Autoimmune Disease Clinical Trial
Official title:
Investigation of Sudoscan in the Evaluation of Small Fiber Dysfunction in Korean Patients With Autoimmune Disorders
Verified date | September 2015 |
Source | The Catholic University of Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Observational |
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).
Status | Completed |
Enrollment | 85 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion criteria: A. for healthy control group - No previous diagnosis of peripheral polyneuropathy, fibromyalgia or rheumatoid arthritis B. For case group - Fibromyalgia diagnosed by the rheumatology department - Rheumatoid arthritis diagnosed by the the rheumatology department. 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 - Severe skin deficits or swelling that may impede nerve conduction study - Concomitant presence of mononeuropathy of the extremities. - Past surgical or traumatic episodes of the foot and distal extremities subject to nerve conduction study - History of chronic alcoholism, of history of heavy alcohol ingestion with the last 24 hours prior o exam - Pregnant status at time of evaluation - presence of pacemaker of defibrillator - physical inability to lay the palms of the hand and soles of the feet on the plate electrodes. - scars on the palm and soles of the feet that may impair recording from the plate electrodes - venous insufficiency, foot swelling or foot ulceration or infection - Abnormal fasting glucose or Vit B12, thyroid dysfunction, Vit D and abnormal levels of lipid profile, HbA1c > 7 - Medications with anticholinergics, TCA, anti-histamine, anti-muscarinic medication within the last 48hours - Patients currently taking Anti Parkinson agents, ranitidine, or other muscle relaxants, beta blockers and atropine - Heavy alcohol ingestion within the last 24 hour |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Bucheon St Mary's Hospital | Bucheon | |
Korea, Republic of | Bucheon St Mary's Hospital, Catholic University of Korea | Bucheon | Gyenoggido |
Lead Sponsor | Collaborator |
---|---|
The Catholic University of Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sudoscan values | Small fiber function from sweat glands, using Sudoscan | once at time of enrollment | No |
Secondary | NCS studies | NCS values of the upper and lower extremity sensory nerves performed by an electromyographer | once at time of enrollment | No |
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