NCT03347669
Last Updated: 2017-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-11-06
2018-09-30
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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FM patients
50 fibromyalgia patients/50 healthy subjects
Sudoscan®
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.
Healthy subjects
50 fibromyalgia patients/50 healthy subjects
Sudoscan®
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.
Interventions
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Sudoscan®
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Gisèle PICKERING
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Patrick LACARIN
Role: primary
References
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Giesecke T, Williams DA, Harris RE, Cupps TR, Tian X, Tian TX, Gracely RH, Clauw DJ. Subgrouping of fibromyalgia patients on the basis of pressure-pain thresholds and psychological factors. Arthritis Rheum. 2003 Oct;48(10):2916-22. doi: 10.1002/art.11272.
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Caro XJ, Winter EF. Evidence of abnormal epidermal nerve fiber density in fibromyalgia: clinical and immunologic implications. Arthritis Rheumatol. 2014 Jul;66(7):1945-54. doi: 10.1002/art.38662.
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Oaklander AL, Herzog ZD, Downs HM, Klein MM. Objective evidence that small-fiber polyneuropathy underlies some illnesses currently labeled as fibromyalgia. Pain. 2013 Nov;154(11):2310-2316. doi: 10.1016/j.pain.2013.06.001. Epub 2013 Jun 5.
Uceyler N, Zeller D, Kahn AK, Kewenig S, Kittel-Schneider S, Schmid A, Casanova-Molla J, Reiners K, Sommer C. Small fibre pathology in patients with fibromyalgia syndrome. Brain. 2013 Jun;136(Pt 6):1857-67. doi: 10.1093/brain/awt053. Epub 2013 Mar 9.
Ramirez M, Martinez-Martinez LA, Hernandez-Quintela E, Velazco-Casapia J, Vargas A, Martinez-Lavin M. Small fiber neuropathy in women with fibromyalgia. An in vivo assessment using corneal confocal bio-microscopy. Semin Arthritis Rheum. 2015 Oct;45(2):214-9. doi: 10.1016/j.semarthrit.2015.03.003. Epub 2015 Mar 19.
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Selvarajah D, Cash T, Davies J, Sankar A, Rao G, Grieg M, Pallai S, Gandhi R, Wilkinson ID, Tesfaye S. SUDOSCAN: A Simple, Rapid, and Objective Method with Potential for Screening for Diabetic Peripheral Neuropathy. PLoS One. 2015 Oct 12;10(10):e0138224. doi: 10.1371/journal.pone.0138224. eCollection 2015.
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Pickering G, Achard A, Corriger A, Sickout-Arondo S, Macian N, Leray V, Lucchini C, Cardot JM, Pereira B. Electrochemical Skin Conductance and Quantitative Sensory Testing on Fibromyalgia. Pain Pract. 2020 Apr;20(4):348-356. doi: 10.1111/papr.12857. Epub 2019 Dec 24.
Other Identifiers
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CHU-362
Identifier Type: -
Identifier Source: org_study_id