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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia case group | Patients diagnosed with fibromyalgia from the department of rheumatology will be subject to sudoscan evaluation and NCS studies. | ||
| Control | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sudoscan values | Small fiber function from sweat glands, using Sudoscan | once at time of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| NCS studies | NCS values of the upper and lower extremity sensory nerves performed by an electromyographer | once at time of enrollment |
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Inclusion criteria:
A. for healthy control group
- No previous diagnosis of peripheral polyneuropathy, fibromyalgia or rheumatoid arthritis
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
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patients who meet the following diagnostic criteria for either 1. Fibromyalgia or 2. Rheumatoid arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Su-Jin Monn, M.D., PhD | Catholic University of Korea, College of Medicine Bucheon St. Mary's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon St Mary's Hospital, Catholic University of Korea | Bucheon-si | Gyenoggido | 420-717 | South Korea | ||
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D005356 | Fibromyalgia |
| D011115 | Polyneuropathies |
| D000071075 | Small Fiber Neuropathy |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Bucheon St Mary's Hospital |
| Bucheon-si |
| South Korea |
| D009468 |
| Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |