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Sudoscan in Patients With Autoimmune Disorders

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ClinicalTrials.gov Identifier: NCT02434458
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Sun Im, The Catholic University of Korea

Brief Summary:
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).

Condition or disease
Autoimmune Disease

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Sudoscan values [ Time Frame: once at time of enrollment ]
    Small fiber function from sweat glands, using Sudoscan


Secondary Outcome Measures :
  1. NCS studies [ Time Frame: once at time of enrollment ]
    NCS values of the upper and lower extremity sensory nerves performed by an electromyographer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients who meet the following diagnostic criteria for either 1. Fibromyalgia or 2. Rheumatoid arthritis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434458


Locations
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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
Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Study Director: Su-Jin Monn, M.D., PhD Catholic University of Korea, College of Medicine Bucheon St. Mary's Hospital
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Responsible Party: Sun Im, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02434458    
Other Study ID Numbers: HC15DISI0040
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Sun Im, The Catholic University of Korea:
fibromyalgia,
polyneuropathy
small fiber neuropathy
rheumatoid arthritis
sudomotor
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases