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NCT02925351
Aortic Arch Syndromes, Aortic Diseases
Los Angeles, California, United States
View Trial DetailsNCT Number: NCT02434458
The purpose of this study is to assess the diagnostic utility of Sudoscan in assessing small fiber nerve function, specifically those of the sudomotor, in patients with autoimmune disorders (i.e fibromyalgia and rheumatoid arthritis).
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Notify Me18 year–80 year
All sexes
Observational
Bucheon St Mary's Hospital, Catholic University of Korea, Bucheon-si, Gyenoggido, South Korea
Small fiber neuropathy can manifest in different autonomic and painful symptoms, but current diagnostic tools are confined to nerve conduction studies and quantitative sensory testing.
The former can only asses the large nerve fibers and fail to reflect sudomotor function, the latter tool can be subject to technical error. Pain and autonomic dysfunction, which reflect small fiber dysfunction has recently gained much interest in disorders with polyneuropathy but current studies have been confined mostly to diabetic polyneuropathies. There has been growing evidence that autoimmune disorders such as fibromyalgia can also manifest in small fiber dysfunction. Because of the complexity of diagnosing small fiber dysfunction, there are yet no standard protocols on how to assess and treat these patients. Sudoscan uses reverse iontophoresis to assess the function of the sweat glands. The tool is easy to use, non-invasive with quantitative results that are objective.
The objective of this study is to assess the small fiber function; that is the sudomotor function; using Sudoscan in patients diagnosed with fibromyalgia and rheumatoid arthritis.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A. for healthy control group
B. For case group
Exclusion criteria
For control group
-Participants with previously diagnosed with medical conditions that are known to cause peripheral polyneuropathy (i.e. diabetes mellitus, chronic renal failure, hepatitis, malnutrition), or participants taking medications related to peripheral polyneuropathy(chemoagents, anti Tbc medication) or manifest with symptoms and signs of tingling sensation and gait disturbance that indicate presence of underlying peripheral polyneuropathy.
For both control and case groups
Time frame: once at time of enrollment
Small fiber function from sweat glands, using Sudoscan
Time frame: once at time of enrollment
NCS values of the upper and lower extremity sensory nerves performed by an electromyographer
The Catholic University of Korea
Other
Investigation of Sudoscan in the Evaluation of Small Fiber Dysfunction in Korean Patients With Autoimmune Disorders
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