Sudoscan in Patients With Autoimmune Disorders
|ClinicalTrials.gov Identifier: NCT02434458|
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : September 15, 2015
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||85 participants|
|Official Title:||Investigation of Sudoscan in the Evaluation of Small Fiber Dysfunction in Korean Patients With Autoimmune Disorders|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Fibromyalgia case group
Patients diagnosed with fibromyalgia from the department of rheumatology will be subject to sudoscan evaluation and NCS studies.
Healthy control subjects
Rheumatoid arthritis group
Patients diagnosed with rheumatoid arthritis at the department of rheumatology will be subject to sudoscan evaluation and NCS studies.
- Sudoscan values [ Time Frame: once at time of enrollment ]Small fiber function from sweat glands, using Sudoscan
- NCS studies [ Time Frame: once at time of enrollment ]NCS values of the upper and lower extremity sensory nerves performed by an electromyographer
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434458
|Korea, Republic of|
|Bucheon St Mary's Hospital, Catholic University of Korea|
|Bucheon, Gyenoggido, Korea, Republic of, 420-717|
|Bucheon St Mary's Hospital|
|Bucheon, Korea, Republic of|
|Study Director:||Su-Jin Monn, M.D., PhD||Catholic University of Korea, College of Medicine Bucheon St. Mary's Hospital|